Sex: M
Vaccine: COVID19
Symptoms: Body mass index, 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-HCP. This consumer reported similar events for 37 patients. This is 27th of 37 reports. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1), dose 2 via an intramuscular route of administration on 23Feb2021 (Lot Number: EL9266) as DOSE 2, SINGLE and dose 1 via an intramuscular route of administration on 28Jan2021 (Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. on 08Aug2021, the patient experienced covid-19. On 08Aug2021, the patient was tested positive for Covid virus after being fully vaccinated longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 31.9 on an unspecified date, NAAT Covid test (Nucleic Acid Amplification): positive on 08Aug2021. The patient outcome of the event was unknown at the time of this report. Assistant Director of Health (non-HC) calling today from a (state withheld) Health Department. She stated they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15 percent 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 upon transfer. 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: Lot number: (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, Lot Size: 2856, Manufacturing Date (GMT): 19Dec2020, Package Date (GMT): 21Dec2020, Release Date (GMT): 18Jan2021 and the formulated drug product lot EN5316. 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 were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients;US-PFIZER INC-202101081272 similar report from same reporter