Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Suspected COVID-19; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FH8030), as dose number unknown, single (Lot number: EW0171) and as dose number unknown, single (Lot number: EP6955) for covid-19 immunisation. The patient's relevant medical history and 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 "Suspected COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  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.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer-biontech covid-19 vaccine lot EP6955 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 EP6955, fill lot EP6954, and the formulated drug product lot EP6953. 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.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer-biontech covid-19 vaccine injectable lot EW0171 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0171, fill lot EP8702, and formulated drug product lot EP8604. A complaint sample was not returned. No related quality issues were identified during the investigation that had potential to impact product quality. All release testing performed prior to the release of the reported batch was within specifications. No root cause or CAPA were identified. The controls in place were determined to be sufficient in order to prevent complaints of this nature.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot FH8030 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 FH8030, fill lot FH4343, and the formulated drug product lot FA9187. 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.  No follow-up attempts possible. No further information expected.