The VAERS (Vaccine Adverse Event Reporting System) is used to detect
problems that are due to vaccines. The VAERS site is very specific
about cautioning against taking these reports to imply causality;
however, the people who monitor these reports consider background
adverse events and an acceptable level of adverse events that are
caused by the vaccines. What is disturbing is that we are not being
given information of possible adverse events. This table is taken
directly from the CDC data
set available at https://vaers.hhs.gov/data/datasets.html?
| VAERS_ID | RECVDATE | STATE | AGE_YRS | SYMPTOM_TEXT | VAX_DATE | ONSET_DATE | NUMDAYS | LAB_DATA | V_ADMINBY | OTHER_MEDS | CUR_ILL | HISTORY | PRIOR_VAX | SPLTTYPE | FORM_VERS | TODAYS_DATE | OFC_VISIT | ER_ED_VISIT | ALLERGIES | Spontaneous Abortion/Miscarrage |
| 917540 | 1/2/2021 | VA | 40 | starting 10 minutes after the vaccine was
given my mouth was very briefly tingling, warm wave came over me, my
heart starts to race and del lightheaded. they told me to lean back and
relax and it went away in less than a minute. (Current illness:
miscarriage) |
12/24/2020 | 12/24/2020 | 0 | PVT | miscarriage | 2 | 1/2/2021 | nka | M | |||||||
| 917595 | 1/2/2021 | RI | 31 | I was about 6 weeks pregnant when I received the vaccine on 12/26/20. I had a miscarriage on 1/1/21. I have a pregnancy history of one prior healthy full term pregnancy in 2019. | 12/26/2020 | 1/1/2021 | 6 | 1/1/21 - emergency room visit at Hospital. Bloodwork and ultrasound confirmed miscarriage. | PVT | Pre-natal vitamin | None | None | 2 | 1/2/2021 | Y | None | M | |||
| 920320 | 1/5/2021 | FL | 33 | Painful axilar Lymphadenopathy same side of injection arm (Current illness: miscarriage) | 12/29/2020 | 1/3/2021 | 5 | PVT | Multivitamin | Miscarriage | None | 2 | 1/5/2021 | None | M | |||||
| 922289 | 1/6/2021 | CA | 34 | I suffered a miscarriage on 12/31/2020. I was at 5 weeks gestation. This was my first pregnancy. I had uterine bleeding and abdominal cramps on 12/31/2020 and underwent evaluation by my Obstetrician and was diagnosed with a miscarriage after ultrasound. | 12/17/2020 | 12/31/2020 | 14 | Falling HCG level Transactional ultrasound confirmed miscarriage | PVT | Pre natal vitamins | No | No | 2 | 1/6/2021 | Y | No | M | |||
| 923743 | 1/6/2021 | TX | 32 | I had a miscarriage on 01/01/2021 Estimated date of Delivery 09/7/ 2021 | 12/26/2020 | 1/1/2021 | 6 | Follow blood work HCG- negative Progesterone level -Normal | PVT | Prenatal Vitamin | None | None | vsafe | 2 | 1/6/2021 | Y | None | M | ||
| 924247 | 1/6/2021 | CA | 38 | I was 5.5 weeks pregnant when I revived the Pfizer Covid Vaccine. Everything was seemingly going fine with my pregnancy until about 4 hours after receiving the vaccine when I went to the bathroom nd wiped and saw pink discharge on the toilet paper. I then began to have mild low abdominal cramping. The abdominal cramping and vaginal bleeding steadily increased in severity over the next 24 hours until I eventually had an obvious miscarriage the evening of 12/31/2020. I cant help but think the vaccine in some way caused my body to reject the pregnancy. Along with the miscarriage, I also had extreme tiredness with GI upset 12/31/20 - 1/02/2021. | 12/30/2020 | 12/30/2020 | 0 | UNK | Prenatal Vitamin | None | None | 2 | 1/6/2021 | Y | NKA | M | ||||
| 926723 | 1/7/2021 | OR | 37 | I suffered from a miscarriage. 12 weeks along. It had been a healthy pregnancy otherwise. | 12/19/2020 | 12/25/2020 | 6 | Ultrasound. | WRK | Over the counter | vsafe | 2 | 1/7/2021 | Y | Y | M | ||||
| 926770 | 1/7/2021 | AL | 30 | When patient presented to get immunization she reported previous mild reaction of hives with flu immunization. She reported prior to receiving her flu immunization she would take 50mg diphenhydramine. We had her take 50mg diphenhydramine & then wait 30 minutes prior to receiving the first COVID-19 dose. After receiving the vaccine we had her stay in the room directly in front of us for 30 minutes so we could monitor her. It was noted she seemed to be having difficulty breathing & at that point we administered the first epinephrine 0.3mg dose. She reported feeling better & her color got better. We continued to closely monitor her & in approximately 7 to 8 minutes her breathing became labored again. A second epinephrine 0.3mg dose was administered & we called to have her transported to the hospital. | 1/7/2021 | 1/7/2021 | 0 | SEN | 50mg diphenhydramine | miscarriage on 1/5/2021 | asthma | adverse event of mild skin hives, influenza immunization, unknown date/type/brand/pt age | 2 | 1/7/2021 | Y | latex, Percocet, dairy products | M | |||
| 932028 | 1/9/2021 | CA | 27 | Miscarriage at 6 weeks pregnant | 12/18/2020 | 12/20/2020 | 2 | PVT | 2 | 1/9/2021 | Oats, scallops | M | ||||||||
| 932107 | 1/10/2021 | NY | 37 | Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms (cramping) started 1/8/21, confirmed 1/10/21; estimated date of delivery 8/30/21) | 1/6/2021 | 1/8/2021 | 2 | PVT | Fluticasone, azelastine, prenatal vitamin | None | None | 2 | 1/10/2021 | Y | None | M | ||||
| 936919 | 1/12/2021 | SD | 32 | G3 P1 mother, estimated gestational age of baby = 4 weeks. On day 4 post-vaccine (1/11/21) started with heavy bleeding and labs confirmed miscarriage. | 1/7/2021 | 1/11/2021 | 4 | 1/11/21 Blood HCG: positive 1/11/21 Blood progesterone: 0.7 | PVT | Prenatal vitamin | None | None | 2 | 1/12/2021 | Sulfa | M | ||||
| 941086 | 1/13/2021 | CA | 37 | Miscarriage | 12/31/2020 | 1/8/2021 | 8 | PVT | prenatal vitamins | none | none | 2 | 1/13/2021 | NKDA | M | |||||
| 943837 | 1/14/2021 | MA | 32 | Approximately 5 days after administration at 6 weeks pregnant, I began bleeding. The following day (6 days after administration) miscarriage was confirmed via ultrasound | 1/7/2021 | 1/12/2021 | 5 | 1/13/2021: Intravaginal ultrasound showing no gestational sac or embryo which would have been expected for gestation 1/13/2021: Hcg, Total, Quantitative 971 mIU/mL | PHM | Levetiracetam 500mg , Folic acid 4mg, prenatal vitamin, vitamin C 500mg, Zinc 50mg, Omega 3 fatty acids | Seizure disorder | 2 | 1/14/2021 | Y | Amoxicillin | M | ||||
| 947745 | 1/15/2021 | KY | 37 | When this individual received her Moderna Covid-19 vaccine (Dose #1) on 12-29-2020 she did not know her pregnancy status. She did not think she was pregnant. On Thursday 1-7-2021 around 4 AM she started experiencing severe abdominal pain. She did not go to work that day but did go in on Friday 1-8-2021. On Saturday 1-9-2021 she woke up with significant vaginal bleeding. On Monday 1-11-2021 she went to the OB/GYN and there she had a positive pregnancy test. The diagnosis of miscarriage was made at that time. A couple of days later, a repeat pregnancy test resulted in a negative reading. | 12/29/2020 | 1/7/2021 | 9 | Pregnancy Test #1: Positive 1-11-2021 Pregnancy Test #2: Negative 1-13-2021 | PVT | 2 | 1/15/2021 | Y | no known allergies | M | ||||||
| 949729 | 1/15/2021 | NC | 29 | Miscarriage. Expected due date in August 2021. No prior pregnancy history. | 12/23/2020 | 1/1/2021 | 9 | PVT | Prenatal vitamins | bicornuate uterus | 2 | 1/15/2021 | Y | M | ||||||
| 950091 | 1/16/2021 | NC | 35 | I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage. | 12/28/2020 | 1/1/2021 | 4 | Positive pregnancy test 12/26/2020 & 12/28/2020 with associated fatigue, hunger & pregnancy symptoms. Vaginal bleeding & cramping for 2 days starting 1/1/2021 with a negative pregnancy test 1/2/2021 | WRK | None | None | 2 | 1/16/2021 | None | M | |||||
| 950562 | 1/16/2021 | GA | 36 | 9 days after vaccine, I had a miscarriage. I was 5 weeks pregnant at that time. I had confirmation lab test 2 weeks prior of pregnancy and had labs with bhcg lower at time of bleeding to confirm miscarriage | 12/22/2020 | 12/22/2020 | 0 | PVT | None | None | Migraines Eczema Seasonal allergies | 2 | 1/16/2021 | Y | Sulfa, eggs | M | ||||
| 953086 | 1/18/2021 | TN | 31 | I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; I had a very early miscarriage at five weeks; This is a spontaneous report from a contactable Physician (patient). A 31-year-old female patient received BNT162B2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJI685) intramuscular at arm right on 19Dec2020 06:30 at single dose for covid-19 immunization. Facility type vaccine was hospital. Medical history was none. The patient had no known allergies or other medical history. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient experienced a very early miscarriage at five weeks on 01Jan2021. The event result in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event miscarriage was recovered in Jan2021. No covid prior vaccination and no covid tested post vaccination.; Sender's Comments: All pregnancies have a risk of birth defect, loss, or other adverse outcomes. The data on BNT162B2 administered to pregnant women is insufficient to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | 12/19/2020 | 12/19/2020 | 0 | PVT | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None | USPFIZER INC2021014948 | 2 | 1/18/2021 | Y | M | ||||||
| 953737 | 1/18/2021 | OH | 37 | 3 weeks pregnant at time of first dose on 12/21/2020. Due date would have been 09/09/2021. Miscarriage on 01/14/2021 at 6 weeks. | 12/21/2020 | 1/14/2021 | 24 | Hcg on 01/07/2021 was 1224 Hcg on 01/14/2021 was 596 | PVT | Prenatal vitamin | N/A | Mitral valve prolapse | 2 | 1/18/2021 | Y | N/A | M | |||
| 955432 | 1/19/2021 | PA | 33 | I had vaginal bleeding and receive a Ultra sound. Which I had a miscarriage. My estimated delivery was August 25,2021. | 1/10/2021 | 1/14/2021 | 4 | Ultra sound and ACT level | PVT | Prenatal vitamin | None | None | vsafe | 2 | 1/19/2021 | Y | None | M | ||
| 959645 | 1/20/2021 | MN | 25 | I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue. ER doctor and nurses did tests and found I was having a miscarriage. | 1/7/2021 | 1/15/2021 | 8 | OTH | I was unaware I was pregnant at time of vaccine. Turns out I was, I had a miscarriage a week later at about 4-5 weeks. | 2 | 1/20/2021 | Y | Y | M | ||||||
| 960019 | 1/20/2021 | IL | 31 | miscarriage, estimated 5 weeks | 1/4/2021 | 1/15/2021 | 11 | WRK | atomoxetine, guanfacine, trazodone, fish oil, vitamin d, probiotic, iron | none | none | 2 | 1/20/2021 | Y | none | M | ||||
| 962952 | 1/21/2021 | OR | 29 | Miscarriage | 1/10/2021 | 1/11/2021 | 1 | HCG test 1/11 and 1/13 | WRK | Herbal remedy from acupuncturist | None | None | 2 | 1/21/2021 | Allergy to doxycycline | M | ||||
| 964070 | 1/22/2021 | RI | 31 | Hi, I actually not sure if the couse of my problem was couse by the Vaccine given to me on January 17 2021. At the time of the injection given to me I was pregnant don't know how long because I just had found out about it. I took the injection because I wanted to be safe for the health of my baby and my family..am just curious about the side effect of this covi19 vaccine. On January 19 I started seen some spot of blood at first I thought it was nothing to worried about but then around 8am I that day I saw that I was bleeding more and more not a crazy bleeding but I ended up at the emergency room on January 19 around 3:45pm. To find out that I was having a miscarriage..so now I don't know if this was couse by the injection or not. Am just worried that these is a side effect of this injection and nobody knows about it. Please reply me back I want to know more I already have both covi19 vaccine. | 1/17/2021 | 1/19/2021 | 2 | Miscarriage of an early pregnanct | WRK | None | None | None | 2 | 1/22/2021 | None | M | ||||
| 965558 | 1/22/2021 | WI | 29 | Miscarriage; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable nurse (patient). This pregnant 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK5730), intramuscular at single dose in the left arm on 20Dec2020 for COVID-19 immunisation. Medical history included none. Concomitant medication included venlafaxine. The patient experienced miscarriage (medically significant) on 09Jan2021 with outcome of recovering. Treatment unknown. The event required a visit to the emergency room. The patient was pregnant while taking BNT162B2. The patient was 4 weeks pregnant at the onset of the event. Patient last menstrual period date was 27Nov2020. The pregnancy due to deliver was on 03Sep2021. The vaccine was administered at Workplace Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. She received the second dose of BNT162B2 (Lot number EL0142), intramuscular in the left arm on 13Jan2021.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be complete excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | 12/20/2020 | 12/20/2020 | 0 | WRK | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none | USPFIZER INC2021025914 | 2 | 1/22/2021 | Y | M | ||||||
| 966887 | 1/22/2021 | IA | 31 | Miscarried at 7.5 weeks between vaccination #1 and #2. I do not believe the vaccine was a cause, however, it was recommended to report just in case. This was a second pregnancy, first miscarriage. EDD was 9-1-2021. First pregnancy was uncomplicated. Pregnancy tests were negative prior to receiving the first vaccine and then turned positive on 12-29-2020 (5 days after getting first vaccine.) | 12/24/2020 | 1/16/2021 | 23 | None | UNK | Prenatal | None | None | 2 | 1/22/2021 | Sulfa medication | M | ||||
| 967169 | 1/22/2021 | TX | 27 | Miscarriage? around 7 weeks pregnant at the time of vaccine, estimated delivery date was 8/19/2021 | 1/16/2021 | 1/21/2021 | 5 | Blood, urine, and ultrasound on 1/21/2021 | PVT | Prenatal vitamins | N/A | Asthma | 2 | 1/22/2021 | Y | N/A | M | |||
| 968006 | 1/23/2021 | CT | 41 | Miscarriage on 01/03/21 (due date 08/08/21) 2 previous pregnancies with live births (2006,2010) | 1/2/2021 | 1/3/2021 | 1 | Ultrasound to confirm 01/04/21 | SEN | Labetalol Sertraline | None | Hypertension | 2 | 1/23/2021 | Y | Penicillin and all cousins Suprax Cipro Percocet Tetracycline | M | |||
| 970490 | 1/25/2021 | TX | 32 | Miscarriage | 12/30/2020 | 1/21/2021 | 22 | PVT | My second first dose dose took place on 12/30 and second on 1/19. I had a miscarriage on 1/21. | Asthma | 2 | 1/25/2021 | Y | M | ||||||
| 970929 | 1/25/2021 | FL | 34 | A miscarriage was determined on 1/18/2021. There is no history of miscarriages. | 12/30/2020 | 1/18/2021 | 19 | Ultrasounds were completed on facility. On 1/17, after sx of bleeding a low fetal heartbeat was found. On the 20th, it was found that there was no heartbeat. | PVT | Prenatal vitamins, iron, calcium | No | None | 2 | 1/25/2021 | Y | Y | NKDA | M | ||
| 975126 | 1/26/2021 | MI | 26 | G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage. | 1/20/2021 | 1/25/2021 | 5 | HCG, QUANTITATIVE; Status: Final result Visible to patient: Yes (MyChart) Dx: Spotting in early pregnancy Human Chorionic Gonadotropin Quantitative <5 mIU/mL 12High | PVT | butalbital-acetaminophen-caffeine, MVI, sumatriptan | Pregnancy - 1st trimester, just confirmed; history of miscarriages; | history of miscarriages; anemia, migraines, sinus arrhythmia | 2 | 1/26/2021 | Y | NKDA | M | |||
| 977029 | 1/26/2021 | IL | 34 | First day after the injection, a small pustule was found at the site. On day seven, after the injection, a 0.5 inch knot was found at the injection site (not involving the previously mentioned pustule, which had scabbed over). This knot grow over the next 12 hours to be 3-4 inches in diameter. It was tender, red, and hot. After approximately 24 hours, the swelling/knot subsided. On day 11, post injection, the site was found to have an irregular, red, raised border, approx 3.5 inches in diameter in an almost circular shape. (Current illness: miscarriage) | 1/15/2021 | 1/16/2021 | 1 | PUB | Sertraline, Prenatal Vitamins | Miscarriage | Depression, Anxiety, Fatty liver | 2 | 1/26/2021 | Nickel | M | |||||
| 977171 | 1/27/2021 | MS | 24 | Sore arm, neck stiffness, flushed (Current illness: miscarriage at time of vaccination) | 1/26/2021 | 1/27/2021 | 1 | None | PVT | Tylenol | Miscarriage at time of vaccination | None | 2 | 1/27/2021 | NKA | M | ||||
| 981097 | 1/28/2021 | NY | 41 | A large area around my injection site was red, swollen, warm to touch, firm and itchy covering 3/4 of my upper arm into my underarm and lymph nodes. I received my first vaccine on 12/23/20 several days after injection the site became very itchy, red and swollen but in a much smaller area and persisted for several days leaving a small area of skin hyper pigmented for ~2 weeks. However I did not think it was considered an "Adverse" event and would have not reported it if the second dose was to a similar scale. Also, when I received first vaccine I did not know I was pregnant at the time. When I went to the doctor on 1/23/21 I was told I was 7.5 weeks pregnant, but there was no heart beat and I had miscarried. Being that I am over the age of 40 and a high risk for pregnancy and miscarriage I am unsure if my miscarriage is directly related to the vaccine but I felt it should add it to the report. My first vaccine was administered on 12/23/20 @ 5:30pm at Hospital | 1/25/2021 | 1/27/2021 | 2 | Abd Ultrasound 1/23/21 | PVT | wellbutrin Adderall xr | none | 2 | 1/28/2021 | NKA | M | |||||
| 985511 | 1/29/2021 | CA | 32 | 1/4 - RECEIVED MODERNA VACCINE, PREGNANCY TEST CAME OUT NEGATIVE. 1/8 - PREGNANCY TEST CAME OUT POSITIVE 1/18 - HAD MISCARRIAGE, SAW TISSUE, NEGATIVE PREGNANCY HOME TEST, NEGATIVE HCT | 1/4/2021 | 1/17/2021 | 13 | HCG NEGATIVE PREGNANCY HOME TEST NEGATIVE AFTER | PVT | VITAMIN C PRENATAL | NO OTHER ILLNESSES | NO OTHER HEALTH CONDITIONS | 2 | 1/29/2021 | Y | NO ALLERGIES | M | |||
| 985993 | 1/29/2021 | TX | 34 | Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage. | 12/22/2020 | 1/2/2021 | 11 | Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. | PVT | omega 3 fatty acids 1gm PO BID NP thyroid 60 mg PO QAM | None | Hypothyroidism | 2 | 1/29/2021 | Egg ovalbumin, raw - rash/hives | M | ||||
| 987914 | 1/30/2021 | IA | 33 | Received COVID vaccine on Friday afternoon, 1/22, developed some slight abdominal cramping 1/24 and 1/25, had severe abdominal and back pain resulting in miscarriage evening of 1/25. Estimated date of delivery: August 27, 2020 Also had known subchorionic hematoma, diagnosed on 1/19 via ultrasound at physician's (OBGYN) office | 1/22/2021 | 1/25/2021 | 3 | Bloodwork and Ultrasound done 1/26/2020 in ER after miscarriage, have follow up appt with OBGYN on 2/15 | PVT | Zyrtec, 200 mg Progesterone | Subchorionic hematoma, diagnosed by ultrasound on 1/19/2021 | GERD | 2 | 1/30/2021 | Y | Y | None | M | ||
| 990450 | 2/1/2021 | IN | 33 | Miscarriage after 2nd vaccine.; Miscarriage after 2nd vaccine.; This is a spontaneous report from a contactable nurse reported for herself. This 33-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Es1686), via intramuscular at left arm on 11Jan2021 08:00 am at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 21Dec2020 10:15 AM for COVID-19 immunisation. The patient had no known allergies. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient was pregnant. Last menstrual date was 14Dec2020. Delivery due date was 16Sep2021. Gestation period was 3 weeks. The patient experienced miscarriage on 16Jan2021 after 2nd vaccine. AE resulted in congenital anomaly or birth defect. The patient had no COVID prior vaccination. The patient had COVID tested/nasal swab post vaccination with negative results on 11Jan2021 and 13Jan2021. Outcome of the events was unknown.; Sender's Comments: Based on the available information, a causal relationship between event miscarriage after the second COVID-19 vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | 1/11/2021 | 1/16/2021 | 5 | Test Date: 20210111; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210113; Test Name: Nasal Swab; Test Result: Negative | UNK | USPFIZER INC2021035452 | 2 | 1/29/2021 | Y | Y | M | |||||
| 994135 | 2/2/2021 | CA | 38 | I am 38 years old with no history of medical problems. I do NOT have a history of miscarriages and have one healthy child who is 22 months old. On 1/13/21, I took a home pregnancy test which came back positive. At that time, I had a missed period but also had several common pregnancy symptoms such as bloating, acne, fatigue and tender breast. later that week, I called OB/Gyn and spoke to an RN to schedule my 8/9 week ultrasound and to inquiry about the vaccine during pregnancy since I had no clue whether it was recommended/safe or not. the RN, very confident and without any disclaimer, stated that hospital is recommending all of their pregnant patients to receive the vaccine. Obviously, I decided to trust this medical professional who was so confident in her response. My normal pregnancy symptoms continued. On 1/19/21, I was 5 weeks pregnant and received my first dosage of the vaccine. felt fine other than a sore left arm. on 1/20/21, I woke up with a lot of abdominal cramping and pain. It was new to me but assumed it was normal. My cramping and pain continued until 1/21/21. On 1/21/21, I woke up without the cramping and pain. But, I also noticed that my breast were no longer tender and my skin had completely cleared up. I became concerned but prayed everything was fine since my home pregnancy test was still positive. On 1/22/21, by cramps continued once again but more mild. My pregnancy symptoms seemed as if they were no longer present but remained hopeful. On 1/23/21, I woke up with light spotting that only lasted through the morning. Soon after, I started having extreme abdominal pains. I prayed everything was fine. The pain continued and became worse. That night, the pain was so bad that I just went to bed. Right before going to bed, I noticed I had started spotting again. A little heavier than in the morning. I made sure to lay on my left side, hoping it was normal in pregnancy. On 1/24/21, I woke up with heavy bleeding and clotting. I went to the doctor and got an ultrasound and blood test. I was told by the doctor at Hospital that I had a miscarriage. | 1/19/2021 | 1/20/2021 | 1 | 1/24/21 had ultrasound to confirm miscarriage | OTH | Prenatal Vitamins | None | None | 2 | 2/2/2021 | Y | None | M | |||
| 995875 | 2/2/2021 | VT | 34 | Miscarriage Estimated date of delivery 09/12/2021 I was give IV fluids | 1/9/2021 | 1/23/2021 | 14 | HCG TRACT | PVT | Prenatal Vitamins | None | None | vsafe | 2 | 2/2/2021 | Y | Sulfa Shellfish | M | ||
| 995949 | 2/2/2021 | WI | 39 | Miscarriage reported | 1/22/2021 | 2/1/2021 | 10 | PHM | Unknown | 2 | 2/2/2021 | Y | None noted | M | ||||||
| 1004202 | 2/5/2021 | PA | Presumed miscarriage; human chorionic gonadotropin decreased; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 31-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced vaccine exposure during pregnancy, human chorionic gonadotropin decreased and presumed miscarriage. The patient's medical history was not provided. The patient's prior history of pregnancies were two miscarriages (2013 and 2015) and two full term births (2017 and 2019) were reported. The patient's last menstrual period was 25 Nov 2021. The estimated due date was 1 Sep 2021. Concomitant medications included sertraline hydrochloride and vitamins. On 27 Dec 2020, the patient found out she was pregnant, but she already had some bleeding. On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On undisclosed date, after receiving the vaccine her human chorionic gonadotropin (hCG) levels went down to 0. Her health care professional presumed it was a miscarriage. Treatment for the event was not reported. On 19th Jan 2021, her hCG levels started to climb back up again. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, presumed miscarriage, and human chorionic gonadotropin decreased was unknown. The outcome of the event, vaccine exposure during pregnancy, was resolved on 28 Dec 2020.; Reporter's Comments: This spontaneous report concerns a 31-years-old, G5P2 female patient who experienced vaccine exposure during pregnancy and presumed miscarriage. The patient's last menstrual period was 25-Nov-2020 with estimated date of delivery as 01-Sep-2021. One day after the patient discovered she was pregnant; she received the first dose of mRNA-1273 vaccine (lot # 026L20A expiration date unknown). The event of presumed miscarriage (human chorionic gonadotropin (hCG) levels went down to 0) was diagnosed on an unknown date after vaccine administration. The HCG level began to climb up again 22 days after the vaccine administration. Based on the information provided which includes, the patient's obstetric history, vaginal bleeding the day prior to mRNA-1273 vaccination and without definitive confirmation of pregnancy loss, there is not enough evidence to assess that that there was a miscarriage and is also unlikely to be associated with mRNA-1273 administration. The event of vaccine exposure during pregnancy is considered not applicable | 12/28/2020 | 12/28/2020 | 0 | Test Name: hCG; Result Unstructured Data: 0; Test Date: 20210119; Test Name: hCG; Test Result: Inconclusive ; Result Unstructured Data: Started to climb back up again; Test Date: 20201227; Test Name: USG; Result Unstructured Data: Got it done, but it was too early so it didn't show anything. | UNK | ZOLOFT; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS | Medical History/Concurrent Conditions: Miscarriage; Term birth | USMODERNATX, INC.MOD20210 | 2 | 2/4/2021 | M | ||||||
| 1006011 | 2/5/2021 | TX | 27 | Miscarriage; The mother reported she became pregnant while taking bnt162b2; The mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old female patient (Pregnant) received first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left arm on 16Jan2021 16:30 at single dose for covid-19 immunization. Medical history included asthma, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant drug included prenatal vitamins. The patient experienced miscarriage on 21Jan2021 with outcome of recovering. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event. The mother was due to deliver on 19Aug2021. Last menstrual date: 22Nov2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies to medications, food, or other products. | 1/16/2021 | 1/16/2021 | 0 | PVT | Medical History/Concurrent Conditions: Asthma; COVID-19 | USPFIZER INC2021063959 | 2 | 2/4/2021 | Y | M | ||||||
| 1006169 | 2/5/2021 | MA | 43 | I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion. | 1/14/2021 | 1/18/2021 | 4 | OTC pregnancy test 1/20/21 Beta HCG 1/20/21 CBC and follow-up CBC 1/20/21 and 1/21/21 Vaginal and abdominal Ultrasounds 1/20/21 | WRK | Celexa, 40mg daily, Naltrexone, 50 mg daily, Cranberry supplement x1 Daily | Yes diagnosed as COVID positive on 12/24/20 | no | 2 | 2/5/2021 | Y | Y | Sulfa, morphine | M | ||
| 1007832 | 2/6/2021 | VA | 24 | I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed. I developed a weakened immune system from the vaccine. I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date. Rather not release any info regarding the pregnancy | 12/21/2020 | 1/10/2021 | 20 | no | MIL | no | no | no | vsafe | 2 | 2/6/2021 | Y | Y | no | M | |
| 1008618 | 2/6/2021 | TX | 32 | I was pregnant, embryo estimated 6 weeks gestation. I started having spotting approximately 34 hours after the 2nd dose. I went to my OB for heavy vaginal bleeding with an ultrasound completed 49 hours post vaccine with no concerns visually. Estimated miscarriage <72 hours after vaccine administration with confirmation via ultrasound 1 week and 2 days after vaccine. | 1/25/2021 | 1/26/2021 | 1 | Ultrasound on 1/27/2021 and 2/3/2021. Blood test on 2/3/2021. | PHM | Prenatal vitamin | None | None | 2 | 2/6/2021 | Y | None known | M | |||
| 1010028 | 2/7/2021 | PR | 27 | The day I got the first shot of Moderna Covid19 vaccine I was 4 weeks pregnant. Starting week 6 I start to have symptoms of miscarriage (January 14 2021). This continued until January 18 when I lost the baby. I was due in September 2, 2021. | 12/30/2020 | 1/14/2021 | 15 | UNK | 2 | 2/7/2021 | Y | Y | Aspirin and Peninsilin | M | ||||||
| 1010113 | 2/7/2021 | WI | 28 | Miscarriage - first vaccine at 10 weeks and 3 days with prior proof of heartbeat/movement, second vaccine at 13 weeks and 3 days; learned of miscarriage at 14 weeks 3 days with measurements of 12 weeks 3 days on U/S | 1/7/2021 | 1/21/2021 | 14 | Fetal U/S on 2/4 | PVT | Prenatal vitamin, Diclegis | None | None | 2 | 2/7/2021 | Y | None | M | |||
| 1010528 | 2/8/2021 | NY | 32 | unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | 12/31/2020 | 12/31/2020 | 0 | Test Date: 2020; Test Name: pregnancy test; Test Result: Negative ; Test Date: 202101; Test Name: pregnancy test; Test Result: Positive ; Comments: she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose. | PVT | IRON; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] | USPFIZER INC2021062785 | 2 | 2/5/2021 | Y | M | |||||
| 1010817 | 2/8/2021 | NY | 32 | fever; chills; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient's friend). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 21Jan2021 in the Left arm at single dose for COVID-19 immunization in hospital. Medical history included she had a negative pregnancy test before getting the first vaccine dose, but then had a positive pregnancy test a few days after the first dose. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); Iron. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), on 31Dec2020 in the Left arm at single dose for COVID-19 immunization at the age of 32-year-old and had mild symptoms after first dose, but unfortunately she had a miscarriage about 5-6 days before her second dose. After second dose in Jan2021 she experienced worse symptoms such as fever, chills, nausea and fatigue. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, patient had not been tested for COVID-19. Events were resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The outcome of the events was recovering. | 1/21/2021 | 1/1/2021 | PVT | IRON; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS | Medical History/Concurrent Conditions: Negative pregnancy test (before getting the first vaccine dose); Positive pregnancy test (a few days after the first dose) | USPFIZER INC2021082808 | 2 | 2/5/2021 | Y | M | ||||||
| 1015666 | 2/9/2021 | GA | 39 | patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage. However, information is limited, and miscarriage is multifactorial event. In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | 12/28/2020 | 1/8/2021 | 11 | WRK | Medical History/Concurrent Conditions: Asthma; Eosinophilic esophagitis | USPFIZER INC2021092594 | 2 | 2/6/2021 | Y | M | ||||||
| 1016753 | 2/9/2021 | CT | 42 | 42yo G2P0010 at 3+6 weeks GA by LMP 1/1/2021 with EDD 10/8/2021 on day of Vaccine Dose #2 (1/28/2021), positive urine pregnancy test on 1/30/21. Bleeding began on 2/4/2021, and complete miscarriage occurred on 2/5-2/6. | 1/28/2021 | 2/4/2021 | 7 | serum quantitative beta-hCG drawn on 2/4/21 (results not available). | PVT | Prenate DHA | None | None | 2 | 2/9/2021 | none | M | ||||
| 1017013 | 2/9/2021 | TX | 28 | Gravida 1 with last menstrual period of 12/05/2020. Patient received 2nd dose of vaccine on 01/19/2021. Patient had fever and body aches the next day 1/20/2021 and subsequently (3 weeks later) was diagnosed with a miscarriage of pregnancy at 6 weeks 4 days, which exactly corresponds with the date of the vaccine and symptoms. | 1/19/2021 | 1/20/2021 | 1 | Sonogram showing 6 weeks 4 days embryonic demise, corresponding to approx. 01/20/2021 as the date of demise. | PVT | Prenatal vitamin, fluoxetine | None | None | 2 | 2/9/2021 | Y | None | M | |||
| 1018222 | 2/9/2021 | IN | 28 | I found out I was pregnant the day after receiving the first dose of the COVID-19 vaccine. My last period was on December 8th and I received the vaccine on Dec 30th. I developed a fever and muscle aches after the first dose, but was managed with Tylenol. I received the second dose on January 22nd and again developed a fever that was managed by Tylenol. I began having vaginal bleeding on 24th. I had an ultrasound revealing a heartbeat on the 25th. After continually bleeding, another ultrasound a week later on Feb. 2nd confirmed a miscarriage. I've had two healthy pregnancies prior to this one. | 12/30/2020 | 1/25/2021 | 26 | I had lab work done prior to having a D&C procedure on Feb. 4th. The "remains" were sent to pathology at Hospital. | PVT | Prenatal vitamin, Escitalopram | None | None | 2 | 2/9/2021 | None | M | ||||
| 1019778 | 2/10/2021 | MO | 28 | Miscarriage 1 week post getting dose 1 of vaccine. Estimated due date was 08/18/2021. Previous pregnancy history is 3 pregnancies, with 3 full term live births, no complications. | 2/1/2021 | 2/8/2021 | 7 | Ultrasound 2/8/21 | PVT | prenatal vitamin | none | childhood asthma | 2 | 2/10/2021 | Y | none | M | |||
| 1020877 | 2/10/2021 | PA | 43 | I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregnancy with no complications. I'm in healthcare and in the operating often for airway and ENT procedures. I received my shot at 9:00am on 1/29/20201 and began spotting at 11:00am. The spotting continued (very light) until 9:00pm. I decided to go to bed since I wasn't feeling well. I woke at 2:00am with contractions and heavy bleeding. I went to the ED at 3:00am on 1/30 to confirm my miscarriage. I weighed 121 at the ED when triaged. My EDD was 08/19/2021 | 1/29/2021 | 1/29/2021 | 0 | PUB | Pre-natal vitamins | none | none | 2 | 2/10/2021 | Y | none | M | ||||
| 1023866 | 2/11/2021 | NC | 28 | Miscarriage at 6 weeks 1 day. Vaginal bleeding and decline in HCG hormone. Pregnancy not viable. | 1/15/2021 | 2/11/2021 | 27 | HCG and CBC blood work. 2/11. Vaginal exam by OBGYN 2/11 | WRK | Prenatal vitamin | None | None | 2 | 2/11/2021 | Y | None | M | |||
| 1025363 | 2/12/2021 | OH | 40 | About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage. | 2/5/2021 | 2/6/2021 | 1 | Pregnancy was on 2/11, Second vaccine dose was on 2/5 | PVT | Folic acid 800mg | none | no | 2 | 2/12/2021 | Y | no | M | |||
| 1025517 | 2/12/2021 | CA | 37 | Raised large patch around vaccination site
arising about a week after the shot, some pain and redness, nausea
(Current illness: Miscarraige) |
2/4/2021 | 2/11/2021 | 7 | OTH | Miscarriage | 2 | 2/12/2021 | Y | M | |||||||
| 1028368 | 2/13/2021 | CA | 32 | Miscarriage in first trimester. First dose received 12/22/2020 Conception date 01/03/2021 Second dose 01/27/2021 Miscarriage started 02/03/2021 First pregnancy. No other medical problems or pregnancy risks. | 1/27/2021 | 2/5/2021 | 9 | UNK | Prenatal vitamins | None | None | 2 | 2/13/2021 | Y | None | M | ||||
| 1028819 | 2/14/2021 | MO | 39 | First trimester miscarriage after receiving both vaccine doses while pregnant. Granada 5, Para 3 at time of vaccine administration. Due date 9/17/2021 | 12/18/2020 | 2/3/2021 | 47 | 2/3 - ultrasound showed no heartbeat 2/5 - beta hcg quant - 41,xxx 2/7 - beta hcg quant - 40,xxx 2/11 - 2nd confirmation ultrasound. 2/11 - beta hcg quant - 35,xxx | PVT | Wellbutrin, Zyrtec, Benadryl, flexeril, prenatal vitamins. | None | Anxiety, migraines | 2 | 2/14/2021 | Y | Latex, PCN, sulfa, reglan, phenergan | M | |||
| 1033516 | 2/16/2021 | MN | 32 | At the time of administration of the first does of Moderna vaccine, I was 6 weeks pregnant. I had confirmed pregnancy with home positive test and missed period. I had an estimated due date of 9/24/2021. This was my 4th pregnancy. I have had two uncomplicated pregnancies to term. In September 2020 experienced a chemical pregnancy with early pregnancy loss at 5 weeks. The first 24 hours after 1st dose of vaccine I experienced extreme arm soreness in the arm that was vaccinated, causing headache and unable to sleep. After 24 hours I felt "normal". 2 weeks and 3 days following the first dose of Moderna, I had a miscarriage. On the night of 2/15/21 I lost the pregnancy with vaginal bleeding, bright red blood, passing tissue, clots/ sac. I had an uneventful pregnancy up to that point, feeling well as I had with prior pregnancies. | 1/29/2021 | 2/15/2021 | 17 | On 2/16/21 I had an abdominal and vaginal ultrasounds, which confirmed absence of fetus in the uterus. Eptopic pregnancy was ruled out. MD was consulted on the same day regarding miscarriage. | PUB | prenatal multivitamin, iron supplement | On 1/20/2021 tested for Covid-19 via nasal swab due to having sore throat, fatigue, and headache. Test results came back negative that same day. | No chronic health issues, otherwise very healthy. | 2 | 2/16/2021 | Y | NKA | M | |||
| 1035009 | 2/17/2021 | MN | 28 | embryonic demise/loss of pregnancy; patient was pregnant at the time of vaccination of the second dose; patient was pregnant at the time of vaccination of the second dose; This is a spontaneous report from a contactable healthcare professional. A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), intramuscular in the left arm on 12Jan2021 at 08:00 at a single dose, received in the Doctor's office/urgent care for covid-19 immunisation. Medical history included anxiety and allergies: gets hives from anything cold (fluid, food, air) that touches her. Concomitant medication included venlafaxine for anxiety. The patient was pregnant at the time of vaccination of the second dose, last menstrual date was 23Nov2020, delivery date was 30Aug2021, gestation period was 7 weeks. The patient experienced embryonic demise/loss of pregnancy in Jan2021, patient was hospitalized for 1 day and treatment was received for the event. The patient underwent lab tests and procedures which included didn't see a fetal heartbeat at 6 week on u/s, and 7 weeks still no heartbeat on u/s, HCG didn't go down until second u/s, so fetal demise occurred between 6 -7 weeks, D&C performed and no genetic abnormalities were found in fetal tissue. Doctor and patient, who is a nurse, do not think the fetal demise is related to the vaccine, but wanted to document the loss for data in case they would start to see a trend. The patient does not intend to pursue further investigation into the vaccine as a cause. After the first dose (received on 21Dec2020 at 08:00, the patient had a sore arm and then two days later found out she was pregnant. The doctor discussed with patient and pharmacist whether to get second dose. Patient is a nurse and decided to get second dose. No major symptoms were reported after second dose until the miscarriage. The patient recovered from the event with lasting effects/sequel.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | 1/12/2021 | 1/1/2021 | Test Name: heartbeat; Result Unstructured Data: Test Result:didn't see a fetal heartbeat at 6 week on u/s; Comments: 7 weeks still no heartbeat on u/s; Test Name: HCG; Result Unstructured Data: Test Result:didn't go down until second u/s, so fetal demise; Comments: occurred between 6 -7 weeks; Test Name: D & C; Result Unstructured Data: Test Result:no geneticabnormalities were found in fetal tissue | OTH | VENLAFAXINE | Medical History/Concurrent Conditions: Anxiety; Cold urticaria (gets hives from anything cold (fluid, food, air) that touches her) | USPFIZER INC2021106680 | 2 | 2/16/2021 | M | ||||||
| 1038096 | 2/18/2021 | VA | 31 | Pt is G1P0. At the time she received the vaccine on 1/26/21 she was 13 weeks pregnant. She had normal 1st trimester ultrasound and normal prenatal labs. Her EDD is August 5, 2021. On 2/9/21 she had a spontaneous miscarriage. No subsequent complications. No history of drug or alcohol abuse. No s/sx of other causes of a early 2nd trimester miscarriage. Of note the 1st trimester genetic testing was unable to be performed due to low fetal free cell DNA when she was at 10w. We were in the process of repeating the labs when the miscarriage happened. No history of COVID infection, no s/sx of COVID infection at the time of the miscarriage or subsequently. She was not tested. | 1/26/2021 | 2/9/2021 | 14 | No testing performed. | OTH | prenatal vitamin malarone daily for malaria prophylaxies | none | history of PCOS | 2 | 2/18/2021 | Y | none | M | |||
| 1038491 | 2/18/2021 | 28 | Patient was newly pregnant, received 2nd dose of covid vaccine. Patient then began bleeding on 2/13/21. On 2/15/21 confirmed with OBGYN that HCG levels were low and that she was having a miscarriage. Patient has a healthy 2 year old living child. No past history of miscarriages, no family history of miscarriage. | 1/20/2021 | 2/13/2021 | 24 | UNK | 2 | 2/18/2021 | Y | M | |||||||||
| 1040307 | 2/18/2021 | WA | 31 | Early miscarriage occurred on Sunday, 2/7/2021. No previous pregnancies | 2/5/2021 | 2/7/2021 | 2 | none | WRK | Endometrin, progesterone in oil IM shots, Estrogen pills | none | none | 2 | 2/18/2021 | Y | NKA | M | |||
| 1041373 | 2/19/2021 | PA | 36 | I was 4 weeks pregnant when I received the vaccine and had a miscarriage at 5 weeks 3 days. I had one healthy pregnancy to 41 weeks in 2019 and I was and still am breastfeeding. | 12/21/2020 | 12/31/2020 | 10 | I had HCG level on 1/8/2021 which was 17,500 and US at 10 weeks which confirmed miscarriage at 5 weeks. At 10.5 weeks but body naturally miscarried without medical intervention. I am 37 yrs old and healthy. I have no way of knowing if the vaccine played a part in this as my odds are 20% to have a miscarriage. | PVT | prenatal | n/a | n/a | 2 | 2/19/2021 | Cipro | M | ||||
| 1042347 | 2/19/2021 | Miscarriage; This is a spontaneous report from a contactable consumer(patient). This is a maternal report. A female patient of an unspecified age (Age: 29; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that her first dose of the Pfizer vaccine was on 15Jan2021 and reported that she had a miscarriage on Thursday 04Feb2021. It was reported that the patient missed her scheduled second dose of the Pfizer COVID-19 vaccine due to a miscarriage. The event was assessed as serious (medically significant). The outcome of the event was unknown. Information on the lot/batch number has been requested. | 1/15/2021 | 2/4/2021 | 20 | UNK | USPFIZER INC2021130569 | 2 | 2/18/2021 | M | ||||||||||
| 1044756 | 2/21/2021 | NY | 32 | I received my first dose of the COVID19 Pfizer vaccine on 12/30/20. At this point I was 4 weeks pregnant. I received my second vaccine dose for the series on 1/22/21. At this point I was 7 weeks pregnant. On 2/18/21 I was diagnosed with a miscarriage due to no fetal heartbeat on ultrasound. I now have to undergo a D&C in the operating room. | 1/22/2021 | 2/18/2021 | 27 | PVT | synthroid prenatal vitamin calcium supplement | none | hypothyroid | 2 | 2/21/2021 | Y | none | M | ||||
| 1045927 | 2/22/2021 | NE | 32 | positive at home pregnancy test 2/4/21 (same date as vaccine given). However, light bleeding/spotting started that night/next day but thought still normal. Heavier bleeding started 2/6/21 (Saturday) and continued through the weekend. Made appointment at hospital lab for Monday 2/8 to check HcG levels in blood. See below for details, but Dr. suggested repeat blood work on 2/10 as Hcg levels showed positive pregnancy, but very low. 2/10 Hcg levels slightly lower, which confirmed early miscarriage occurring. | 2/4/2021 | 2/6/2021 | 2 | 2/8/2021: blood work to test hCG Quantitative levels. Levels were 29.54 mIU/mL showing positive pregnancy, but very low levels. Dr. suggested to repeat blood test in 2 days to see if levels were increasing or not to determine if miscarriage or possibly just very early pregnancy. 2/10/2021: repeat blood work to test hCG Quantitative levels. Level was 23.21 mIU/mL, slightly lower than previous level. Dr. confirmed this would mean early miscarriage, as a normal pregnancy they would expect that level to double each 24-48 hours. 02/18/2021: office visit as miscarriage symptoms had gotten worse on 2/17 w/ severe abdomen and back pain. Did repeat hCG Quantitative levels again which were 14.99, so still decreasing as expected. Ran blood work and urine tests to test for any anemia or infection, but all results were normal for that. Dr. confirmed symptoms still related to miscarriage and should improve soon. | PVT | Omemprazole, Setraline, Claritin-D, Prenatal Vitamin | none | none | 2 | 2/22/2021 | Y | dust, pet dander, seasonal | M | |||
| 1047157 | 2/22/2021 | MN | 28 | Miscarriage at 8 weeks of pregnancy, 2/14/21. Tissue passed naturally without medical intervention. Hormone levels dropped without concern. The week prior to miscarriage sharp sporadic headaches (migraine-like but only lasting a few minutes at a time and coming frequently) started, and have continued daily through today (2/22/21) | 1/25/2021 | 2/14/2021 | 20 | Miscarriage completed naturally without medical intervention. Cause unknown. | SEN | Prenatal vitamins with omega 3; vitamin d3 | N/a | Digestive issues related to previous gastritis/stress | 2 | 2/22/2021 | Y | N/a | M | |||
| 1047536 | 2/22/2021 | DE | 31 | Received vaccine on 02/02, 4 weeks pregnant on 02/03 02/03-02/05: Severe lethargy, tiredness, pain at injection sites, fever all lasting 48 hours. Symptoms subsided after taking tylenol on 02/05. I'm not attributing this to the vaccine, but on 02/12, my hcg started to plateau and decline, no egg yolk or fetal pole was seen at 6 weeks (2/17). Sac was measuring at 5 weeks. I eventually had a miscarriage on 2/21 | 2/2/2021 | 2/3/2021 | 1 | N/A | UNK | Tylenol on day 2 after vaccination | N/A | N/A | 2 | 2/22/2021 | N/A | M | ||||
| 1048833 | 2/23/2021 | 31 | ~ 5 weeks pregnant at the time of 2nd vaccination. Miscarriage ~2 weeks later. Transvaginal ultrasound shows gestational age only 5 weeks when should have been 7. HCG level reflects only 4-5 weeks when should have been 7. | 1/22/2021 | 2/7/2021 | 16 | HCG & Transvaginal ultrasound 2/8 & 2/9 | WRK | zyrtec, calcium w/ vitamin d, prenatal vitamns | N/A | N/A | 2 | 2/23/2021 | Y | ibuprofen, shrimp, strawberries | M | ||||
| 1051018 | 2/24/2021 | TN | 29 | After the vaccine the patient miscarried the baby; This is a spontaneous report from Pfizer-sponsored program via a contactable pharmacist. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), 0.3 ml via an unspecified route of administration on 15Jan2021 at 10:00-11:30am as a single dose for COVID-19 immunization, administered in the right arm. Patient has no past medical history. Concomitant medication includes One-a-day vitamin, Ongoing. No prior Vaccinations within 4 weeks prior. First Day of Last menstrual period: 6-13 Dec2020. Patient reports one previous pregnancy: full term live birth via vaginal birth with epidural at 40 weeks and 1 day. The father used marijuana, at an unspecified frequency. Patient was unaware that she was pregnant, guesses she was about 3 weeks when she got the first shot of the vaccine. Ten days after the vaccine, the patient miscarried the baby. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Miscarriage of pregnancy cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | 1/15/2021 | 1/1/2021 | UNK | Medical History/Concurrent Conditions: Pregnancy (full term live birth via vaginal birth with epidural at 40 weeks and 1 day) | USPFIZER INC2021153606 | 2 | 2/22/2021 | Y | M | |||||||
| 1054987 | 2/25/2021 | MD | 32 | Pregnancy history: 1 previous pregnancy with healthy full term vaginal delivery. No complications. Estimated due date: Sept, 23, 2021. Symptoms: vaginal bleeding starting Jan 26th. Progressing to miscarriage on 1/29/21 | 1/20/2021 | 1/27/2021 | 7 | Ultrasound with low heart rate of fetus. Hcg levels decline from Wednesday 26-friday 29 from 5,400 to 1,500. | WRK | Prenatal vit | None | None | 2 | 2/25/2021 | Y | Y | None | M | ||
| 1055663 | 2/25/2021 | 34 | I was 8-weeks pregnant when I received my first dose of the Pfizer COVID-19 vaccine. This first dose was administered on Friday January 29, 2021. Three days later on Monday February 1, 2021, I was told my baby did not have a heartbeat on the ultrasound in the clinic (confirmed by radiology that day as well) and that I was having a miscarriage. I had no other signs or symptoms of miscarriage or illness. Pregnancy history - I do not have any other children yet. | 1/29/2021 | 2/1/2021 | 3 | UNK | prenatal vitamin | none | none | 2 | 2/25/2021 | Y | none | M | |||||
| 1057062 | 2/26/2021 | TX | 30 | 1/8 vaccination 1/9 I woke up with severe HA, muscle aches, and fatigue. That evening I got chest pains. 1/10 CP resolved. Everything resolved. 1/17 positive pregnancy test 1/22 miscarriage. First pregnancy. 2/10 finally able to see dr. | 1/8/2021 | 1/9/2021 | 1 | blood panel; confirmed pregnancy 1/21 miscarriage | PVT | prenatal vitamins, vit D, magnesium | N/A | N/A | VSAFE | 2 | 2/26/2021 | Y | Bactrum | M | ||
| 1057557 | 2/26/2021 | PA | 31 | Miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; receiving 2nd vaccine at 6 weeks pregnant; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration in the left arm on 28Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 07Jan2021 at 09:00 AM for COVID-19 immunization. Patient was pregnant. Patient has no other vaccines in four weeks and no other medications in two weeks. Patient has no COVID prior vaccination and no known allergies. On 05Feb2021 at 06:00 PM, patient experienced miscarriage 8 days after receiving 2nd vaccine at 6 weeks pregnant. No treatment received for the event miscarriage. The event resulted in doctor's office/clinic visit. The patient was not tested for COVID post vaccination. The outcome of the event miscarriage was recovering. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the compatible temporal association, a possible contributory role of the vaccination with BNT162B2 in triggering the onset of miscarriage in this patient at 6 weeks pregnant cannot be excluded. Additional information regarding relevant medical history, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate. | 1/28/2021 | 1/28/2021 | 0 | PVT | USPFIZER INC2021148323 | 2 | 2/25/2021 | Y | M | |||||||
| 1058581 | 2/26/2021 | NY | 35 | Miscarriage at 6 weeks; 4 days gestation. | 1/14/2021 | 2/26/2021 | 43 | Ultrasound, quantitative HCG measurements. | MIL | Prenatal vitamins. | None. | None. | 2 | 2/26/2021 | Y | None. | M | |||
| 1058924 | 2/26/2021 | MD | 39 | Two weeks after the vaccine I had a miscarriage. | 1/15/2021 | 1/30/2021 | 15 | blood work. normal | OTH | Prenatal Vitamin | No | No | vsafe | 2 | 2/26/2021 | No | M | |||
| 1059615 | 2/27/2021 | TN | 33 | Miscarriage after receiving first Moderna vaccine dose | 1/15/2021 | 2/16/2021 | 32 | Confirmed miscarriage at OB appt 2/24/2021 | UNK | Prenatal Vitamin | None | None | 2 | 2/27/2021 | Y | NKA | M | |||
| 1060131 | 2/27/2021 | TX | 32 | 1st vaccine: December 31 2020 2nd vaccine: January 28, 2021 Positive pregnancy test January 29 (2 positive tests on January 29, and 2 positive pregnancy tests on January 30) Estimated Due date October 8, 2021 Miscarriage on February 15, 2021 | 1/28/2021 | 2/15/2021 | 18 | PHM | Prenatal vitamin | 2 | 2/27/2021 | M | ||||||||
| 1060779 | 2/28/2021 | FL | 37 | At 5 weeks, 5 days pregnant I received the 1st Covid-19 dose. I started bleeding the evening of Feb. 7, 2021. The bleeding continued to increase. I visited the Emergency Department on Feb. 10, 2021 and learned my baby had died around 7 weeks into the pregnancy. | 1/12/2021 | 2/7/2021 | 26 | Feb. 10, 2021: Ultrasound (showing embryo of approx. 7 weeks with no heartbeat) Feb. 10, 2021: beta hCG levels. (approx. 17,000+) Feb. 12, 2021: Repeat of beta hCG levels. (approx. 7,000+, consistent with miscarriage) Feb. 19, 2021: Ultrasound (confirming loss of gestational sac and contents) | PVT | Pre-natal vitamins Vyvanse 50mg Citalopram 40mg | None | None | 2 | 2/28/2021 | Y | Y | Amoxicillin | M | ||
| 1061033 | 2/28/2021 | CT | 27 | I was 6 weeks pregnant at the vaccine, two weeks later I started bleeding and had a miscarriage. Exactly 2 weeks after the vaccine. I left work that day to see the OB , had ultra sound, labs and a follow up a week later. | 12/3/2020 | 1/13/2021 | 41 | Ultra sound labs | WRK | Prenatal | vsafe | 2 | 2/28/2021 | Y | M | |||||
| 1061109 | 2/28/2021 | CA | 33 | I was pregnant when I received my second dose of the Covid-19 Pfizer vaccine. My first Covid 19 vaccine was administered 12/28/2020. I got pregnant on 12/31/2020, received my second dose on 01/18/2021 and miscarried on 2/25/2021. I have had two prior uncomplicated pregnancies, and have never experienced a miscarriage. I gave birth to my two daughters, one at 42 weeks and one at 40 weeks and 5 days. My EDD for the pregnancy that ended in a miscarriage was due 09/23/2021. | 1/18/2021 | 2/25/2021 | 38 | My miscarriage was confirmed by decreasing HCG levels from 2/24/2021 to 2/26/2021 and by ultrasound. | PVT | prenatal vitamins , vitamin D, probiotics | none | none | 2 | 2/28/2021 | Y | latex, tree nuts | M | |||
| 1063601 | 3/1/2021 | AZ | 34 | COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Jan 11th, 2021 pregnancy diagnosed Jan 26th, 2021. ED Oct 4th, 2021. US confirmation of pregnancy with gestational sac on Feb 14th, 2021. Miscarriage/SAB/pregnancy loss occurred spontaneously on Feb 18th, 2021 with bleeding, cramping. Pregnancy loss confirmed by ultrasound with OBGYN. | 1/16/2021 | 2/18/2021 | 33 | US of pregnancy (Feb 14th), then confirming pregnancy loss (Feb 18th) | PVT | Prenatal vitamins | None | None | 2 | 3/1/2021 | Y | None | M | |||
| 1063749 | 3/1/2021 | MI | 31 | fast heartbeat, dizziness and weakness; patient presented to the ED on 2/26 with pelvic pain and cramping for possible miscarriage or ectopic pregnancy. Pt was at approximately 5 weeks gestation | 2/24/2021 | 2/25/2021 | 1 | Quantitative beta-hCG was 43, which was decreased from 2/25. Pelvic ultrasound no intrauterine pregnancy. | PUB | folic acid, trinate | Allergic rhinitis, chronic eczema of hand, transient insomnia | 2 | 3/1/2021 | Y | sulfa drugs, pumpkin seeds | M | ||||
| 1063971 | 3/1/2021 | WI | 39 | Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a fever. 24 hours later they all disappeared. I found out I was pregnant on the 8th. I had a normal ultrasound and a heartbeat at the end of January (the 29th) and February 8, there was no heartbeat anymore. I miscarried. This was my fifth pregnancy. I had one other miscarriage. I had a pregnancy where I had twins and one of the twins miscarried. So I have miscarried three babies. The expected date of delivery for this pregnancy was September 13, 2021. | 1/5/2021 | 1/5/2021 | 0 | I had a DNC surgery on February 12, 2021. They did do chromosome testing and those results are still pending. | PVT | Topical - Metronidazole; Multi-Vitamin | no | no | vsafe | 2 | 3/1/2021 | Y | no | M | ||
| 1065703 | 3/2/2021 | KY | 34 | Miscarriage at approximately 7 weeks pregnant | 1/26/2021 | 2/12/2021 | 17 | PVT | fluoxetine, pre-natal vitamins | none | none | 2 | 3/2/2021 | Y | none | M | ||||
| 1065910 | 3/2/2021 | MA | 34 | Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage. The patient's medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy. On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter's Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient's detailed medical history including any trauma and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable. | 12/30/2020 | 12/30/2020 | 0 | UNK | PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; BONJESTA | Medical History/Concurrent Conditions: Miscarriage (18 May 2021); Pregnancy (live birth on 21 Feb 2016); Pregnancy (live birth on 08 Mar 2018) | USMODERNATX, INC.MOD20210 | 2 | 2/22/2021 | M | ||||||
| 1066049 | 3/2/2021 | ND | 33 | Reported by patient to have been 9.5weeks pregnant when miscarriage happened. | 1/6/2021 | 2/21/2021 | 46 | Ultra sound confirmed but dates not reported. No medical intervention reportedly needed to complete miscarriage. | PUB | prenatal vitamins | none | none | 2 | 3/2/2021 | Y | NKA | M | |||
| 1066456 | 3/2/2021 | UT | 32 | 1st dose: 037K20A Dec 30, 2020 - 5 weeks along, date of miscarriage 1/12 arm pain swelling itching for a few days, fatigue aches, fevers, nausea, no vomitting, joint pain, my entire body hurt inside and out, chills, I also didn't sleep well, I was alternating tylenol and motrin, I drank lots of fluids I called my employee health for my symptoms I didn't go to the Dr. symptoms only lasted about 48 hours | 1/27/2021 | 1/27/2021 | 0 | no | PVT | folic acid | no | exercise induced asthma, migraines | vsafe | 2 | 3/2/2021 | strawberries, seasonal | M | |||
| 1069793 | 3/3/2021 | NY | 27 | 1/8 vaccination HA went away after a week bleeding in between vaccinations ultra sounds weekly, blood work 1st went to ER, 2nd bleeding episode went to PCM for same day visit 2/2 miscarriage, D&C | 1/8/2021 | 2/2/2021 | 25 | blood work | PUB | n/a | n/a | asthma | VSAFE | 2 | 3/3/2021 | Y | Y | n/a | M | |
| 1069822 | 3/3/2021 | NY | 27 | 2/12 vaccination 2/13 woke up with flu like symptoms; fever, body chills, muscle aches. Symptoms lasted for 24 hours. HA started sat morning and still persisting daily. I have to Excedrin daily. | 2/12/2021 | 2/13/2021 | 1 | n/a | PUB | n/a | *miscarriage 2/2/2021 **D&C 2/11/2021 | asthma | COVID, 1st vaccine; Miscarriage | VSAFE | 2 | 3/3/2021 | n/a | M | ||
| 1070733 | 3/3/2021 | NC | 30 | miscarriage; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose on 08Jan2021 in right arm and 1st dose on 15Dec2020 in left arm, both via intramuscular at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took amoxicillin and experienced allergy. Concomitant medication included prenatal vitamins. The patient experienced miscarriage on 11Jan2021 with outcome of recovered. The event resulted in doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 11 weeks pregnant at the onset of the event. The mother was due to deliver on 07Aug2021. Date of LMP was 26Oct2020. Therapeutic measures were taken as a result of miscarriage included misoprostol (CYTOTEC). Information of lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Considering the product-event temporal relationship, a causal association between the reported 'miscarriage' and the administration of bnt162b2 cannot be completely excluded. Case will be reassessed once with additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. | 1/8/2021 | 1/11/2021 | 3 | PVT | USPFIZER INC2021182471 | 2 | 3/3/2021 | Y | M | |||||||
| 1070770 | 3/3/2021 | TX | Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus. This is a fetus report. A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D), folic acid (FOLATE), ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg, all transplacental. It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter, different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21, fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21. | 2/4/2021 | 2/1/2021 | Test Date: 20210203; Test Name: heartbeat; Result Unstructured Data: Test Result:152 bpm; Test Date: 20210220; Test Name: heartbeat; Result Unstructured Data: Test Result:no heartbeat; Test Date: 20210203; Test Name: ultrasound; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210220; Test Name: ultrasound; Result Unstructured Data: Test Result:fetus stopped growing | PUB | VIT D; FOLATE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; ZOLOFT | USPFIZER INC2021225027 | 2 | 3/3/2021 | Y | M | |||||||
| 1070952 | 3/3/2021 | NE | 37 | I was not pregnant at the time of the first vaccine, but was pregnant at the time of the second vaccine. I had a miscarriage on 2/24/2021 | 12/21/2020 | 2/23/2021 | 64 | N/a | WRK | Prenatal vitamin, magnesium, fluoxetine, Allegra, nexium, unisom | N/a | Chronic migraine , iron deficiency anemia | 2 | 3/3/2021 | Allergies to penicillin and the nuva ring. | M | ||||
| 1071787 | 3/4/2021 | KY | 34 | Miscarriage after 2nd dose given | 12/1/2020 | 2/1/2021 | 62 | PVT | Synthroid, Prozac, vitamin d, vitamin b complex, melatonin, guanfacine, theracurmin, prenatal vitamin, prebiotic, miralax, stool softener, pepcid | Hashimotos | 2 | 3/4/2021 | Y | M | ||||||
| 1073958 | 3/4/2021 | MN | 31 | This was an IVF pregnancy. My 2nd pregnancy. I got my first positive pregnancy test on Jan. 27th at exactly 4 weeks pregnant. I received my first vaccine at 4 weeks 4 days. I then went in for my first ultrasound at 6 weeks 5 days. The doctor told me the baby wasn?t developed normally and a miscarriage had already started. I believe the gestational sac measured about 5 weeks 3 days. | 1/31/2021 | 2/15/2021 | 15 | Ultrasound on February 15th HCG levels February 15th Ultrasound on February 18th HCG levels February 18th HCG levels February 25th | OTH | Progesterone in oil, estradiol patches, baby aspirin, prenatal vitamin, vitamin D | None | Nine | 2 | 3/4/2021 | Y | None | M | |||
| 1075320 | 3/5/2021 | CA | 34 | I ended up on Sunday night (48 hours later) having a lot of contractions. More than 8 in an hour. I called the DR and they told me to go to LABOR/DELIVERY to be monitor contractions. They determined I was going into pre-term labor. They gave me an injection to try to stop the contractions. It worked. They monitored for me a bit longer and I went home. March 29, 2021 - estimated date of delivery; This is my third pregnancy. I have one other living child and one pregnancy ended in miscarriage. I had developed gestational hypertension - after the vaccines. | 1/29/2021 | 1/31/2021 | 2 | Urine test - normal | PVT | 25mg Zoloft; 2 baby aspirin a day; Prenatal Vitamin | no | no | vsafe | 2 | 3/5/2021 | Y | no | M | ||
| 1075754 | 3/5/2021 | CA | 37 | I had some arm soreness that started the morning after (22nd) and that lasted until the 27th of January....it got better each day. I had fever to 102 that started on the 22nd. The fever ended on 23rd. I took Tylenol - it didn't help on the 22nd but by 23rd it did. I felt fatigue -22nd and went away on 24th. I miscarried 27th-29th -30th- that timeframe. The miscarriage prompted care. I went to Medical Center. I was not pregnant at time first vaccination. Estimated date of delivery had been - September 22, 2021; I have no prior pregnancy history. | 1/21/2021 | 1/22/2021 | 1 | These were at Medical Center I was having serial beta HCGs done - I had my first one on the 19th of January - 170 MIU per ml; 21st - 250 MIU per ml; 25th of January - 330 MIU per ml; 27th of January - 404.8 MIU per ml; 29th of January - 478 MIU per ml;, I think I had one the first or second of February but don't have the results - think that was lower. February 8 - 2 MIU per ml I had my thyroid test done on the January 19th - my TSH was 3.85 UIU per ml; I had a free T4 - 1.35 ng/dl | PVT | Levothyroxine; prenatal vitamins | -adverse symptoms from December 24's first dose of COVID vaccine - headache - three hours and arm soreness that lasted until the 28th. -no other acute symptoms | no | vsafe | 2 | 3/5/2021 | Y | no | M | ||
| 1078957 | 3/7/2021 | CT | 30 | Found out pregnant in between doses 1 (12/21)and (1/11). Lmp 12/13/2020. Was informed on 7 week ultrasound the fetal heart rate was low and Miscarriage likely. Miscarriage 2/4/2021. | 12/21/2020 | 2/4/2021 | 45 | Ultrasound | UNK | Prenatal | Migraine | 2 | 3/7/2021 | Y | Antibiotics | M | ||||
| 1080262 | 3/8/2021 | TX | 38 | Mar 5-2:30pm: arm began to feel sore. Mar6-12:00am I can barely lift my left arm above chest level. The soreness has traveled from the injection site down to my wrist and fingers. The injection site is slightly pink, not really noticeable, and warm to the touch. I start to feel a little nauseous and also starting to get body aches and chills. From 12:00am-4:00am i constantly wake up because of arm soreness and body aches. At 4:00am, I woke up to use the restroom and realized even the bottom of my feet hurt with every step I took. Took my temperature and it was at 101.5. I went back to bed and fell asleep even though I kept waking. At 7:00am, the migraine started. I was trying to avoid taking meds just to be able to get a clear picture of how my body responds to the vaccine, But by 9:30am (22hrs post vaccine) I ended up taking Tylenol for severe migraine. It feels like someone is stabbing my temples with a very sharp object. Turning or even slightly moving my head strengthens the migraine. My arm is still so sore that I can barely move it! Tylenol brings temperature down to 100.7°. 10:30am I began with extreme fatigue. By 12:30pm I went back to bed because I couldn?t stand my body aches and migraine. I slept until 4:00pm woke up feeling a little better. Migraine was still there but not as bad. At 8:00pm I began to feel pressure on my chest. That pressure slowly turned into pain. By 9:20pm I was in excruciating pain, I was in tears and I literally thought I was going to die. It hurt to breath. I checked into the ER by 9:30pm the pain was sharp and it would come, last a few minutes, then slowly ease off a bit. On a scale of 1-10 if was definitely a TEN!!!! The ER said it wasn't cardiac so they sent me home. The DR did say that the chest pain could have possibly been caused by the vaccine, as many have seen different symptoms and everyone has reacted differently. I was home by 1:15am. The pains continued until 3:00am. By 8:30am on Sunday Mar 7, the only thing I was suffering from was soreness in the arm and my chest was sore from the pain. The pain in my chest was a 1 or 2 compared to the 10 that it was when I went to the ER, And that pain/discomfort has lingered all day. I?m currently 22weeks 4days pregnant with a boy and expected to deliver July 7th. I?ve been pregnant 19 times have 4 living children and suffered 14miscarriages. | 3/5/2021 | 3/6/2021 | 1 | MIL | None | Started with Covid symptoms Jan 24 but multiple test came back negative until Feb 6 when I tested positive. | Asthma, IgA deficiency with zero traces of IgA, skin cancer, TBI, PTSD. | 2 | 3/8/2021 | Y | None | M | ||||
| 1082396 | 3/8/2021 | CA | 38 | Patient suffered a miscarriage about 9 days after getting a covid vaccine. | 2/16/2021 | 2/25/2021 | 9 | Procedure on 3/8/21 for miscarriage management | OTH | Prenatal vitamin, levothyroxine | none | hypothyroidism, depression, prediabetes | 2 | 3/8/2021 | Y | NKDA | M | |||
| 1084312 | 3/9/2021 | ID | 29 | Fever of 102.4, chills, hard time breathing, body aches lasted about 5 hours until I fell asleep, woke up the next morning at 8:00 AM with body aches | 2/24/2021 | 2/24/2021 | 0 | 6 weeks pregnant at the time of second vaccine 2/23, miscarriage 3/5. | PVT | Prenatal vitamin | None | None | 2 | 3/9/2021 | None | M | ||||
| 1084690 | 3/9/2021 | CA | 26 | Miscarried. Due date had been Sept 16, 2021. This was my first pregnancy. | 1/14/2021 | 2/1/2021 | 18 | Just basic labs - during my pregnancy everything came back normal February 2 - Hospital - After back miscarriage - HCG - that was low but that is to be expected; ultrasound; technically I went to ER but it wasn't a regular ER visit as my doctor doesn't take miscarriages in | PVT | Multi-vitamin | no | no | vsafe | 2 | 3/9/2021 | Y | no | M | ||
| 1085314 | 3/9/2021 | TX | 46 | Exactly a week after the vaccine shot, I started a very heavy menstural period. It was not time yet. I am on birth control pills and I am very regular. It's been a week and I am still on a heavy period. It was so bad that I purchased a pregnancy test because I was having a miscarriage. Test was negative. | 2/23/2021 | 3/2/2021 | 7 | None | PVT | Over the Counter Probiotics, prescribed Vitamin D, Iron (not taken daily), Yaz (generic) Birth Control Pills and I get allergy shots every 7-14 days | None | Poly Cystic Ovarian Syndrome, seasonal allergies, migraines | 2 | 3/9/2021 | None | M | ||||
| 1085357 | 3/9/2021 | PA | 33 | The day after vaccine administration, I had flu-like symptoms of muscle pain, headache, minor nausea. A couple weeks after my second dose of the vaccine, I found out I was pregnant - 2/24/2021. Based on ovulation tests, I likely conceived on 2/9/2021, which was prior to my second dose, but after my first dose. This may be unrelated, but I had a miscarriage at 6 weeks pregnancy this Sunday, 3/7/2021. | 2/16/2021 | 2/17/2021 | 1 | hcg level taken at facility 3/8/2021: 105 mIU/mL. Scheduled to have another blood test done tomorrow to check trend of hcg level. | PVT | enoxaparin injections 94 mg daily, fluoxetine 20mg/daily, biotin, prenatal vitamin with folic acid | Antiphospholipid Antibody Syndrome | 2 | 3/9/2021 | the pill form of N plate, used for ITP | M | |||||
| 1086358 | 3/9/2021 | NY | 37 | Janssen COVID-19 Vaccine EUA High fever started 9 hours after vaccination, continued until 24 hours after vaccination. Nausea and dizziness started 9 hours after vaccination, continued until 12 hours after vaccination. 5 weeks pregnant- spotting started 25 hours after vaccination. No proven correlation between potential miscarriage and Vaccine. Generalized, spotty red rash, slightly raised, no itch, on the front torso, from top of legs, groin area, up to shoulders, on front torso only (not on arms or back) 33 hrs after vaccination. | 3/8/2021 | 3/8/2021 | 0 | SCH | Pre-natal vitamins L Theanine CoQ10 Fish Oil | None | None | 2 | 3/9/2021 | Y | Allergic to Lipstick and scented hair products | M | ||||
| 1086384 | 3/9/2021 | TX | 36 | On the following day after receiving my first dose of the vaccination, my arm was throbbing, completely swollen, decreased ROM and skin was RED and severely tender to the touch. Took OTC Tylenol (2) po and had no signs of relief. Pain , swelling, and skin redness lasted for 3 days. On February 10th, 2021 I had a positive pregnancy test (confirmed by bloodwork and urine) which indicated I was 6-7 weeks pregnant and had a miscarriage on March 2021, after giving live births 3 prior times. The cause of the miscarriage is unknown. I also developed a blood clot on the arm that was inserted for an IV. I have no family history or personal history of needing blood thinners. | 1/5/2021 | 1/5/2021 | 0 | WRK | Supplements: Vitamin D3 k2 Iron Prescriptions: Adderall 20mg Adderall 30mg | None | NONE | 2 | 3/9/2021 | Y | Mushroom allergy | M | ||||
| 1087386 | 3/10/2021 | 37 | Patient received the Moderna COVID Vaccine on 29 January, at which time she was 7 weeks pregnant. No other comorbities noted. On 01 February she had a miscarriage. She also received the first dose while pregnant, first dose was given on 30 December 2020 and she was 3 weeks pregnant | 1/29/2021 | 2/1/2021 | 3 | none | MIL | Pre natal | None noted | None | 2 | 3/10/2021 | Y | None | M | ||||
| 1087526 | 3/10/2021 | NJ | 33 | I received my second vaccination in the morning on 02-04-21. I visited my OBGYN that afternoon learned that I was approximately seven weeks pregnant, and that my baby was healthy with a heartbeat, I returned to the OBGYN four weeks later for my routine visit and leaned that the fetus had died around week 8, which was approximately one week after receiving the vaccine. I had no other issues or complications that would have contributed to my miscarriage. | 2/4/2021 | 2/1/2021 | Ultrasound. on 03-04-21. DC/DE surgery on 03-09-21. | PUB | Pre Natal Vitamin | None | None | 2 | 3/10/2021 | Y | Y | Sulfa Drugs | M | |||
| 1089690 | 3/10/2021 | NJ | 40 | Miscarriage | 3/1/2021 | 3/10/2021 | 9 | PUB | 2 | 3/10/2021 | Y | Seafood | M | |||||||
| 1089763 | 3/10/2021 | MA | 40 | 1. Joint pain start 02112021 end 02222021 2. Skin rash and itchy start 02182021 and faded overtime. 3. Pregnant 02172021?miscarriage 03072021 | 1/26/2021 | 2/11/2021 | 16 | Hug test 03/08/2021 and 03/10/2021 | PVT | Prenatal vitamin | None | None | 2 | 3/10/2021 | Y | None | M | |||
| 1090296 | 3/10/2021 | UT | 28 | Miscarriage | 2/8/2021 | 2/12/2021 | 4 | PHM | Omeprazole, buspar, lexapro | None | Gerd | 2 | 3/10/2021 | Y | None | M | ||||
| 1090217 | 3/11/2021 | TX | 39 | Miscarriage; This is a Spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report. A 39-year-old female consumer reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9269), via an unspecified route of administration at left arm on 04Feb2021 14:00 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. No other vaccine in four weeks. Concomitant medications included (in two weeks) Prenatal vitamin, colecalciferol (VITAMIN D), folic acid (FOLATE) and sertraline hydrochloride (ZOLOFT 25mg). The patient's last menstrual date was 14Dec2020 and the delivery date was on 17Sep2021 (Gestational period: 8, as reported). An OB exam on 03Feb2021 showed healthy baby at 7w5d- heartbeat detected 152bpm; no abnormalities identified via ultrasound, Labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine 04Feb2021. Per ultrasound on 20Feb2021, fetus stopped growing on 09Feb2021 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb2021. AE resulted in Emergency room/department or urgent care, congenital anomaly (as reported). No treatment was administered. No COVID prior vaccination. Patient not COVID tested post vaccination. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225027 fetus case | 2/4/2021 | 2/22/2021 | 18 | Test Date: 20210203; Test Name: heartbeat; Result Unstructured Data: Test Result:152 bpm; Test Date: 20210220; Test Name: heartbeat; Result Unstructured Data: Test Result:no heartbeat detected; Test Date: 20210203; Test Name: hormone levels; Result Unstructured Data: Test Result:normal ranges. No issues detected.; Test Date: 20210203; Test Name: OB exam; Result Unstructured Data: Test Result:showed healthy baby at 7w5d; Test Date: 20210203; Test Name: Labs; Result Unstructured Data: Test Result:normal ranges. No issues detected.; Test Date: 20210203; Test Name: ultrasound; Result Unstructured Data: Test Result:no abnormalities identified; Test Date: 20210220; Test Name: ultrasound; Result Unstructured Data: Test Result:fetus stopped growing on 09Feb21 (8w4d) | UNK | VITAMIN D; FOLATE; ZOLOFT | Medical History/Concurrent Conditions: Penicillin allergy | USPFIZER INC2021204433 | 2 | 3/9/2021 | Y | M | ||||
| 1090818 | 3/11/2021 | CO | 33 | My last period was Jan 7, 2021. Received Vaccine, dose 2 on 1/25/21 (I did not know I was pregnant at that time). Had a miscarriage and lost baby Feb 18-21 | 1/25/2021 | 2/18/2021 | 24 | PVT | 2 | 3/11/2021 | Y | M | ||||||||
| 1094454 | 3/12/2021 | PA | 34 | I experienced a miscarriage on February 27th, 2021. I was approximately 10 weeks pregnant when I experienced the miscarriage. It was accompanied by severe pain/cramps in the abdomen and lower back. Expected delivery would have been in September 2021. This was my first pregnancy. | 2/11/2021 | 2/27/2021 | 16 | I had my blood drawn, an ultrasound, and a pelvic exam in the Emergency Room on 2/27/2021. Results were consistent with incomplete miscarriage at that time. No other abnormalities were noted. | SCH | prenatal vitamins with choline tablet (One-A-Day) Calcium supplement with Vitamin D | none | none | 2 | 3/12/2021 | Y | Y | none | M | ||
| 1095528 | 3/12/2021 | CA | 35 | Started bleeding the 17th, went to the doctor OB/GYN office and had an Ultrasound - I was supposed to be measuring at 8 weeks and I was measuring at 6 weeks. Miscarried. My due date 9/26/2021 would have been due date; That was my fifth pregnancy. That was my 3rd miscarriage. I have had two full term vaginal deliveries. | 2/2/2021 | 2/17/2021 | 15 | Ultrasound - 17th Beta HTG level | PVT | prenatal vitamin | Husband and son had COVID in December - but I tested negative and had negative antibodies to COVID - and I never had any symptoms except a headache | no | vsafe | 2 | 3/12/2021 | Y | no | M | ||
| 1096648 | 3/13/2021 | MI | 43 | After my second dose Pfizer vaccine, on the day or day after I suffered a miscarriage. | 1/26/2021 | 1/26/2021 | 0 | PVT | vsafe | 2 | 3/13/2021 | Y | M | |||||||
| 1096812 | 3/13/2021 | KS | 34 | After my second dose I had a miscarriage but it was identified on 02/22/2021, I was 11 weeks pregnant and I had no complications with my pregnancy, Before my 1st dose my platelet blood count was at 400 then after my 1st dose it went to 538. | 2/3/2021 | 2/22/2021 | 19 | Blood work- platelet blood count elevated | MIL | Zyrtec | vsafe | 2 | 3/13/2021 | Y | Y | M | ||||
| 1096971 | 3/13/2021 | AZ | 36 | I had abdominal pain and bleeding. I suffered a miscarriage. | 2/20/2021 | 2/23/2021 | 3 | Labs were drawn about a week later looking for HCG. | PVT | I was taking prenatal vitamins, a probiotic, vitamin D and magnesium. | No | No | vsafe | 2 | 3/13/2021 | No | M | |||
| 1097090 | 3/13/2021 | 39 | A couple of minutes of having the vaccine I started having heart palpitations. I didn't see much of it so I left but it kept on going for the next couple of days then on the following Sunday I ended up going to the urgent care & they sent me to the Emergency room from there. On march 1st I had a miscarriage I was 6 weeks pregnant, There was some questions when I found out I was pregnant to see if I was going to have some issues or not. | 2/18/2021 | 2/18/2021 | 0 | EKG- abnormal (urgent care) EKG- abnormal (ER) Blood work- Normal (ER) long heart CT Scan- normal (ER) | PVT | zoloft | Depression Anxiety Ehlers syndrome | vsafe | 2 | 3/13/2021 | Y | Demerol | M | ||||
| 1098925 | 3/14/2021 | UT | 27 | I received the vaccination on Friday and on Sunday my bleeding increased. I already had some mild bleeding that had been constant since Feb 23rd or 24th. But I had an appointment on Feb 26th that confirmed I had a baby with a healthy heartbeat. I was also diagnosed with a very small uterine cyst. They told me the cause of the bleeding was pro ant implantation bleeding. I had light bleeding (bleeding just needing one or two pant liners each day) until Sunday the 7 when I saw an increase in bleeding. I called my doctor on Tuesday (I decided not to call Monday because I felt I would get the same answer I had already gotten, which was that everything was fine) and they had me come in die an urgent same day appointment. At that appointment I learned my baby did not have a heartbeat. The baby was measuring at just over 8 weeks. The due date given to me based on my last period was October 12th. So I was exactly 9 weeks when I went into the appointment Tuesday to find out the baby didn?t have a heartbeat. I officially miscarried the embryo and the placenta on Friday March 12th. This would have been my second baby. My first is a male and he is 18 months old. My first pregnancy didn?t have any complications. I do not have a history of miscarriage in my family, and this was the first one I have had. I did have to take 150mg of Clomid to get pregnant with this baby. | 3/5/2021 | 3/7/2021 | 2 | I just had an ultrasound on Tuesday March 9th. | SCH | Prenatal Vitamin, Co-Q10 vitamin, and probiotics. | 2 | 3/14/2021 | Y | M | ||||||
| 1099240 | 3/14/2021 | NY | 32 | Complete spontaneous Miscarriage at 6 weeks and 5 days | 12/30/2020 | 3/11/2021 | 71 | Serial hcg on 3/4/2020 and 3/11/2020 | UNK | Prenatal | None | Mild intermittent asthma, season and environmental allergies | 2 | 3/14/2021 | Y | Aspirin, nsaids, sulfa | M | |||
| 1100545 | 3/15/2021 | OH | miscarriage after receiving both doses of COVID19 vaccine; This is a spontaneous report received from Pfizer sponsored program from a contactable consumer reported for self. A female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient is pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient had a miscarriage after receiving both doses of COVID-19 vaccines. The patient received no treatment. The outcome of event was unknown. Information about lot/batch number has been requested. | UNK | USPFIZER INC2021243074 | 2 | 3/10/2021 | M | ||||||||||||
| 1101580 | 3/15/2021 | TX | 26 | I received my second dose Pfizer vaccine 01-27-2021. I found out I was pregnant the beginning of March 2021. On 03-10-2021, I found out I was having a miscarriage. I am in the process of recovering. | 1/27/2021 | 3/1/2021 | 33 | SEN | Zyrtec | vsafe | 2 | 3/15/2021 | Y | M | ||||||
| 1103353 | 3/15/2021 | IL | 35 | Miscarriage 2 weeks after receiving the first dose (March 1, 2021). Baby had a heart beat, then slowly died. Ultra Sound Showing Fetal Bradycardia on 2/26/21. | 2/15/2021 | 3/1/2021 | 14 | Ultra Sound, Blood work on 3/1/21 (No fetal heart tones) Ultra Sound confirming no heart beat 3/8/21 Blood Transfusions on 3/5/21 Dilation and Curettage on 3/8/21 | PUB | Pre-Natal Vitamins | None | None | 2 | 3/15/2021 | Y | Y | Augmentin, Vancomycin | M | ||
| 1104214 | 3/16/2021 | MA | 31 | I was 9 weeks and 2 days pregnant with my first pregnancy (no history of miscarriages) when I received my first dose of the Moderna vaccine on 1/9/2021. I had a routine appointment with my OB-GYN the day prior, 1/8/2021, during which they completed a routine ultrasound. At that time, the ultra sound was completely normal with a healthy fetus and heart rate, and my due date was estimated to be 8/13/2021. Also at that time, I was advised by my OB-GYN to get the COVID vaccine, when offered to me, given my higher risk of contracting COVID due to my job as a healthcare worker with direct patient contact, and my higher risk for more severe illness if I contracted COVID due to pregnancy. I received the vaccine the next day with no immediate adverse reactions/events aside from some considerable arm soreness at the site of the vaccine and fatigue. Then 2 weeks and 6 days later I had another routine appointment with my OB-GYN (1/29/2021) at which point in time I was 12 weeks and 1 day pregnant. During this visit they conducted a second routine ultrasound. From this ultra sound they identified multiple abnormalities including an increased nuchal translucency of 3.5 mm, absent nasal bone, and presence of fluid around the fetus?s abdomen. These abnormalities were concerning for a chromosomal/genetic abnormality. Given these concerns I had labs drawn for maternal carrier screening (the Panorama and the Horizon 274), and I was referred to maternal fetal medicine for further imaging and testing. The results of the lab work took approximately 2 weeks to receive, but they came back normal without increased risk identified for any of the chromosomal/genetic conditions tested. I was seen by a high risk doctor and a genetic counselor within the maternal fetal medicine department on 2/2/2021. At this appointment I had a third ultrasound completed which confirmed the presence of an increased nuchal translucency now 4.3mm, and also found the presence of a cystic hygroma. These findings were again consistent with concerns for a chromosomal, genetic or other anatomical/structural condition and as such I had a chorionic villus sampling done that same day to assess the DNA of the fetus. These results also came back all normal without concern for any of the chromosomal or genetic conditions tested. I then had a follow up appointment and ultrasound with the maternal fetal medicine department on 2/19/2021, at which point I was 15 weeks and 1 day pregnant. This early anatomical scan revealed even more concerning findings with the fetus?s humerus measuring in the 1st percentile for gestational age and the fetus?s femur measuring in the 3rd percentile for gestational age. Per consultation with our genetic counselor this was indicative or some severe condition; however, it was not clear exactly what condition. Given the severity of the findings it was recommended to terminate the pregnancy. As such I had to undergo a dilation and evacuation procedure on 2/24/2021. We are currently still awaiting results of further genetic testing (exome testing), the results of which can take 2-3 months from the time of sending out the labs (sent out around 2/24/2021). | 1/9/2021 | 1/29/2021 | 20 | Ultrasound 1/29/2021: increased nuchal translucency of 3.55mm, absent nasal bone, fluid around fetus?s abdomen. Abnormalities concerning for chromosomal/genetic condition. Panorama and Horizon 274 maternal carrier screenings 1/29/2021: normal without increased risk identified for any of the chromosomal/genetic conditions tested Ultrasound 2/2/2021: increased nuchal translucency now 4.3mm, and also found the presence of a cystic hygroma. Abnormalities concerning for chromosomal/genetic condition not yet tested. Chorionic villus sampling 2/2/2021: all results normal without concern for any of the chromosomal or genetic conditions tested. Ultrasound 2/19/2021: the fetus?s humerus measured in the 1st percentile for gestational age and the fetus?s femur measured in the 3rd percentile for gestational age. Dilation and evacuation 2/24/21: awaiting results of pathology report from procedure. Exome testing 2/24/21: awaiting results of testing, can take 2-3 months to receive. | WRK | Acyclovir 400mg 1x/day, Ritual essential prenatal vitamin 2 capsules/day, and Folic acid 3mg 1x/day. | None. | Cold sores, headaches/migraines | 2 | 3/16/2021 | Y | Flagyl- fever and diarrhea. Bee stings - toxic reaction (no anaphylaxis). | M | |||
| 1104476 | 3/16/2021 | WA | 36 | Miscarriage: LMP 11/17/20, diagnosis of MAB on 1/26/21. Chromosomal testing of the embryo determined cause of miscarriage to be trisomy 12. Prior to this most recent miscarriage I had 3 previous miscarriages and 1 live birth (1 living child). To be clear, I do not blame the vaccine for the miscarriage, the chromosomes of the embryo were determined before I got my first Covid vaccine. | 1/9/2021 | 1/26/2021 | 17 | Genetic testing of embryo showed trisomy 12. | PVT | Sertraline 200mg daily Trazodone 25mg nightly Prenatal vitamin | None | Depression/Anxiety Recurrent miscarriages | 2 | 3/16/2021 | Y | No known allergies | M | |||
| 1104712 | 3/16/2021 | TX | 31 | Miscarriage after vaccine. I was 11 weeks pregnant. Estimated date of delivery is 9/20/21. | 3/6/2021 | 3/9/2021 | 3 | PVT | 2 | 3/16/2021 | Y | M | ||||||||
| 1105105 | 3/16/2021 | TX | 38 | 1. Fevers 2. Chills 3. Body aches 4. Soreness at site of injection 5. Deliriousness 6. Extreme weakness Symptoms Lasted for about 48 hours post vaccination time. Was pregnant at the of the second shot (4 weeks pregnant - 01/12/2021). Expected due date was 09/15/2021. Had a sound heartbeat at 8 weeks (02/11/2021). Lost the heartbeat at 12 weeks(03/03/2021). Had a natural miscarriage at 13 weeks (03/09/20201). | 1/12/2021 | 1/12/2021 | 0 | Sonogram performed to assess heartbeat on 02/11/2021. Sonogram performed to confirm loss of pregnancy on 03/03/2021 | SCH | 2 | 3/16/2021 | M | ||||||||
| 1106442 | 3/16/2021 | OK | 33 | Within 24 hour I began to bleed and ultimately had a complete miscarriage of baby. I was at 6 weeks, with 2 healthy children (3 1/2 and 1 1/2 years old) with no prior pregnancy issues or complications. | 2/24/2021 | 2/25/2021 | 1 | HCG level checks until zero to confirm pregnancy loss. | PVT | Prenatal vitamin | No | No | 2 | 3/16/2021 | Y | Sulfa and Chlordexidine | M | |||
| 1107257 | 3/17/2021 | 34 | Miscarriage; Pregnant at time of vacciation; Pregnant at time of vacciation; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient (16 weeks pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced miscarriage at a routine OBGYN visit on 19Feb2021. The patient was hospitalized for the miscarriage on an unknown date for 2 days. The clinical outcome of the event miscarriage was unknown. The patient had not had COVID prior to the vaccination and has not tested positive post vaccination. Information about lot/batch has been requested. | 1/29/2021 | 1/29/2021 | 0 | OTH | USPFIZER INC2021223221 | 2 | 3/12/2021 | Y | M | ||||||||
| 1107944 | 3/17/2021 | TX | 35 | After Dose1 I was 10 weeks pregnant went to doctor for sonogram. I went to doctor heart rate 160 doctor stated everything was fine I could start telling everyone I wa pregnant. On 2/5 I started having a miscarriage the fetus was 12 weeks. My blood work was good no abnormalities from the enzymes.(estimated of delivery 8/17/2021) | 1/22/2021 | 2/5/2021 | 14 | Sonogram, Bloodwork ABG level | OTH | Labetalol 200 mg | No | High blood pressure | vsafe | 2 | 3/17/2021 | Y | No | M | ||
| 1108773 | 3/17/2021 | IN | 30 | I suffered a miscarriage at 7 weeks 4 days. Miscarriage occurred on 1/23/21. Vaccination 1 was on 12/26/20 & Vaccination 2 was 1/12/21 | 12/26/2020 | 1/23/2021 | 28 | Miscarriage confirmed on 1/25/21 | WRK | Wellbutrin XL 300 mg once daily prenatal vit daily | none | depression | 2 | 3/17/2021 | Y | none | M | |||
| 1109162 | 3/17/2021 | MN | 28 | Miscarriage of baby due on 10/3/21. | 1/28/2021 | 3/2/2021 | 33 | Received 1st vaccine on January 7. Confirmed pregnant at facility on January 26. Received 2nd vaccine on January 28 (4w4d pregnant). Began bleeding on March 2. First ultrasound at Clinic when seen for bleeding (on March 7) measured gestational sac at 6w4d, was 10w at the time. HCG levels at 13,200. Seen at Clinic on March 8, HCG levels at 9,000. Passed gestional sac on March 11/12. Ultrasound done on March 15 showed no gestational sac. | PVT | Prenatal vitamin Nasacort nasal spray Pantoprazole Tylenol prn | Asthma, gerd | Cellulitis in arm from Pneumovax | 2 | 3/17/2021 | Y | Y | Latex, penicillin, poppy seeds | M | ||
| 1109887 | 3/18/2021 | patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; fetal cystic hygroma; This is a spontaneous report from contactable consumers (one of them is patient herself) communicated to a Pfizer sales representative. A 32-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, first dose on 18Dec2020 (first dose given pre/peri conception), second dose on an unspecified date in 2021 (second dose given around 4 weeks gestation); both at single dose for COVID-19 immunization. This is my daughter and grandchild. The patient's medical history and concomitant medications were not reported. The patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020. The conception date was reported as 01Dec2020. The patient underwent lab test and procedures which included urine pregnancy test: Positive on 28Dec2020. Upon follow-up on 03Mar2021, it was reported that, miscarriage at 13 weeks gestation due to fetal cystic hygroma on 04Mar2021 05:30. The outcome of the event was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained. Follow-up (03Mar2021): New information received from a contactable consumer communicated to a Pfizer sales representative includes: New reporter (consumer), gestational period (13 weeks), suspect drug details (second dosage regimen), new event (fetal cystic hygroma) added. No follow-up attempts are needed. No further information is expected. | 12/18/2020 | 3/4/2021 | 76 | Test Date: 20201228; Test Name: urine pregnancy test; Test Result: Positive | UNK | USPFIZER INC2020516672 | 2 | 3/16/2021 | M | |||||||||
| 1110463 | 3/18/2021 | MI | 32 | Miscarriage determined at 19 weeks gestation on 3/10/2021. | 2/18/2021 | 3/10/2021 | 20 | WRK | 2 | 3/18/2021 | Y | M | ||||||||
| 1111960 | 3/18/2021 | GA | 34 | Miscarriage G3P2 2002 | 2/4/2021 | 2/18/2021 | 14 | Transvaginal US | PVT | Prenatal medicatiom | None | None | 2 | 3/18/2021 | Y | None | M | |||
| 1113620 | 3/19/2021 | CA | 38 | I was trying for a pregnancy and was likely pregnant but not detectable at vaccine number 1. Found out about pregnancy a week or so before vaccine 2. (I was likely about 5 weeks pregnant then based on LMP of dec 22 with avg cycles of 35 days. Decided to get vaccine due to general advice that it is okay during pregnancy. (No known adverse effects). After dose 2, had about 10-12 hours of chills without fever and general fatigue. Shortly afterwards experienced mild cramps. This is my 5th pregnancy and I have no history of complications of any sort. Cramps are not usual for my pregnancies but I know it can be normal so I did not think anything of it. Mild spotting occurred but again did not think anything of it as I know it can be normal. I was scheduled for a first OB visit Mar 3 where I should have been 10 weeks. (Initial positive pregnancy test was Jan 29). Ultrasound showed empty 5.6 week gestational sac with a yolk sac and subchorionic hemorrhage. OB suspected pregnancy failure. We followed pregnancy with ultrasound of better quality 10 days later which showed a possible fetal pole and yolk sac but no heart beat and gestational sac measured at 6.0 weeks. Today March 18 awaiting repeat ultrasound tomorrow but started bleeding and cramping. Consistent with the start of the miscarriage. With no histories of abnormal pregnancies and with the gestational sac consistently measure at 6 weeks (matching to about the time of shot#2), I am inclined to believe that the second covid shot stopped the progression of my pregnancy. I am a huge pro vaccine health care provider but would recommend now an investigation into first trimester covid vaccinations and possibly not recommend this during that time period. | 2/7/2021 | 3/3/2021 | 24 | Ultrasounds on March 3 and 12. May still ultrasound again March 19 although I am bleeding today consistently. | UNK | Prenatal | None | None | 2 | 3/19/2021 | Y | None | M | |||
| 1113942 | 3/19/2021 | 34 | miscarriage; pregnant patient received BNT162B2; pregnant patient received BNT162B2; This is a spontaneous report from a non-contactable consumer. This consumer (patient) that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: en6201) at the age of 34-years, via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient was pregnant at time of vaccination, last menstrual date was 21Jan2021. No other vaccine in four weeks, no COVID-19 prior vaccination. Concomitant medication included ustekinumab (STELARA). The patient experienced miscarriage on an unspecified date (on 03Feb2021, as reported). The pregnant patient received BNT162B2 on 20Feb2021. No COVID-19 tested post vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238716 Same product and AE , different patient | 2/20/2021 | 2/20/2021 | 0 | UNK | STELARA | USPFIZER INC2021238565 | 2 | 3/17/2021 | M | ||||||||
| 1114093 | 3/19/2021 | WA | 41 | Miscarriage | 3/16/2021 | 3/18/2021 | 2 | PHM | 2 | 3/19/2021 | M | |||||||||
| 1116359 | 3/19/2021 | OH | 34 | After my second vaccine, and few weeks later, I suffered a miscarriage on 02-18-2021. I went to see my OBGYN who performed an ultrasound. My baby at that time was 6 weeks old. | 1/25/2021 | 2/18/2021 | 24 | Ultrasound | PVT | vsafe | 2 | 3/19/2021 | Y | M | ||||||
| 1116526 | 3/19/2021 | WI | 25 | I experienced a missed miscarriage. I was pregnant during both doses of the vaccine (1st dose 1/15/21), but 2/12/21 (the day of the 2nd dose) was the day the gestational sac stopped growing. I was 8 weeks pregnant at this point. The ultrasound was on 2/17/21 and it was reported that I was supposed to be 8wk 6days, but gestational sac was only 8wk 1day. I was due on 9/23/21. My PCP encouraged me to get the vaccine, knowing that I was pregnant. So I did. Upon receiving my 2nd dose of the vaccine, I did not experience any symptoms and believe that my body was focused more on the vaccine than the development of the baby. Obviously I'm not positive that this was the cause, but I wanted to make it known, so I can hopefully prevent this from happening again, if the vaccine was indeed a contributor. | 2/12/2021 | 2/12/2021 | 0 | PVT | Prenatal Vitamin Folic Acid Vitamin D | N/A | N/A | 2 | 3/19/2021 | Y | N/A | M | ||||
| 1116562 | 3/19/2021 | 38 | Patient received first dose of Moderna vaccine on 1/15/21 and was not aware of pregnancy. On 2/12/21, she called and cancelled her 2nd dose appointment because she found out she was pregnant. On 3/16/21 she contacted the pharmacy to schedule a second dose vaccine appointment because she said she had a miscarriage. Called Moderna to report it and Moderna confirmed to give second dose past the 42 days cdc recommendation instead of restarting the series. Patient received 2nd dose on 3/17/21 and has a follow up appointment with OB/GYN on 3/20/21. | 1/15/2021 | 2/26/2021 | 42 | PHM | 2 | 3/19/2021 | Y | M | |||||||||
| 1117494 | 3/19/2021 | MN | 39 | I started experiencing flu-like symptoms at around 5 PM on 3/14/21. I was feverish and had chills, muscle aches, and a headache. I had very strong chills for a few hours and then I noticed that my resting heart rate was around 128 bpm at around 1:30 AM on 3/15/21. I was running a 100.6 fever at that time. My fever subsided in the morning and the headache persisted throughout the day, and I was very tired as I did not get much sleep the night before. I did not work that day (Monday, 3/15). At the time I was about 7 weeks pregnant. I noticed some very light spotting later in the day on 3/15, and then I continued spotting on 3/16. I consulted a midwife at the facility at 4 PM on 3/16/21 and took a blood test to measure my hCG hormone levels. The following day, 3/17, I received the results that I had a normal level of hCG hormone and normal hemoglobin levels. As the day continued, the spotting turned into bleeding, and eventually the bleeding became heavy starting around 4 PM. I received an ultrasound on 3/18/21 at 8 AM and later spoke with a midwife from facility at 11 AM that day, confirming that there was no viable pregnancy detected via ultrasound. I had lost quite a bit of blood at that point. I am, as of 8:35 PM on Friday, March 19th, still bleeding and experiencing the impact of miscarriage. | 3/14/2021 | 3/14/2021 | 0 | Blood test to determine hCG hormone levels conducted at facility, 3/16/21 at 4 PM Transvaginal ultrasound conducted at facility, 3/18/21 at 8 AM | PUB | Megafood Baby & Me 2 Prenatal multivitamin, Nordic Naturals Prenatal DHA Supplement, NatureMade Vitamin D3 supplement | N/A | N/A | 2 | 3/19/2021 | Y | IVP Contrast Dye (Iodine) | M | |||
| 1117511 | 3/19/2021 | TX | 33 | Adverse event: miscarriage Estimated date of delivery: October 2021 Pregnancy history: two previous pregnancies, carried full term, vaginal deliveries, healthy | 2/12/2021 | 3/9/2021 | 25 | HCG labs: 3/10 and 3/16 | WRK | Prenatal vitamins | None | None | 2 | 3/19/2021 | Y | Y | None | M | ||
| 1120233 | 3/21/2021 | VA | 34 | Persistent itching and burning began about one week after injection. The injection was given in a tattooed area of skin (full sleeve tattoo) and the lines of the tattoo became raised and irritated early on and is very uncomfortable. | 3/12/2021 | 3/19/2021 | 7 | SCH | Cymbalta, pre-natal vitamins | Miscarriage | Alpha-1 Antitrypsin Deficiency, Chronic Bullous Emphysema | 2 | 3/21/2021 | Sulfa drugs, Valium | M | |||||
| 1121865 | 3/22/2021 | WA | 33 | Began spotting 2 days after the vaccine, it progressed over two more days and just had first miscarriage at 2AM on 3/22/2021 | 3/18/2021 | 3/20/2021 | 2 | Going to Obgyn tomorrow | PUB | Prenatal, vitamin D, Claritin, stool softener | None | None | 2 | 3/22/2021 | Y | None | M | |||
| 1124086 | 3/22/2021 | NY | 42 | Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested. | 2/26/2021 | 3/2/2021 | 4 | Test Date: 20210304; Test Name: Covid PCR test; Result Unstructured Data: Test Result:Pending | PVT | USPFIZER INC2021240019 | 2 | 3/18/2021 | Y | M | ||||||
| 1124428 | 3/22/2021 | AZ | 32 | No previous history of miscarriages. Miscarriage began 4 weeks after first covid vaccine dose. Est. Date of birth October 2021 Unusual menstrual cycles following miscarriage. Unsure if there is any relation. | 2/25/2021 | 3/4/2021 | 7 | OTH | None | None | None | 2 | 3/22/2021 | Y | None | M | ||||
| 1124657 | 3/22/2021 | VA | 30 | Received 2nd dose of covid vaccine at 11 weeks, 6 days. Had follow up normal ultrasound at 12 weeks, 2 days. Missed miscarriage noted at 15 weeks, 1 day. Last measurement of baby noted to be 12 weeks, 6 days. Closely monitored during first trimester with no abnormalities noted. Normal ultrasound at 12 weeks, several days after baby stopped growing with fetal demise at some point there after | 2/9/2021 | 2/16/2021 | 7 | Autoimmune workup, genetic workup, D and E performed 3/8/2022 | PVT | prenatal vitamin | none | 2 | 3/22/2021 | Y | Y | Minocycline, clomid | M | |||
| 1127239 | 3/23/2021 | TX | 28 | Miscarriage confirmed on 3/23/2021 at approximately 5 weeks and 6 days. | 3/9/2021 | 3/22/2021 | 13 | Ultrasound 3/23/2021 | PHM | Prenatal vitamins | 2 | 3/23/2021 | Y | M | ||||||
| 1128192 | 3/24/2021 | OK | 31 | Pregnant with second child at first and second dose of the covid vaccine. Due date was 10/15/2011. I experienced a miscarriage at 9 weeks pregnant on 3/17/2021. | 1/19/2021 | 3/17/2021 | 57 | D and C procedure | PVT | Lupus | 2 | 3/24/2021 | Y | M | ||||||
| 1130755 | 3/24/2021 | VA | 36 | On 02-26-2021 I had a miscarriage, I found out my fetus had died during a pre-natal doctor's appointment. My fetus had expired before I received the first dose Pfizer vaccine. I believe it was coincidental and the Pfizer vaccine did not cause the miscarriage. After my miscarriage I was under heavy medication. | 2/10/2021 | 2/26/2021 | 16 | Ultrasound | OTH | vsafe | 2 | 3/24/2021 | M | |||||||
| 1134221 | 3/25/2021 | NJ | 48 | Pt reports: "feeling of itchiness across her entire body and 'burning on the inside.'" "Itchiness and a tightness in her throat" | 12/23/2020 | 12/23/2020 | 0 | 12/23/21 12 lead ECG - unremarkable 12/23/21 CBC/BMP - WNL Treated with: famotidine 20mg IVP Solu-MEDROL 40mg IVP Benadryl 25mg IVP Sodium Chloride 0.9% 1000mL IV bolus | PVT | Amlodipine 2.5mg PO daily Lipitor 20mg PO qHS Metformin 500mg PO daily KLOR-CON 8mEq PO BID Diovan-HCT 160-25mg 0.5tab PO daily Biotin 5mg cap PO daily Vitamin D3 5000 units PO daily | No known | Asthma Hyperlipidemia Hypertension Miscarriage - twice Prediabetes Preeclampsia | 2 | 3/25/2021 | Y | NKA | M | |||
| 1135569 | 3/25/2021 | PA | 30 | Early miscarriage; This is a spontaneous report from a contactable other health care professional (Patient). A 30-year-old female patient (pregnant, last menstrual date 19Jan2021, Delivery date: 26Oct2021, Gestational period 4 weeks) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269), via an unspecified route of administration on right arm on 19Feb2021 at 15:15 at the age of 30 years old at a single dose for COVID-19 immunisation at hospital. The patient's medical history included rheumatoid arthritis. There were no known allergies. Concomitant medications included prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced early miscarriage on 01Mar2021. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event early miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of rheumatoid arthritis are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | 2/19/2021 | 3/1/2021 | 10 | PVT | Medical History/Concurrent Conditions: Rheumatoid arthritis | USPFIZER INC2021289435 | 2 | 3/21/2021 | Y | M | ||||||
| 1136131 | 3/25/2021 | MA | 35 | Miscarriage at 6 weeks | 1/27/2021 | 2/25/2021 | 29 | Ultrasound showed missed miscarriage | PVT | Prenatal vitamins | none | Asthma | 2 | 3/25/2021 | Y | Penicillin allergy | M | |||
| 1137248 | 3/26/2021 | NE | 31 | I had a miscarriage on 3/23/2021 at 6.4 weeks pregnant. I received the vaccine when I was about 4 weeks pregnant. My estimated due date was Nov. 13, 2021. I went to the doctor to get blood drawn to test progesterone and HGC levels. That evening, I miscarried. We are doing testing to see what may have caused the miscarriage but I have not had a miscarriage in the past. On Sept 9, 2020 I experienced a chromosomal stillbirth of a baby boy. His death was due to triploidy which is a fatal chromosomal abnormality. | 3/1/2021 | 3/23/2021 | 22 | We are still testing the lab results. | SCH | Zoloft, 100 mg Prenatal vitamins | None | None | 2 | 3/26/2021 | Y | None | M | |||
| 1138434 | 3/26/2021 | NJ | 42 | Miscarriage at week 5 | 3/13/2021 | 3/19/2021 | 6 | Blood test taken March 22 and pregnancy test was negative (pregnancy test was positive March 16) | OTH | None | None | None | 2 | 3/26/2021 | Y | None | M | |||
| 1139170 | 3/27/2021 | CA | 36 | I discovered I was pregnant just after receiving the 2nd dose of the Moderna vaccine. I have had one pregnancy before, six years ago, that ended in a healthy, full-term child with no complications. I received the vaccine on Thursday morning. Thursday evening - Saturday morning I had extreme body aches, fever and night sweats, headache and grogginess. On Saturday evening, my miscarriage began. The estimated date of delivery would have been November 20, 2021. | 3/18/2021 | 3/20/2021 | 2 | PVT | None. | None. | None. | 2 | 3/27/2021 | Y | None. | M | ||||
| 1141203 | 3/28/2021 | OH | 32 | Moderna COVID?19 Vaccine EUA Received 1st vaccine Dec 29, 2020, received 2nd vaccine while unknowingly pregnant on January 27, 2021. Had chills, fatigue, body aches night of 2nd vaccination. Found out pregnant Feb 7, 2021 at 4 weeks pregnant. Had blighted ovum/anembryonic pregnancy with miscarriage March 12, 2021. | 12/29/2020 | 3/6/2021 | 67 | Ultrasound showing blighted ovum | PVT | Prenatal vitamin, vitamin D | 2 | 3/28/2021 | Y | Nkda | M | |||||
| 1141764 | 3/28/2021 | GA | 40 | Miscarriage | 1/1/2021 | 3/15/2021 | 73 | MIL | Miscarriage | 2 | 3/28/2021 | Y | M | |||||||
| 1143480 | 3/29/2021 | PA | 31 | Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. Concomitant medications included folic acid, iron (PRENATAL) and fluoxetine. The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) at the age of 31-years-old, intramuscular at right arm on 14Jan2021 at 12:30 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient was pregnant, her last menstrual period was on 19Dec2020. Her expected due date is on 25Sep2021 and gestational period was 7 weeks (also reported as 3). The patient experienced miscarriage and spotting on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. She was not tested for COVID post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of miscarriage and vaginal hemorrhage due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. | 2/4/2021 | 2/9/2021 | 5 | PVT | PRENATAL [FOLIC ACID;IRON]; FLUOXETINE | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None | USPFIZER INC2021274265 | 2 | 3/26/2021 | Y | M | |||||
| 1143591 | 3/29/2021 | PA | 30 | ~2 weeks pregnant during time of vaccination, | 3/6/2021 | 3/15/2021 | 9 | Began spotting/bleeding on 3/15/21 through 3/23/21 and experienced very early miscarriage approximately ~4-5 weeks on/around 3/22/21. Completed blood work and ultrasounds on 3/23/21. | OTH | N/A | N/A | N/A | 2 | 3/29/2021 | Y | N/A | M | |||
| 1145544 | 3/29/2021 | TX | 43 | Previously described above | 1/10/2021 | 1/10/2021 | 0 | 2 hospitalizations at hospital in the med center include all my test results - unable to add here | PHM | Advair 500/50 1 puff am and pm Spiriva 2.5 mcg 2 puffs am Pantoprazole 40 mg eve Ubiquinol 400 mg am and 200 mg pm R-lipoid acid 240 mg before dinner Vitamin c 1000 mg am Vitamin D 5000 IU am Prenatal am N-acetyl-cysteine 600 mg anytime L | None | Asthma though I have swelling throughout my body not just airways - with asthma flareups avg recovery 2-3 months, worse 9-10 mths.. Allergies Reflux Insulin Resistance with fructose sensitivity/adrenal fatigue Endometriosis and fertility (close to 20 surgeries/procedures for that in last 5 yrs) Moderate Liver scarring from fatty liver Severe obstructive sleep apnea Gallbladder and tonsils removed; sinus surgery also done to try to help with asthma from infectious sources I get lots of skin infections - belly button, groin, breast and my skin is thinning and tearing in groin and above butt; shaving causes infections so I can?t do it TMJ - may go along with muscle distonia Learned in 2nd hospital stay after vaccination that I?m hypothyroid Was doing keto and low carb most of last year to reduce inflammation naturally and help with metabolism/insulin resistance | 2 | 3/29/2021 | Y | Y | history of: 2021 moderna shot - swelling in throat within 2 hrs, went away overnight and replaced by nasal stuffiness and sore throat by day 4 - asthma flareup; has resulted in 2 hospitalizations thus far in trying to recover over the last 11 weeks compounded by other triggers like dust storm, reflux, snow storm with generator admitting carbon dioxide and no heat or ability to get neb treatments, excessive talking in trying to do my care and that for my mom in heart failure Past few years - sometimes tampons cause swelling vaginally; irritation and swelling to spermacides, semen Past few years - cuts, any bites take forever to heal - some close to a year Latex - 5 to 10 years - rash/itchiness Aloe - past 2 years - airway Strong smells/exhaust/bathroom deodorizers - past 5-10 years - airway Perfumes - past 5-10 yrs - red rash on neck, itchy, airway - stopped wearing prefume years ago but airway effected by smell Chlorine in pool - past 2-3 yrs - airway minor Food Peanuts - 10-15 yrs ago - hives/airway/sinus Dr Pepper - last 2-3 yrs - throat swelling and congestion (stopped drinking 1 yr ago) Eggs - nauseous - just in 2020 Milk and cheese - lactose intolerant?congestion, diarrhea, constipation Household - dust/paper - airway Biggest allergic or asthma events aside from peanuts example above and now moderna response 2020 Bee sting - nothing worked but leftover prednisone - not ice, rx anti-inflammotories or anti-histamines to relieve pain for 24 hrs 2019 essential oil at dentist office - landed me in hospital with asthma flareup 2019 depressed breathing - tramadol used during miscarriage 2018? Sesame seed oil - rash, itchiness and swelling for months after fertility treatment with it 2017? Cold air-tried to walk up ramp - severe asthma flareup 2009? Set at cafe outdoors by tree whose blooms were blowing in the air in the spring - started feeling allergy symptoms and ended up in hospital next day 2007-2015 colds/bronchitis/pneumonia cause asthma flareups - this source seems resolved since sinus surgery and tonsil removal 2005 elevation/altitude/smog - difficult to breathe climbing stairs where I worked; airway issue when exposed to cigars there - had to leave event Have taken allergy shots and drops at different clinics as an adult - last report I had showed allergies to trees, grasses, dogs, mold Child - took allergy shots from about age 5-12; developed barking cough 1 month after stopping and then diagnosed with exercise induced asthma - allergens were dog, cat, dust mites, dust, many trees and grasses, unsure of others - allergy to one tree so severe that when around it, it would make me run a fever; always severe issues breathing around cigarette smoke Had unknown allergic reaction to amoxycillain as a kid | M | ||
| 1146214 | 3/30/2021 | WA | 28 | Was 5 weeks pregnant at time of vaccine with strong HCG levels, approximately 2 weeks after vaccination patient suffered a miscarriage. Vaginal bleeding, cramping and passed large clots including a sac like tissue. | 3/17/2021 | 3/28/2021 | 11 | HCG levels test at 488 on March 29th 2021 should have been over 3000 for week 7 gestation. | PVT | None | None | None | 2 | 3/30/2021 | Y | None | M | |||
| 1153120 | 3/31/2021 | TX | 39 | Bleeding right after the first shot; Pregnant; A spontaneous report was received from consumer, concerning herself, a 39-year-old, pregnant female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a bleeding right after the 1st shot, pregnant. The patient's medical history include 3 miscarriages on Dec 2013 , Feb 2013, Apr 2013 (all not more 2months). Products known to have been used by the patient, included Progesterone 300mg indicated for after 3miscarriages, Tylenol, Folic acid 1mg . On 18JAN 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 FEB 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She experienced bleeding right after the 1ST shot. She would like to be enrolled into the pregnancy registry. On 15JAN2021, the patient received a positive pregnancy test. Her last menstrual period was on 07 DEC 2020 and conception date was unknown. The patient's estimated due date is 12SEP2021. No treatment information was provided. Relevant laboratory test on 22 Feb 2021 last Ultrasound were done and the Result were normal. Action taken with mRNA-1273 in response to events were not provided. The outcome of the event bleeding right after the 1st shot was unknown and pregnant is ongoing.; Reporter's Comments: This is a case of product exposure on a 39-year-old pregnant of unknown gestation (LMP 07 DEC 2020) and experienced PV bleed right after the first shot. Very limited information regarding this event has been provided at this time. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. | 1/18/2021 | 1/18/2021 | 0 | Test Date: 20210115; Test Name: pregnancy test; Result Unstructured Data: positive; Test Date: 20210222; Test Name: ultrasound; Result Unstructured Data: normal | UNK | Pregnancy | Medical History/Concurrent Conditions: No adverse event (no reported medical history) | USMODERNATX, INC.MOD20210 | 2 | 3/26/2021 | M | |||||
| 1159039 | 4/2/2021 | NY | 33 | Miscarriage 6 days after vaccination | 2/23/2021 | 3/29/2021 | 34 | None | UNK | Pre natal | None | None | 2 | 4/2/2021 | None | M | ||||
| 1163402 | 4/3/2021 | WI | 33 | Miscarriage - due date was 10/16/2021 | 3/16/2021 | 3/17/2021 | 1 | Ultrasound - 03/31/2021 Showed baby stopped growing around 03/17/21 | PVT | Levothyroxine .75mg | N/A | N/A | 2 | 4/3/2021 | Y | Cinnamon | M | |||
| 1163458 | 4/3/2021 | VA | 35 | 2 prior first trimester miscarriages unrelated. 1 second trimester miscarriage at 21weeks gestation in March 2021, normal weight and size at time of delivery. Vaccine was given 12/2020 and 1/2021 | 12/1/2020 | 3/1/2021 | 90 | PUB | Prenatal vitamin | None | None | 2 | 4/3/2021 | Y | None | M | ||||
| 1165228 | 4/4/2021 | VA | 34 | no history of miscarriage until the most recent pregnancy with the COVID vaccine. I previously had 4 healthy pregnancies and 4 living children (now 5 pregnancies and 4 living children). I conceived on 12/18/2020 the day after I received my 1st covid vaccine. I began spotting blood on 3/7/2021 and miscarried an approximately 7 week old embryo. I had a D & C procedure to remove the baby that stopped growing weeks before ( I was 14 weeks and 1 day into my pregnancy before the miscarriage).Due date was sept 4th 2021. | 12/17/2020 | 4/4/2021 | 108 | pregnancy test march 8th 2021- positive. ABO compatibility- O neg. D & C procedure 3/8/2021 | PVT | Zoloft, abilify, benedryl, tylenol | none | depression | 2 | 4/4/2021 | Y | Y | none | M | ||
| 1173008 | 4/6/2021 | MA | 40 | I had a miscarriage on 4/2 estimated and my estimated date of delivery 11/7/2021. | 2/28/2021 | 3/7/2021 | 7 | DNE, Blood work, 2 Ultrasounds | PVT | No | No | No | vsafe | 2 | 4/6/2021 | No | M | |||
| 1175464 | 4/7/2021 | MD | 36 | At the time of my first vaccine on 1/14/21 I was 9 weeks pregnant and on lovenox for DVT and progesterone for pregnancy maintenance. On 2/5/21 I miscarried the baby and ended up hemmoraging thus requiring a blood transfusion. The fetus was sent to pathology and I was informed that at 12 weeks when I miscarried that the baby had termed at 9 weeks which was the time of my first vaccine injection. | 1/14/2021 | 1/14/2021 | 0 | Yes fetus was sent to pathology miscarriage occurred 2/5/21. Required EMT services. Passed out twice and flatlined for 4 seconds. Blood transfusion on 2/6/21. D AND C surgery on 2/7/21. All at hospital. | PUB | Lovenox Prenatal vitamins | None | PVC Right bundle branch block Hx TBI Hx DVT Asthma | 2 | 4/7/2021 | Y | Y | Dilaudid Tramadol | M | ||
| 1176890 | 4/7/2021 | HI | 30 | Miscarriage of baby at 20 weeks and 3 days of gestation. Preterm labor. Due date was August 6, 2021. Baby was surgically removed on March 22, 2021. | 3/12/2021 | 3/21/2021 | 9 | Ultrasounds, fetal heart monitoring, routine blood work, examination of cervix. | OTH | Lithium, Latuda, Concerta | Bipolar Disorder | 2 | 4/7/2021 | Y | Y | Amoxicillian | M | |||
| 1178741 | 4/7/2021 | MO | 29 | HIVES - BENADRYL (LIQUID SUSPENSION) 5O MG - HIVES GONE WITHIN 2 HOURS | 4/7/2021 | 4/7/2021 | 0 | WRK | VITAMIN D, PRENATAL VITAMINS | PREGNANCY (MISCARRIAGE ON 3/22) | NONE | 2 | 4/7/2021 | PENICILLIN, MORPHINE | M | |||||
| 1179680 | 4/8/2021 | NC | 36 | Note: Very difficult to read product name and/ Manufacture Lot number secondary poor handwriting so there may be an error there. Healthy pregnancy this far. Was fourth pregnancy for patient with no history of prior miscarriage. No bleeding etc. prior to event or following event. Fetus was found to have no heart beat at well visit on 4/1. Ultrasound records reported fetus stopped growing appropriately at time of first vaccination. Estimated Due Date was 10/4. | 3/19/2021 | 4/1/2021 | 13 | Ultrasound 4/1. D and C completed on 4/1 | OTH | Prenatal vitamins, | none | none | 2 | 4/8/2021 | Y | dairy intolerance, latex intolerance | M | |||
| 1180270 | 4/8/2021 | IL | 30 | Approximately 8 hours after shot, I experienced sudden onset of extreme fatigue, extreme muscle aches and joint pain, slight headache, and 103 degree fever. The muscle pain and joint pain were so intense that it was difficult to be still and caused me to constantly try to shift positions. After 4 hours of running a fever (12 hours subsequent to shot) the fever fell to 100.1. The extreme muscular pain also diminished around the same time that the fever reduced. The fever stayed between 99.9 and 100.6 for the next 12 hours and achiness, joint pain, and fatigue remained but were comparatively milder. All symptoms were gone 28 hours after the shot. I did NOT take any pain relievers or medications during the time that I experienced symptoms. | 4/2/2021 | 4/2/2021 | 0 | PUB | Latin FE 1/20 (birth control) B12 supplement 1500 mg/day | Miscarriage of pregnancy. Miscarriage occurred at 6 weeks. My HcG levels returned to normal (less than 5) 3 days prior to receiving the shot. | Na | 2 | 4/8/2021 | Na | M | |||||
| 1182483 | 4/8/2021 | NM | 39 | Miscarriage; This is a spontaneous report from a contactable Other HCP (Nurse), reported for herself. This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 25Feb2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 19Mar2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination and the last menstrual date was 02Sep2020. Gestational period 5 weeks and delivery date 19Nov2021. Relevant medical history included Hashimoto's thyroiditis. Past drug history included allergy to amoxicillin and omeprazole. Relevant concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 21Mar2021 (at 14:00), the patient had miscarriage. The event required physician office visit. The patient did not receive any treatment for the event. She was recovering from the event. Information on the lot/batch number has been requested.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of Hashimoto's thyroiditis are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | 3/19/2021 | 3/21/2021 | 2 | PHM | PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS | Medical History/Concurrent Conditions: Hashimoto's thyroiditis | USPFIZER INC2021321057 | 2 | 4/6/2021 | Y | M | |||||
| 1183041 | 4/8/2021 | CA | 31 | Chills started at 6 pm the day of. Highest fever 102.7 with medication (ibuprofen) around midnight on 04/08. Significant joint pain causing difficulty sleeping but severe fatigue. Around 9:00 am on 04/08/21 vomited stomach acid. Continued low grade fever (100-101) past 5 pm on 04/08. No medical treatment sought. | 4/7/2021 | 4/7/2021 | 0 | None | UNK | Probiotics, celebs, daily vitamins | Miscarriage within last 4 weeks. | General Anxiety | 2 | 4/8/2021 | None | M | ||||
| 1195464 | 4/11/2021 | IN | 29 | Patient was about 15 weeks pregnant and this was her first pregnancy. Her anticipated due date was Oct 1st 2021. On April 9th 2021 during a scheduled doctor visit at 3pm both baby and mother were in good health. On the same evening after the appointment she went for vaccination at Pharmacy and received the J&J vaccine. After receiving the vaccine in about 15 mins she felt like urinating and noticed blood in the urine and felt vaginal dilation. Within the next 15 to 20 mins she started experiencing mild labor pains and contractions. In the next 30 mins she started bleeding and was immediately taken to the ER. In the ER it was confirmed that she was having a miscarriage and the fetus was delivered. She also had to undergo emergency surgery to remove any remaining placenta in the uterus. | 4/9/2021 | 4/9/2021 | 0 | All tests and laboratory results will be made available at Hospital. Placenta tests also performed at the same location. Reports maybe sent to Dr. at clinic | PHM | None | Gestational Diabetes due to pregnancy and UTI | No | 2 | 4/11/2021 | Y | None | M | |||
| 1198495 | 4/12/2021 | CA | 34 | Fever of 101.8F, shivers, and sever vertigo. Vertigo resulted in me falling down multiple times and hitting my head on the stairs. I could not see where I was going and what was in front of me. | 4/3/2021 | 4/3/2021 | 0 | CT scan of my head because I hit my head during the fall on April 11, 2021 | UNK | Cymbalta 70 mg for generalized anxiety disorder, Keflex for bacterial infection | Miscarriage 2 weeks prior and was not over on the day of the vaccine. Pill taken to complete miscarriage did not finish the job. Suction was done the day after vaccine to empty the uterus from pregnancy tissue. | Generalize Anxiety Disorder | 2 | 4/12/2021 | Y | None | M | |||
| 1203230 | 4/13/2021 | PA | 36 | Initially I had arm soreness at the area of the shot. Saturday evening following the vaccine I had pain in my left side of the neck. Sunday the pain went from the left side of my neck down to the base of my ribs and then progressed to include the back and chest almost constantly instead of just on inhalation. I went to the ER on Sunday evening, assuming very bad costochondritis; however, was diagnosed with multiple pulmonary embolisms in the left lung, areas of possible infarction, and pleurisy. I had a CT scan at a Medical Center prior to receiving the Moderna vaccine for a suspected PE and it was negative. | 2/25/2021 | 2/28/2021 | 3 | CT scan 2/15: negative for PE D-dimer 2/28: 5,000, indicating clots CT scan 2/28: positive for multiple PEs | PHM | Levothyroxine 100 mcg; sertraline 25; Vitamin D occasionally, Prenatal multivitamin | Late-term miscarriage/stillbirth followed by emergency D&E (February 5th) I had elevated Anticardiolipins and Beta-2 glycoproteins and now know I have a prothrombin gene mutation | Hashimoto's thyroiditis | 2 | 4/13/2021 | Y | Y | Amoxicillin; all inhalant allergens | M | ||
| 1205095 | 4/13/2021 | WA | 35 | 6hrs after the vaccine I started having chills, body aches, light headed, & headache. Also at the same time I started spotting which I found out it was the symptoms of a miscarriage. On 04/11/2021 I continued with the same symptoms then later on that night i started feeling dizzy the bleeding continued. Around 2am on 4/12/2021 I was bleeding a lot & at 7am I went to the ER and they confirmed I had a miscarriage. I was 11 weeks pregnant. My estimated delivery date was 10/28/2021. On my previous appointments they said everything was going good with my pregnancy the only complication was hyperthyroidism which I had been taking medication for. | 4/10/2021 | 4/10/2021 | 0 | Lab work- normal low blood pressure low pulse | OTH | Levothyroxine | Hyperthyroidism | vsfae | 2 | 4/13/2021 | Y | M | ||||
| 1205793 | 4/13/2021 | AK | 33 | Wife got pregnant in between the 2 shots. She had a miscarriage. | 2/1/2021 | 3/17/2021 | 44 | MIL | Fish oil, multivitamin, vitamin d, seroquel, luenesta, omprazole, celexa | None | 2 | 4/13/2021 | M | |||||||
| 1209601 | 4/14/2021 | NC | 44 | miscarriage a week after receiving Janssen vaccine | 3/19/2021 | 3/25/2021 | 6 | PVT | multivitamins | none | none | 2 | 4/14/2021 | Y | Y | none | M | |||
| 1209945 | 4/14/2021 | CA | 39 | The minute after the vaccination I had fainted, vision went, low blood pressure, after laying down became better. Rested almost an hour in order to be able to walk. next day, I had severe headache, with nausea, and a day later I had bleeding. Bleeding became severe, I had miscarriage. I was 7 weeks pregnant. | 4/5/2021 | 4/5/2021 | 0 | I had 2 blood test to confirm the levels of pregnancy hormone and progesterone on 4/8 and 4/12 . Confirmed that I had miscarriage. | PHM | prenatal vitamin and prozac | n/a | n/a | 2 | 4/14/2021 | Y | n/a | M | |||
| 1210176 | 4/14/2021 | WA | 28 | Patient had miscarriage with 5 month stillborn baby | 4/7/2021 | 4/11/2021 | 4 | PUB | 2 | 4/14/2021 | Y | M | ||||||||
| 1212515 | 4/15/2021 | IA | 38 | Patient was pregnant. Had a viable pregnancy confirmed on 3/17/2021 with a 9wk gestation fetus and + cardiac activity and no abnormalities noted. Patient returned for prenatal visit on 4/14/21 and was confirmed to have had a miscarriage with no cardiac activity noted and a fetus measuring 12wks 0 days gestation. | 4/6/2021 | 4/14/2021 | 8 | Ultrasound | PUB | Folic Acid, Prenatal multivitamin | None | None | 2 | 4/15/2021 | Y | None | M | |||
| 1215397 | 4/15/2021 | AL | 25 | 4/1/2021 patient received JNJ Vaccine 4/12/2021 Miscarriage was confirmed on Ultrasound done by and also Right Pelvic vein thrombosis seen. 4/13/2021 Patient placed on Anticoagulation. | 4/1/2021 | 4/12/2021 | 11 | Ultrasound 4/12/2021 | PVT | Wellbutrin | none | none | 2 | 4/15/2021 | none | M | ||||
| 1220313 | 4/16/2021 | WA | 27 | Spontaneous Abortion. Miscarriage started on it's own at home. Bleeding lasted 14 days, then turned to excessive hemorrhaging and ended up getting an emergency D&C. Was 10 weeks pregnant at time of miscarriage. EDD was 10/23/2021. | 3/16/2021 | 3/25/2021 | 9 | 3/17/2021 - Ultrasound showing nonviable pregnancy. 3/18/2021 - Blood Draw to check HCG level. 3/20/2021 - Blood Draw to check HCG Level. 3/23/2021 - Ultrasound confirming nonviable pregnancy. 4/2/2021 - labs for checking blood chemistry and pathology test on miscarriage products | PVT | prenatal vitamins, 15mg adderall 3 times a day, pristiq 50mg 1 time a day | None | None | 2 | 4/16/2021 | Amoxicillin, hydromorphone, seafood, shrimp, pollin | M | ||||
| 1226011 | 4/18/2021 | OH | 33 | Miscarriage at 25 weeks. No hx of pregnancy related issues. No hx of miscarriage. Reason for miscarriage not established/no clear reason for miscarriage. | 3/14/2021 | 3/19/2021 | 5 | PUB | Prenatal vitamin, Vit D | None | Asthma | 2 | 4/18/2021 | PCN | M | |||||
| 1236339 | 4/21/2021 | TX | 37 | LMP 2/10/2021. Estimated due date 11/17/2021. Received vaccine on 3/23/2021. During initial prenatal visit 4/1/2021 there was no reported heartbeat and baby was measuring later than calculated based on LMP. On next appointment 4/8/2021 heartbeat was found and baby was estimated to be due on 11/21/2021. On follow up appointment 4/15/2021 baby no longer had heartbeat based on measurement was due 11/21/2021. Doctor noted a missed miscarriage on 4/15/2021. On appointment 4/19/2021 still no heartbeat and no growth. D&C took place 4/21/2021. | 3/23/2021 | 4/15/2021 | 23 | PVT | Prenatal vitamin, vitamin d3 | None | None | 2 | 4/21/2021 | None | M | |||||
| 1240248 | 4/22/2021 | UT | 39 | Miscarriage at approximately 11 weeks 2 days. 1st pregnancy. Estimated due date Oct 7, 2021. | 3/9/2021 | 3/20/2021 | 11 | Obgyn exam on 03/26/2021 by midwife OB/GYN. Pregnancy test to confirm no longer pregnant after all bleeding stopped, self administered on 03/30/2021. | PHM | prenatal vitamins, vitamin d | None | None | 2 | 4/22/2021 | Y | None | M | |||
| 1240486 | 4/22/2021 | TX | 36 | I am having extreme shortness of breath and sharp chest and right shoulder pains. I also feel congested and really exhausted. | 4/20/2021 | 4/22/2021 | 2 | SCH | Lexapro, prenatal, Buspirone | Miscarriage | PE, EOE, GERD, PMDD, PCOS, DDD, obesity | 2 | 4/22/2021 | Corn, soy, peanuts, watermelon Clindamyocin, Wellbutrin, Abilify, morphine, diladid, xarelto | M | |||||
| 1247382 | 4/23/2021 | MD | 29 | Had a miscarriage (due date was 12/02/21) Have had high blood pressure which required er visit since getting vaccine | 3/10/2021 | 4/6/2021 | 27 | OTH | None | None | No | 2 | 4/23/2021 | Y | Y | None | M | |||
| 1252121 | 4/24/2021 | WA | 34 | I had a fast heart rate (approx 120 beats per minute while resting). I called my consulting nurse who advised me to go into Urgent Care. I went to Urgent Care. They gave me an EKG, which showed my increased heart rate, but nothing abnormal. I was given Tylenol to see if that decreased my heart rate, but it didn't. I was told to drink lots of water to see if dehydration might be why my heart rate was increased. The Urgent Care doctor consulted with an OB Doctor and concluded that my increased heart rate was due to my body's response to the vaccine in connection with the pregnancy. At the time of the adverse event, I was 23 weeks pregnant. My estimated date of delivery is July 13, 2021. This current pregnancy is my 3rd. My second pregnancy ended in a miscarriage. During my first pregnancy, I developed Gestational Diabetes and Preeclampsia. I needed insulin to manage the Gestational Diabetes and I was induced at 37 weeks pregnant because of the Preeclampsia. My daughter had to be in the NICU after birth for 5 days due to low oxygen, low blood sugar, low muscle tone, dusky color, and no cry. | 3/21/2021 | 3/21/2021 | 0 | EKG (March 21, 2021) | PVT | POLYCYCSTIC OVARIAN SYNDROME, DEPRESSION | 2 | 4/24/2021 | Y | M | ||||||
| 1254933 | 4/25/2021 | PA | 31 | spotting vaginally; miscarriage; Following the vaccine on 18Mar; This is a spontaneous report from a contactable consumer (patient). A pregnant 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 18Mar2021 at 17:00 (at the age of 31 years old) (Lot Number: EN6204, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included anxiety. No known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) and unspecified prenatal vitamins. The patient reported that following the vaccine on 18Mar2021 at 23:00 (11:00 pm), she began spotting vaginally which persisted for two weeks and resulted in a miscarriage at 7 weeks pregnant. The patient is pregnant on 04Jan2021. The mother was supposed to deliver on 19Nov2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected. | 3/18/2021 | 3/18/2021 | 0 | PHM | LEXAPRO | Medical History/Concurrent Conditions: Anxiety | USPFIZER INC2021387492 | 2 | 4/21/2021 | Y | M | |||||
| 1264894 | 4/27/2021 | ME | 30 | Early Miscarriage after vaccine. About 5 weeks pregnant when miscarriage happened. | 4/1/2021 | 4/19/2021 | 18 | PVT | Levothyroxine | Runny nose- cold | 2 | 4/27/2021 | Y | M | ||||||
| 1266322 | 4/28/2021 | OK | 44 | patient was pregnant at time shot was given . She came in for her second dose and reported she had miscarriage | 3/31/2021 | 4/4/2021 | 4 | PHM | 2 | 4/28/2021 | M | |||||||||
| 1272570 | 4/29/2021 | WA | 32 | Event: REFRACTORY Pre-Eclampsia (Refractory Hellp Syndrome) Pregnancy History: Second pregnancy, first was a very early miscarriage on 9/11/2020 Due Date: 6/18/2021 Delivery Date: 4/22/2021 (emergency c section) Birth Weight: 3 lb 3.5 ounces | 4/2/2021 | 4/17/2021 | 15 | Countless, can provide if requested. | SCH | 2 | 4/29/2021 | Ceclor, sulpha antibiotics | M | |||||||
| 1277327 | 5/1/2021 | NJ | 43 | I was on my 4th week pregnancy. The next day I took my second dose I had spotting and the third day I'm having a miscarriage. ( this is my third pregnancy); I was on my 4th week pregnancy. The next day I took my second dose; I was on my 4th week pregnancy. The next day I took my second dose; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female patient (pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534), second dose via an unspecified route of administration, administered in Arm Left on 13Apr2021 14:45 (at 43 years old, pregnant), single dose for covid-19 immunisation. The patient's medical history included that this was her third pregnancy. The patient's concomitant medications were not reported. The patient had his first dose of bnt162b2 on 23Mar2021 14:45 for covid-19 immunisation, left arm, lot number EP7534. Patient was on her 4th week pregnancy. The next day, she took her second dose, she had Spotting and the third day (also reported as 14Apr2021 15:00) she was having a miscarriage. Treatment was Received. The outcome of the event Miscarriage of pregnancy was recovering. No covid prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Allergies to medications, food, or other products.; Sender's Comments: Based on the information currently available and known safety profile of the drug, a possible contributory role of suspect product Bnt162b2 to the reported events can not be ruled out. But product is not indicated in this population group. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. | 4/13/2021 | 4/13/2021 | 0 | UNK | Medical History/Concurrent Conditions: Pregnancy (third pregnancy) | USPFIZER INC2021416004 | 2 | 4/28/2021 | M | |||||||
| 1279405 | 5/2/2021 | WI | 30 | miscarriage of the 16-17 week fetus; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number : ER8730), via an unspecified route of administration, administered in the left arm on 26Mar2021 at 16:30 as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient's concomitant medications included unspecified prenatal vitamins. The patient did not have other vaccines in four weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient had a miscarriage of the 16-17 week fetus. The patient had surgery to remove the fetus and tissue. The mother was due to deliver on 09Sep2021. The outcome of the event was recovering. The patient had a nasal swab COVID-19 test on 22Apr2021 with a result of negative. The event was reported as life-threatening. | 3/26/2021 | 3/1/2021 | Test Date: 20210422; Test Name: COVID-19 test; Test Result: Negative ; Comments: nasal swab | PHM | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None | USPFIZER INC2021456214 | 2 | 4/28/2021 | Y | M | ||||||
| 1287331 | 5/4/2021 | CA | 35 | Pt with miscarriage at approx 7-8 weeks GA after J&J covid vaccine 3/26/21 LMP 2/27/21 | 3/26/2021 | 4/29/2021 | 34 | PVT | 2 | 5/4/2021 | Y | Y | M | |||||||
| 1290173 | 5/5/2021 | VA | 40 | 7 weeks at vaccination due date 11/14/2021 was due third pregnancy had successful pregnancy, Normal pregnancy and next two days was very sick, body aches, fatigue, Tues. Tuesday 03-30-2021 she experienced bleeding and at that time was 7 weeks 2 days pregnant ER went to the doctor and they indicated that she would need to return, then on Thursday 04-01-2021 she had a miscarriage and it was confirmed that she was having a miscarriage. | 3/26/2021 | 3/27/2021 | 1 | 03-30-2021 HCG and the did an ultra sound and they could not locate a heart beat and they indicated her hormones levels was off for the timeframe of pregnancy timeframe. Another HCG Test Thursday 04-01-2021 she had a miscarriage it was confirmed that she was having a miscarriage. | PVT | Pre-Natal Vitamins | No | Chronic Migraines for 15 yrs. | vsafe | 2 | 5/5/2021 | Y | Y | Allergic to Gold , Cipro antibiotic , Gab pinto and Tigerton | M | |
| 1293007 | 5/6/2021 | CA | 33 | The day after the vaccine I had a headache, chills and fatigue for the whole day. The following day I felt normal. Five days after the vaccine I had a silent miscarriage and I was diagnosed on 04/19/2021. The doctor identified 04/10/2021 as the day that the fetus was no longer viable. I was in my seventh week. The Pathology returned identifying Chromosomal abnormality. Due Date-11/21/2021 First Pregnancy | 4/5/2021 | 4/6/2021 | 1 | Sonogram | PHM | Prenatal Vitamin | vsafe | 2 | 5/6/2021 | Y | M | |||||
| 1299199 | 5/8/2021 | FL | 37 | absence of heartbeat and estimated the embryo stopped growing at 7 weeks; had a very difficult time keeping her glucose levels; lightheaded; possible threatened miscarriage; persistent vertigo; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 11:00 (Lot Number: EN6204) as single dose for covid-19 immunisation, administered at the hospital. No other vaccine received in four weeks. Medical history included type 2 diabetes, fatty liver disease, high cholesterol, and known allergies: Pineapples and Zoloft. Concomitant medications included metformin; glipizide; escitalopram oxalate (LEXAPRO); and meclozine hydrochloride (MECLIZINE [MECLOZINE HYDROCHLORIDE]). The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 03Feb2021. On 25Mar2021, 03:00 PM, patient sought treatment for persistent vertigo at a hospital and was given meclizine. On 03Apr2021, patient went to the emergency room to be assessed for a possible threatened miscarriage. They found her embryo sac and determined she was pregnant. She was released and told to go home. Patient is a type 2 diabetic and was ordered to go on insulin. On 05Apr2021, she had another threatened miscarriage and returned to the hospital. She was given an ultrasound and her due date changed from 10Nov2021 to 28Nov2021. Ultrasound discovered a heartbeat at 132 bpm. On 23Apr2021, at a routine ultrasound and OB visit, doctor discovered absence of heartbeat and estimated the embryo stopped growing at 7 weeks. She was electing for a D&C surgical procedure and requesting pathology testing to investigate the cause of death. She had a very difficult time keeping her glucose levels within the recommended pregnancy range of 90-150. She had persistent lightheaded still. Outcome of events vertigo, possible threatened miscarriage, and lightheaded was not recovered. The patient received treatment for vertigo and did not receive treatment for other events. | 3/8/2021 | 3/25/2021 | 17 | Test Name: ultrasound; Result Unstructured Data: Test Result:heartbeat at 132 bpm; Test Date: 20210423; Test Name: ultrasound; Result Unstructured Data: Test Result:absence of heartbeat; Comments: absence of heartbeat and estimated the embryo stopped growing at 7 weeks | PVT | METFORMIN; GLIPIZIDE; LEXAPRO; MECLIZINE [MECLOZINE HYDROCHLORIDE] | Medical History/Concurrent Conditions: Fatty liver; Fruit allergy; High cholesterol; Type 2 diabetes mellitus | USPFIZER INC2021456113 | 2 | 5/7/2021 | Y | M | ||||
| 1299228 | 5/8/2021 | IL | 30 | Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 17:00 (Lot Number: ER8729) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination, last menstrual date was 20Feb2021, due date was 27Nov2021, the patient was 6 weeks pregnant at the onset of the events. The patient did not test positive to COVID-19, pre or post vaccination. Medical history was none. No known allergies. There were no concomitant medications. On 15Apr2021 at 07:00, the patient experienced Bell's palsy and miscarriage. the events required emergency room visit and physician office visit, the patient was hospitalized for one day due to the events. Therapeutic measures were taken as a result of the events and included ultrasound. The patient outcome of the events not recovered. | 4/8/2021 | 4/15/2021 | 7 | PHM | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None | USPFIZER INC2021457028 | 2 | 5/7/2021 | Y | Y | M | |||||
| 1307381 | 5/11/2021 | TX | 31 | conceived 10- 12 days after vaccine shot administered and ultimately had a miscarriage in first trimester | 3/6/2021 | 4/26/2021 | 51 | vaginal ultrasound 4/26/2021 and 5/10/2021 | PHM | Prenatal | No | No | 2 | 5/11/2021 | Y | No | M | |||
| 1309565 | 5/12/2021 | NE | 30 | Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the second dose on 08Apr2021 at 07:30 (Lot Number: ER8729) and the first dose on 16Mar2021 at 07:30 (Lot Number: EN6207), both via an unspecified route of administration, administered in the left arm, as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline (manufacturer unknown); vitamin d3 (manufacturer unknown) and folic acid, iron (PRENATAL) all taken for an unspecified indication, start and stop date were not reported. The patient had a miscarriage on 20Apr2021 at 04:30. The patient did not receive any treatment for the event. The event resulted in a visit to the doctor or health care professional office/clinic visit and hospitalization on an unspecified date. The outcome of the event was recovering. The patient had a nasal swab Covid test on 23Apr2021 with a result of negative. No follow-up attempts are needed. No further information is expected. | 4/8/2021 | 4/20/2021 | 12 | Test Date: 20210423; Test Name: Covid test; Test Result: Negative ; Comments: Nasal Swab | PHM | SERTRALINE; VITAMIN D3; PRENATAL [FOLIC ACID;IRON] | USPFIZER INC2021470679 | 2 | 5/11/2021 | Y | M | |||||
| 1309633 | 5/12/2021 | I had a very early miscarriage; This is a spontaneous report from a contactable consumer reporting for herself. This pregnant female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date after the first vaccine shot the patient had a very early miscarriage. The outcome was unknown. Information on the lot/batch number has been requested. | UNK | USPFIZER INC2021502339 | 2 | 5/10/2021 | M | |||||||||||||
| 1310166 | 5/12/2021 | CA | 30 | Adverse event miscarriage. First pregnancy. Estimated due date middle of November. Received vaccine approximately around 7 weeks of pregnancy. Post vaccination had chills and fatigue starting 12 hours after vaccine lasting about 48 hours. | 4/1/2021 | 4/26/2021 | 25 | 4/26 had ultrasound which showed the baby stopped growing and was only measuring around a little more than 6 weeks when the gestational sac was measuring a little more than 9 weeks. Also the baby had no heart beat. Based off my last period should have been around 10 weeks pregnant. 4/26 repeat hcg was performed and was I believe 8 or 10K. First one done on 3/10 was around 21K. Another hcg was performed on 4/28 which showed a lower hcg I believe 7K. Unable to check exact labs right now due to entire system being down. | PVT | Prenatal | None | None | 2 | 5/12/2021 | Y | Penicillin, doxycycline, flexiril | M | |||
| 1310580 | 5/12/2021 | CA | 33 | Starting at about 05:00 in morning, I woke up feeling shaky and chilly. I was very achy. I had a fever. I took my temperature and it was 102 fever. I took Tylenol. (Extra Strength) I went back to sleep. I woke up about 08:00 am and I still had chills and was extremely achy and had a really bad headache. My temperature was 101.8. Then I started throwing up every 20 minutes for the whole entire day. I still had a fever. It was 102.6 at one point. I had been taking extra strength Tylenol as often as I could take it. I still had a headache was very very achy. I was throwing up constantly and couldn't get out of bed. I had my husband come home to take care of toddler. That lasted then for a full 28 hours - through the next evening. When I woke up on April 7 I had a light headache, a little achy but fever was gone. At the time of my vaccine, I was just 8 weeks pregnant. I had an ultrasound when I was seven weeks along they could hear the heartbeat. I had a miscarriage around 8 weeks and four days. It would have been about one day after the vaccine when I was having my reaction to the vaccine. I am still having bleeding from the DMC - removal - but otherwise I'm recovered. Pregnancy history - It was my second pregnancy. Estimated due date - November 15, 2021. | 4/5/2021 | 4/6/2021 | 1 | No they scheduled for a DMC to remove the fetus and I had that done last week. Outpatient surgery. It was at the OB/GYN department. | PHM | Prenatal vitamin | no | no | vsafe | 2 | 5/12/2021 | Y | no | M | ||
| 1314678 | 5/13/2021 | FL | 33 | On 04/20/2021 I had a miscarriage I was 6 weeks pregnant. My due date was around Christmas. | 3/21/2021 | 4/20/2021 | 30 | PUB | Prenatal vitamins | vsafe | 2 | 5/13/2021 | latex | M | ||||||
| 1031823 | 2/15/2021 | TN | 34 | The patient, who is my wife, went into preterm labor and delivered at 30 weeks and 3 days. Date of delivery was 2/9/21. EDD was 4/17/21. My wife is a G3P2. She had a very early miscarriage in 2016. She delivered a healthy child at 37 weeks and 3 days in 2018. During this current pregnancy, all prenatal visits, tests, and scans were unremarkable. Based on a gross examination of the placenta and a review of all clinical data by the patient's OBGYN, there was no obvious stimulus for the preterm labor. Fortunately, the baby is doing ok in the NICU at hospital. | 2/6/2021 | 2/9/2021 | 3 | I do not have access to the data from the hospital. Based on a verbal report from the OBGYN, the fetal fibronectin was negative on 2/9/21. This false-positive likely led to a delay in the diagnosis of preterm labor; however, it is unknown whether this would have affected the outcome. | PUB | Prenatal vitamin, omega 3 supplement, Zyrtec | Mild viral URI symptoms several weeks prior. Multiple people in family tested negative for COVID at that time. | Chronic urticaria | 2 | 2/15/2021 | No | P | ||||
| 924551 | 1/6/2021 | NE | 47 | Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid. | 1/5/2021 | 1/6/2021 | 1 | ECG normal sinus rhythm, Labs normal except K 3.4, glucose 124, wbc 11.34. CXR negative. BP (!) 130/98 (BP Location: Right arm, Patient Position: Lying) | Pulse (!) 125 | Temp 37.3 °C (99.2 °F) | Ht 1.6 m (5' 3") | Wt 166 lb 14.2 oz (75.7 kg) | SpO2 97% | BMI 29.56 kg/m² Multiple diagnoses were considered in evaluating this patient. Available pertinent medical records were reviewed. Pertinent Labs & Imaging studies reviewed. (See chart for details). Patient was given cardiac monitor and pulse oximeter. | PVT | MECLIZINE 25mg PO TID PRN dizziness | See item 18 | 2 | 1/6/2021 | Y | cephalosporins, indomethacin, ketoprofen, penicillins | S | ||||
| 925639 | 1/7/2021 | ID | 34 | Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID. Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00. The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event. Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to agency, Ethics Committees, and Investigators, as appropriate. | 12/22/2020 | 12/22/2020 | 0 | Test Name: tested for COVID-19; Result Unstructured Data: Test Result:Unknown results; Test Date: 20201228; Test Name: Nasal Swab; Test Result: Negative | PVT | Sleep apnoea | USPFIZER INC2021000238 | 2 | 1/7/2021 | S | ||||||
| 979951 | 1/27/2021 | WA | 41 | I was about 3 weeks pregnant at time of vaccination (Due date 9/3/2021). I experienced spontaneous abortion at 6 weeks gestation. Uncomplicated, no doctors visits or hospitalization required (though I am a physician so tracked HCG levels throughout). G3P1, one prior missed spontaneous abortion 2017, one live birth 2019. | 12/18/2020 | 1/5/2021 | 18 | HCG positive 1/4, 1/3, 1/2 | WRK | Prenatal vitamin | None | None | Oral typhoid, in mid-20s, severe abdominal pain | 2 | 1/27/2021 | Sulfonamides | S | |||
| 992848 | 2/1/2021 | TX | 30 | Pt is G1P0. EDD was 8/15 by LMP. The patient had an ultrasound on 1/6 showing a live intrauterine pregnancy with crown rump length measuring 8 weeks 0 days. She had covid vaccine 1/7. Came in with vaginal bleeding 1/29 and found to have missed abortion on ultrasound (no heart tones, crown rump length measuring 8 weeks 3 days). Underwent D&C 2/1. | 1/7/2021 | 1/7/2021 | 0 | Pathology of products of conception sent 2/1. Results pending. Microarray genetic testing sent 2/1. Results pending. | PVT | prenatal vitamins | No | No | 2 | 2/1/2021 | Y | No | S | |||
| 1006634 | 2/5/2021 | CA | 34 | Spontaneous abortion. Pt was 9w1d at time of first Moderna COVID vaccine (EDD 8/9/2021). Two weeks later she began bleeding and was found to have an incomplete abortion with embryo measuring 9w1d. Proceeded to bleed heavily and D&C performed. Uncomplicated recovery. Genetic studies in process. Unknown if SAB is related to vaccine, though it appears embryonic demise occurred within a few days of vaccine administration. | 1/6/2021 | 1/17/2021 | 11 | 1/19/21 - ultrasound confirming embryonic demise 1/20/21 - D&C for incomplete abortion | PVT | prenatal vitamin | none | asthma, migraine | 2 | 2/5/2021 | Y | Y | Ceclor, doxycycline, PCN, sulfa | S | ||
| 1038034 | 2/18/2021 | CT | Pregnancy loss; Vaginal bleeding; Vaccine exposure during pregnancy; A spontaneous report was received from a nurse practitioner who was 31-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine exposure during pregnancy, pregnancy loss (abortion spontaneous), and vaginal bleeding (vaginal hemorrhage). The patient's medical history was not provided. Concomitant medications reported as taken since conception included magnesium, prenatal vitamins, vitamin B and vitamin C. On 10 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011LZ0A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. On 02 Feb 2021, the patient developed vaginal bleeding, so she went to her obstetrician and had an ultrasound exam. The patient reported that there was no heartbeat at fifteen weeks and five days. No treatment information was provided. The patient's prior positive pregnancy test, last menstrual period, conception and due dates were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pregnancy loss and vaccine exposure during pregnancy, was considered resolved. The outcome of the event, vaginal bleeding, was unknown.; Reporter's Comments: This case concerns a 31 year old, female subject, who experienced a spontaneous abortion and drug exposure before pregnancy. Very limited information has been provided at this time. Further information has been requested | 1/10/2021 | 1/10/2021 | 0 | Test Date: 20210202; Test Name: ultrasound; Result Unstructured Data: No heartbeat at 15 weeks and 5 days | UNK | MAGNESIUM; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VITAMIN B [VITAMIN B NOS]; VITAMIN C [ASCORBIC ACID] | Medical History/Concurrent Conditions: No adverse event (No reported medical history) | USMODERNATX, INC.MOD20210 | 2 | 2/17/2021 | Y | S | |||||
| 1046322 | 2/22/2021 | MN | 33 | Missed abortion - received first shot while pregnant (did not know), missed abortion of ~5 weeks gestational age, diagnosed Feb 2021 | 1/5/2021 | 1/25/2021 | 20 | Beta HCGs and early OB pelvic ultrasounds | PVT | 2 | 2/22/2021 | Y | S | |||||||
| 1072165 | 3/4/2021 | IL | 39 | pt experienced shortness of breath, chest pain, Hheadache, palpitations, nausea, abdominal pain within 1/5-2 hours of injection | 2/26/2021 | 2/26/2021 | 0 | unknown- went to ER, states she was on O2 | PUB | none | missed abortion | none | 2 | 3/4/2021 | Y | amoxicillin | S | |||
| 1074063 | 3/4/2021 | PA | 32 | Miscarriage, first trimester | 12/27/2020 | 2/3/2021 | 38 | Follow up ultrasound following complete spontaneous abortion | WRK | Unithroid - thyroid medication; multivitamin | No | History of papillary thyroid cancer; hypothyroidism, post surgical | 2 | 3/4/2021 | Y | NKDA | S | |||
| 1074149 | 3/5/2021 | Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous report was received from a healthcare professional concerning a 32 year old female patients who received Moderna's Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks. The patient's medical history was not provided. Concomitant product use was not provided. The patient received second of two planned dose of mRNA-1273 for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna vaccine. The patient received both scheduled doses of mRNA-1273 prior to the events ; therefore, action taken with the drug in response to the events is not applicable. The outcome of the event, miscarriage spontaneous was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter's Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested. | UNK | Medical History/Concurrent Conditions: No adverse event (No reported medical history.) | USMODERNATX, INC.MOD20210 | 2 | 3/2/2021 | S | ||||||||||||
| 1076331 | 3/5/2021 | CO | 27 | Really bad headache, fatigue, I was throwing up, I was running about 100 fever but it didn't go higher than that. Those symptoms lasted about a week and a half. Talked to healthcare provider with video chat - put me on bedrest. I had a positive pregnant test about three days after the first dose of COVID vaccine. And went to the Hospital about 1 week and 1/2 after finding out. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy. Had the second dose of vaccine, I think of February 9, 2021. | 1/11/2021 | 1/11/2021 | 0 | No | OTH | no | no | no | vsafe | 2 | 3/5/2021 | Y | no | S | ||
| 1081203 | 3/8/2021 | TN | 33 | Patient had LMP on 1/12/21, so was most likely early pregnant at the time of her first vaccine. She then experienced a miscarriage on 3/1/21. She was assessed in the ER and then in our OBGYN office. | 2/4/2021 | 3/4/2021 | 28 | Ultrasound confirmed spontaneous abortion | PUB | Azelastine nasal spray, benadryl, Prenatal vitamins, Breo Ellipts, Zyrtec, Pristiq | Asthma, Anxiety | Asthma, Anxiety | 2 | 3/8/2021 | Y | Cats, Grass Pollen, Mold, Oak trees | S | |||
| 1086871 | 3/10/2021 | WI | Miscarriage; Vaccine exposure during pregnancy; A spontaneous report was received from a consumer who was also a 41-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event miscarriage/ abortion spontaneous and vaccine exposure during pregnancy. The patient's medical history included environmental allergies and an allergy to an unknown beauty product, kidney stone, endometriosis, anxiety, and paroxysmal supraventricular tachycardia. Products known to have been used by the patient, within two weeks prior to the event, included pre-natal vitamins and escitalopram oxalate. The patient received their first of two planned doses of mRNA-1273 (Batch number: 042L20A) intramuscularly on 14 Jan 2021. On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2020, the patient had a positive pregnancy test. The first day of the patient's last menstrual period was on 24 Dec 2020. The estimated date of conception was not provided. The due date was estimated as 30 Sep 2021. On 22 Feb 2021, the patient had a miscarriage. There was no fetal heartbeat on the ultrasound. On 24 Feb 2021, the patient underwent a procedure to complete the miscarriage. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events was considered recovered.; Reporter's Comments: This is a case of product exposure during pregnancy with an Adverse event of Spontaneous abortion for this 41-year-old female. Very limited information regarding this event has been provided at this time. Further information has been requested. | 1/14/2021 | 1/14/2021 | 0 | Test Date: 20210222; Test Name: Blood Test; Result Unstructured Data: Normal test results; Test Date: 20210222; Test Name: HCG; Result Unstructured Data: 21297 (expected to be); Test Date: 20210222; Test Name: HIV/ Chlamydia /gonorrhea; Test Result: Negative ; Result Unstructured Data: HIV/ Chlamydia /gonorrhea; Test Date: 20210222; Test Name: Ultrasound; Result Unstructured Data: no fetal heart beat; Test Date: 20210222; Test Name: Urine; Result Unstructured Data: Tested normal/negative | UNK | PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LEXAPRO | Medical History/Concurrent Conditions: Anxiety; Cosmetic allergy (an allergy to an unknown beauty product); Endometriosis; Environmental allergy (environmental allergies); Kidney stone; Paroxysmal supraventricular tachycardia | USMODERNATX, INC.MOD20210 | 2 | 3/5/2021 | S | ||||||
| 1106398 | 3/16/2021 | CA | 26 | Initial prenatal visit on 2/4/2021, pregnancy measuring 6 weeks with visible cardiac activity. Vaccine received 2/9/2021. Repeat ultrasound 2/18/2021, no cardiac activity seen, pregnancy still measuring 6 weeks. D&C procedure on 2/23/2021 for missed abortion. | 2/9/2021 | 2/18/2021 | 9 | CBC unremarkable on 2/4/2021 and 2/18/2021. UA unremarkable 2/4/2021. Chlamydia/GC PCR negative, quantiferon TB negative, syphilis negative 2/4/2021. Varicella and Rubella titers positive for immunity 2/4/2021. HgbA1c 5.0 2/4/2021. | PVT | Prenatal vitamins | No | No | 2 | 3/16/2021 | Y | No | S | |||
| 1109612 | 3/17/2021 | 30 | Missed abortion noted about one month after 1st COVID vaccination Patient was supposed to be around 11weeks pregnant. She had a prior ultrasound with a single live intrauterine pregnancy on Feb 24, 2021. EDD was October 3rd, 2021. Fetus with no heart tones noted on March 17th, 2021. Fetus measuring about 8 weeks pregnant patient only noted elevated temperature after COVID vaccination | 2/10/2021 | 3/17/2021 | 35 | UNK | prenatal vitamins | none | none | 2 | 3/17/2021 | Y | no known allergies | S | |||||
| 1110523 | 3/18/2021 | WI | 37 | Pregnancy dated by LMP consistent with 7 week ultrasound. Received first dose before pregnancy was known, received second dose at 7 weeks gestation. Started prenatal care, and had normal labs, euthyroid state, negative/normal fetal cell free DNA (non-invasive prenatal testing) done at 11 weeks with normal fetal nuchal translucency and nasal bone present. Missed spontaneous abortion discovered at 12 weeks 6 days (no fetal heart beat), D&C done, awaiting cytogenetics now. | 12/31/2020 | 3/2/2021 | 61 | PVT | Synthroid 112 mcg, prenatal vitamin | No | Graves disease post-ablation, iatrogenic hypothyroidism, euthyroid state | 2 | 3/18/2021 | Y | Penicillin, sulfa, mangos | S | ||||
| 1140309 | 3/27/2021 | LA | 33 | Last menstrual period either Nov 1-8 (light, abnormal, pregnancy symptoms) or Nov 29-12/2 (light, abnormal, pregnancy symptoms). Possible dates of conception 10/16, 10/18, 10/19, 11/14, 11/15. Negative pregnancy test on 11/26 & 11/29. +Pregnancy test 12/10. Estimated delivery dates were either 7/8/21 or 8/8/21. First covid vaccine received on 12/30. First OB ultrasound on 1/5/21, estimated to be 6 weeks + 3 days gestation, with no heartbeat. Repeat ultrasound on 1/13/21, continued to measure 6 weeks + 3 days gestation, again with no heartbeat. Spontaneous miscarriage did not occur, 1 time dose of intravaginal Cytotec was taken and medical abortion completed. | 12/30/2020 | 1/5/2021 | 6 | As stated above. OB ultrasound 1/5/21. OB ultrasound 1/13/21. | PVT | Prenatal Vitamin | None | None | 2 | 3/27/2021 | Y | None | S | |||
| 1142921 | 3/29/2021 | PA | 38 | Pregnant patient miscarried; got pregnant in between the first and second dose; A spontaneous report was received from a pharmacist ,concerning a 38-year-old, female patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced getting pregnant in between the first and second doses (Exposure during pregnancy) and miscarried/abortion spontaneous. The patient's medical history was not reported. Concomitant medications were not reported. On 15 Jan 2021, patient received the first of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine intramuscularly for prophylaxis of COVID-19 infection. Between an unknown date and 17 Mar 2021, the patient become pregnant and experienced a miscarriage. On March 17 2021, the patient received the second of two planned doses of mRNA-1273 (Lot/batch: unknown) vaccine for prophylaxis of COVID-19 infection. The event, miscarriage, was medically significant. Laboratory details were not reported. Treatment information was not reported. Action taken with mRNA-1273 in response to the events was not applicable. At the time of report , the outcome of events; got pregnant in between first and second dose and pregnant patient miscarried were, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. | 1/15/2021 | UNK | Medical History/Concurrent Conditions: No adverse event | USMODERNATX, INC.MOD20210 | 2 | 3/26/2021 | S | |||||||||
| 1145902 | 3/29/2021 | UT | 43 | spontaneous abortion at approximately 8 weeks gestation, 10 days after vaccine administration | 3/16/2021 | 3/26/2021 | 10 | pelvic ultrasound showing yolk sac and gestational sac but no fetal pole after previously seen on ultrasound, bHCG 5000> 741 | PVT | none | unknown | periodontal disease | 2 | 3/29/2021 | Y | Y | nkda | S | ||
| 1151400 | 3/31/2021 | TX | 40 | I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case) | 2/20/2021 | 2/24/2021 | 4 | Test Date: 20210312; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown results | PVT | PRENATAL VITAMINS [ASCORBIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;ERGOCALCIFEROL;NICOTINAMIDE;PYR | Medical History/Concurrent Conditions: Shellfish allergy | USPFIZER INC2021277400 | 2 | 3/26/2021 | Y | Y | S | |||
| 1157569 | 4/1/2021 | PA | Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine. The patients medical history was not provided.No concomitant medication information was provided. On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine. Laboratory details was not provided.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Pregnancy and Miscarriage was resolved. The outcome of the event well past 42 days was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown). Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. . | 1/1/2021 | UNK | Medical History/Concurrent Conditions: No adverse event (no adverse event reported) | USMODERNATX, INC.MOD20210 | 2 | 3/30/2021 | S | ||||||||||
| 1175159 | 4/7/2021 | NC | 31 | miscarriage/spontaneous abortion; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing herpes simplex 2 and sulfa allergy. Patient previously received the first dose of bnt162b2 for covid-19 immunisation. Concomitant medication included acyclovir) taken for an unspecified indication, start and stop date were not reported. The mother was 7 Weeks pregnant at the onset of the event. The patient experienced miscarriage/spontaneous abortion on 25Feb2021 16:45. The patient was supposedly due to deliver on 18Oct2021. The with outcome of event was recovered with sequelae. No follow-up attempts are possible, information about batch/lot number has already been obtained. | 2/17/2021 | 2/25/2021 | 8 | PVT | ACYCLOVIR [ACICLOVIR] | Herpes simplex type II | Medical History/Concurrent Conditions: Sulfonamide allergy | USPFIZER INC2021314046 | 2 | 4/6/2021 | Y | S | ||||
| 1178242 | 4/7/2021 | IL | 31 | This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABORTION OF ECTOPIC PREGNANCY (Miscarriage) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypospadias on 15-Jun-2019 and Pregnancy (one). Concurrent medical conditions included Subfertility (Treated since 2018). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On 04-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 05-Mar-2021, the patient experienced ABORTION OF ECTOPIC PREGNANCY (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Ectopic pregnancy. On 04-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, ABORTION OF ECTOPIC PREGNANCY (Miscarriage) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion.; Sender's Comments: This is a case of product exposure during pregnancy with abortion ectopic pregnancy for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs post abortion. | 3/4/2021 | 3/4/2021 | 0 | UNK | Subfertility (Treated since 2018) | Medical History/Concurrent Conditions: Hypospadias; Pregnancy (one) | USMODERNATX, INC.MOD20210 | 2 | 4/5/2021 | S | ||||||
| 1206919 | 4/14/2021 | CT | 39 | spontaneous miscarriage; conceived following second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder, Drug allergy (sulfa), Drug allergy (cephalosporins) and Drug allergy (codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication. On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, PREGNANCY (conceived following second dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (spontaneous miscarriage) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Date of last menstrual period was 29Jan2021 This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (spontaneous miscarriage) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy loss (first trimester loss) on 01-Jun-2013 and Pregnancy loss (first trimester loss) on 23-Sep-2019. Concurrent medical conditions included Anxiety disorder and Drug allergy (sulfa, cephalosporins, codeine). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN D [VITAMIN D NOS], DOCOSAHEXAENOIC ACID (DHA), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTIC BLEND), LORATADINE and MAGNESIUM for an unknown indication. On 19-Jan-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PREGNANCY (conceived following second dose). On 06-Mar-2021, the patient experienced ABORTION SPONTANEOUS (spontaneous miscarriage) (seriousness criterion medically significant). On 06-Mar-2021, ABORTION SPONTANEOUS (spontaneous miscarriage) and PREGNANCY (conceived following second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pregnancy test: positive (Positive) positive. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Date of last menstrual period was 29 Jan 2021. This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: This is a case of product exposure during pregnancy (5 weeks gestational age) with spontaneous abortion for this 39-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded | 1/19/2021 | 2/13/2021 | 25 | Test Date: 20210226; Test Name: pregnancy test; Test Result: Positive ; Result Unstructured Data: positive | UNK | PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; DHA; PROBIOTIC BLEND; LORATADINE; MAGNESIUM | Anxiety disorder; Drug allergy (sulfa, cephalosporins, codeine) | Medical History/Concurrent Conditions: Pregnancy loss (first trimester loss) | USMODERNATX, INC.MOD20210 | 2 | 4/12/2021 | S | ||||
| 1210781 | 4/14/2021 | MN | 29 | Had a early pregnancy loss at 7th week gestation, Spontaneous abortion, Having regular check ups and follow up with the doctors | 3/5/2021 | 3/28/2021 | 23 | Beta- Hcg levels and ultrasound 3/29/2021 Beta- Hcg levels 3/31/2021 Beta Hcg levels 4/5/2021 | OTH | Prenatal Vitamins | no | no | 2 | 4/14/2021 | Y | No | S | |||
| 1225589 | 4/18/2021 | DC | 22 | Vaccine received 4/7/2020. On Wednesday 4/14/2020, pt went to the gym and did high intensity interval training involving body weight exercises, specifically an exercise called "v-ups". Exercise was not more strenuous than usual, and pt was well hydrated. Pt reports that she exercises often and this was not a new exercise. Soon after workout, pt began having muscular pain in the hip, radiating into her inner thighs bilaterally with associated tingling. On 4/15, pain worsened and pt had difficulty ambulating. Denies any edema, erythema in her legs or unilateral leg swelling. Presented to the ED on 4/16 and found to have elevated CK of 127,768 with UA significant for large blood and protein, without RBC, indicative of rhabdomyolysis. Pt did not have any known risk factors that may precipitate rhabdomyolysis. On admission, fluids were initiated with downtrending CK, LFTs, and renal function remained stable. er D&C was done at on 4/2 and she reports there were no complications during or after the procedure. Her BHCG was elevated at the time and she tried an oral abortion pill but still had some fetal remnants so went for a D&C. She had the J&J vaccine shortly after on 4/7 and she reports no complications around and shortly after getting the vaccine. Denies vaginal bleeding or odor. Denies fevers, chills, abd pain, diarrhea, constipation, dysuria, chest pain, palpitations, shortness of breath, nausea/vomiting. | 4/7/2021 | 4/14/2021 | 7 | 4/16: CK 127768. WBC 12.66, Hgb 14.6, platelets 278. BMP, CRP wnl. Cr:0.6. Urine pregnancy negative. UA with large blood, 100 protein 4/17: CK 76,406. AST 1772, ALT 513. Cr: 0.6 4/18: CK 46034. AST: 1220 ALT:454 | PVT | None | D+C due to retained products of conception on 4/2 after voluntary interruption of pregnancy via medication on 3/22 | Mitral valve prolapse, asymptomatic | 2 | 4/18/2021 | Y | NKDA | S | |||
| 1235494 | 4/21/2021 | WI | 25 | pain in arm; Miscarried; No fetal heartbeat.; Menstrual bleeding; Pregnant; General sick and tired feeling; Did not want to get out of bed; Pretty tired; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarried) in a 25-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety on 01-Jan-2010. Concomitant products included FLUOXETINE for Anxiety, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, MISOPROSTOL (CYTOTEC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). 12-Mar-2021, the patient experienced MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), FATIGUE (Pretty tired) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Menstrual bleeding). On 01-Apr-2021, the patient experienced FOETAL GROWTH ABNORMALITY (Baby had not grown). On 09-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarried) (seriousness criterion medically significant), FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) and HEREDITARY DISORDER (Genetic issue). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 09-Apr-2021, ABORTION SPONTANEOUS (Miscarried), FOETAL GROWTH ABNORMALITY (Baby had not grown) and FOETAL HEART RATE ABNORMAL (No fetal heartbeat.) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (Menstrual bleeding), MALAISE (General sick and tired feeling), FEELING ABNORMAL (Did not want to get out of bed), HEREDITARY DISORDER (Genetic issue), FATIGUE (Pretty tired) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Ultrasound foetal abnormal: abnormal (abnormal) Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not. On 01-Apr-2021, Ultrasound scan: abnormal (abnormal) Saw baby heartbeat but was informed baby had not grown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information provided mentioned ultrasound and cytotec. Action taken with mRNA-1273 in response to the event was not applicable as patient took both doses of the vaccine. Patient reported that she does not blame Moderna, as her OB feels the miscarriage was related to a "genetic issue. This case was linked to MOD-2021-060699 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient updated AE and mentions fetal complications resulting in miscarriage. Events and outcome of case thus updated with new information.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. | 2/12/2021 | 3/12/2021 | 28 | Test Date: 20210325; Test Name: Ultrasound; Result Unstructured Data: Had some bleeding and found out it was subchorionic hemorrhage. Bleeding is in another part of the uterus where is baby is not; Test Date: 20210401; Test Name: Ultrasound; Result Unstructured Data: Saw baby heartbeat but was informed baby had not grown | UNK | FLUOXETINE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; CYTOTEC | Medical History/Concurrent Conditions: Anxiety | USMODERNATX, INC.MOD20210 | 2 | 4/15/2021 | S | |||||
| 1240260 | 4/22/2021 | UT | 39 | Miscarriage at the 11th week of pregnancy. 1st pregnancy; no previous pregnancies, miscarriages or abortions. Estimated due date Oct 7, 2021. | 3/9/2021 | 3/20/2021 | 11 | OBGYN exam on 03/26/2021 OB GYN by midwife. Pregnancy test after bleeding stopped on 3/30/2021, self administered to confirm negative pregnancy. | PHM | Prenatal vitamins, vitamin d | 2 | 4/22/2021 | Y | S | ||||||
| 1255216 | 4/25/2021 | CO | 31 | Late-term miscarriage; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization in a hospital. The patient's medical history was not reported. There were no concomitant medications. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient has not had COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced late-term miscarriage on 22Mar2021 that required physician clinic visit and hospitalization for 1 day. The mother was 15 weeks pregnant at the onset of the event. Gestation period at exposure was not reported. Pregnancy due date was reported to be scheduled on 07Sep2021. The pregnancy resulted in spontaneous abortion. Fetal outcome was not reported. Therapeutic measures were taken as a result of late-term miscarriage which includes dilation and evacuation (D&E). The outcome of the event was unknown. | 3/18/2021 | 3/22/2021 | 4 | PVT | USPFIZER INC2021392693 | 2 | 4/22/2021 | Y | S | |||||||
| 1261506 | 4/27/2021 | IN | 30 | Miscarriage; Patient was unaware that she was pregnant; This spontaneous case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy test (Negative home pregnancy test.) on 02-Mar-2021. On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant). On 19-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and EXPOSURE DURING PREGNANCY (Patient was unaware that she was pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No treatment or concomitant mediation were reported. | 3/3/2021 | 3/3/2021 | 0 | UNK | Medical History/Concurrent Conditions: Pregnancy test (Negative home pregnancy test.) | USMODERNATX, INC.MOD20210 | 2 | 4/24/2021 | S | |||||||
| 1262037 | 4/27/2021 | PR | MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient's height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS | 4/10/2021 | OTH | Comments: Unknown | PRJNJFOC20210430100 | 2 | 4/27/2021 | S | ||||||||||
| 1265911 | 4/28/2021 | NY | 39 | miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage was unknown while for all other events was not recovered. | 4/9/2021 | 4/9/2021 | 0 | Test Date: 20210411; Test Name: blood work; Result Unstructured Data: Test Result:she was only 3 weeks pregnant; Test Date: 20210411; Test Name: sonogram; Result Unstructured Data: Test Result:no fetal heartbeat | UNK | MESALAMINE | Colitis | USPFIZER INC2021403467 | 2 | 4/26/2021 | Y | S | ||||
| 1266336 | 4/28/2021 | TX | 41 | Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to ER due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C. She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy. | 4/21/2021 | 4/21/2021 | 0 | Sonogram | PUB | none | none | none | 2 | 4/28/2021 | none | S | ||||
| 1278735 | 5/1/2021 | TX | 41 | I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested. | 4/14/2021 | 4/14/2021 | 0 | Test Date: 20210317; Test Name: Pregnancy test; Test Result: Positive ; Comments: I tested positive for pregnancy in 17Mar2021.; Test Date: 20210405; Test Name: ultrasound; Result Unstructured Data: Test Result:OK; Comments: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat.; Test Date: 20210414; Test Name: ultrasound; Result Unstructured Data: Test Result:Abortion; Comments: the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. | UNK | USPFIZER INC2021424348 | 2 | 4/29/2021 | Y | S | ||||||
| 1279188 | 5/1/2021 | IL | 40 | had a natural miscarriage; This is a spontaneous report from a contactable consumer (patient). A 40-year-old pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: G06026), via an unspecified route of administration, administered in Arm Left on 10Mar2021 16:00 as single dose for COVID-19 immunization in an public health clinic. The patient's medical history was not reported. No known allergies. The patient's concomitant medication includes an unspecified multivitamin. The patient previously received the first dose of bnt162b2 (lot number: not reported) on an unspecified date for COVID-19 immunization. No other vaccinations in four weeks. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. The patient's last menstrual period was on 25Jan2021 with gestation age at exposure reported as 6 weeks. Expected due date was on 08Nov2021. On 09Apr2021, the patient visited the emergency room and physicians office and it was reported that the patient had a natural miscarriage, do not know if it was related to the vaccine. Baby stopped developing around time of vaccination at 10 weeks of gestation. The pregnancy resulted in spontaneous abortion. It was unknown if the patient received any treatment. The fetal outcome is intrauterine death. The outcome of the patient was recovering. No follow-up attempts are possible. No further information is expected. | 3/10/2021 | 4/9/2021 | 30 | PUB | USPFIZER INC2021439506 | 2 | 4/29/2021 | Y | Y | S | ||||||
| 1284722 | 5/4/2021 | IL | went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021. After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage. No treatment product information was not provided Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. | 4/11/2021 | 4/11/2021 | 0 | UNK | PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] | Comments: No medical history was provided by the reporter. | USMODERNATX, INC.MOD20210 | 2 | 5/3/2021 | S | |||||||
| 1290767 | 5/5/2021 | IL | 53 | Forced abortion; Maternal exposure during pregnancy; Feeling unwell; Crohns flare up; Digestion issues; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CROHN'S DISEASE (Crohns flare up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. The patient's past medical history included No adverse event (No reported medical history). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 04-Apr-2021, the patient experienced CROHN'S DISEASE (Crohns flare up) (seriousness criterion medically significant) and DYSPEPSIA (Digestion issues). On an unknown date, the patient experienced ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell). The delivery occurred on an unknown date. At the time of the report, CROHN'S DISEASE (Crohns flare up), DYSPEPSIA (Digestion issues), ABORTION INDUCED (Forced abortion), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (Feeling unwell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The fetus was exposed to maternal use of humira in utero.Physician had given a new drug to induce labor and force abortion but she went off after five days because she did not well with it. Unspecified medication for labor and force abortion was also considered suspect. No concomitant medications were reported. No treatment information was provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. | 4/1/2021 | 4/4/2021 | 3 | UNK | Medical History/Concurrent Conditions: No adverse event (No reported medical history) | USMODERNATX, INC.MOD20210 | 2 | 5/5/2021 | S | |||||||
| 1299121 | 5/8/2021 | FL | 30 | The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient's last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown. Information on the lot/batch number has been requested. | 4/21/2021 | UNK | USPFIZER INC2021449208 | 2 | 5/5/2021 | Y | Y | S | ||||||||
| 1299282 | 5/8/2021 | IL | 27 | spontaneous abortion; This is spontaneous report from a contactable nurse. A 27 year old female patient who was not pregnant at the time of vaccination received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot Number: EL3247) dose 1 intramuscular administered on Arm left on 15Feb2021 as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Seriousness criteria was reported by the patient that it was not serious, no death life-threatening or cause of prolonged hospitalisation. It was not disabling and did not have any congenital birth defect. COVID-19 vaccine was administered at the hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive medications within 2 weeks of vaccination. 12Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test negative. On 29Mar2021, the patient had spontaneous abortion and was taken to emergency room in hospital. On 25Apr2021, the device date given. vaccine facility, race and ethnicity information was available. The outcome of the event was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, spontaneous abortion cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2021458221 mother/baby case | 2/15/2021 | 3/29/2021 | 42 | Test Date: 20210312; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative | PVT | USPFIZER INC2021463525 | 2 | 5/6/2021 | Y | S | ||||||
| 1299321 | 5/8/2021 | GA | Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS), and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021513072 Pfizer;US-PFIZER INC-2021513093 Pfizer;US-PFIZER INC-2021513094 Pfizer;US-PFIZER INC-2021513095 Pfizer;US-PFIZER INC-2021513097 Pfizer;US-PFIZER INC-2021513098 Pfizer;US-PFIZER INC-2021513099 Pfizer;US-PFIZER INC-2021513096 Pfizer | UNK | USPFIZER INC2021480902 | 2 | 5/7/2021 | S | ||||||||||||
| 1299371 | 5/8/2021 | GA | Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS) and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513072 | 2 | 5/7/2021 | S | ||||||||||||
| 1299373 | 5/8/2021 | GA | This is a literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513094 | 2 | 5/7/2021 | S | ||||||||||||
| 1299374 | 5/8/2021 | GA | Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a publication. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons in the are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513095 | 2 | 5/7/2021 | S | ||||||||||||
| 1299375 | 5/8/2021 | GA | This is a literature report from The New England Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513096 | 2 | 5/7/2021 | S | ||||||||||||
| 1299376 | 5/8/2021 | GA | Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report from a Journal of Medicine, 2021, pages 1-10 entitled Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : PFIZER INC-2021480902 Pfizer;PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513097 | 2 | 5/7/2021 | S | ||||||||||||
| 1299377 | 5/8/2021 | GA | This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports. Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the "safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021480902 Pfizer;US-PFIZER INC-2021480902 Pfizer | UNK | USPFIZER INC2021513098 | 2 | 5/7/2021 | S | ||||||||||||
| 1303430 | 5/10/2021 | NH | 31 | It started on my birthday - I started having contractions - I was only 23 weeks pregnant. I was admitted to the hospital for pre-term labor on - March 6, 2021; (date of delivery removed). Pregnancy history - 2nd pregnancy - first - abortion - four years ago. Estimated due date - June 29, 2021 . I was re-admitted to the hospital two days later for a delayed post delivery hemorrhage - after that I had a pretty typical recovery, I think. | 2/26/2021 | 2/28/2021 | 2 | Hospital - blood cultures - were taken - I have not been able to seen the results of these. Some test I don't have access to because they are not giving me my son's medical records. They are waiting for documentation - and there seems to be a lot of red tape. | OTH | Wellbutrin; Prenatal vitamins | no | no | vsafe | 2 | 5/10/2021 | Y | no | S | ||
| 1312872 | 5/13/2021 | GA | 25 | Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use. Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking. Additional information has been requested.; Sender's Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use. Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking. Additional information has been requested. | 3/22/2021 | 3/22/2021 | 0 | UNK | LEXAPRO | Asthma | USMODERNATX, INC.MOD20211 | 2 | 5/12/2021 | Y | S | |||||
| 1313020 | 5/13/2021 | IL | 30 | Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 14Apr2021 (Batch/Lot Number: Ew0162) as 2nd dose, single for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS) received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received an unspecified vaccine on 14Apr2021 (same date) in right arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced miscarriage on 27Apr2021. At 6 weeks there was a heartbeat detected. Patient received her second dose and at 8 weeks there was no heartbeat. Abortion pill was reported as treatment. Event result in Doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Outcome of event was recovering. | 4/14/2021 | 4/27/2021 | 13 | UNK | PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none | USPFIZER INC2021470815 | 2 | 5/12/2021 | S |