Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus bradycardia, Vaccination site pain
Clinical narrative: bradycardia; sinus bradycardia; systolic was 118/120 but it reached 110/63; pulse fell between 30 and 37; horrific pain on the injection site; hypotensive; cardiovascular side effects; This is a spontaneous report received from a Physician from medical information team.  A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Nov2024 as dose 1, single (Lot number: LN2210) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obsessive compulsive physician" (unspecified if ongoing); "does not smoke" (unspecified if ongoing). The patient's family history included: "hyperlipidemia" (ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] (ongoing). The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , lot number 0186), administration date: 16Jul2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE , lot number 0196), administration date: 06Aug2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , lot number where they write so small and it is something like FT6369), administration date: 09Jan2022, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE , lot number GJ2524), administration date: 21Sep2022, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE , lot number that looks like GJ6796), administration date: 06Jan2023, when the patient was 72-year-old, for COVID-19 immunization; comirnaty (2023-2024 formula) (DOSE 6 (BOOSTER), SINGLE , lot number HF9275), administration date: 27Apr2024, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: CARDIOVASCULAR DISORDER (non-serious) with onset Nov2024, outcome "unknown", described as "cardiovascular side effects"; VACCINATION SITE PAIN (non-serious) with onset 15Nov2024, outcome "recovered" (16Nov2024), described as "horrific pain on the injection site"; HYPOTENSION (non-serious) with onset 15Nov2024, outcome "recovered" (16Nov2024), described as "hypotensive"; HEART RATE DECREASED (non-serious) with onset 16Nov2024, outcome "recovered" (17Nov2024), described as "pulse fell between 30 and 37"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 16Nov2024, outcome "recovered" (17Nov2024), described as "systolic was 118/120 but it reached 110/63"; BRADYCARDIA (non-serious) with onset 17Nov2024, outcome "recovered" (18Nov2024); SINUS BRADYCARDIA (non-serious) with onset 17Nov2024, outcome "recovered" (18Nov2024). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, hypotension, bradycardia, sinus bradycardia. Additional information: The patient called in to report an AE as result of his injection about 4 days ago on 15Nov2024. He would like information on who he can call or talk to medically. The patient reported that he is 74 years old and had multiple vaccinations- since he worked in another country for a time years ago. He only used Pfizer products, had full initial vaccinations had all the boosters for COVID-19. He had a muscular injection in his left shoulder he experienced horrific pain, no swelling, no redness in the arm and became slightly hypotensive his pulse fell between 30 and 37. On the second day, his pulse went up to 65bpm, the next day everything has been totally fine in his pulse and blood pressure to normal after 48 hours. His concern was the cardiovascular side effects. He is aware of the myocarditis and pericarditis. But what concerns him most was the bradycardia, the horrific pain on the injection slight was very different from his previous vaccination. It didn't bother him that he became slightly hypotensive. systolic was 118/120 but it reached 110/63 so he had to run a cardiogram and it was a narrow complex EKG. He thinks that he is asymptomatic about the bradycardia but it all went away after 48 hours. He added that he remained an athlete and still works out 5 times a week in the gym. He is taking a "statin" drug for hyperlipidemia and a mini aspirin every morning. Prior to the vaccination he took an aspirin. He is still practicing that's why he still wants to be vaccinated. Caller mentioned that he is taking a "statin" drug for hyperlipidemia and a mini aspirin every morning. Prior to the vaccination he took an aspirin. The only reason is he is concerned is that he is an ER doctor and was more concerned about the bradycardia and if he was in a heart block where the QRS complex on an EKG and that is very concerning and he wanted to make sure his QRS complexes were very narrow and that he had P waves and that it was saying that he is not in 3rd degree cardiac block; clarified he did go to on Sunday to an urgent care and asked them if they would do a 12 lead cardiogram and was pleasantly surprised that he was making all normal P waves and was not in heart block and his QRS complexes were very narrow and had no evidence of heart block and was just sinus bradycardia. He then said ok and he did not have to admit himself to the ER and hospital and just wanted to see how things go as he was still asymptomatic the entire time through all this and would take his pulse; he went to the urgent care on 17Nov2024 in early afternoon and jokingly said the only reason he went was because he did not want to upset his wife if he woke up dead. Regarding causality: He has to say unknown for causality as he does not have any other issues for medical issues other than hyperlipidemia that runs in his family and he has not any other illnesses and still loves sports and just does not have any problems and is training for another triathlon at his age; he still has been doing sports all his life and it is what he likes to do and was concerned about the 30 to 37 pulse rate; it would really annoy his wife if he could not make coffee for her as she gets coffee made in bed for her. He did not take anything for hypotension or bradycardia and does not take pills for pain because he knows it goes away. Asks if is there any possibility if Pfizer finds that somebody else has reported this low clinical bradycardia and is there any way to let him know about that or either by text or mail or something. He has been wracking his brain the entire weekend and was trying to think if there is anything other than this and just because you have a vaccination and something happens to you does not necessarily mean it is because of the vaccine and thought is there anything else he took and he does not have any other illnesses and does not take any other prescription medications except a mini aspirin and the statin drug; he is not a diabetic, does not drink and does not smoke and does not use drugs and does not know what else it could be so was calling to see if something has already been reported as it would make him feel a lot better. Asks if someone else has reported this and he would like to know because he does not really know and if Pfizer has not reported this or had it reported then he may start thinking maybe he should see a cardiologist and do a full cardiac workup to see why he went into bradycardia and the Pfizer vaccine may be coincidental. If agency could give him a call if that have information on this and if not that is fine but if they do then great; if they would say they are positive they have had this occur then yes he would like if someone could give him a call.