Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, 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 Non-HCP. This is 9 of 37 reports. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN5318 and Expiry date was not reported), dose 2 via an unspecified route of administration on 06Feb2021 as dose 2, single dose and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686 and Expiry date was not reported), as dose 1, single dose, both for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. She states they are monitoring and tracking the vaccine break through cases in their area, and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. 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. Transferred successfully for further capture of data from the caller regarding breakthrough cases (AE) as well as PQC with lot number involved that has been the cause for concern today. Agent states the caller called because she had some concerns, and the health department was tracking breakthrough cases in her area. Agent reports that caller states 15% of breakthrough cases are from one Pfizer COVID-19 Lot number: EN5318. Agent confirms caller was calling about the Pfizer COVID-19 vaccine. Caller reclarifies later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller states, reclarified later in report, she had 37 patients with partial identifiers. Caller states she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller states she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for COVID-19, and the type of COVID-19 test utilized. Partial identifiers provided by Caller. Caller was not allowed to provide some identifying details, at this time. Caller reports 37 breakthrough cases, for fully vaccinated patients testing positive for COVID-19. Some identifying details provided. On 22Jul2021 patient experienced tested positive for COVID-19 virus, after being fully vaccinated (vaccination failure). She states that COVID-19 positive was defined as having both vaccines and testing positive for COVID-19 longer than two weeks after both doses. Testing positive for COVID-19 virus, after both vaccines. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 22Jul2021. The outcome of the event 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/event, different patient.