Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: dose received: 3; contracted COVID-19 as a breakthrough case; contracted COVID-19 as a breakthrough case; 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 25-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 14:00 (Lot number: EW0196) at the age of 25 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 16Apr2021 09:00 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm right, administration date 26Mar2021 09:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no history of allergies. The patient's concomitant medications were not reported. Vaccination history included: Flu shot. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Dec2021 17:00, outcome "not recovered" and all described as "contracted COVID-19 as a breakthrough case". The event "contracted covid-19 as a breakthrough case" and "contracted covid-19 as a breakthrough case" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Unknown date) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  On 28Dec2021, product investigation results were received. For Lot Number EW0196: Conclusion of Previously Completed Investigation:The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0196 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 EW0196, fill lot EP8741, and the formulated drug product lot EP8622.A complaint sample was not returned. 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.  For Lot Number: EP6955: Conclusion of Previously Completed Investigation:The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history or the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and he formulated drug product lot EP6953. 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. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.