Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 70 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 29Nov2021 as dose 3 (booster), single (Lot number: 33030BD), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medications included: FLOVENT HFA, start date: Jan2019; ALEVE; BENADRYL, stop date: 07Nov2022; B COMPLEX WITH VITAMIN C [ASCORBIC ACID;VITAMIN B COMPLEX], stop date: 07Nov2022; CALCIUM; FLUTICASONE PROPIONATE, stop date: 07Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Covid-19 test in 2022: Positive. Therapeutic measures were taken, COVID-19 Treatment included Paxlovid from 07Nov2022 to 12Nov2022.  Product Quality Group provided investigational results on 17Nov2022 for BNT162B2 and BNT162B2, BNT162B2 OMI BA.4-5: Conclusion: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6199 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 EN6199, fill lot EN5331, and the formulated drug product lot EN5320. 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 a Lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot 33030BD 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 pre formulated bulk and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 33030BD. 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. 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 GJ2524. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA 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.