Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | FH8020 | — |
Pt diagnosed with FMD; Upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period.; Upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period.; Upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period.; Pt also developed bilateral lower-extremity tremors.; Pt was referred to the ER, where pt was diagnosed with myalgia; This is a spontaneous report received from a Consumer or other non HCP. A 25-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 as dose 2, single (Lot number: FH8020) at the age of 25 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pfizer biontech COVID-19 vaccine (DOSE 1, SINGLE ; lot number: 30B08R.), administration date: 27Sep2021, for Covid-19 immunization. The following information was reported: TREMOR (disability, medically significant) with onset 18Oct2021, outcome "recovered with sequelae" (Feb2024), described as "Pt also developed bilateral lower-extremity tremors."; MYALGIA (disability) with onset 18Oct2021, outcome "recovered with sequelae" (Feb2024), described as "Pt was referred to the ER, where pt was diagnosed with myalgia"; PALPITATIONS (disability, medically significant), TACHYCARDIA (disability), CHEST DISCOMFORT (disability) all with onset 18Oct2021, outcome "recovered with sequelae" (Feb2024) and all described as "Upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period."; FIBROMUSCULAR DYSPLASIA (disability, medically significant) with onset Jan2023, outcome "recovered with sequelae" (Feb2024), described as "Pt diagnosed with FMD". The events "upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period.", "pt also developed bilateral lower-extremity tremors." and "pt was referred to the er, where pt was diagnosed with myalgia" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: (25Oct2021) did not reveal any abnormalities, notes: pt was placed on a 7-day cardiac monitor; Electrocardiogram: (21Oct2021) Normal. Therapeutic measures were taken as a result of fibromuscular dysplasia, palpitations, tachycardia, chest discomfort, tremor, myalgia. Clinical course: It was reported that following receipt of 2nd vaccine dose, patient began experiencing palpitations & a sensation of chest pressure. Patient reduced normal activity level at that time. Upon resuming regular activity, pt experienced persistent palpitations, tachycardia, &chest pressure lasting for an abnormally prolonged period. Pt also developed bilateral lower-extremity tremors. On 21Oct2021, pt presented to an onsite clinic where an ECG was performed & interpreted as normal; however, symptoms persisted. Pt was referred to the ER, where pt was diagnosed with myalgia & prescribed hydroxyzine. There was no improvement in symptoms. By 25Oct2021, pt was placed on a 7-day cardiac monitor, which did not reveal any abnormalities. Pt was advised to take aspirin. During this period, Pt noted that increases in palpitations were consistently associated with the onset or worsening of lower-extremity tremors. In Jan2023, Pt diagnosed with FMD and now taking CBT for tx. Tremors continued off/on until Feb2024. adverse event start date: 18Oct2021ae resulted in disability or permanent damage, patient was recovered with lasting effects, adverse event stop date was Feb2024. Patient received treatment with Dx of FMD with Tx of CBT and use of walker, sertraline management, and physical therapy. It was unknown if patient have any known allergies, no other medical history for patient. Patient received other vaccine 4weeks product: Pfizer BioNTech COVID-19 vaccine, other vaccine 4weeks vaccine date: 27Sep2021, other vaccine 4weeks lot number: 30B08R.
Test Date: 20211025; Test Name: cardiac monitor; Result Unstructured Data: Test Result:did not reveal any abnormalities; Comments: pt was placed on a 7-day cardiac monitor; Test Date: 20211021; Test Name: ECG; Result Unstructured Data: Test Result:Normal