Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 13:45 as dose 1, single (Lot number: EN6204), in left arm, on 07Apr2021 at 13:30 as dose 2, single (Lot number: ER8734), in left arm and on 29Nov2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 23Sep2021; ROSUVASTATIN, start date: 06Dec2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: Positive rapid test on day 8 post Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment of COVID-19 included Paxlovid from 27Jun2022 to 02Jul2022. Product Quality Group provided investigational results on 12Jul2022 for BNT162b2: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6204 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 EN6204, fill lot EN5335, and the formulated drug product lot EN5325. 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. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 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 ER8734, fill lot EP8686, and the formulated drug product lot EP8573. 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 complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. 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.