Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ankyloglossia congenital, Foetal exposure during pregnancy, Jaundice neonatal, Macrocephaly
Clinical narrative: macrocephaly; tongue tie; jaundice neonatal; fetal exposure during pregnancy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  A 4-month-old male patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: on 09Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), transplacental, administration details for the mother: on 08Apr2021 (gestation age of 3 weeks and 5 days) as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother of the patient was 29 years old. The patient's relevant medical history was not reported. The mother's relevant medical history included: "ectopic pregnancy" (unspecified if ongoing); "attention deficit hyperactivity disorder" (unspecified if ongoing); "e-cigarette smoker" (unspecified if ongoing); "Recreational drug use" (unspecified if ongoing); "concurrent condition included: attention deficit hyperactivity disorder" (unspecified if ongoing). The mother is expected to deliver a baby(s) on 18Dec2022. The mother had no history of exposure to tobacco and alcoholic beverages. Concomitant medication(s) included: FLU VACCINE VII, on 29Oct2021 as dose number unknown, single; TDAP transplacental, on 29Oct2021 as dose number unknown; ADDERALL transplacental, start date: 13Mar2021, stop date: 30Jun2021; PRENATAL DHA transplacental, start date: 13Mar2021; FLONASE ALLERGY RELIEF transplacental, start date: 13Mar2021, stop date: 01Sep2021; CLARITIN ALLERGIC transplacental, start date: 13Mar2021, stop date: 22May2021; DIMETAPP DM CHILDRENS COLD & COUGH transplacental, start date: 09Jun2021, stop date: 11Jun2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE] transplacental, start date: 01Jun2021.The following information was reported: FOETAL EXPOSURE DURING PREGNANCY (non-serious) with onset 08Apr2021, outcome "recovered" (01Dec2021), described as "fetal exposure during pregnancy"; JAUNDICE NEONATAL (non-serious) with onset Dec2021, outcome "unknown"; MACROCEPHALY (prolonged hospitalization), outcome "unknown"; ANKYLOGLOSSIA CONGENITAL (prolonged hospitalization), outcome "unknown", described as "tongue tie". The baby weighed 3429.593 grams. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (Dec2021) Unspecified; Parity: (unspecified date) 1, notes: The patient's gravida was 2, and para was 1; Pregnancy: (unspecified date) 2, notes: The patient's gravida was 2, and para was 1.  The reporter's causality assessments of suspects Janssen covid-19 vaccine (Covid-19 vaccine AD26.COV2.S) (Suspension for injection) (Covid-19 vaccine AD26.COV2.S) and PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) in response to the events was not reported. 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 possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU 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