Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear pain, Gait disturbance, Head discomfort, Headache, Inappropriate schedule of product administration
Clinical narrative: severe vertigo lost ability to walk; severe vertigo lost ability to walk; I was so scared I am having a stroke; I could not turn my head or move; lost coordination balance; I was dizzy; fever; headache; pain an pressure in my ears; pressure in my ears; Dose 4, Dose5 08Nov2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, other vaccine same date lot number: FJ5683, other vaccine same date vaccine location: Left arm), administration date: 08Nov2022, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "fever", "headache", "pain", "I was dizzy", "pressure in my ears", "severe vertigo lost ability to walk", "severe vertigo lost ability to walk", "I was so scared I am having a stroke", "I could not turn my head or move", "lost coordination balance"; Covid-19 vaccine (Dose 3; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer unknown), for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (hospitalization, medically significant) with onset 08Nov2022 at 12:00, outcome "unknown", described as "Dose 4, Dose5 08Nov2022"; PYREXIA (hospitalization, medically significant) with onset 09Nov2022 at 14:30, outcome "recovered" (Nov2022), described as "fever"; HEADACHE (hospitalization, medically significant) with onset 09Nov2022 at 14:30, outcome "not recovered"; EAR PAIN (hospitalization, medically significant) with onset 09Nov2022 at 14:30, outcome "not recovered", described as "pain an pressure in my ears"; EAR DISCOMFORT (hospitalization, medically significant) with onset 09Nov2022 at 14:30, outcome "not recovered", described as "pressure in my ears"; DIZZINESS (hospitalization, medically significant) with onset 10Nov2022, outcome "not recovered", described as "I was dizzy"; HEAD DISCOMFORT (hospitalization, medically significant) with onset 11Nov2022 at 22:00, outcome "not recovered", described as "I could not turn my head or move"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 11Nov2022 at 22:00, outcome "not recovered", described as "I was so scared I am having a stroke"; BALANCE DISORDER (hospitalization, medically significant) with onset 11Nov2022 at 22:00, outcome "not recovered", described as "lost coordination balance"; VERTIGO (hospitalization, medically significant), GAIT DISTURBANCE (hospitalization, medically significant) all with onset 11Nov2022 at 22:00, outcome "not recovered" and all described as "severe vertigo lost ability to walk". The patient was hospitalized for pyrexia, headache, ear pain, ear discomfort, dizziness, vertigo, gait disturbance, cerebrovascular accident, head discomfort, balance disorder, inappropriate schedule of product administration (hospitalization duration: 2 day(s)). The events "fever", "headache", "pain an pressure in my ears", "pressure in my ears", "i was dizzy", "severe vertigo lost ability to walk", "i was so scared i am having a stroke", "i could not turn my head or move" and "lost coordination balance" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (09Nov2022) 38.5 C; SARS-CoV-2 test: (12Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, headache, ear pain, ear discomfort, dizziness, vertigo, gait disturbance, cerebrovascular accident, head discomfort, balance disorder which include Prednisone for 2 days and for 7 days after.  Clinical course: The patient got the Pfizer bivalent shot on noon 8Nov2022 and developed fever and headache the next day in the 38.5 C and pain an pressure in her ears like ear fullness felt like her ears inside will explode from pressure inside both ears. The second day the fever went away never came back, but was dizzy and it got worse the third day Friday 11Nov2022 in the morning and had a severe dizzy spell and was resting all day but at 22:00 Friday, the patient had severe vertigo lost ability to walk or stay on her feet so was so scared. The patient had a stroke could not get up from lying position. She could not turn her head or move if, did it was scary like the patient was being moved violently like thrown away left or right totally lost coordination balance ability to walk and her ears and head were full under pressure even on the day of reporting day 7, the patient feel pressure. Saturday 07:00, the patient called emergency to take her to the hospital manage on the floor to drag herself to open the door and they took her to Emergency. The patient had no known allergies. The patient had no covid prior vaccination. The patient did not received any other vaccines in four weeks and received other medication in two weeks of vaccination.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events inappropriate schedule of product administration,head discomfort, dizziness, cerebrovascular accident, pyrexia, headache, balance disorder, pain, ear discomfort, vertigo, gait disturbance  and suspect drug BNT162B2 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.