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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: A Regulatory Authority report was received from a pharmacist for a 78 year old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and who experienced fatigue, nausea, vomiting, and decreased oral intake (hypophagia). The patient''s medical history included cerebrovascular accident, type 2 diabetes mellitus, urinary tract infection, alzheimer''s dementia, and plasma cell myeloma. The concomitant medications included clopidogrel, nortriptyline, calcium carbonate, amlodipine, paracetamol, hydroxocobalamine, clobetasol, fosinopril, metformine [metformin], nitrofurantoine, brimonidine tartrate timolol maleate and oxazepam. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 30042721) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-2021, one day after receiving the vaccine, the patient experienced fatigue, nausea and vomiting. A SARS-CoV-2 test was performed which was negative. On a date not reported, the patient experienced decreased oral intake. The patient died on 18 Feb 2021. The cause of death was reported as nausea and decreased oral intake. No autopsy was performed. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the events nausea, vomiting, and decreased oral intake was fatal and the outcome for the event of fatigue was unknown. On 11Mar2021, follow up information was received which provided cause of death as decreased oral intake with no autopsy performed. A SARS-CoV-2 test was performed on 12Feb2021 which was negative.; Reporter''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. However, the patient''s comorbidities may confound causality assessment. This case concerns a 78-year-old female who experienced serious unexpected events of fatigue, nausea, vomiting. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. As above, a causal relationship cannot be excluded.
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