Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cerebrovascular accident, Nerve conduction studies
Clinical narrative: recently had a stroke; recently had a stroke and has Afib; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (recently had a stroke) and ATRIAL FIBRILLATION (recently had a stroke and has Afib) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) and PNEUMOCOCCAL VACCINE for an unknown indication.    On 16-Sep-2022, 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 an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (recently had a stroke) (seriousness criterion medically significant) and ATRIAL FIBRILLATION (recently had a stroke and has Afib) (seriousness criterion medically significant). The patient was treated with METOPROLOL TARTRATE (BETAONE) ongoing since an unknown date at an unspecified dose and frequency and GABAPENTIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (recently had a stroke) and ATRIAL FIBRILLATION (recently had a stroke and has Afib) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Nerve conduction studies: which did not definitively show peripheral neuropathy..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had no swelling. She feels her balance was a little off because of her feet. She cannot go to the gym and walk on the treadmill because of her feet. Her symptoms are not getting better or worse with medication. Patient has been discussing her symptoms with a neurologist and hematologist who discussed multiple myeloma, and Monoclonal G of Undetermined Source. She has also recently had a stroke and has Afib.  She was wearing a heart monitor, taking a beta blocker, and also taking gabapentin.  She has been taking her regular flu and pneumonia vaccines.  Her hematologist told her that other people have reported similar symptoms after taking the COVID-19 vaccines.  Since she had taken the COVID-19 vaccines she not had COVID-19, though she had a cold once. She has plans to see a podiatrist for her symptoms next. Company Comment: This spontaneous case concerns an adult female patient, with no medical history reported, who experienced the unexpected, serious (due to medically significant criteria) AESIs of cerebrovascular accident and atrial fibrillation, after a dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT was administered as fifth dose of her vaccination schedule. Temporal association cannot be assessed due to lack of information on onset date of the events. Gabapentin, use of heart monitor, and a beta blocker were administered (details not provided).Patient has been discussing her symptoms with a neurologist and hematologist who discussed multiple myeloma, and Monoclonal G of Undetermined Source. No further information was available for medical review.  At the time of the latest report the events had not resolved. Mentioned myeloma and gammopathy could suggest presence of underlying risk factors. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT is not affected by this report.