Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test: COVID, Result: Pos; Test: COVID, Result: Pos; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8730), on 13Apr2021 as dose 2, single (Lot number: EW0181), on 22Nov2021 as dose 3 (booster), single (Lot number: 330308D) and on 21Jul2022 as dose 4 (booster), single (Lot number: FP7139), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Lumbar Fusion L-4.5", start date: Jul2006 (not ongoing), notes: Fusion due to Auto Accident; "Cervical Fus.- C5-7", start date: Nov2006 (not ongoing), notes: Fusion due to Auto Accident; "Cervical Fusion- C4 5", start date: Oct2021 (not ongoing), notes: Degradation from previous fusion; "Hypertension" (ongoing); "Chronic Pain" (ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension, start date: 2018 (ongoing); ATENOLOL oral taken for hypertension, start date: 2018 (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL] oral taken for pain, start date: 2021 (ongoing); CYCLOBENZAPRINE oral taken for pain, start date: 2021 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "unknown" and all described as "Test: COVID, Result: Pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive.  Based on investigation result conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8730, EW0181 and FP7139 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 and product type. The final scope included the reported finished goods lot ER8730, fill lot EP8682, and the formulated drug product lot EP8569. The final scope included the reported finished goods lot EW0181, fill lot EP8732, and bulk formulation lot EP8613. The final scope included the reported finished goods lot FP7139, fill lot FP7130, and the formulated drug product lot FP6266. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Based on investigation result conclusion: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 33030BD 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 33030BD. 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 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300348176 Same patient/product, different dose/events.;