Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 17Apr2021 as dose 2 , single (Lot number: OR8731), in left arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; ZOLOFT; PRILOSEC [OMEPRAZOLE MAGNESIUM]; DEPLIN [CALCIUM LEVOMEFOLATE]; GABAPENTIN; VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on home test for covid, after previously testing negative a few days before; Negative, notes: Tested positive on home test for covid, after previously testing negative a few days before. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was taking other medication in previous two weeks.  Conclusion for Lot#EP6955: 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is 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.  Conclusion for Lot#ER8731: 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 ER8731, fill lot EP8683, and the bulk formulated drug product lot EP8570. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is 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.  Conclusion for Lot#FJ8757: 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 FJ8757, fill lot FJ1608, and formulated drug product lot FK2442. A complaint sample was not returned. No related quality issues were identified during the investigation. There is 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.