Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm; Swollen arm; He developed lymphadenopathy; Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm) and VACCINATION SITE PAIN (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (Dose 2 (primary series)) and Moderna Covid-19 vaccine (Dose 1 (primary series)). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm) (seriousness criterion medically significant), VACCINATION SITE PAIN (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (He developed lymphadenopathy). At the time of the report, VACCINATION SITE SWELLING (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm), PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (He developed lymphadenopathy) had resolved and VACCINATION SITE PAIN (Patient developed a serious COVID arm, characterized by swelling and painfulness of the arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 08-NOV-2023, it was reported that a patient started treatment on an unreported date with Moderna COVID-19 vaccine dose 1 and dose 2 primary series and dose 3 as a booster for COVID-19 vaccination.  Treatment information was not reported.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) event of vaccination site pain and vaccination site swelling and non serious events of peripheral swelling and lymphadenopathy. The events occurred after the third dose of SPIKEVAX 2023-2024. As reported, after dose 3, the patient developed a serious 'COVID arm,' characterized by swelling and painfulness of the arm. He developed lymphadenopathy and swollen arms, and it lasted for 8 months. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.