Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid this morning/GI symptoms/extreme fatigue/mental brain fog/headache/slight temperature of 99.8 degrees; tested positive for covid this morning/GI symptoms/extreme fatigue/mental brain fog/headache/slight temperature of 99.8 degrees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205, Expiration Date: 30Jun2021), on 24Mar2021 as dose 2, single (Lot number: EP7533, Expiration Date: Jul2021), on 22Nov2021 as dose 3 (booster), single (Lot number: FJ1620) and on 14Jun2022 at 08:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 2014 (ongoing), notes: hypertension which is controlled by medications. diagnosed with that probably in 2014; "Depression", start date: 2008 (ongoing), notes: Depression; "Anxiety", start date: 2008 (ongoing), notes: Anxiety; "IBS" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "unknown" and all described as "tested positive for covid this morning/GI symptoms/extreme fatigue/mental brain fog/headache/slight temperature of 99.8 degrees". The patient underwent the following laboratory tests and procedures: Body temperature: (22Jun2022) 99.8; SARS-CoV-2 test: (25Jun2022) Negative, notes: it was done on approximately 4:30pm; (30Jun2022) Positive, notes: Unit: Not Provided; (21Jun2022) Negative; (22Jun2022) Negative; (27Jun2022) Negative, notes: it was done on approximately 4:30pm. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter states she started having symptoms last week but had three negative PCR tests and one negative home test and was about to go to work and tested again as she had two family members that had COVID last week; states she had some initial symptoms but her PCR came back negative and took a home test that popped right up. As reported patient did not visit to emergency room and physician office for AE. States she was going to do a phone appointment with her physician later today to talk about if she was a candidate for Paxlovid so she will be talking to her doctor.  Prior Vaccinations (within 4 weeks) reported as None. Reporter states she started having GI symptoms and a lot of fatigue on 22Jun2022 and this is not ongoing and is slow mo COVID; states she had GI symptoms on the 22nd and then on the 23rd had extreme fatigue on the 23rd and 24th and had some mental brain fog on the 23rd and the 24th and then on the 25th and 26th she felt better and on the 27th she started noticing she had a headache and it prompted her to take the third PCR test. Reporter states her headache was about the same and seems to come on in the evenings and if she takes Tylenol she was fine and they go away; clarified it was 8 hour Tylenol for arthritis and lasts all night and her IBS symptoms have her stay away from NSAIDS; states she works for company and J&J and clarified the Tylenol is actually Pharmacy brand pain reliever Acetaminophen 650mg caplets and she took two and probably has taken it the last three nights; states she started noticing her headache on Sunday night and it started Sunday night but she might not have taken the Acetaminophen or was being stubborn if it was not bad enough to need to take it and she is stubborn about taking medication; states she self administered the PCR test and has the lab reports but all three PCR tests were negative and she kept getting them negative and thought are you kidding me. Reporter states she has a diagnosed of depression and anxiety and takes medications for those and was diagnosed in 2008 and while trying to state the date that was diagnosed states she thinks this was the mental fog she has. States she takes the medications Lexapro and Clonazepam and started those prior to the COVID vaccines and this was years prior to the vaccines and had not started on any medications since 2020 and if anything had come off of a few but nothing recently. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6205 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 and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EP7533 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 EP7533, fill lot EP7531, and the bulk formulated drug product lot EP7527. 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 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. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FJ1620 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FJ1620, fill lot FJ1606, and the bulk formulated drug product FJ8507. 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 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.  No follow-up attempts are possible. No further information is expected.