Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: having Covid and tested positive was 20Aug2022; having Covid and tested positive was 20Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2, NDC number of Covid19 vaccine: Unknown, Expiry Date of Covid19 vaccine: Unknown), on 09Mar2021 as dose 1, single (Lot number: EN6205), in arm, on 01Apr2021 as dose 2, single (Lot number: EN6202), in arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2589), in arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "coronary bypass surgery", start date: 07Feb2022 (unspecified if ongoing); "blood thinner" (unspecified if ongoing), notes: blood thinner; "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: LIPITOR taken for coronary artery bypass (ongoing) Additional Information for Other medicines Lipitor: probably been on Lipitor for 12 years. Indication: coronary bypass surgery and has seen a cardiologist for a number of years and cardiologist recommended it; CLOPIDOGREL taken for coagulopathy, start date: 15Feb2022 (ongoing) generic Plavix; METOPROLOL taken for blood pressure abnormal, start date: 15Feb2022 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Aug2022, outcome "recovered" (25Aug2022) and all described as "having Covid and tested positive was 20Aug2022". Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), >/12 years - 15/15 mcg per dos. Male patient called about the Pfizer COVID-19 Vaccine Bivalent Booster. Caller had COVID on 20Aug2022. Caller had been fully vaccinated and fully boosted. Caller is considered high-risk since he had triple bypass surgery in Feb2022. Caller wanted to know if he should wait 3 months before getting the Pfizer COVID-19 Vaccine Bivelent Booster or not. Offered to send but caller declined. Additional Context: He is 69 years old and full vaccinated and fully boosted with Pfizer Covid19 vaccine. Had Covid 25Aug. Considered high risk because he had triple bypass surgery in Feb. Asking if he should get the new bivalent vaccine prior to 3 months or should he wait 3 months from Covid infection. Clarified details provided by transfer agent. 25Aug2022 was when he was symptoms free. First date of having Covid and tested positive was 20Aug2022. He has recovered completely. Vaccine Supplemental Form: Time the Vaccination Was Given: not provided Anatomical Location of Administration of Pfizer vaccine considered as suspect: All Covid 19 Vaccines were given in arm, but doesn't remember left or right. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): see above report. Additional Vaccines Administered on Same Date of the Pfizer Suspect: With one of the vaccines he might have gotten his flu shot also, but he is not sure. He knows he has had his flu shot. No further details provided. Did any AE(s) require a visit to: Emergency Room: No; Physician Office: No. Prior Vaccinations (within 4 weeks): not that he thinks. AE(s) following prior vaccinations: not provided. Patient's Medical History (including any illness at time of vaccination): None. Family Medical History Relevant to AE(s): not provided. Relevant Tests: rapid Covid test was positive on 20Aug2022. For Lack of Efficacy, request the following information if not included in the initial. What is the primary infection site: not provided. Please specify any secondary site(s) (e.g. empyema): not provided. Are there predisposing factors: not provided. Was a culture performed: not provided. If Yes, was the culture positive: n/a. If Yes, was serotyping done: n/a. Please specify the culture source (e.g. blood): n/a. Please specify Antipyretic Use (around the date(s) of Vaccination): not provided. Is there a product complaint to report: Yes. Description of Product Complaint: Description of complaint: full vaccinated and fully boosted with Pfizer Covid19 vaccine. Had Covid. Frist date of having Covid and tested positive was 20Aug2022. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Positive.  No follow-up attempts are possible. No further information is expected.