Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, COVID-19 immunisation, Dizziness, Interchange of vaccine products, Ischaemic stroke
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID 19 vaccine; visual issues; visual auras; was very sensitive to light; lightheadedness; ischemic strokes; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (ischemic strokes) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE on 25-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE on 25-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster on 28 Sep 2021) on 28-Sep-2021 and PFIZER BIONTECH COVID-19 VACCINE (2nd booster on 27 May 2022) on 27-May-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced ISCHAEMIC STROKE (ischemic strokes) (seriousness criterion medically significant). On 07-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VISUAL IMPAIRMENT (visual issues), AURA (visual auras), PHOTOPHOBIA (was very sensitive to light) and DIZZINESS (lightheadedness). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID 19 vaccine). At the time of the report, ISCHAEMIC STROKE (ischemic strokes) and DIZZINESS (lightheadedness) had resolved with sequelae and VISUAL IMPAIRMENT (visual issues), AURA (visual auras), PHOTOPHOBIA (was very sensitive to light), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: had tests from top to bottom, and they haven't found any real red flags.. On an unknown date, Ophthalmological examination: didn't find any issues with eyes..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient's doctor ordered an MRI on 3-Dec-2022. It was reported that she had 3 ischemic strokes. Estimated at the time that they had occurred 3-6 weeks prior to 3-Dec-2022, which would put it in the time frame when she was having the symptoms. The reporter stated that now she still gets some symptoms, but not as intense as the first time.  Company comment: This spontaneous case concerns a 71-year-old, female patient with no medical history information reported, previously vaccinated with 4 doses of Pfizer Biontech COVID 19 vaccine,  who experienced the unexpected serious (medically significant) event of ischemic stroke. Interchange of vaccine product and revaccination with different COVID 19 vaccine were also noted. The event was diagnosed approximately 2 months after a dose of mRNA-1273 bivalent BA.1(administered as the fifth dose) with symptoms starting approx. 8 days after 5th dose. As reported, patient had visual issues and visual auras and was very sensitive to light and had lightheadedness. Patient went to get an ophthalmology exam, but no issues with her eyes were found. These symptoms continued for a while, so MRI was done and doctors reported that patient had 3 ischemic strokes with estimation they had occurred 3-6 weeks prior to MRI (which was done 2 months after 5th dose). Reportedly, patient had tests from top to bottom, and they haven't found any real red flags. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 bivalent BA.1 is not affected by this report.