Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: incapacitating dizziness; extreme vertigo and nausea it was so severe; extreme vertigo and nausea it was so severe; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Sep2024 at 16:00 as dose 1 0.3 ml, single (Batch/Lot number: unknown) at the age of 67 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (ongoing). Concomitant medication(s) included: RALOXIFENE oral taken for osteoporosis (ongoing). Vaccination history included: BNT162b2 (Site: Left arm, Lot: EN6208, DOSE 1, SINGLE), administration date: 22Mar2021, for COVID-19 immunization, reaction(s): "Muscle fatigue", "Chills", "body aches"; BNT162b2 (Site: Left arm, Lot: EW0164, DOSE 2, SINGLE), administration date: 20Apr2021, for COVID-19 immunization; BNT162b2 (Site: Left arm, Lot: FE2593, DOSE 3 (BOOSTER), SINGLE), administration date: 22Oct2021, for COVID-19 immunization; BNT162b2 (Site: Left arm, Lot: FK9893, DOSE 4 (BOOSTER), SINGLE), administration date: 29Apr2022, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Site: Left arm , Lot: GJ2524, DOSE 5 (BOOSTER), SINGLE), administration date: 16Sep2022, for COVID-19 immunization; BNT162b2 omi xbb.1.5 (Site: Left arm , Lot: HG4628, DOSE 6 (BOOSTER), SINGLE), administration date: 25Sep2023, for COVID-19 immunization; BNT162b2 omi xbb.1.5 (Site: Left arm, DOSE 7 (BOOSTER), SINGLE), administration date: 06Mar2024, for COVID-19 immunization, reaction(s): "Inappropriate dose of vaccine administered". The following information was reported: VERTIGO (non-serious), NAUSEA (non-serious) all with onset 11Sep2024 at 04:00, outcome "not recovered" and all described as "extreme vertigo and nausea it was so severe"; DIZZINESS (non-serious), outcome "unknown", described as "incapacitating dizziness". The events "extreme vertigo and nausea it was so severe" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, nausea. Additional information: On 11Sep2024, 36 hours after vaccination, patient woke up with extreme vertigo and nausea it was so severe, paramedics were called and went to the hospital because she couldn't walk or stand. Patient was given anti-vertigo medication that initially helped a little bit, but her symptoms getting worse again. Patient also added incapacitating dizziness side effect. After the trip to the ER, the medicine that they gave her made it a little bit better, and on 12Sep2024, she thought it was better, but on 13Sep2024 her symptoms are worse again. She is otherwise healthy and takes no medication, and there is nothing wrong with her. This is out of the blue. Patient stated that it was difficult to walk. She has never had covid and was tested in the ER and did not have it. They did blood work in the hospital and made sure she did not have a heart attack and stroke. Covid test was negative.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400256473 same reporter, patient and product; different dose and event;