Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 18:00 as dose 1, single (Lot number: EN6200), in left arm, on 02Apr2021 at 17:00 as dose 2, single (Lot number: ER8732), in left arm and on 09Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 30130BA) at the age of 48 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "chronic migraine" (unspecified if ongoing). Concomitant medication(s) included: MEMANTINE; CANDESARTAN; XYZAL; CHELATED MAGNESIUM [MAGNESIUM CHELATE]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; BIOTIN; TURMERIC & BLACK PEPPER, CoQ10 with Tocotrienols were also the other medication in 2weeks product. Past drug history included: Cortisone, reaction(s): "Known allergies: cortisone", notes: Known allergies: cortisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Paxlovid, treatment start date: 16May2022, treatment stop date: 20May2022 lot number: FY8914. Lot (CR): 30130BA: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for a Lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot 30130BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer (site name withheld). The final scope was determined to be lot 30130BA. No quality issues were identified during the investigation. There is no impact on product quality. An RA was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held as a result of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required. Lot (CR): ER8732: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot ER8732 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 ER8732, fill lot EP8684, and bulk formulation lot EP8571. 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. Lot (CR): EN6200: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-Biontech Covid-19 Vaccine lot EN6200 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. 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. No follow-up attempts are needed. No further information is expected.