Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result:Positive; covid test result:Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 03Dec2021 as dose 3 (booster) , single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "unknown" and all described as "covid test result:Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Nasal Swab.  Clinical course of the events: Facility type vaccine: Workplace clinic. Other vaccine in fourweeks: Unknown. Adverse event: 22Mar22 congestion fevers chills body aches, then 24May22 positive Ag test. covid prior vaccination: Unknown. covid tested post vaccination: Yes. Updated information included: Batch and lot tested and found within specifications. Additional information: This is a notification generated from the 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: PR ID (CR): 7208663. Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): EL3247. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3247 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 EL3247, fill lot EL3230, and the formulated drug product lot EL3223. 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/preventat ive actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5702833. PR Link (Previously Investigated CR): 5697797. PR ID (CR): 7208664. Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): FF2589. Conclusion of Previously Completed Investigation: The complaint for 'Lack of Effect' of the PFIZER BIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318. 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/preventat ive actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6436984. PR Link (Previously Investigated CR): 6435935.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on reported information, causal association of event vaccination failure, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.