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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: stroke; feeling exhausted; problems with her eye after the stroke; threw up everything/ vomiting; fever; diarrhea; no energy; dizzy; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis and Common variable immunodeficiency. Concomitant products included ZOLEDRONIC ACID (RECLAST) for Osteoporosis, LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 02-May-2021 at 10:20 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 03-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant), DIARRHOEA (diarrhea), ASTHENIA (no energy), VOMITING (threw up everything/ vomiting) and PYREXIA (fever). On 04-May-2021, the patient experienced EYE DISORDER (problems with her eye after the stroke). On 07-May-2021, the patient experienced FATIGUE (feeling exhausted). The patient was hospitalized from 03-May-2021 to 04-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), DIARRHOEA (diarrhea), ASTHENIA (no energy) and VOMITING (threw up everything/ vomiting) outcome was unknown and DIZZINESS (dizzy), EYE DISORDER (problems with her eye after the stroke), NAUSEA (nauseous), PYREXIA (fever) and FATIGUE (feeling exhausted) had not resolved. Patient gets Immunoglobin infusion for autoimmune disease Common variable immunodeficiency (CVID). At the hospital patient was treated with intravenous medication, blood thinners and she took Ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-106750 (Patient Link).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
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