Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Polymyalgia rheumatica
Clinical narrative: ischemic Stroke/She had a stroke after the second booster; After the second dose she developed PMR (Polymyalgia Rheumatica)/Her shoulder, hips and knees hurts/ She had aches and pains; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (ischemic Stroke/She had a stroke after the second booster) and POLYMYALGIA RHEUMATICA (After the second dose she developed PMR (Polymyalgia Rheumatica)/Her shoulder, hips and knees hurts/ She had aches and pains) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 031L20A and 016B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced POLYMYALGIA RHEUMATICA (After the second dose she developed PMR (Polymyalgia Rheumatica)/Her shoulder, hips and knees hurts/ She had aches and pains) (seriousness criterion medically significant). On 13-Aug-2022, the patient experienced ISCHAEMIC STROKE (ischemic Stroke/She had a stroke after the second booster) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (ischemic Stroke/She had a stroke after the second booster) and POLYMYALGIA RHEUMATICA (After the second dose she developed PMR (Polymyalgia Rheumatica)/Her shoulder, hips and knees hurts/ She had aches and pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had Moderna Bivalent 3rd Booster was 22Sep2022 and the lot number as AS7165B. Further it was reported that after the second dose patient developed PMR (Polymyalgia Rheumatica) in April 2022. Patient had aches and pains. Patient's shoulder, hips and knees hurts. Patient had a stroke after the second booster. Patient do not have any information on the first booster.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 78-year-old female patient with no medical history, who experienced the unexpected, serious (medically significant) events of polymyalgia rheumatica and ischaemic stroke (AESI). The event of polymyalgia rheumatica occurred an unknown time after the second dose of mRNA-1273, and ischaemic stroke occurred 2 months after the second booster of mRNA-1273. Polymyalgia rheumatica symptoms included pain in shoulder, hips, and knees. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.