Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 infection after immunization; COVID-19 infection after immunization; 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ep7534), in right arm, on 09Apr2021 as dose 2, single (Lot number: ew0151), in right arm and on 20Oct2021 as dose 3 (booster), single (Lot number: fh8020) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cephalosporin, reaction(s): "Known allergies: cephalosporin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infection after immunization". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient was not pregnant at time of vaccination. The patient did not receive other medication in 2weeks. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, start date: 23May2022, Treatment stop date: May2022, Lot number: GA3588, Indication: treatment of COVID-19. Adverse event: On23May2022 patient experienced Bitter taste in mouth, muscle aches, shin splints, headache, grip weakness.It was unknown patient was recovered from, no treatment for ae, Known allergies: cephalosporin  Investigation results and conclusions: This is a daily notification generated from the gQTS 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. compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1, Lot# FH8020. The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. 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.  Investigation results and conclusions: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0151 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 EW0151, fill lot EP8691, and the formulated drug product lot EP8588. 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.  Investigation results and conclusions: The complaint for lack of effect of the PFIZER BIONTECH 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.