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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||- / 2||- / -|
Administered by: Other Purchased by: ??
Symptoms: Abortion spontaneous
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Diagnostic Lab Data:
CDC 'Split Type': FIPFIZER INC2021310503
Write-up: Miscarriage on week 8-9; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first and second doses of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient was pregnant at the time of vaccination. The patient had received the vaccine approximately on pregnancy weeks 2 and 5 (the patient did not know she was pregnant). The patient had a miscarriage on pregnancy week 8-9. This was diagnosed in ultrasound on pregnancy week 12. On ultrasounds performed in weeks 6 and 8, the fetus was normal and the heart rate was strong. It was not known what caused the miscarriage but the patient wanted to know if the relationship of the vaccine with miscarriages was investigated at some point. The patient had considered the reported event to be serious (medically significant). The patient had no other medications or illnesses, and was basically healthy. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted into spontaneous abortion. The fetal outcome was intrauterine death.; Sender''s Comments: Based on a reported drug event chronological association, the company cannot completely rule out a reasonable possibility that BNT162B2 (COMIRNATY) caused the miscarriages (PT: Abortion spontaneous). 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.
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