Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Moderate malaise/ feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/ Significant injection site tenderness (tenderness during rest); Mild injection site redness; Significant injection site swelling; Moderate fever (101.3 to 102 °F); Severe fatigue with significant interference with activity; Severe muscle pain significantly interfering with activity; Joint pain with some interference with activity; Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting; Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting; 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/ Significant injection site tenderness (tenderness during rest)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Significant injection site swelling) and PYREXIA (Moderate fever (101.3 to 102 °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/ Significant injection site tenderness (tenderness during rest)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Significant injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Severe fatigue with significant interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity), ARTHRALGIA (Joint pain with some interference with activity), NAUSEA (Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting), VOMITING (Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting) 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/ Significant injection site tenderness (tenderness during rest)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Significant injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Severe fatigue with significant interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity), ARTHRALGIA (Joint pain with some interference with activity), NAUSEA (Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting), VOMITING (Mild nausea/ vomiting and no interference with activity or 1-2 episodes of nausea/ vomiting) 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: Moderate fever (101.3 to 102 °F).         No concomitant medication was reported.   Patient had experienced malaise, vaccination site pain (Significant injection site tenderness (tenderness during rest)), vaccination site erythema, significant vaccination site swelling, pyrexia, fatigue, myalgia, arthralgia, vomiting, nausea 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.   The Subject ID was reported.   No other treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 80