Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported similar events for 37 patients. This report is for 35th patient of 37 patients. An 81-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9266) as dose 2, single and dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 14Aug2021, the patient experienced tested positive for covid virus, after being fully vaccinated. Laboratory tests on 14Aug2021 included NAAT Covid test: positive. Assistant Director of Health (non-HC) calling today from a (facility). She stated that they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide. Further stated that she cannot provide some identifying details and that she would need to check with her legal department first. She can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of Covid test utilized. As part of the 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 Q1215 and/or Q1252. Refer to the below table for details. Product-Description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot (CR): EN5318. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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. When more than one investigation was found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion was blank in the table above, then the investigation record was likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients