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Life Threatening? No
Write-up: testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain. The patient''s medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C. On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, patient experienced fever for 3 hours after vaccination. The patient also experienced headache, joint pain, and severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down. Treatment information was not provided. Follow-up received on 21 Feb 2021, from the patient''s husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021. The patient never recovered from her symptoms and the patient died on 02 Feb 2021. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown. The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter''s Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID
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