Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased, X-ray
Clinical narrative: pregnant while vaccinated; lethargic; high white blood cell; breathing issue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 39 week-old female patient was exposed to bnt162b2 (BNT162B2), transplacental (mother's route: intramedullar) administered in arm left, administration date 23Apr2021 (Lot number: EW0153, Expiration Date: Jul2021) as dose 1, single and transplacental (mother's route: intramuscular) administered in arm left, administration date 14May2021 (Lot number: EW0172, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. The mother of the patient was 34 years old at the time of vaccination. The mother's relevant medical history included: "Migraines" (unspecified if ongoing). Date of last menstrual period of the mother: 06Jan2021. The mother was 15 weeks pregnant at the time of exposure to bnt162b2; 3 weeks pregnant to ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc, colecalciferol, folic acid, paracetamol. The mother is expected to deliver a baby(s) on 12Oct2021.  Concomitant medication(s) included: PRENATAL S, start date: 31Jan2021 (ongoing); B12 [CYANOCOBALAMIN], start date: 2020 (ongoing); VIT D [COLECALCIFEROL], start date: 01Feb2021; IMITREX, start date: 2010 (ongoing); BIOTIN, start date: 2020 (ongoing); B6, start date: 2020 (ongoing); FOLIC ACID, start date: 31Jan2021 (ongoing); TYLENOL, start date: 31Jan2021 (ongoing); MAXALT, start date: 2010; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 2021; MAGNESIUM, start date: 2021; ACYCLOVIR [ACICLOVIR], start date: 2015. Drug taken by the father: CAFFEINE, start date: 2009; ADVIL [IBUPROFEN], start date: 2019; CBD OIL, start date: 2018; WELLBUTRIN, start date: 2021; ZOLOFT, start date: 2021. Family history of mother: Mother: Lung cancer; Father: Diabetic. Outcome of Infant included:Other neonatal problem/abnormality (neonatal illness), X-ray + High white blood cell, Follow up X-rays ER Visit due to being lethargic. Normal, some breathing issues The first week No resolved. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset 2021, outcome "unknown", described as "pregnant while vaccinated"; LETHARGY (hospitalization) with onset 2021, outcome "unknown", described as "lethargic"; WHITE BLOOD CELL COUNT INCREASED (medically significant) with onset 2021, outcome "unknown", described as "high white blood cell"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "breathing issue". The event "lethargic" was evaluated at the emergency room visit. The baby was delivered full-term, via vaginal route, delivery date 05Oct2021. The baby weighed 3990.8 grams. APGAR Score was 1, 5. The patient underwent the following laboratory tests and procedures: investigation: normal; white blood cell count: high; x-ray: unknown results.; Sender's Comments: We cannot totally exclude the causal association of reported events in relation to BNT162B2 based on temporal relation and exposure to the vaccine. Case will be reassessed pending new 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,Linked Report(s) : US-PFIZER INC-2021466066 mother case;US-PFIZER INC-202200301415 same patient (baby), different product/event (Maternal / Paternal EDP)