Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Significant injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 degree F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Significant injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and PYREXIA (Mild fever (100.4 to 101.2 degree F)) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Significant injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Significant injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 degree F.         The Subject ID was reported as 5469855.  The Agency Subject ID was reported as 79427-77717.  Concomitant medications were not reported.  Patient had experienced the events anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 13, 2023 and Friday, Dec 14, 2023.  Headache that interfered with activity required repeated use of a nonprescription pain reliever.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 6 out of 49