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Write-up: Hand pain; Maternal exposure during pregnancy; This is a solicited report from a regulatory authority from a contactable consumer. This is a report from received from a regulatory authority (RA). The regulatory authority report number is GB-MHRA-YCVM-202106031438033550-DC2QL, Safety Report Unique Identifier GB-MHRA-ADR 25494183. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jun2021 (Lot Number: EW2245) at the age of 33-year-old as single dose for COVID-19 vaccination. Medical history included ongoing pregnancy (estimated due date: 14Oct2021), and folic acid supplementation. Patient was exposed to the vaccine second-trimester (13-28 weeks). Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 03Jun2021 with outcome of unknown, hand pain on 04Jun2021 with outcome of recovered on 05Jun2021. The event hand pain was reported as serious (medically significant). Patient did not think vaccination had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures on an unspecified date which included covid-19 virus test: no - negative covid-19 test; scans: normal. Patient had not tested positive for COVID-19 since having the vaccine. The reporter''s assessment of the causal relationship of the hand pain with the bnt162b2 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: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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.
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