Information Center
Your Health. Your Family. Your Choice.
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National Vaccine Information Center Your Health. Your Family. Your Choice. |
MedAlerts.org |
| Table |
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| Vaccine/Manufacturer | Count | Percent |
| TOTAL | † 5,205 | † 106.99% |
| COVID19 / PFIZER/BIONTECH | 3,805 | 78.21% |
| COVID19 / MODERNA | 1,151 | 23.66% |
| COVID19 / JANSSEN | 182 | 3.74% |
| COVID19 / UNKNOWN MANUFACTURER | 26 | 0.53% |
| UNK / UNKNOWN MANUFACTURER | 24 | 0.49% |
| FLUX / UNKNOWN MANUFACTURER | 3 | 0.06% |
| RSV / PFIZER/WYETH | 2 | 0.04% |
| HEPA / UNKNOWN MANUFACTURER | 2 | 0.04% |
| FLUC4 / SEQIRUS, INC. | 2 | 0.04% |
| COVID19-2 / PFIZER/BIONTECH | 2 | 0.04% |
| TDAP / UNKNOWN MANUFACTURER | 1 | 0.02% |
| TDAP / GLAXOSMITHKLINE BIOLOGICALS | 1 | 0.02% |
| TD / SANOFI PASTEUR | 1 | 0.02% |
| IPV / SANOFI PASTEUR | 1 | 0.02% |
| FLU4 / GLAXOSMITHKLINE BIOLOGICALS | 1 | 0.02% |
| COVID19 / NOVAVAX | 1 | 0.02% |
| † Because VAERS cases can have multiple vaccinations, symptoms, and event outcomes, a single case can account for multiple entries in this table. This is why the Total Count is greater than 4,865 (the number of cases found), and the Total Percent is greater than 100. | ||
| Case Details (Sorted by State) |
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: she had a miscarriage; was pregnant when got the vaccine; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of ABORTION SPONTANEOUS (she had a miscarriage) in a 34-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3915B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna (1st Dose, Lot number: 012L20A) on 14-Jan-2021, Moderna (2nd Dose, Lot number: 031M20A) on 05-Aug-2021, Moderna (3rd Dose) on 22-Oct-2021, Moderna Bivalent (4th Dose and Lot number: AS7140C) on 06-Sep-2022; for Product used for unknown indication: Flu Shot (one week ago). Past adverse reactions to the above products included No adverse event with Flu Shot, Moderna, Moderna, Moderna and Moderna Bivalent. On 29-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine). On 01-Nov-2023, the patient experienced ABORTION SPONTANEOUS (she had a miscarriage) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 29-Sep-2023, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant when got the vaccine) had resolved. At the time of the report, ABORTION SPONTANEOUS (she had a miscarriage) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided. Company Comment: This Spontaneous case describes the occurrence of maternal exposure during pregnancy in a 34-years-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Abortion spontaneous, which occurred approximately 1 month after SPIKEVAX 2023-2024, administered as fifth dose within COVID-19 vaccination schedule, at unknown weeks of gestation. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live significant follow-up received contains historical vaccines added, suspect drug information updated, event added. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Slight fever and chills. Spotting. Miscarriage. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; JOINT PAIN; SORE ARM; FATIGUE; HEADACHE; MUSCLE PAIN; This solicited pregnancy report received from a patient concerned a 36 year old white female of an unspecified ethnic origin. The patient was enrolled in a non-company sponsored study. The patient''s weight was 66.67 kilograms, height was 165 centimeters, and body mass index (BMI) was 24.26. The patient''s past medical history included: one previous pregnancy, which resulted in a miscarriage, and concurrent conditions included: multigravida, no history of exposure to drugs for recreational use, tobacco use, or alcoholic beverage consumption. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total was administered on 21-MAR-2021 for covid-19 immunisation. Concomitant medications included prenatal Vitamin and Lamotrigine. On 21-MAR-2021 (gestational age 3 weeks 6 days), the patient had maternal exposure during pregnancy, chills, feeling unwell, joint pain, sore arm, fatigue, headache, and muscle pain. On 11-May2021 (gestational age 11 weeks and 1 day), the study participant experienced spontaneous abortion. No additional details were provided. The first day of the last menstrual period (LMP) was reported to be 22-Feb-2021. The estimated delivery date (EDD) was calculated to be 29-Nov-2021. It was reported that this was singleton pregnancy. The para was 0 and gravida was 2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from maternal exposure during pregnancy, chills, feeling unwell, joint pain, sore arm, fatigue, headache, and muscle pain on 23-MAR-2021, and the outcome of spontaneous abortion was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and spontaneous abortion, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, joint pain, sore arm, fatigue, headache, and muscle pain was related. This report was serious (Other Medically Important Condition). Additional information was received from patient on 27-JUL-2021. The following information was updated and incorporated into the case narrative: Race (white), height (165 centimeters), BMI (24.26), medical history (multigravida, no history of exposure to drugs for recreational use, tobacco use, or alcoholic beverage consumption.), concomitant medication (prenatal Vitamin and Lamotrigine), event (spontaneous abortion), seriousness (serious), outcome (unknown), cessation date of previous events, LMP (22-Feb-2021), EDD (29-Nov-2021), para (0), Gravida (2), and narrative was updated accordingly.; Sender''s Comments: V1: 20210728695-Covid-19 vaccine ad26.cov2.s-spontaneous abortion. 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: MEDICAL HISTORY 20210728695-Covid-19 vaccine ad26.cov2.s-maternal 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Pregnancy resulted in a miscarriage; Did not receive 2nd dose; Found out she was pregnant after receiving 1st dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 22-Mar-2021, EXPOSURE DURING PREGNANCY (Found out she was pregnant after receiving 1st dose) had resolved. At the time of the report, ABORTION SPONTANEOUS (Pregnancy resulted in a miscarriage) had resolved and PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that the patient received first shot and then found out she was pregnant. The pregnancy resulted in a miscarriage and patient wanted to knowif she should now get her 2nd shot, or restart the vaccination series. This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected. Reporter did not allow further contact; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse event of abortion spontaneous. Based on temporal association a causal relationship cannot be excluded. Also This report refers to a case of Product dose omission. further information is not expected. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Pt received 3rd booster covid vaccine on 12/27/21. Her LMP was 12/3/21, and she found out she was pregnant. Then on January 30th she started passing large clots. Ultrasound imaging on 2/1/22 showed patient was experiencing miscarriage. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Preeclampsia; Three areas of infarct on the placenta; Anxiety; High blood pressure (started in this pregnancy); Delivery at 36 weeks; Sore arm; Chills; Maternal exposure during pregnancy; Headache; Muscle pain; Fever; Nausea; On 21-JUN-2023, this non-serious, initial sponsored trial safety report was received from a nurse via the Registry and was sent to Novavax on 21-JUL-2023. A 35-year-old female of an unspecified race was vaccinated with Nuvaxovid 10 ug/mL suspect Covid-19 vaccine unspecified dose on 21-JUN-2023. Route of administration of vaccine was unknown. Medical history included COVID-19 on 10-AUG-2022, Miscarriage (past 2 pregnancies), Multi gravida (past 10 pregnancies with 8 live babies), and Body mass index high. Concomitant medications included unspecified prenatal vitamins daily, Aspirin 81 (acetylsalicylic acid) daily (From start date on 24-MAR-2023, 13 weeks gestation period at time of exposure), and vitamin D 3 daily (From start date on 01-FEB-2023, 5 weeks gestation period at time of exposure). On 21-JUN-2023, at the time of vaccination, the individual experienced maternal exposure during pregnancy (PT: Maternal exposure during pregnancy). At the time of reporting, the event outcome of Maternal exposure during pregnancy was unknown. Registry''s narrative was provided as follows: This case refers to a 35 year-old study participant. On 17-JUL-2023, significant follow-up information was received from a nurse via the Registry, and was sent to Novavax on 16-AUG-2023. The following information has been updated in the case: On 12-JUL-2023, the individual was vaccinated with a second unspecified dose of intramuscular Nuvaxovid 10 ug/mL suspect Covid-19 vaccine. On 12-JUL-2023, the same day after vaccination, the individual experienced headache (PT: Headache), muscle pain (PT: Myalgia), and sore arm (PT: Pain in extremity). On 13-JUL-2023, 1 day after vaccination, the individual experienced fever (PT: Pyrexia), chills (PT: Chills), and nausea (PT: Nausea). On 14-JUL-2023, the event outcomes of Pyrexia, Chills, and Nausea were recovered/resolved. At the time of reporting, the event outcomes of Headache, Myalgia, and Pain in extremity were recovering/resolving. The Sponsor assessed the causality between the vaccine and the events Headache, Myalgia, Pain in extremity, Pyrexia, Chills, and Nausea as Related, and the causality between the vaccine and the event Maternal exposure during pregnancy as Not Applicable. Registry''s follow-up narrative was provided as follows: This case refers to a 35 year-old study participant. Additional information received on 17-Jul-2023 from the study participant: Second dose of Novavax (Nuvaxovid) added. Pyrexia, Chills, Headache, Myalgia, Nausea and Pain in extremity added as adverse events. On 22-SEP-2023, significant follow-up information was received from a nurse via registry and was sent to Novavax on 29-SEP-2023. During processing of the follow-up a significant case correction was identified. The report type was updated from Sponsored Trial to Non-Interventional Study. The case was upgraded to serious, and the following information has been updated in the case: Concomitant medications were updated as follows: vitamin D 3 was updated to vitamin D NOS, taken daily since 01-FEB-2023, and Aspirin 81 (acetylsalicylic acid) was updated to Aspirin Low, taken daily since 24-MAR-2023. On 20-JUL-2023, 8 days after the last vaccination, the individual experienced anxiety (PT: Anxiety). On 24-AUG-2023, 1 month 12 days after vaccination, she experienced high blood pressure, which started in this pregnancy (PT: Gestational hypertension). On 31-AUG-2023, 1 month 19 days after vaccination, the individual experienced pre-eclampsia (PT: Pre-eclampsia) (Serious: Hospitalization and Medically Significant), and was hospitalized. On 01-SEP-2023, she delivered at 36 weeks (PT: Premature delivery). On an unreported date in 2023, the individual experienced 3 areas of infarct on the placenta (PT: Placental infarction). On 01-SEP-2023, the event outcome of Maternal exposure during pregnancy was recovered/resolved. On 05-SEP-2023, the event outcome of Pre-eclampsia was recovered/resolved. At the time of reporting, the event outcomes of Anxiety and Gestational hypertension were not recovered/not resolved, and Premature delivery and Placental infarction were unknown. The Sponsor assessed the causality between the vaccine and the events Anxiety, Gestational hypertension, Pre-eclampsia, Premature delivery, and Placental infarction as Not related. Registry''s follow-up narrative was provided as follows: This case, received on 21-Jun-2023, refers to a 35 year-old study participant. The study participant''s concurrent condition included body mass index high (40.344). Historical condition included COVID-19 on 10-Aug-2022. Concomitant medications included prenatal vitamins, vitamin D and Adult Low Dose Aspirin (acetylsalicylic acid). The study participant''s obstetrical history included 10 previous pregnancies with eight live babies and two miscarriages. The study participant had no history of tobacco, e-cigarettes, alcohol or recreational drug use. The first day of the last menstrual period (LMP) was calculated to be 23-Dec-2022. The estimated delivery date (EDD) was reported to be 29-Sep-2023. Type of pregnancy was reported as singleton. On 21-Jun-2023, at gestational age of 25 weeks and four days, the study participant received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001. On 12-Jul-2023, at gestational age of 28 weeks and four days, the study participant received the first dose of Novavax (Nuvaxovid) vaccine for the prevention of COVID-19. Batch number reported was 5433MF001. On the same day, a couple of hours after vaccination, the study participant experienced headache. It started with migraine-like qualities but quickly was throughout entire head. The study participant had sensitivity to light and sound, as well as movement would make it worse. The headache did not go away, but was improved with Tylenol. Additionally, the study participant experienced muscle pain that started as the injection site but then lead to generalized muscle aches. By the end of day, the whole arm become sore. On 13-Jul-2023, overnight the study participant started getting chills. It would wake her and then go away for about 30 minutes and come back little later. During the day, the study participant noted fever of 101.7 degrees Fahrenheit. Fever was on and off that day and night, but resolved with Tylenol. Additionally, the study participant experienced intense intermittent nausea that required the use of Zofran. On 14-Jul-2023, the study participant recovered from chills, fever and nausea. On 20-Jul-2023, the study participant started having anxiety with shortness of breath. On 24-Aug-2023, the study participant experienced high blood pressure with headache and visual changes like blurry vision and seeing stars. She had swelling in hands and face. Headache did not improve with medication. On 31-Aug-2023, the study participant developed severe pre-eclampsia and was admitted to hospital due to it. The mother had severe range blood pressure and persistent headache and dizziness, was seeing spots and flashes of light. At gestational age 36 weeks, the study participant delivered a live, preterm, male neonate by cesarean section (C-section). Primary reason for C-section was reported to be severe preeclampsia with prior C-section due to which they needed to deliver as quickly as possible. The study participant spent four days in hospital for the delivery. Neonate''s birth weight was 7 pounds and 4 ounces, body length was 19 inches. On the same day, after delivery, the baby was transferred to Neonatal Intensive Care Unit (NICU) due to problems with breathing as the baby experienced respiratory distress requiring surfactant. Treatment included ampicillin. On 05-Sep-2023, the study participant recovered from pre-eclampsia. On 09-Sep-2023, the neonate recovered from respiratory distress. On an unspecified date in 2023, the pathology showed three areas of infarction on the placenta. At the time of this report on 22-Sep-2023, the study participant had not recovered from high blood pressure and anxiety, while she was recovering from headache, muscle pain and sore arm. Outcome of placental infarction and premature delivery was not reported. The study participant did not provide causality assessment. The case is linked with 2023-US-00164 (corresponding baby case). Additional information received on 17-Jul-2023 from the study participant: Second dose of Novavax (Nuvaxovid) added. Pyrexia, Chills, Headache, Myalgia, Nausea and Pain in extremity added as adverse events. Additional information received on 22-Sep-2023 from the study participant: Pregnancy outcome provided. Events premature delivery, placental infarction, gestational hypertension, anxiety and pre-eclampsia were added. Case upgraded from non-serious to serious. Narrative updated accordingly. Principal Investigator''s assessments: The event of pre-eclampsia is serious and unexpected for the Novavax (Nuvaxovid). Temporal relationship is not compatible. Advanced maternal age and increased BMI (40.344) are confounding factors. Based on the provided information, causality is assessed as not related.; Sender''s Comments: This 35 year-old female experienced: Pre-eclampsia, Placental infarction, Maternal exposure during pregnancy, Headache, Myalgia, Pain in extremity, Chills, Nausea, Pyrexia, Anxiety, Gestational hypertension and Premature delivery after vaccination with Nuvaxovid 10 ug/mL. The event Pre-eclampsia was reported as serious. The events Placental infarction, Maternal exposure during pregnancy, Headache, Myalgia, Pain in extremity, Chills, Nausea, Pyrexia, Anxiety, Gestational hypertension and Premature delivery were reported as non-serious. Considering the current knowledge of the vaccine, the causal relationship between Nuvaxovid and Maternal exposure during pregnancy, Nuvaxovid and Headache, Nuvaxovid and Myalgia, Nuvaxovid and Pain in extremity, Nuvaxovid and Chills, Nuvaxovid and Nausea, Nuvaxovid and Pyrexia and Nuvaxovid and Anxiety were assessed as related, Nuvaxovid and Placental infarction, Nuvaxovid and Gestational hypertension, Nuvaxovid and Pre-eclampsia and Nuvaxovid and Premature delivery were assessed as not related. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Mother is the vaccinee. BABY DIED; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer in social media via a company representative concerned multiple patients of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The patient was gravida1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had vaccine exposure during pregnancy and baby died. The date of the patient''s last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and baby died was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20220251162-Covid-19 vaccine ad26.cov2.s-Baby died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220251162-Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: At 8 weeks pregnancy (2 weeks after first shot) started bleeding and had a subchorionic hematoma. By 10 week subchorionic hematoma resolved. Received second shot and of Feb. 1 week later, at 12 weeks pregnancy , fetus had no heart beat! It measured normal size (as expected) and limited normal first trimester anatomy by ultrasound. But NO heart beat. Something insulted this placenta to lead to fetal demise. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: lost her baby; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reported stated that the patient lost her baby. The mother reported she became pregnant while taking bnt162b2. It was reported that the doctors said that can''t prove it was from the vaccine but they say they are pretty damn sure it was because of the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. | |||||||||||||||||||
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: stractty throat and itchy eyes for 12 hrs and sore arm for 48 hours. Pregnant on Jul and in August no fetal heart beat at late august and no symptoms DNC on 3 sep2021 | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: reported to ED on 4/3 with miscarriage, abdominal pain, vaginal bleeding. I don''t have the info on date of delivery it isn''t in the ED providers note. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: This spontaneous pregnancy report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The patient was gravida 1. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had vaccine exposure during pregnancy and lost baby (Miscarriage). The date of the patient''s last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). Sender''s Comments: V0: 20220312606- Covid-19 vaccine ad26.cov2.s-Miscarriage. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220312606- Covid-19 vaccine ad26.cov2.s- Vaccine exposure during pregnancy. The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: VACCINE EXPOSURE DURING PREGNANCY; MISCARRIED; This spontaneous pregnancy report received from a parent via a company representative concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included: clotting. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine exposure during pregnancy. Reporter stated that, the report showed that the fetus stopped developing at five weeks. On an unspecified date in JUL-2021, the patient miscarried at ten weeks and the pregnancy resulted in a spontaneous abortion. The date of the 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 patient recovered from vaccine exposure during pregnancy on JUL-2021, and the outcome of miscarried was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210941603-COVID-19 VACCINE AD26.COV2.S-miscarried. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s) 20210941603-COVID-19 VACCINE AD26.COV2.S-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 | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Placental abruption (with heavy bleeding) occurred two days short of week 36 in first pregnancy (which was achieved via IVF with PGS-tested embryo), resulting in stillbirth on 5/6/2021; baby was 4lb 8oz upon delivery. Due date was June 4, 2021. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: I had a miscarriage two days post COVID vaccine administration at 8 weeks pregnant. It may or may not be related to the vaccine. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: miscarried; Maternal Drug Exposure; This is a spontaneous report from a non-contactable consumer. A female patient (reporter''s friend''s daughter-in-law) of unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose, and via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced miscarried on an unspecified date. Patient got pregnant, received the Pfizer vaccine, miscarried; got pregnant again, got the Pfizer vaccine and miscarried again. Outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Approximately 4 months after receiving my second dose of Pfizer Covid 19 vaccine, I suffered a 2nd trimester miscarriage in a otherwise completely healthy pregnancy and baby. NIPS test results showed no chromosomal abnormalities. Ultrasound confirmed no heartbeat. Baby girl was measuring 13 weeks. | |||||||||||||||||||
Administered by: Military Purchased by: ?
Life Threatening? No Write-up: 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Presented to emergency department (ED) with 16week 2 day pregnancy, increased vaginal bleeding with clots and lower abdominal cramping. Started with vaginal spotting and bleeding at 14 weeks. LMP 11/9/2021. Had COVID-19 infection during first trimester. In ED BP 152/80, HR 96, afebrile. White blood cell count was elevated - 18,300. Pelvic examination revealed blood in the vault and fetal tissue at the cervical os consistent with a spontaneous abortion. Final diagnosis was spontaneous second trimester abortion. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Fetal demise at 18 weeks 4 days | |||||||||||||||||||
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: Patient had elevated blood pressure affecting pregnancy. Her cesarean section due date was moved up from 3/22 to 3/10. Per notes from Doctor on 3/10/21: Estimated Date of Delivery: 3/28/21 who presented for repeat C/S at 37 wks due to GHTN. Her BP''s did normalize following delivery and she did not require antihypertensive medications. Procedure was uncomplicated as was her postoperative stay. Baby did get admitted to NICU and is doing well. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: I become pregnant within 30 days of my 2nd vaccine (last menstrual period (LMP) was February 3rd and I ovulated around February 18th). I then miscarried at 6 weeks and 1 day (3/18/21). I found out I miscarried at 9 weeks and 2 days (4/9/21), but I had a "missed miscarriage" and the baby stopped growing with no heartbeat at 6 weeks and 1 day (3/18/21). My due date would have been November 10th 2021. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: miscarriage | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer concerned multiple patients. ''This case reported 49 instances of miscarriages post vaccination.'' No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The patients were pregnant at the time of vaccination (maternal exposure during pregnancy). The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. The date of the patient''s last menstrual period and expected delivery date were not reported. On an unspecified date, the patients experienced miscarriage (spontaneous abortion). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and maternal exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Spontaneous Abortion. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0-20210924179-Covid-19 Vaccine Ad26.CoV2.s-Maternal 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Maternal exposure during pregnancy; unwell; Miscarriage; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization prolonged, medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 01-Mar-2021, ABORTION SPONTANEOUS (Miscarriage) had not resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and MALAISE (unwell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABORTION SPONTANEOUS (Miscarriage) to be related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). It was reported that the patient was pregnant at the time she received the second dose, 1st trimester. This was her first pregnancy. Right after she was given the vaccine, she started feeling unwell, 2 days later, she miscarried her baby No information on concomitant medication were reported. No treatment details were reported. Company comment: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.; Sender''s Comments: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Amenorrhoea; Abortion spontaneous; Ovulation disorder; Pregnancy; Uterine spasm; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 29-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. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy) and UTERINE SPASM (Uterine spasm). On an unknown date, the patient experienced AMENORRHOEA (Amenorrhoea). At the time of the report, ABORTION SPONTANEOUS (Abortion spontaneous), OVULATION DISORDER (Ovulation disorder), PREGNANCY (Pregnancy), UTERINE SPASM (Uterine spasm) and AMENORRHOEA (Amenorrhoea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the provided. No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender''s Comments: This is a case of product exposure during pregnancy which resulted in Abortion spontaneous, for this 29 years old female. Very limited information has been provided at this time. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: My daughter just had a miscarriage; Maternal exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (My daughter just had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (My daughter just had a miscarriage) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (My daughter just had a miscarriage) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication is provided by reporter. No treatment was provided. Company Comment: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender''s Comments: This is a case of maternal exposure during pregnancy of this female patient, unknown age with no disclosed medical history, who experienced the serious, unexpected event of spontaneous abortion. The patient received the unspecificied dose of vaccine at unknown weeks of gestation. Spontaneous abortion occurred on unknown date after the unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report. | |||||||||||||||||||
Administered by: Pharmacy Purchased by: ?
Life Threatening? No Write-up: The first Moderna shot caused me to miss my next menstrual cycle, which had never happened to me prior to receiving the shot. In the week I received the 2nd shot on 3/13/21, I had uterine cramping that same day within a few hours of getting the shot. I also noticed a change to my cervical mucus during my ovulation cycle 2 weeks later. I then became pregnant the following month and was found to have a missed miscarriage at 6 weeks 1 day. It seems like their is a strong correlation between the side effects from the Moderna shot and the miscarriage. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage at 8 weeks. Blighted ovum measuring 5 weeks, 6 days. Due date was 4/2022. | |||||||||||||||||||
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: ~ 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Z37.1 - Single stillbirth | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: MISCARRIED WITHIN A WEEK OF HER J&J VACCINE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative via social media concerned a 30 year old female. The patient''s height, and weight were not reported. The patient was pregnant at the time of vaccination (gravida 1). The date of the patient''s last menstrual period and expected delivery date was not reported. The patient''s obstetrician (OB) told her that it was safe to get vaccinated. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (vaccine exposure during pregnancy). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, within a week after vaccination, the patient had miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of miscarried within a week of vaccination was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210648705.; Sender''s Comments: V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Miscarriage within a week of her J&J vaccine. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has an unknown/unclear 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Baby was born at 35 weeks.; Mother did not receive 2nd dose of primary series vaccine; Mother was administered first dose of primary series in April 2022, became pregnant in June 2022; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE DELIVERY (Baby was born at 35 weeks.), PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) and MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 001m21a) for COVID-19 prophylaxis. No Medical History information was reported. In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In June 2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022). On an unknown date, the patient experienced PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. In June 2022, MATERNAL EXPOSURE BEFORE PREGNANCY (Mother was administered first dose of primary series in April 2022, became pregnant in June 2022) had resolved. At the time of the report, PREMATURE DELIVERY (Baby was born at 35 weeks.) and PRODUCT DOSE OMISSION ISSUE (Mother did not receive 2nd dose of primary series vaccine) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided. It was reported that patient administered first dose of primary series in April 2022, became pregnant in June 2022. Patient did not receive 2nd dose of primary series vaccine. Baby was born at 35 weeks. Company Comment: This is a spontaneous case concerning a 33 year-old, female patient with maternal exposure before pregnancy and no reported medical history, who experienced the non-serious unexpected, event of premature delivery, which occurred after the first dose of mRNA-1273 vaccine. It was reported that the patient became pregnant approximately 2 months after vaccination. The patient did not receive a second dose of primary series, thus Product dose omission issue was considered as an additional event. Baby was born at 35 weeks. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live follow up was received by safety on 30-Mar-2023 contains significant information: Event was added, description as reported and description to be coded, event LLT were updated and route of administration of suspect product was added. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: I know someone that just had a miscarriage from it (Covid Vaccine); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter said: " I know someone that just had a miscarriage from it (Covid Vaccine)". The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: EDC 9/8/21 Fetus developed severe hydrops after COVID vaccination Patient had normal anatomy scan on 4/21/21 at 20 weeks Patient had COVID vaccine on 5/21/21 Patient had a repeat US on 6/3 at 26+1 weeks which showed severe hydrops Patient terminated pregnancy - birth weight unavailable | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage in first trimester of pregnancy day after receiving vaccine. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Miscarriage 1 week after vaccine "On 10/5/21 I had an ultrasound and they said they saw the yolk sac and gestational sac, however there was no fetal pole or heartbeat. They wanted me to wait 11 days to have another ultrasound in case my dates were off or it was just too early. So on 10/18/21 I had the 2nd ultrasound and was diagnosed with a miscarriage. They suspected the baby died/stopped growing the same week of the first ultrasound. I then was given medication to induce the miscarriage on 10/20/21. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Intrauterine fetal death discovered at 24 weeks and 3 days gestation. Infant girl delivered on March 24, 2022. This is patient''s second pregnancy. First pregnancy was successful. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: miscarriage when she became sick from the first vaccine; became sick from the first vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) (seriousness criterion medically significant), ILLNESS (became sick from the first vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (miscarriage when she became sick from the first vaccine) and ILLNESS (became sick from the first vaccine) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case concerns of a female patient with no age and no relevant medical history reported who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset from the vaccine administration with Moderna since the date of the first dose of the vaccine is also unknown. Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns of a female patient with no age and no relevant medical history reported who experienced the unexpected events of spontaneous abortion, illness and Maternal Exposure during pregnancy. The occurrence of these events are unknown as well as the time to onset from the vaccine administration with Moderna since the date of the first dose of the vaccine is also unknown. Other details of the pregnancy was also not reported like the LMP and EDD. The benefit-risk relationship of Spikevax is not affected by this report. | |||||||||||||||||||
Administered by: Pharmacy Purchased by: ?
Life Threatening? No Write-up: Miscarriage | |||||||||||||||||||
Administered by: Military Purchased by: ?
Life Threatening? No Write-up: For a year and a half since the pandemic started to the date I was forced to get the vaccine I had not been sick once with any illness or positive with COVID despite being in close contact with multiple people who tested positive for the virus. Prior to the pandemic I don''t even remember the last time was sick. I was finally "forced" to get the vaccine, or face dire consequences that would have completely ruined my life, so I reluctantly took the vaccine in October 2021. For the two months following vaccination I have been sick twice, one of which I had tested positive with COVID. I also became pregnant during that time and after 7 weeks experienced a miscarriage. Two of my friends recently had miscarriages as well. One who already had a baby prior to getting vaccinated and miscarried with her second at 12 weeks and another who was 13 weeks with her first child. I doubt they will report any adverse effect. I would love to know if our miscarriages are part of the statistical data that''s being promoted to show this novel vaccine is safe in early pregnancy. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage shortly after the 1st dose; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date. At the time of the report, ABORTION SPONTANEOUS (Miscarriage shortly after the 1st dose) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was not given. No treatment information was given.; Sender''s Comments: This is a case of exposure of product during pregnancy with the vaccine mRNA -1273 with reported AE of spontaneous abortion. There is very limited information regarding this events has been provided at this time. Further information has been requested. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: miscarried; patient was pregnant at the time of the vaccine; patient was pregnant at the time of the vaccine; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, at the age of 29-year-old, on 30Jan2021 02:00 AM, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient had no known allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient was pregnant at the time of the vaccine 30Jan2021 and miscarried on 01Feb2021. LMP was provided as 01Jan2021, gestation period was reported as 4 weeks and due date was provided as 08Oct2021. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient did not receive any treatment in response to the event miscarried. Outcome of the event miscarried was not recovered. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the compatible temporal association, a possible contributory role of suspect vaccine BNT162B2 in triggering the misarrange in this 29-year-old pregnant patient cannot be excluded. Additional information regarding relevant medical history, underlying conditions, 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Estimated delivery day 10/10/22- miscarriage after vaccine | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: miscarriage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). A female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "miscarriage". The pregnancy resulted in spontaneous abortion. Clinical course: The caller said his ex-girlfriend actually had a miscarriage. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program via non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had a miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination and the causal role of BNT162B2 vaccine cannot be excluded for the reported events. 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-202101144532 Same reporter/event, diff patient | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Spontaneous abortion as of 6/17/2021. Due date of January 2022 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Received second dose of Moderna vaccine on 1/23/21, likely conceived on 1/24/21. Lost pregnancy between 8-9 weeks with noted fetal bradycardia on during ER visit on 3/14/21 and no FHR on 3/18/21. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Tested pregnant shortly after getting the vaccine, then I believe I miscarried very early, period cycle started. This happened twice in a row. Since getting the covid shot, my breasts have been tender often and my period cycles have been irregular. Still trying to get pregnant again with no success. | |||||||||||||||||||
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: Miscarriage (two times). | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Intrauterine fetal demise (miscarriage) | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? Yes Write-up: I received the first COVID vaccine on 15 October 2021 and the second vaccine on 12 November 2021. I found out that I was pregnant on 16 November 2021 and my due date was 27 July 2022. I started bleeding on 20 November 2021 and that continued for 40 days until I lost the baby on 29 December 2021. I had hemorrhaging very badly on 2 December 2021 and on 27 December 2021. I bled so much, I temporarily blacked out and was shaking uncontrollably. After testing was completed on the fetus, it was found to have hemorrhaging between its eyes. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: spontaneous abortion; booster; This is a spontaneous report from a contactable other hcp. This other hcp reported information for mother.This is a maternal report A 32-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 29Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient did not have covid prior to vaccination. The patients concomitant medications were not reported. It was unknown that the patient received other vaccine in four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was, and expiration date were not reported), via an unspecified route of administration, on 10Jan2021 (Age at vaccination was 69 years) as dose 2, single and dose 1 via an unspecified route of administration (lot number was, and expiration date were not reported) on 20Dec2020 for COVID-19 immunization. Age at vaccination was 32 years. On 29Sep2021 the patient experienced booster. On an unspecified date patient also experienced spontaneous abortion. The last menstrual date was Nov2021. The mother reported she became pregnant while taking bnt162b2. It was unknown that therapeutic measures were taken or not. Adverse event resulted in doctor or other healthcare professional office. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test with unknown result (If COVID tested post vaccination: Yes, COVID test post vaccination: COVID test type post vaccination: Unknown). The outcome of event was unknown. The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender''s Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) booster and reported event abortion spontaneous cannot be fully assessed/exclude. 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 RAs, Ethics Committees, and Investigators, as appropriate. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: SPONTANEOUS ABORTION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a patient concerned a 36 year old female of unspecified race and ethnic origin. The patient was enrolled in a non-company sponsored study. The patient''s weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 24-MAY-2021 for prevention of covid-19 (covid-19 immunisation). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The date of the patient''s last menstrual period was 09-APR-2021 and expected delivery date was 14-JAN-2022. On 24-MAY-2021, the patient experienced maternal exposure during pregnancy. On 28-JUN-2021, the patient experienced spontaneous abortion. Laboratory data included: Ultrasound scan (NR: not provided) Baby B was diagnosed as no longer having a heartbeat. On 28-JUN-2021, the pregnancy resulted in a spontaneous abortion. Gestational age 6 weeks and 3 days. That was twin pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spontaneous abortion, and maternal exposure during pregnancy on 28-JUN-2021. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and spontaneous abortion, and maternal exposure during pregnancy as related. Company causality between covid-19 vaccine ad26.cov2.s, and spontaneous abortion, and maternal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210803924. This case was reassessed as serious based on additional information received from patient on 30-JUL-2021, the following information was updated and incorporated into case narrative: Pregnancy (Gestation Period changed from 4 weeks to 6 weeks, outcome updated from ongoing/continuing to spontaneous abortion, EOP date, Expected Delivery Date); Event (spontaneous abortion), upgraded the seriousness of event maternal exposure during pregnancy, outcome of maternal exposure during pregnancy changed from unknown to recovered, lab (Ultrasound scan), Product (Indication changed from prophylactic vaccination to Prevention of Covid-19 (Covid-19 immunisation).; Sender''s Comments: V1: Follow up information received to previous non serious case updates, addition of serious event (spontaneous abortion), Pregnancy details (Gestation Period changed from 4 weeks to 6 weeks), Expected Delivery Date); upgraded the seriousness of event maternal exposure during pregnancy, laboratory data (Ultrasound scan), Product (Indication changed from prophylactic vaccination to Prevention of Covid-19 (Covid-19 immunization). 20210754070-covid-19 vaccine ad26.cov2.s-Spontaneous abortion. Follow-up received regarding Clinical Details. 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: UNDERLYING DISEASE 20210754070-covid-19 vaccine ad26.cov2.s-maternal exposure during pregnancy. Follow-up received regarding Clinical Details. 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. | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: I do not know if the vaccine had any effect on what occurred, but thought it was worth reporting. I got vaccinated (first dose) a week after my period. I got pregnant that cycle-my first pregnancy. My due date would have been November 13, 2021. At week 5, shortly after I discovered I was pregnant, I began bleeding slightly. At the hospital, after taking an ultrasound they diagnosed me with an angular pregnancy--in other words, the embryo had implanted on the very edge of the uterus. I was advised that this put me at high risk of early miscarriage. I didn''t miscarry, and the pregnancy seemed to be going normally for some weeks. At week 15, however, an early anatomy scan revealed severe IUGR-the baby was measuring two weeks behind. Further investigation revealed that the cause was a placenta that seemed never to have formed correctly. By week 25, we were told that the baby was dying, would not survive delivery at that birth weight, and that continuing the pregnancy was putting me at high risk of complications. Based on this, we chose a medical abortion at 26 weeks. I delivered stillborn; the baby weighed 380 grams, a weight appropriate to 21 weeks. Doctors do not know exactly what caused the IUGR. But as I tested negative for blood clotting disorders, they said the likeliest culprit is the angular pregnancy. I was also scanned to see if there were any anomalies in my uterine shape to make me more prone to poor embryo implantation, and the test came back normal. Given that I was vaccinated only a week or two before implantation would have occurred, I thought it was at least worth considering if there was a connection. I was vaccinated in another country. I only received one dose of the vaccine, as I had recovered from COVID in March 2020 (I had a mild case, with no lingering symptoms). Per the country''s vaccination policy, people who have recovered only receive a single dose. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage; bleeding started on May 28 and was confirmed on June 1 | |||||||||||||||||||
Administered by: Pharmacy Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101144476 Same reporter/ event, diff patient | |||||||||||||||||||
Administered by: Pharmacy Purchased by: ?
Life Threatening? No Write-up: miscarry her baby; vaginal bleeding; back pain; difficulty breathing; body began to shake; felt like passing out; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Aug2021 (Lot Number: FF2588, at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included pregnant at time of vaccination, non smoker and non-alcoholic. The concomitant product included prenatal vitamins. There were no other vaccine in four weeks. There were no covid prior vaccination. There were no covid tested post vaccination. Within one to two hours after the vaccine on 29Aug2021 patient felt like passing out, difficulty breathing and her body began to shake. Patient was pregnant at the time. She was previously healthy with no existing health conditions. She did not smoke, drink, or use drugs. At 24 hours post vaccine on 30Aug2021 she began to miscarry her baby. She had severe back pain with vaginal bleeding. This continues as of today. Treatment for events included blood work, intravenous (IV) fluids, and monitoring. The events resulted in emergency room/department or urgent care. Last menstrual date was on 23Jul2021. The mother was due to deliver on 29Apr2022. Gestational period was 5 weeks. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: got the vaccine lost her baby a week later; This is a spontaneous report from a contactable other healthcare professional via the Pfizer-sponsored Program. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiry date unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The reporter informed that a mother (patient) that she knows who got the vaccine lost her baby a week later. The reporter thinks that the patient''s physician may have already reported this. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new 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. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Patient received the first dose 3/26/21 and believes she conceived 3/10/21. She began spotting on 4/5/21 and the bleeding continued getting heavier until 4/19/21. The OB confirmed miscarriage on 4/28/21. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage; Pain/soreness; This is a solicited report based on the information received by Pfizer (manufacturer control number: 21K-163-4056010-00). A contactable consumer (patient) reported that a pregnant 32-year-old female patient received bnt162b2 (BNT162B2), dose 1 via intramuscular on 25May2021 (Lot Number: EW0183; Expiration Date: Aug2021) (at the age of 32-year-old) as single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled syringe), via subcutaneous from an unspecified date to 2021 (Lot Number: 1143165), at 40 mg, weekly for plaque psoriasis, psoriatic arthritis. The patient had a relevant medical history of weight loss surgery from 25Sep2019, polycystic ovary syndrome, obesity, Psoriatic arthritis, Asthma, high blood pressure and Bipolar. The patient was Alcohol use and Non-tobacco user. The family medical history of high blood pressure on maternal side, family medical history of endometrial cancer on maternal side and family medical history of diabetes on maternal side. Concomitant medications included human chorionic gonadotropin taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for asthma, start and stop date were not reported; lurasidone hydrochloride (LATUDA) taken for bipolar, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for bipolar, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; chorionic gonadotrophin (OVIDREL) taken for an unspecified indication, start and stop date were not reported; letrozole taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for supplementation therapy, start and stop date were not reported. The patient had other concomitant therapy of Prenatal Multivitamins. The patient previously took ciprofloxacin (CIPRO) and experienced itchiness, ciprofloxacin lactate (CIPRODEX) and experienced ear itchiness, hydrocodone bitartrate; paracetamol (VICODIN) and experienced hallucination and paranoia, naloxone hydrochloride (NARCAN) and experienced hallucination and paranoia. The patient previously took adalimumab (HUMIRA), via subcutaneous from Nov2020 (Batch/Lot Number: 1143165) to 2021, at 40 mg, weekly for plaque psoriasis, psoriatic arthritis and experienced Gallbladder stone in Apr2021 and Weight gain in 2020. In 2021, the patient experienced soreness. On an unknown date, the patient experienced maternal exposure during pregnancy. On 10Jun2021, the patient experienced miscarriage. BNT162b2 was also considered suspect. On 01Jun2021, the pregnancy was confirmed via home pregnancy test and pregnancy test by blood. Last menstrual period (LMP) was 03May2021. It was her first pregnancy after starting on HUMIRA. The fetus was exposed to maternal use of HUMIRA in utero. The estimated date of delivery (EDD) was 07Feb2022. On 10Jun2021, the fetus died. She was off of HUMIRA for three weeks when she had the miscarriage because of a recent gall bladder surgery as of 02Sep2021. The alternative etiology of the reporter for miscarriage was COVID 19 vaccine. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 25May2021, she received first dose COVID-19 Vaccine manufactured by Pfizer. In Jun2021, she received second dose COVID-19 Vaccine manufactured by Pfizer via intramuscular. The patient underwent lab tests and procedures which included pregnancy test by blood: positive on 01Jun2021, home pregnancy test: positive on 01Jun2021, gall bladder ultrasound: gall bladder stones were seen in Apr2021. The action taken in response to the events for adalimumab was Post-Therapy and therapy ongoing from 10Jun2021, at 40 mg, weekly. The outcome of the event pain/soreness was recovered in 2021, the outcome of the event Miscarriage was unknown. The reporter''s causality for the event(s) of miscarriage with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter''s causality for the event(s) of gall bladder surgery and maternal exposure during pregnancy was not provided. AbbVie''s opinion is that there is no reasonable possibility that the events of miscarriage, gall bladder surgery and maternal exposure during pregnancy are related to HUMIRA(ADALIMUMAB). The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on temporal association, the reported event Abortion spontaneous and Pain is possibly related to BNT162B2. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Gave birth on the 6th of August, 10 days after the vaccination at 37 weeks 0 days. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the first of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101154145 different patient, same reporter/product/event | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: patient had miscarriage after vaccination; This is a spontaneous report from a non-contactable consumer via a Pfizer Sponsored Program. This consumer reported for two female patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had miscarriage after vaccination on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101154129 different patient, same reporter/product/event | |||||||||||||||||||
Administered by: Pharmacy Purchased by: ?
Life Threatening? No Write-up: Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel. No follow-up attempts are possible. No further information is expected. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: three babies died one of them being stillborn and all 3 mother were vaccinated.; This is a spontaneous report from a contactable Other HCP. A female patient (pregnant) received BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunization on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced stillborn on unknown date. The mother was vaccinated. The outcome of event was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up. | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: March 24th was the last first day of my period, became pregnant. Received my first covid 9 vaccine moderna on April 27th. Noticed bleeding on May 1st morning. Went into hospital and received rhogam shot and went for ultrasound same day. Pregnancy was still there and went for another ultrasound the following week. A heartbeat was detected and sizing was accurate for gestation period. May 13th was my 3rd ultrasound and when they noticed the decreased heartrate and the lack of growth. I miscarried on May 19th. Went for my last ultrasound on May 27th when they determined that my pregnancy was no longer there. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: 5 weeks pregnant, due date December 29, 2021. Next day after the vaccine fever 102.2 for 24 hrs, chills, dizziness, heavy bleeding the day after. Confirmed miscarriage on May 1st. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Work Purchased by: ?
Life Threatening? No Write-up: Was pregnant at time of second vaccine should have been approximately 4 weeks but was not aware I was pregnant. At viability ultrasound there was no heart beat and it did not match with how far along i should have been. Repeat ultrasound a week later showed no growth and was diagnosed with a missed miscarriage. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: friends pregnant daughter lost her baby after the jab; friends pregnant daughter lost her baby after the jab; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION (friends pregnant daughter lost her baby after the jab) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION (friends pregnant daughter lost her baby after the jab) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. lost her baby after getting the jab. At the time of the report, ABORTION (friends pregnant daughter lost her baby after the jab) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (friends pregnant daughter lost her baby after the jab) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. A friend pregnant daughter lost her baby after getting jab. COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-438341 (Patient Link).; Sender''s Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of ABORTION and MATERNAL EXPOSURE DURING PREGNANCY The events occurred unknown days after a dose of mRNA-1273. The rechallenge was not applicable since only information about a dose was disclosed Authority report states the doses were given on same date (providing different lots). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 25 year old pregnant female received covid vaccination approximately 2-3 weeks prior to her expected delivery date. Her and her husband lost their baby due to placenta separation caused by a blood clot to the fetus. The root cause of the blood clot was determined to be the vaccination. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Pregnancy 1 week post COVID vaccination #2. Miscarriage at 6-7weeks. Managed with expectant management. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 10/06/21 COVID-19 1st dose 14/06/21-18/06/21 Sharp pains on left side building up everyday. 18/06/21 heavy sharp pains, cramping front and back and brown gooey stretchy substance came out which felt like when you are passing clots and tissue during miscarriage. And then pains subsided over the next few days. Ultrasound confirmed pregnancy loss. Previous missed miscarriage Dec 2019 for reference (however COVID-19 didn?t exist then nor did I take any vaccines at that time. Please concentrate on the fact that I miscarried and got miscarriage pains right after I took the COVID-19 Jab, this is NOT a coincidence). | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: The day I got my shot, by 5:30pm I was to tired and week to even move. I didn?t know I was pregnant at the time because it was so early. 7 days later I found out I was pregnant, 4 weeks along. And three days later on 3/25 I miscarried. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: MISCARRIAGE; SWELLING OF LEFT ARM; VACCINE EXPOSURE BEFORE PREGNANCY; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous report received from a consumer (mother) concerned a 32 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, dose number in series 1, 01 in total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received non-company suspect vaccine BNT 162 (Comirnaty) (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, dose number in series 2, administered at left arm on 14-DEC-2021 for prophylactic vaccination On an unspecified date in DEC-2021 (about 2 weeks after vaccination), the reporter discovered her daughter (patient) was pregnant (vaccine exposure before pregnancy and vaccine exposure during pregnancy) (dose number in series 1). On an unspecified date in DEC-2021, the patient experienced swelling of left arm and she had been suffering for last one month (dose number in series 2). The patient stated that her right arm was fine. On an unspecified date, the patient went to her regular doctor (physician''s office) and did blood work. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. On 21-JAN-2022, the patient had miscarriage (dose number in series 2). Reporter stated her daughter had gone to two different doctors and one said the vaccine caused the miscarriage and the other one said that it did not cause the miscarriage The action taken with bnt 162 was not reported. The patient had not recovered from swelling of left arm, and the outcome of miscarriage, vaccine exposure before pregnancy and vaccine exposure during pregnancy was not reported (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20220201185- covid-19 vaccine ad26.cov2.s Miscarriage. 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: CONMEDS-OTHER SUSPECT DRUGS, NATURE OF EVENT. 20220201185-covid-19 vaccine ad26.cov2.s- vaccine exposure before pregnancy, 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: 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. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: VAGINAL BLEEDING MISCARRIAGE O20.9 - Vaginal bleeding in pregnancy, first trimester | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Miscarriage 4 months after second dose of Moderna vaccine. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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 | |||||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Missed miscarriage diagnosed at 20 weeks. The baby died 5 days after vaccine dose 2 at 16.5 weeks. No abnormalities in previous scans. Placenta pathology noted inflammation and infection. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: After receiving each COVID vaccine, had a couple of irregular periods. Became pregnant about 1 month after receiving 2nd dose of vaccine. At 8.5 week ultrasound, was told baby was only 6.5 weeks judging by size and heart rate. At 10.5 weeks, went in for another ultrasound and there was no heartbeat - baby measured about 6 weeks. Miscarriage. | |||||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: G3P2002 now G3P2012 - Pregnancy, confirmed by UPT at 4 weeks gestation. Spontaneous miscarriage at 6 weeks 5 days. Of note, first covid vaccine was with Pfizer in late April | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: 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 | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage (chemical pregnancy). I didn?t test positive for pregnancy until a week after my vaccine so I put ?unknown? for pregnant at the time of vaccine. I then tested negative a couple days later and had the miscarriage 2 weeks and 2 days after my vaccine | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Pregnant-due date 4/28/22, no complications Got my 2nd covid shot, had a fever, vomiting fatigue for 2 days following that Had a miscarriage just couple weeks later | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage at 6 weeks. Technically, a missed miscarriage. Procedure to remove fetus at 10 weeks. There were complications (retained blood), and needed to return the following day for a repeat, second procedure to aspirate blood. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Pregnant patient miscarried at 17.5 weeks gestation with an otherwise uncomplicated pregnancy and no other current illnesses or conditions. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Miscarriage/infertility | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: High fever that resulted in loss of pregnancy; High fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration on 08Apr2021 12:00 (at the age of 35-year-old) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On an unspecified date, the patient experienced high fever that resulted in loss of pregnancy. Events caused doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The mother reported she became pregnant while taking BNT162B2. The mother was 3 weeks pregnant at the onset of the event. The mother was due to deliver on 17Dec2021, and last menstrual period date was on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel. No follow-up attempts are possible. 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 events Pregnancy loss and fever 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. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: I found out I was pregnant late July. This was my third pregnancy, I had never miscarried before. Relieved the vaccine 8/2. I started bleeding heavily 8/9 and continued thru 8/17. Test confirmed pregnancy was lost. | |||||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Miscarriage 2 months after vaccine | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: lost baby; This is a spontaneous report from a Pfizer-Sponsored Program via Regulatory Authority Support from a non-contactable consumer. The reporter reported three same cases. This is one the three cases. A pregnant female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration as a single dose, on an unspecified date, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had lost her baby after receiving the covid-19 vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101200160 Same reporter/drug/event, different patients.;US-PFIZER INC-202101200159 Same reporter/drug/event, different patients. | |||||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: patients has received both the regular and the booster Pfizer Covid vaccines but subsequently had a baby demise; This is a spontaneous report from a non-contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 2, single, and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 3 (booster), single, all for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received both the regular and the booster Pfizer covid vaccines but subsequently had a baby demise on an unspecified date. It was reported that the patient wants to donate the fetus to Pfizer for eventual studies. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of fetal demise due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed upon receipt of follow-up 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. | |||||||||||||||||||
Link To This Search Result:
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