Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: high heart rate and palpitations; high heart rate and palpitations; wheezing; HERO TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN US HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study for Protocol C4591008.  A 35-year-old patient of unspecified gender received the first dose of BNT162B2 (Batch/Lot number: unknown) on 29Jul2021 at unspecified route of administration as single dose for COVID-19 immunisation. Relevant medical history included: "obesity/overweight" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (hospitalization), PALPITATIONS (hospitalization) all with onset 11Aug2021 and all described as "high heart rate and palpitations"; WHEEZING (non-serious) with onset 11Aug2021, described as "wheezing". The event "high heart rate and palpitations" was evaluated in the emergency room (ER).  Clinical course was reported as follows: The patient received the first dose on 29Jul2021 and went to the ER on 11Aug2021. The patient had been experiencing high heart rate and palpitations for nearly a week and it got to the point he felt sick from it being so high. The ER ran blood tests, X-ray of the chest, and electrocardiogram (EKG). The patient was given beta blocker and anxiety meds in the ER. The patient stated it took a week after that to set up an appointment with a cardiologist. Then a month to do an ultrasound of the heart. The patient added that if patient had myocarditis or pericarditis, it went away on its own before the patient ever got the ultrasound done. The cardiologist reported there was no relationship with the vaccine and heart issues hence it was not considered that the events were vaccine related. The patient was diagnosed with high anxiety and was kept on beta blockers. A week or so after he was diagnosed, the patient asked for a holter monitor. The patient was not sure if it would catch anything since the patient was out on beta blockers but asked for it anyway. It caught a few episodes of early and extra heart beats. The patient assumed that was what the patient was feeling prior to the ER visit. The tests from the ER came back normal, except for the patient's thyroid being elevated, the ultrasound on heart came back normal, the holter monitor only showed the few episodes and the cardiologist said it was less than 5% and he wasn't worried about it. The patient had 100% had an issue with this vaccine regardless of what the cardiologist thought. The patient added that patient was fine until the patient had the vaccine and currently not. The patient also stated he was on beta blockers for the rest of the patient's life. The patient also reported that lung function test was performed because the patient had been wheezing and the lungs had been having spasms. The patient underwent the following laboratory tests and procedures: blood test: (11Aug2021) negative; chest x-ray: (11Aug2021) negative; electrocardiogram: (11Aug2021) normal. The action taken in response to the events for BNT162B2 was not applicable (not reported by the investigator). Outcome of the events "high heart rate and palpitations" was recovering while "wheezing" was unknown.  The investigator considered there was not a reasonable possibility that the events "high heart rate and palpitations" were related to BNT162B2. The reporter's assessment of the causal relationship of the "wheezing" with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the available information, there is agreement with the reporting HCP that the events  heart rate increased, and palpitations are not related to the use of the vaccine. It was considered that the temporal gap between exposure and symptoms makes the causal relationship unlikely. Furthermore, there was information that a cardiologist  indicated that the vaccine is not related to the palpitation/increased heart rate. As such, an alternative diagnosis of anxiety was given with the patient being started on beta blockers, and further cardiac work up did not yield any information to support any causal relationship.  As for the reported wheezing  which was not immediately expressed after vaccination, it is possible that it was triggered by the diagnosed anxiety attack. The chest xray was also normal and did not show hyperinflation. The available information suggests that  wheezing is not related to the vaccination. The case will be assessed further upon receipt of additional information.