Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1 , single (Lot number: EN6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 29Nov2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 13Apr2022 at 08:30 as dose 4 (booster), single (Lot number: 330368D) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "scoliosis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: As reported patient had received treatment for Covid 19 as an anti viral medication (Lot number: FT5407) started on 27May2022. Patient had received other medication in 2 weeks of vaccination. Investigational results reported: As reported on 01Jun2022, 202200774434, 7227848. Compound: BNT162 Covid-19 Vaccine Suspension For intramuscular 2ml Multiple Dose Vial X 1, 33036BD. The complaint for a Lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot 33036BD was investigated. The investigation included reviewing incoming quality nd 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 33036bd. No Quality issues were identified during the investigation. There is no impact on product quality. An was not issued for the complaint. No regulatory notifications 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. The root cause was not determined to be manufacture or vendor related as incoming quality component testing and the results of 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 any lot being released to the market. No further investigation required. 6705425, 6705085. Investigational results reported: As reported on 01Jun2022, 202200774434 7227849. Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1, Ff2587. PFIZERBIONTECH COVID-19 VACCINE lot FF2587 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 FF2587, fill lot FF2556, and the formulated drug product lot FE5315. 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. 6446122, 6443978. Investigational results reported: As reported on 01Jun2022, 202200761286, 7214047. Compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 P7534. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP7534 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 EP7534, fill lot EP7532, and the formulated drug product lot EP7528. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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. 5862218, 5851167. Investigational results reported: As reported on 01Jun2022, 202200757268, 7208869. Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1 en6200. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200was 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. 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. 5706482, 5705159.  No follow-up attempts are possible. No further information is expected.