Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Prenatal screening test, Vaccination failure
Clinical narrative: got covid 11Jan2022; got covid 11Jan2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Apr2021 (Lot number: EW0153, Expiration Date: Jul2021) at the age of 34 years as dose 1, single and intramuscular, administered in arm left, administration date 14May2021 (Lot number: EW0172, Expiration Date: Aug2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Brittle nails" (unspecified if ongoing); "Headaches" (unspecified if ongoing); "Abortion 3" (unspecified if ongoing). Date of last menstrual period: 06Jan2021. The patient was 15 weeks pregnant at the time of exposure to bnt162b2; 3 weeks pregnant to ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12Oct2021. Concomitant medication(s) included: BIOTIN taken for onychoclasis (ongoing); VITAMIN B 6 taken for pregnancy (ongoing); VITAMIN B12 + FOLIC ACID taken for pregnancy (ongoing); TYLENOL taken for headache (ongoing); IMITREX taken for migraine, start date: 2004 (ongoing); PRENATAL + DHA taken for pregnancy, start date: 31Jan2021 (ongoing); MAXALT, start date: 2010 (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 2021 (ongoing); MAGNESIUM, start date: 2021 (ongoing); ACYCLOVIR [ACICLOVIR], start date: 2015 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "got covid 11Jan2022". The baby weighed 3990.8 grams. The patient underwent the following laboratory tests and procedures: prenatal screening test: normal.  Clinical course: Paternal and mother information, exposure to products, recreation drug use: The father use to smoke during the mother's pregnancy, 7 number per day (never around mother) while the mother didn't smoke drug during the pregnancy. The father and mother didn't drink alcohol and did not illicit drugs during the mother's pregnancy.  Conclusion from product quality group providing investigation results: Conclusion of Previously Completed Investigation (FCI/SI/OffCI) (product compound BNT162 COVID-19 vaccine suspension for intramuscular 2 ml multiple dose vial x 1): The complaint for 'Lack of Effect' of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 and lot EW0172 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153 and lot EW0172, fill lot EP8692 and fill lot EP8724, and the bulk formulated drug product lot EW8071 and lot EP8605. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.