Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Immunisation, Vertigo
Clinical narrative: Received booster 10/8 at 12:15PM and developed vertigo; Received booster 10/8 at 12:15PM and developed vertigo; Received booster 10/8 at 12:15PM and developed vertigo; This is a spontaneous report received from a contactable nurse (patient). This nurse reported events after the second and third dose. This is the second of two reports (dose 3). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number 30145BA), administered in left arm on 08Oct2021 12:15 PM (at the age of 68-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant. The patient's medical history included high blood pressure (HBP), irritable bowel syndrome (IBS), hypothyroid, and sinus infection, all from unspecified date, vertigo from 2013. The patient had no COVID-19 prior vaccination, and she had no known allergies. Concomitant medications included amlodipine besilate, nadolol, levothyroxine sodium (SYNTHROID) aliskiren, acetylsalicylic acid (ASA), all from unspecified date and taken within two weeks from vaccination, influenza vaccine inactivate split 3v (FLUZONE HD 65+Pf) on 28Sep2021 as single dose for influenza immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208) on 14Mar2021 12:15 PM (at the age of 67-year-old) as dose 1, single for COVID-19 immunization, and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8733) on 10Apr2021 10:00 AM (at the age of 67-year-old) as dose 2, single COVID-19 immunization and she experienced severe vertigo, nausea and heavy breathing on 12May2021 required an emergency room (ER) visit and treatment received due to the events included intravenous (IV) diphenhydramine (BENADRYL) and ondansetron (ZOFRAN) for nausea and dizzy. She developed several other vertigo events on 17Sep2021 and 20Sep2021 also requiring ER visits with similar symptoms. It was reported that patient received booster on 08Oct2021 at 12:15 PM and developed vertigo at 03:00 AM 09Oct2021. Vertigo continued for next several days with relief from meclizine. She went to ER on 11Oct2021. Vertigo went away on 13Oct2021 after treatment with diazepam (VALIUM) 2 doses 2.5 mg. Vertigo started again on 27Oct2021 with no relief of meclizine or VALIUM. Vertigo continued. She had seen internist and otolaryngologist (ENT) without any relief. The outcome of the events was not resolved.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Immunization, Vertigo, disease recurrence cannot be completely 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.,Linked Report(s) : US-PFIZER INC-202101465313 Same reporter/SD, Different potential/AE