Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient.   A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 10Feb2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 2, single and dose 1 via an unspecified route of administration, administered in arm left on 20Jan2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The patient medical history was not reported. Concomitant medications included LEVOXYL via oral route, progesterone via oral route and ESTROGEN patch via transdermal route. All taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated Although I had both doses of vaccine I still contracted COVID through a primary contact. Symptoms included (fever 100.3, chills, loss of taste, fatigue) and started on 30Jul2021. Covid test (PCR) confirmed positive on 03Aug2021. The events did not result in emergency room/ physician office visit. The patient underwent lab tests and procedures which included fever (body temperature): 100.3 on 30Jul2021 and Sars-Cov-2 test (Nasal Swab/ PCR): positive on 03Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Aug2021.   Investigation report received from product quality complaints group. This report included that: Product-Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULA R 2ML MULTIPLE DOSE VIAL X 1, Lot: EL3248, Conclusion of Previously Completed: Investigation Conclusion. ID of Previously Completed. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3248 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 EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. Consumer calling about the Pfizer COVID19 vaccine, and says that she got the injection twice, and each time she has gotten it and gotten tested after, each test is showing positive. She says the thing is, does Pfizer have information about this, because seems to be herd immunity. Caller does not clarify this last statement. She asks if anyone else has been reporting this. She clarifies that she goes to a nursing home and is tested every 14 days and all times prior to getting the vaccine doses she was negative. She says her first dose of the vaccine was on 26Dec2021, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She says as a medical worker she can wait 5 days after that for it to come up after being positive and after that if it is showing up negative she had to wait 24 hours to confirm negative test and pay again for the test within 24 hours, which was negative too. She says then the time next she got the shot on 16Jan2021 she went to go do the shot on this past Saturday, and then she went to go get tested and again it came back positive. Caller says that the information on the card is handwritten, NDC/EXP were not written on the card. She says the card says Pfizer COVID-19, and the first dose was on 26Dec2021 of LOT: EL5738 given in her right arm. She says that the second dose was 16Jan2021 of LOT EL3248 and it was given in her left arm. Caller says that the test she was given was the rapid test, a PCR test for COVID. Caller says that other than having positive tests for COVID she has had no symptoms. Product strength and count size dispensed: two doses. Additional lot numbers: EL3248. Is a sample of the product available to be returned, if requested, not provided. Packaging sealed and intact, not provided. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE EL3248 Lack Of Effect, Complaint Class: Product Use Attributes, Complaint Sub-Class: Lack Of Effect, (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE, BNT162B2, Product-Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Product-Type: RX, Product-Category: INJECTABLE, Sterile-Product: Yes. Medical-Device No. Lot#: EL3248. Batch-Expiry Year: 2021, Batch-Expiry Month: 04, Batch-Expiry Day: 30. 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 EL3248 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EL3248 pending review of lot genealogy. The investigation will include a review of the returned complaint sample and reserve samples, if necessary. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 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 EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. 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. Follow-up attempts are completed. No further information is expected. Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.