Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Heart rate, Heart rate increased, Lethargy
Clinical narrative: 3rd Troponin level increased from 2nd Troponin; rapid heart beat / rapid pulse / pulse was up some; burning in her chest and throat / her throat was irritated; burning in her chest and throat; blood pressure keeps going up and down; fatigue; felt run down; This is a spontaneous report from a contactable nurse, the patient. A 78-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL8982), via an unspecified route of administration in the right deltoid on 04Feb2021 at 16:55 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. There were no prior vaccinations (within 4 weeks) of BNT162B2. The patient previously received the flu vaccine (manufacturer unspecified) on 25Sep2020, as well as the shingles, pneumonia and Tdap vaccines (manufacturers unspecified) all on unspecified dates for immunization. On 04Feb2021, between 17:25-17:30, the patient developed a rapid heartbeat and burning in her chest and throat. She reported that her throat was irritated, as of 04Feb2021. She clarified the burning sensation was as if someone had heated a gel pack in the microwave and then placed the heated gel pack on her chest and throat area. She went to the Emergency Room (ER). She still had a rapid pulse, so the ER doctor did a series of cardiac enzyme tests (troponin). Her first troponin on 04Feb2021 was negative. The second cardiac enzyme test was done 3 hours later, on 04Feb2021, and the troponin went up a little. The third cardiac enzyme test was taken at 1:30 on 05Feb2021. The ER doctor didn't think it was necessary to keep her in the ER, so he suggested she go home. When she left the ER, her pulse was up some, but not like when she first went to the ER. At the ER, she was not given any medications. She only had the cardiac enzyme tests, and EKGs (unknown results) performed. She had a Heplock placed but received no intravenous fluids. She was woken up by the ER doctor who told her she needed to go back for more tests as he was concerned that she may have heart damage.  The ER doctor said her 3rd Troponin went up more than her 2nd Troponin. At 6:50 on 05Feb2021 she had another cardiac enzyme test and was told she needed to have an echocardiogram. The echocardiogram (05Feb2021) showed no heart damage. The cardiologist said her heart was beating fine and that the COVID-19 vaccine may have elevated her pulse, but he felt there was no damage to her heart. The patient experienced fatigue as of an unknown date in Feb2021 (maybe 05Feb2021 or 06Feb2021 or 07Feb2021). On an unspecified date in Feb2021 (after 05Feb2021), the patient felt run down. The patient reported her blood pressure kept going up and down since the vaccination, as of 04Feb2021. She saw her health care professional (HCP) on 11Feb2021 to pick up new prescriptions. On 12Feb2021, she started to keep a record of her blood pressure readings. One day her systolic blood pressure was 170 "over something", and then the next day her systolic blood pressure was down, as far as 103. The HCP recommended she see an allergist before she received the second dose of the COVID-19 vaccine. She said both the medical doctor and cardiologist said it was OK for her to get the second COVID-19 vaccine (scheduled for 25Feb2021). The patient was unsure if the COVID-19 vaccine caused her symptoms. The reporter considered "rapid heartbeat / rapid pulse / pulse was up some", "burning in her chest and throat / her throat was irritated", "blood pressure keeps going up and down" as medically significant; and fatigue and felt run down as non-serious. The patient received unspecified treatment for the events. The clinical outcome of "rapid heartbeat / rapid pulse / pulse was up some", "3rd Troponin level increased from 2nd Troponin" was unknown; "burning in her chest and throat / her throat was irritated" was resolved on Feb2021; "blood pressure keeps going up and down" was not resolved; fatigue and felt run down was resolving.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  rapid heartbeat and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this elderly patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, chemistry panel and echocardiogram, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.