Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 at 07:45 as dose 1, single (Lot number: EK5730), in right arm, on 12Jan2021 at 08:15 as dose 2, single (Lot number: EL3246), in right arm and on 25Sep2021 at 16:00 as dose 3 (booster), single (Lot number: 30135BA) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus type 2," (unspecified if ongoing), notes: Other  Medical History: diabetes mellitus type 2; "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN XR, start date: May2014, stop date: 25May2022; SPIRONOLACTONE, start date: 02Feb2021, stop date: 25May2022; ATORVASTATIN, start date: May2014, stop date: 16May2022; AMLODIPINE, start date: May2014, stop date: 16May2022; LOSARTAN, start date: May2014, stop date: 25May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (22May2022) Negative; (25May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EK5730 and lot EL3246 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 EK5730 and lot EL3246, fill lot EK3313 and fill lot EL3229, and the formulated drug product lot EK3312 and EL3222 respectively. 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/preventati ve actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion of Previously Completed Investigation of lot 30135BA: The complaint for a Lack of effect of the PFIZER- BIONTECH COVID-19 VACCINE lot 30135BA 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. The final scope was determined to be lot 30135BA. No quality issues were identified during the investigation. There is no impact on product quality. No regulatory notification or 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. 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.  No follow-up attempts are possible. No further information is expected; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.