Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Severe malaise/feeling sick present with significant interference with activity/Severe malaise/feeling sick present with significant interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; Headache and no interference with activity; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Severe malaise/feeling sick present with significant interference with activity/Severe malaise/feeling sick present with significant interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Moderate 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 (Severe malaise/feeling sick present with significant interference with activity/Severe malaise/feeling sick present with significant interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Moderate 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 (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Severe malaise/feeling sick present with significant interference with activity/Severe malaise/feeling sick present with significant interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Moderate 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 (Moderate muscle pain with some interference with activity), ARTHRALGIA (Joint pain with some interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 °F).         No concomitant medications were reported. It was reported that the patient had experienced Moderate injection site pain interfering with activity, Mild injection site tenderness (tender to touch), Moderate injection site redness, Mild injection site swelling, Mild fever, Moderate fatigue with some interference with activity, Severe malaise/feeling sick present with significant interference with activity, Moderate muscle pain with some interference with activity, Joint pain with some interference with activity, Headache and no interference with activity anytime during the 2 days after your COVID-19 vaccination, which occurred Tuesday, 12-Dec-2023 and Wednesday, 13-Dec-2023.  No treatment medications were reported.  The Subject ID was reported as: 36196-58009. The Agency Subject ID was reported as: 5469878.   This case was linked to US-MODERNATX, INC.-MOD-2024-756143, US-MODERNATX, INC.-MOD-2024-756144, US-MODERNATX, INC.-MOD-2024-756147, US-MODERNATX, INC.-MOD-2024-756150, US-MODERNATX, INC.-MOD-2024-756159, US-MODERNATX, INC.-MOD-2024-756182, US-MODERNATX, INC.-MOD-2024-756181, US-MODERNATX, INC.-MOD-2024-756189, US-MODERNATX, INC.-MOD-2024-756191, US-MODERNATX, INC.-MOD-2024-756194, US-MODERNATX, INC.-MOD-2024-756197, US-MODERNATX, INC.-MOD-2024-756199, US-MODERNATX, INC.-MOD-2024-756205, US-MODERNATX, INC.-MOD-2024-756210, US-MODERNATX, INC.-MOD-2024-756216, US-MODERNATX, INC.-MOD-2024-756221, US-MODERNATX, INC.-MOD-2024-756244, US-MODERNATX, INC.-MOD-2024-756264, US-MODERNATX, INC.-MOD-2024-756259, US-MODERNATX, INC.-MOD-2024-756265, US-MODERNATX, INC.-MOD-2024-756280, US-MODERNATX, INC.-MOD-2024-756284, US-MODERNATX, INC.-MOD-2024-756283, US-MODERNATX, INC.-MOD-2024-756281, US-MODERNATX, INC.-MOD-2024-756173, US-MODERNATX, INC.-MOD-2024-756240, US-MODERNATX, INC.-MOD-2024-756179, US-MODERNATX, INC.-MOD-2024-756184, US-MODERNATX, INC.-MOD-2024-756206, US-MODERNATX, INC.-MOD-2024-756243, US-MODERNATX, INC.-MOD-2024-756217, US-MODERNATX, INC.-MOD-2024-756246, US-MODERNATX, INC.-MOD-2024-756227, US-MODERNATX, INC.-MOD-2024-756247, US-MODERNATX, INC.-MOD-2024-756249, US-MODERNATX, INC.-MOD-2024-756230, US-MODERNATX, INC.-MOD-2024-756250, US-MODERNATX, INC.-MOD-2024-756233, US-MODERNATX, INC.-MOD-2024-756251, US-MODERNATX, INC.-MOD-2024-756238, US-MODERNATX, INC.-MOD-2024-756252, US-MODERNATX, INC.-MOD-2024-756241, US-MODERNATX, INC.-MOD-2024-756255, US-MODERNATX, INC.-MOD-2024-756269, US-MODERNATX, INC.-MOD-2024-756267, US-MODERNATX, INC.-MOD-2024-756282, US-MODERNATX, INC.-MOD-2024-756270, US-MODERNATX, INC.-MOD-2024-756272 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756159:Patient 10 out of 49 US-MODERNATX, INC.-MOD-2024-756143:Patient 6 out of 49 US-MODERNATX, INC.-MOD-2024-756150:Patient 9 out of 49 US-MODERNATX, INC.-MOD-2024-756144:Patient 7 out of 49 US-MODERNATX, INC.-MOD-2024-756147:Patient 8 out of 49 US-MODERNATX, INC.-MOD-2024-756265:Patient 38 out of 49 US-MODERNATX, INC.-MOD-2024-756205:Pateint 46 out of 49 US-MODERNATX, INC.-MOD-2024-756283:Patient 25 out of49 US-MODERNATX, INC.-MOD-2024-756284:Patient 26 out of 87 US-MODERNATX, INC.-MOD-2024-756221:Pateint 49 out of 49 US-MODERNATX, INC.-MOD-2024-756197:Pateint 45 out of 49 US-MODERNATX, INC.-MOD-2024-756280:Patient 61 out of 87 US-MODERNATX, INC.-MOD-2024-756181:Patient 43 out of 49 US-MODERNATX, INC.-MOD-2024-756189:Patient 3 US-MODERNATX, INC.-MOD-2024-756199:Patient 5 US-MODERNATX, INC.-MOD-2024-756194:Patient 4 US-MODERNATX, INC.-MOD-2024-756281:Patient 23 out of 49 US-MODERNATX, INC.-MOD-2024-756259:Patient 36 out of 49 US-MODERNATX, INC.-MOD-2024-756264:Patient 37 out of 49 US-MODERNATX, INC.-MOD-2024-756210:Pateint 47 out of 49 US-MODERNATX, INC.-MOD-2024-756191:Pateint 44 out of 49 US-MODERNATX, INC.-MOD-2024-756216:Pateint 48 out of 49 US-MODERNATX, INC.-MOD-2024-756182:Patient 2 US-MODERNATX, INC.-MOD-2024-756244:Pateint 21 out of 49 US-MODERNATX, INC.-MOD-2024-756255:Patient 35 US-MODERNATX, INC.-MOD-2024-756179:Patient no 12 US-MODERNATX, INC.-MOD-2024-756240:Patient no. 27 US-MODERNATX, INC.-MOD-2024-756272:Patient no 42 US-MODERNATX, INC.-MOD-2024-756247:Patient 30 US-MODERNATX, INC.-MOD-2024-756241:Patient no 20 US-MODERNATX, INC.-MOD-2024-756251:Patient 33 US-MODERNATX, INC.-MOD-2024-756173:Patient no 11 US-MODERNATX, INC.-MOD-2024-756243:Patient no. 28 US-MODERNATX, INC.-MOD-2024-756250:Patient 32 US-MODERNATX, INC.-MOD-2024-756249:Patient 31 US-MODERNATX, INC.-MOD-2024-756270:Patient no 41 US-MODERNATX, INC.-MOD-2024-756282:Patient 24 out of 49 US-MODERNATX, INC.-MOD-2024-756269:Patient no 40 US-MODERNATX, INC.-MOD-2024-756238:Patient no 20 US-MODERNATX, INC.-MOD-2024-756233:Patient no 18 US-MODERNATX, INC.-MOD-2024-756230:Patient no 17 US-MODERNATX, INC.-MOD-2024-756227: US-MODERNATX, INC.-MOD-2024-756267:Patient no 39 US-MODERNATX, INC.-MOD-2024-756206:Patient no 14 US-MODERNATX, INC.-MOD-2024-756184:Patient no 13 US-MODERNATX, INC.-MOD-2024-756252:Patient 34 US-MODERNATX, INC.-MOD-2024-756217:Patient no 15 US-MODERNATX, INC.-MOD-2024-756246:Patient 29