Sex: U
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Malaise, Myalgia, Nausea, Pyrexia
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; Significant fever (> 102 °F); Moderate injection site swelling; Severe fatigue with significant interference with activity; Joint pain with some interference with activity; Moderate muscle pain with some interference with activity; Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting; Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting; Headache that prevented daily activity OR required any use of a prescription pain  reliver; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), INJECTION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Significant fever (> 102 °F)) and INJECTION SITE SWELLING (Moderate injection site swelling) 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), INJECTION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Significant fever (> 102 °F)), INJECTION SITE SWELLING (Moderate injection site swelling), FATIGUE (Severe fatigue with significant interference with activity), ARTHRALGIA (Joint pain with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting), VOMITING (Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain  reliver). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), INJECTION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), INJECTION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Significant fever (> 102 °F)), INJECTION SITE SWELLING (Moderate injection site swelling), FATIGUE (Severe fatigue with significant interference with activity), ARTHRALGIA (Joint pain with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting), VOMITING (Moderate nausea/vomiting and some interference with activity or greater than 2  episodes of nausea/vomiting) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain  reliver) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2023, Body temperature: Significant fever (> 102 °F).         Concomitant product use was not provided by the reporter. Treatment information was not provided.  All the events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred Saturday 23-Dec-2023 and Sunday 24-Dec-2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter