Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Developed COVID; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 71 year old female patient non pregnant at the time of vaccination received bnt162b2 (BNT162B2), dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: EK9231) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 vaccination failure and developed covid-19 on 2021 with outcome of recovering. The patient been tested for COVID-19 since vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive.   Upon follow up (04Aug2021) a follow-up spontaneous report from Quality. Reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EK9231 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EK9231 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary.The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EK9231, fill lot EK9229, and the formulated drug product lot EK9226. Manufacturing and packaging batch records were reviewed for the reported complaint lot. received photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes 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 are needed. No further information is expected