Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid; Covid positive breakthrough case; Tested positive for Covid; Covid positive breakthrough case; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent (patients mother).  A 50-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) at the age of 50 years as dose 2, single and intramuscular, administered in arm right, administration date 05Jan2021 (Lot number: EK4176, Expiration Date: 31Mar2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "TBI", start date: 09Sep2009 (ongoing); "Removed spleen" (unspecified if ongoing); "ICU coma 3month" (unspecified if ongoing); "Asthma", start date: 2011 (ongoing); "Congestive heart failure", start date: 2020 (ongoing); "depression" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medications included: SERTRALINE taken for depression, start date: 10Aug2019 (ongoing); SIMVASTATIN taken for hyperlipidaemia, start date: 12Apr2020 (ongoing); TORSEMIDE, start date: 10Jan2021 (ongoing). The following information was reported: VACCINATION FAILURE (hospitalization), COVID-19 (hospitalization) all with onset 14Aug2021, outcome "recovered" (24Aug2021) and all described as "Tested positive for Covid; Covid positive breakthrough case". The patient was hospitalized for vaccination failure, covid-19 (start date: 14Aug2021). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Aug2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. On 14Aug, he did have a Covid positive breakthrough case and was admitted to the hospital and received 5 IV treatments of Anti-viral.   Product Quality Group provided investigational results on 19Nov2021 for bnt162b2: The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and 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 EK4176. 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM 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. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. 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.  Follow-up attempts are completed. No further information is expected.