Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 22Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FD0870), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTINE; METFORMIN ER; DULOXETINE DR; LISINOPRIL; OMEPRAZOLE; SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  PQC investigation results and conclusion: The investigation of the referenced PR ID. Conclusion of Previously: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EM9810 was investigated in PR. 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 EM9810 fill lot EM9806, and the formulated drug product lot EM9808. 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 investigation of the referenced PR ID . Conclusion of Previously: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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 5646998 within specifications. The investigation of the referenced PR ID  Conclusion of Previously: The complaint for PFIZER BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM0698. A complaint sample The complaint for PFIZER BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM0698. A complaint sample confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.