Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Inappropriate schedule of product administration, Injection site pain, Myalgia, Vaccination site lymphadenopathy
Clinical narrative: Received 2nd vaccination 22 days apart; Sore left deltoid; Swelling of the lymph nodes on the same side; Tender axilla; Very very slight tender to touch in the pectoral area; A spontaneous report was received from a 56-year-old male physician who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area and second dose vaccine administered 22 days apart.   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 metoprolol, fish oil, vitamin B, vitamin D3, zinc, vitamin C, turmeric, sertraline, and encapsulated dried fruits and vegetables.   On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient experienced sore left deltoid, swelling of the lymph nodes on the same side, and tender axilla. On 19 Jan 2021, the patient experienced very slight tender to touch in the pectoral area and second dose of vaccine given 22 days after first dose. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273, therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, experienced sore left deltoid, swelling of lymph nodes on the same side, and tender axilla was considered resolved on 30 Dec 2020. The outcome of the events, slight tender to touch in the pectoral area and second dose vaccine given 22 days apart, was considered resolved on 19 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old male patient who experienced second dose vaccine administered 22 days apart (Inappropriate schedule of vaccine administered) and non-serious events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area after the administration of the mRNA-1273 vaccine (Lot # 012L20A., expiration date-unknown).  The events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla occurred the same day after administration of the first dose of the vaccine and event of tender to touch in the pectoral area occurred on the same day after the last dose and 22 days after the first dose.  No treatment was reported, and outcome is resolved for the event of slight tender to touch in the pectoral area. The reported events of sore left deltoid, swelling of lymph nodes on the same side, tender axilla, tender to touch in the pectoral area are consistent with the known safety profile of the vaccine. Hence, based on the information provided a causal association between the administration of mRNA-1273 and the reported events cannot be excluded The event of second dose vaccine administered 22 days apart is considered not applicable.