Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Mild muscle 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) and PYREXIA (Mild fever (100.4 to 101.2 °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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle 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 °F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.   Patient had experienced malaise, vaccination site pain, vaccination site erythema, vaccination site swelling, pyrexia, fatigue, myalgia and headache (that interfered with activity OR required repeated use of a nonprescription pain reliever) anytime during the 2 days after COVID-19 vaccination, which occurred on Wednesday, 20-Dec-2023 and Thursday, 21-Dec-2023.  The Subject ID was reported as 5472042.   The Agency Subject ID was reported as 32028-91450.   No other treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case