Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Immunisations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pulmonary fibrosis" (unspecified if ongoing); "atherosclerosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; RAMIPRIL; BACLOFEN; ATENOLOL; GABAPENTIN; LEVOTHYROXINE; TAMSULOSIN; BABY ASPIRIN; FLAX SEED OIL; CBG HANFEXTRAKT PUR; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; IMMUNISATION (medically significant), outcome "unknown", described as "Immunisations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive, notes: home antigen test. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7228582 PR ID of Previously Completed 5884023 . The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9265 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 EL9265, fill lot EL9256, and the formulated drug product lot EL9247. 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.Reference PR ID 7228583 The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6202 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. 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.PR ID  7228584 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FF2587was 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. 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.PR ID 7228585 and PR ID of Previously Completed 5801363 .The complaint for PFIZERBIONTECH 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 was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be 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.