Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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 64-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), on 15Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 20Nov2021 at 13:15 as dose 3 (booster), single (Lot number: FF8839) at the age of 64 years, in left arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2016. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 14May2022 to 19May2022. There was severe relapse of COVID-19 symptoms worse than the original case approximately 6 days after end of Paxlovid 5-day regimen. Headache, cough, muscle soreness, severe fatigue (unable to do anything for 2 full days), diarrhea, almost delirious. Second prescription for 200mg Benzonatate. The conclusion of previously completed Product quality group investigation included the complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot ER8730 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 and product type. The final scope included the reported finished goods lot ER8730, fill lot EP8682, and the formulated drug product lot EP8569. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The conclusion of previously completed investigation included the complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot ER8729 was investigated. The Investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8729, fill lot EP8681, and the formulated drug product lot EP8568. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The conclusion of previously completed investigation included the complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot FF8839 was investigated. The Investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FF8839, fill lot FF8833, and the bulk formulated drug product FA9148. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.