Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sx 30May22 and AG 31Jun ST dry cough fatigue/ covid test result: Positive; sx 30May22 and AG 31Jun ST dry cough fatigue/ covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1 , single (Lot number: EL3247), in left arm, on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 53 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 30May2022, outcome "unknown" and all described as "sx 30May22 and AG 31Jun ST dry cough fatigue/ covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical Course: This was a notification generated from the data 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): 7238901. 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 was 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. PR ID of Previously Completed Inv: 6436984 PR Link (Previously Investigate d CR): 6435935. PR ID (CR): 7238902. Product Description (CR): Compound Bnt162 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 was 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. PR ID of Previously Completed Inv: 5702833. PR Link (Previously Investigate d CR): 5697797.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out