Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: 301358A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 (the patient received Paxlovid from 02Dec2022 to 06Dec2022). Product Quality Group provided investigational results on 14Dec2022 for BNT162B2, BNT162B2 OMI BA.4-5 and for BNT162B2. Conclusion of Previously Completed Investigation: 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 was no impact on product quality. An NTM was not issued for the complaint. 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 were 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot GJ3277 was investigated. The investigation included a review of manufacturing and packaging records, deviations, and the complaint history for in scope lots. The final scope was determined to be the finished goods lot GJ3277, bulk and fill lots, GJ2421, and GJ2427. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. No corrective or preventative actions were identified because it was determined that the controls in place were sufficient at preventing and removing defects that could cause a complaint of this nature.