Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 33130ba) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Mar2021 as dose 2, single (Lot number: 022m20A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Conclusion of Previously Completed Investigation : The complaint for a lack of effect in a vial of PFIZER-BIONTECH COVID-19 VACCINE 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 33130BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met all release 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 to any lot being released to the market.  Follow-up (16Jun2022): This is a spontaneous follow-up report from product quality group providing investigation results. This report included that:  Updated Information included: Batch and lot tested and found within specifications in Product tab per verbatim (The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met all release specifications); Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.