Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 62-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: em9810), on 05Mar2021 as dose 2, single (Lot number: en6205) and on 28Sep2021 as dose 3 (booster), single (Lot number: fe3592) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "skin cancer" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "BBH" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL; NP THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive, notes: tested positive for Covid on Friday 13May; (26May2022) positive, notes: took home test and it was positive; (20May2022) negative, notes: Took PCR on the 20th and was negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient tested positive for Covid on Friday 13May2022, started Paxlovid course next day. Symptoms abated and were minimal if not asymptomatic by the 19May2022. Took PCR on the 20May2022 and was negative. On 26May2022 felt odd muscular pain in legs, took home test and it was positive.  Product Quality Group provided investigational results on 31May2022 for BNT162B2: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine Injectable lot FE3592 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 FE3592, fill lot FF2553, and the bulk formulated drug product lot FA9141. 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 Pfizer BioNTech Covid-19 Vaccine lot EN6205 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 EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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 Pfizer BioNTech Covid-19 Vaccine lot EM9810 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 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.