Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test, Somnolence
Clinical narrative: Passed out; Severe joint pain; Severe fatigue sleeping throughout day for 2 months; D Dimer and liver enzymes test results were high; D Dimer and liver enzymes test results were high; Fibromyalgia; Sleeping throughout day; My heart would race if I was upright for too long; Severe chest pain 2 days after vaccine; This is a spontaneous report from a contactable consumer (other HCP). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 28May2021 14:30 (at the age of 39-years-old) as dose 2, single for Covid-19 immunization at public health clinic/veterans administration facility. Medical history included migraines and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included escitalopram oxalate (LEXAPRO), imipramine, levothyroxine and levonorgestrel (NORTREL [LEVONORGESTREL]) taken for an unspecified indication, start and stop dates were not reported. The patient previously took Nitrofurantoin, Maxalt, Neomycin and experienced allergy, Flu vaccine and experienced allergy to vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. On 28May2021 16:30, the day of the vaccine patient heart would race if she was upright for too long. She also had severe joint pain, her D Dimer and liver enzymes test results were high, but no other tests/scans showed a blood clot. Severe fatigue sleeping throughout day for 2 months. Went to the heart doctor and tests came back normal. Went to a Rheumatologist and blood work done. She was informed she had developed fibromyalgia from the Covid vaccine. On 29May2021, the day after the vaccine she passed out and was taken to the emergency room. On an unspecified date in May2021, severe chest pain 2 days after vaccine, went to urgent care but tests came back negative, continued chest pain and joint pain. No hospitalization prolonged. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood work: unknown, fibrin d dimer: high and hepatic enzyme: high on an unspecified date in May2021, covid test (nasal swab): negative on 04Aug2021. Treatment received for the adverse events was heart doctor tests and rheumatologist medication. Seriousness of the events was reported as serious (disability). The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Heart rate inceased, Loss of consciousness, Arthralgia, fatigue, chest pain, Fibrin D-Dimer increased, Hepatic enzymes increased, Fibromylagia and Somnolescence which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.