Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 69-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 68 years, in left 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovered", COVID-19 (medically significant), outcome "recovered" (18May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body temperature: low-grade; SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: [product=COVID 19 Treatment, brand=Paxlovid, treatment start date=13May2022, treatment stop date=17May2022}. From Paxlovid - had "rebound" symptoms (congestion and low-grade fever) and positive test a few days following negative home test and no symptoms. This was 6 days after finishing 5-day Paxlovid. This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): 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 30155BA. 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 potency 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.