Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Electrocardiogram, Fatigue, Insomnia
Clinical narrative: Fatigue; Sore arm; she could not sleep; passed out randomly; heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Mar2021 (Lot number: EN6204) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. Patient's grandfather had palpitations but she does not know for sure. He had heart surgery as an older guy in his 70's and 80's. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 43 years old, for covid-19 immunisation, reaction(s): "Tightening in her calf", "Sore arm". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Oct2021, outcome "unknown", described as "passed out randomly"; PALPITATIONS (non-serious) with onset 18Mar2021, outcome "unknown", described as "heart palpitations"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; INSOMNIA (non-serious), outcome "unknown", described as "she could not sleep". The event "passed out randomly" was evaluated at the emergency room visit. The event "heart palpitations" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac monitoring: (unspecified date) confirmed heart palpitations, notes: Heart monitor worn for 2 days, also wore a monitor for 2 weeks; echocardiogram: (unspecified date) confirmed heart palpitations; electrocardiogram: (unspecified date) abnormal, notes: confirmed heart palpitations; magnetic resonance imaging: (unspecified date) confirmed heart palpitations; x-ray: (Oct2021) unknown results. Clinical course: After the second shot, the patient had a sore arm and fatigue. Heart racing, felt her heart speeding and kind of fluttering: The main thing is the evening of that second shot, she started having heart racing. She thinks she had the shot around 1:00pm or 2:00pm. She thinks sometime around 9:00pm or 10:00pm, she started feeling her heart speeding and kind of fluttering. At first it was the fast heartbeat, it was so fast, she could not sleep. The next morning, it was still a little fast. Then, it didn't bother her for a few days and went away. For about 3 days, she didn't notice it. It was the 4th or 5th day, that she started getting random heart palpitations. It just kind of hit her through the day and she would feel skipping and an elevated, fast paced heart rate. That lasted off and on for about a month. She states that she knows that sounds bad. After that day, when it first started, she reached out to her doctor who said she had not heard of any reaction like this and told her to monitor it. The caller states she had no history, so they were not concerned. She waited a few months after, to follow up with her doctor and was referred to cardiologist. They did multiple tests, an EKG that was abnormal, an ECHO, an MRI, and she even wore a heart monitor for 2 days. She also wore a monitor for 2 weeks. They have confirmed heart palpitations on every test she had. Caller states that she did not have any of this prior to the Covid shots. Caller then states that she had another episode, she feels was unrelated and still does not have an answer for. She did pass out, randomly, one day in Oct2021. She went to the ER because at the same time, she was going through these heart things and she was concerned it was her heart. They ran pulmonary tests to make sure there was not a clot in the lung. She thinks it was a pulmonary X-ray. Clarified that this occurred in Oct2021, that she passed out and went to the ER. Clarified that she was not admitted to the hospital, she was just there the one day.  The reporter considered "passed out randomly" not related to bnt162b2. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the event Loss of consciousness and suspected drug cannot be excluded.  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