Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: IUFD; This is a spontaneous report received from a contactable other HCP. This other hcp reported information for both mother and fetus/baby. This is a maternal report. A 21-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER6166) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced iufd (Foetal death in utero, death, hospitalization) on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Trimester pregnant at the onset of the event. The patient died on an unspecified date. It was not reported if an autopsy was performed. Time range was one week. The clinical course was reported as follows: A pregnant woman at week 39 went to the emergency room because her water broke, noted that she did not feel fetal movements from the night denying contractions or bleeding. The anatomical scans during pregnancy were normal. In the emergency room, a fetus was found without a pulse, a normal amount of amniotic fluid, an estimated weight of 2700 grams. Are interested in performing a genetic test. No follow-up attempts are possible. No further information expected; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally 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.; Reported Cause(s) of Death: IUFD
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166