Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased, Hypoaesthesia, Loss of consciousness
Clinical narrative: passing out; fainting; new sudden onset of a cardiac problem; POTS syndrome; tingling and numbness in my arm; tingling and numbness in my arm; some heart palpations; fast heart rates / HR alarm would go off detecting abnormally high heart rates over 100 bpm at rest and without activity; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Apr2021 (Lot number: EW0158) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic migraines" (unspecified if ongoing), notes: chronic migraines. cleft lip and pallet; "cleft lip and pallet" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 07Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "passing out"; SYNCOPE (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "fainting"; PARAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset May2021, outcome "not recovered" and all described as "tingling and numbness in my arm"; PALPITATIONS (disability) with onset May2021, outcome "not recovered", described as "some heart palpations"; HEART RATE INCREASED (disability) with onset May2021, outcome "not recovered", described as "fast heart rates / HR alarm would go off detecting abnormally high heart rates over 100 bpm at rest and without activity"; CARDIAC DISORDER (disability) with onset 2022, outcome "not recovered", described as "new sudden onset of a cardiac problem"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 2022, outcome "not recovered", described as "POTS syndrome". The events "passing out", "fainting", "tingling and numbness in my arm", "tingling and numbness in my arm", "some heart palpations", "fast heart rates / hr alarm would go off detecting abnormally high heart rates over 100 bpm at rest and without activity", "new sudden onset of a cardiac problem" and "pots syndrome" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (May2021) over 100 bpm, notes: over 100 bpm at rest and without activity; sars-cov-2 test: (Dec2021) negative, notes: covid test type post vaccination= Nasal Swab; (Jan2022) positive, notes: covid test type post vaccination= Nasal Swab. It was unknown if therapeutic measures were taken as a result of loss of consciousness, syncope, paraesthesia, hypoaesthesia, palpitations, heart rate increased, cardiac disorder, postural orthostatic tachycardia syndrome. Clinical information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the covid vaccine she began to feel tingling and numbness in her arm.  and some heart palpations/fast heart rates. she wearied a heart rate monitoring watch for exercise and never had issues before the vaccine. after the vaccine she began noticed her HR alarm would go off detecting abnormally high heart rates over 100 bpm at rest and without activity. She didn't think much of it and learned to live with it. She got sick with covid at the end of December and in January she started passing out and fainting. Went to her PCP, who sent him to a neurologist, who now sent her to a cardiologist where they had confirmed she had a new sudden onset of a cardiac problem. She had a lot more testing to confirm a final diagnosis, but they believe she had POTS syndrome now. her family has no history of cardiac related issues, and she was a perfectly healthy individual before the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.