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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Acute pericarditis; Soreness on the left shoulder (injection site); A spontaneous report was received from a consumer who was also a 75-years-old, male patient, who received Moderna''s COVID-19 Vaccine (mRNA-1273) and who experienced soreness on the left shoulder (injection site)/ injection site soreness and acute pericarditis/ pericarditis. The patient''s medical history was not provided. Concomitant medications were not reported. On 16 Jan 2021, seven days prior to onset of the events, the patient received their first two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for the prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient experienced soreness on the left shoulder (injection site), tiredness, headache, and chest pain. On 02 Feb 2021, he had difficulty breathing even with his continuous positive airway pressure (CPAP) machine and called 911. He was taken to emergency room (ER) and was diagnosed with acute pericarditis. Treatment included ibuprofen, pantoprazole, and colchicine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, soreness on the left shoulder (injection site and acute pericarditis, was not reported.; Reporter''s Comments: This case concerns a 75 year old male subject, who experienced a serious unexpected event of Pericarditis and a non-serious expected event of injection site pain after first dose of mRNA1273 (Lot# 039K20A). Very limited information has been provided regarding the event of pericarditis at this time. Further information has been requested.
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