Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac function test, Pyruvate dehydrogenase complex deficiency
Clinical narrative: he was hospitalized and he said his symptoms lasted about a month with the PDC; Arrhythmia; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 3 (booster), 0.3 ml single (Lot number: FK9893, Expiration Date: 16May2022) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot# EH9899), administration date: 21Dec2020, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot# EH9899, Expiration date: 12Jan2021), administration date: 11Jan2021, for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset 19Jun2022, outcome "recovered"; PYRUVATE DEHYDROGENASE COMPLEX DEFICIENCY (hospitalization) with onset 19Jun2022, outcome "recovered", described as "he was hospitalized and he said his symptoms lasted about a month with the PDC". The patient underwent the following laboratory tests and procedures: Cardiac function test: Unknown results, notes: He had 4 cardiac work craft; Unknown results, notes: He had 4 cardiac work craft; Unknown results, notes: He had 4 cardiac work craft; Unknown results, notes: He had 4 cardiac work craft. Therapeutic measures were taken as a result of pyruvate dehydrogenase complex deficiency.  Clinical information: Pfizer Sales Representative stated, he/she need to report an adverse event for the Pfizer BioNTech COVID Vaccine. Pfizer Sales Representative was informed about the role of Pfizer Drug Safety. Reporter stated, the physician that they just talked to it was on himself he had Arrhythmia and sustained PDC (Further not clarified hence event captured as per verbatim). When probed to clarify if patient was also the reporter: Reporter stated, he was fine at the time of reporting but he was hospitalized so, the time that he got the adverse event was on 19Jun2022. He have got his COVID Vaccine record for that all 3 of his information LOT# and stuff and where he got his vaccine.'' LOT#: Reporter stated, first date of vaccination was 21Dec2020 and that LOT# was 12212020. They do not know there was two different numbers there was one it says Mgf LOT and there was different LOT# may be EH9899 (First vaccine LOT#). There was two numbers on that one it was weird (Further not clarified). Reporter thought that was probably the EH. Yeah that was the LOT# for the vaccine that was the first one (first dose) 21Dec2020. Apparently reporter just write the first one because reporter do not know, reporter wish they could show it you the thing it just EH9899. Then the next one was 11Jan2021, that was when he got the vaccine just giving you the date (date of administration). Reporter do have the expiration on here. The first, reporter thought they mix that because it saying that the expiration date was the same day as the date of vaccination that could not be right. Reporter stated rather not give the expiration date because it did not, mean they do not know if they have the Expiration date and then it was good for 18 months later they do not know. The second dose expiration date was 12Jan2021 and he was vaccinated on 11Jan2021 (Clarified 11Jan2021 as date of vaccination of second dose) and they want that LOT# it look like 5 but there was circle on that reporter thought that was 5H9899 and expiration date 12Jan2021. Reporter got the third vaccine number here too. That was given on 11May2022 (Further date and month was not appropriately clarified over the call), LOT# is FK9893, Expiration date 16May2022 (16May2022). Pfizer Sales Representative stated, the patient was at the hospital, he got it at the withheld Hospital, do not know who was the doctor but he (patient) was a doctor, he was basically gotten himself. They do not know who prescribed it to him but he was a Physician in the (Reporter's/Patient's reporter type captured as Physician in tab). He was a MD Medical Doctor. He said he does not have any other health factors. He had 4 cardiac work craft (Further not clarified) because he was hospitalized and he said his symptoms lasted about a month with the PDC (Further clarifications unknown hence event captured as per verbatim). Regarding treatment for adverse event Pfizer Sales Representative stated, he was hospitalized but they do not know what they did. When probed if patient condition was Worsened/ Improved/ Persistent, Pfizer Sales Representative stated, Improved. Regarding reassurance Pfizer Sales Representative stated, No and he said he will be willing to share his EKG and his 4 cardiac work up and help to further report any necessary information. They know for sure he got first 2 vaccine at withheld Hospital but third one representative was not sure where he got it. Pfizer Sales Representative stated, ''One says left deltoid here (Further not appropriately clarified).'' Regarding Causality: Pfizer Sales Representative stated, ''Well, I mean the doctor think so because after his last vaccination, he never had a PDC before so, definitely thinks it is due to the vaccine.'' When probed to clarify if patient was still experiencing the adverse event: Pfizer Sales Representative stated, he was fine.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events arrhythmia, pyruvate dehydrogenase complex deficiency. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.