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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT''s and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter''s Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient''s medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
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