Age: 0.25
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Breech presentation, Foetal exposure during pregnancy
Clinical narrative: baby was in breech or abnormal presentation; fetal exposure during pregnancy; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not available). The reporter is the parent. Other Case identifier(s): 20220221029 (Mfr Control No.).  A 3 month-old female patient was exposed to bnt162b2 (BNT162B2), transplacental, administration date 26Oct2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), transplacental, administration date 04Jun2021 (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: UNISOM SLEEP, start date: 20May2021, stop date: 01Sep2021; PEPCID AC, start date: 16Jul2021; TYLENOL, start date: 01Apr2021; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. The following information was reported: BREECH PRESENTATION (medically significant) with onset 02Nov2021, outcome "recovered" (23Nov2021), described as "baby was in breech or abnormal presentation"; FOETAL EXPOSURE DURING PREGNANCY (medically significant) with onset 04Jun2021, outcome "recovered" (23Nov2021), described as "fetal exposure during pregnancy". The patient underwent the following laboratory tests and procedures: acoustic stimulation tests: (Nov2021) unknown results.  Clinical course: The patient's mother received COVID-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection) one total, administered on 04Jun2021 for COVID-19 immunization and patient exposed to vaccine via transplacental route (foetal exposure during pregnancy) (dose number in series 1). The patient mother additionally received booster non-company suspect vaccine included: BNT 162 Pfizer-Biothech (Comirnaty) (dose number in series 2) administered on 26Oct2021 for COVID-19 immunization and patient exposed to vaccine via transplacental route.  Sender comments: Janssen COVID 19 vaccine Ad26. Cov.s baby was in breech or abnormal presentation. This event is considered not related. The events has a compatible/suggestive temporal relationship, is unlabelled and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: other suspect drugs, nature of event. Janssen COVID 19 vaccine Ad26. Cov.s-fetal exposure during pregnancy. This event is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: Special situation.  Causality: The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided while it was not reported with janssen COVID-19 vaccine 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; 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 BNT162B2 vaccine cannot be excluded for the reported events of Breech presentation and Foetal exposure during pregnancy. 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.