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Life Threatening? No
Write-up: death of unknown cause; Swelling on Right side of the neck and under chin; Warmth on right side of neck and under chin; Redness on right side of neck and under chin; A spontaneous report was received from a healthcare professional concerning an 89-year-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced events of redness, warmth and swelling on right side of neck and under chin, and death of unknown cause. The patient''s medical history included Alzheimer''s and chronic obstructive pulmonary disease (COPD). No concomitant medications were reported. On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient experienced the events of redness, warmth and swelling on right side of neck and under chin. There was no indication that the patient was transferred out to hospital, which was unlikely because she was under hospice care. On 01 Jan 2021, the patient died due to an unknown cause of death. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 01 Jan 2020. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter''s Comments: This case concerns a 89-year-old, female subject with a medical history of Alzheimer''s and chronic obstructive pulmonary disease (COPD) who experienced redness, warmth and swelling on R side of neck and under chin and expired from an unknown cause. The events of redness, warmth and swelling on R side of neck and under chin occurred 2 days after administration of the first and only dose of the mRNA-1273 vaccine and patient expired 4 days after mRNA-1273 vaccine administration. Lot # of the vaccine was not provided. De-challenge and re-challenge are not applicable. The events of redness, warmth and swelling on R side of neck and under chin are temporarily associated with the administration of the mRNA-1273 and thus, a causal relationship cannot be excluded. Due to limited information, the fatal outcome was considered unrelated to mRNA-1273 administration pending additional information. Fatal outcome is confounded by the patient''s underlying condition and advanced age.; Reported Cause(s) of Death: Unknown cause of death
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