Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had Atrial fibrillation 2 1/2 months after getting the second dose of the vaccine; tested positive for covid on 16Jul while her husband, 17Jul; tested positive for covid on 16Jul while her husband, 17Jul; This is a spontaneous report from a Pfizer Sponsored Program a contactable consumer or other non hcp. This consumer reported for a male patient (Husband) that:  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8734, Expiration Date: 31Jul2021) via an unspecified route of administration in left arm on 31Mar2021 09:45 as dose 2, single for COVID-19 immunization (At the age of 63-year-old). The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6207, Expiration Date: Jul2021) via an unspecified route of administration in left arm on 11Mar2021 09:45 as dose 1, single for COVID-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient experienced had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine on 10Jul2021, tested positive for covid on 16jul while her husband, 17Jul on 17Jul2021, they both received both doses of the pfizer biontech covid vaccine in Mar2021, and now they both have covid on an unspecified date. It was reported that, caller and her husband got their first dose of the Pfizer Covid 19 vaccine last 11Mar2021 and their second dose was on 31Mar2021. Patient was diagnosed with COVID 17Jul2021. Reporter enquired that why they got covid since they already got both doses of the vaccine and asked if the vaccine they got was effective. Patient had had Atrial fibrillation 2 1/2 months after got the second dose of the vaccine and wanted to know if Pfizer shot can cause Atrial fibrillation. The patient he went to the ER with A-fib, was hospitalized for had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine from 10Jun2021 to 13Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Jul2021. Therapeutic measures were taken as a result of had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine. The outcome of the events was unknown.  Lot-# (CR): ER8734 Conclusion of Previously Completed Investigation: Truncated Conclusion -See PR ID of Previously Completed Inv for full text The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lotEP8573. A complaint sample was not returned  Lot-# (CR): EN6207 Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 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 EN6207, fill lot EN5340, and the formulated drug product lot EN5328. 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.  Description of complaint: Caller reporting adverse events. Caller states she got real sick, like with a flu/cold and she took some over the counter medicine, pain medicine but caller states on Wednesday, 21Apr2021, she had to go to the emergency room because she was having trouble breathing and has continued coughing up of green stuff and worsened coughing. Albuterol Nebulizer: Caller states she has been doing the nebulizer, the albuterol nebulizer machine. Caller states that's only if she's having an attack, but she hasn't had one prior to this. Caller verifies she hasn't had an attack prior to getting the shots. Caller provides Albuterol Nebulizer LOT: 021331, Expiry Date: Apr2022. Caller unsure of NDC.  Follow-up attempts are completed. No further information is expected.