Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Actively has Covid-19 after first dose), PAIN IN EXTREMITY (Right arm was extremely sore) and VACCINATION SITE MASS (Nickel-sized lump under his skin for 8-9 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Actively has Covid-19 after first dose), PAIN IN EXTREMITY (Right arm was extremely sore) and VACCINATION SITE MASS (Nickel-sized lump under his skin for 8-9 days). At the time of the report, COVID-19 (Actively has Covid-19 after first dose) had not resolved, PAIN IN EXTREMITY (Right arm was extremely sore) outcome was unknown and VACCINATION SITE MASS (Nickel-sized lump under his skin for 8-9 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date. No concomitant medications were reported. No treatment medications were reported. Company comment: This case concerns a 77-year-old male patient with no medical history provided, who experienced non serious unexpected event of special interest - COVID-19, non serious unexpected event of Pain in extremity and non serious expected event of Vaccination site mass. The event occurred after the patient had received the first dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined since the start date of the reported events was not provided. At the time of this report, the event of COVID-19 was ongoing. The event of Vaccination site mass had resolved, while the outcome of the event of Pain in extremity was unknown. No further details regarding the clinical course of the events were provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a 77-year-old male patient with no medical history provided, who experienced non serious unexpected event of special interest - COVID-19, non serious unexpected event of Pain in extremity and non serious expected event of Vaccination site mass. The event occurred after the patient had received the first dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined since the start date of the reported events was not provided. At the time of this report, the event of COVID-19 was ongoing. The event of Vaccination site mass had resolved, while the outcome of the event of Pain in extremity was unknown. No further details regarding the clinical course of the events were provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.