Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vertigo
Clinical narrative: vertigo/Dizziness/could barely walk; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (vertigo/Dizziness/could barely walk) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VERTIGO (vertigo/Dizziness/could barely walk) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was hospitalized on 26-Apr-2023 due to VERTIGO. At the time of the report, VERTIGO (vertigo/Dizziness/could barely walk) had not resolved and PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Inconclusive. On an unknown date, Cardiac monitoring: Inconclusive. On an unknown date, Computerised tomogram: Inconclusive. On an unknown date, Magnetic resonance imaging: Inconclusive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered VERTIGO (vertigo/Dizziness/could barely walk) to be related. No further causality assessments were provided for PYREXIA (fever) and CHILLS (chills).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that this was her fifth. She had the regular side effects - fever, chills, and all of that stuff. But this time she got very dizzy and went to the hospital because it got progressively worse.  It was reported that on Sunday morning 23-Apr-2023 patient could barely walk. She had 2 dizzy episodes on Sunday and 1 on Monday and 1 on Tuesday. The one on Tuesday lasted almost 30 minutes. She was in a state of just dizziness, so she went into emergency. She went to the hospital on Wednesday 26-Apr-2023. She had an episode at the hospital also. They did a bunch of tests blood work, monitored her heart, Computed Tomography Scan (CAT) scan, and Magnetic resonance imaging (MRI). They found that it was from the vaccine and said it would wear off. They said she had a form of vertigo that can be caused by certain viruses. The patient still experiences the symptoms now, but it is not as severe. She might feel it for a couple seconds and that is it.   Company Comment: This spontaneous case concerns a 70  year  old female patient, with no medical history reported, who experienced the unexpected, serious (due to hospitalization) event of vertigo, which occurred approximately 5 days after a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine, reported as fifth dose of her COVID  19 immunization schedules. The patient previously had 4 doses of mRNA - 1273 COVID  19 vaccines. The report stated that the patient experienced different episodes of dizziness and difficulty walking. She consulted the hospital because it got progressively worse. Unspecified blood tests, a heart monitor, computed tomography scan, and magnetic resonance imaging were performed. The result were not disclosed for medical reviewing. "They found that it was from the vaccine. They said she had a form of vertigo that can be caused by certain viruses." No further clinical details were provided. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.  This case was linked to MOD-2023-723836 (Patient Link).