Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: States she was in bed due to symptoms from 6pm Saturday until Tuesday night; experiencing nausea that was ongoing for 3-4 days; tinnitus in both ears; States the lymph nodes under armpit are swollen one lymph node is size of golf ball.; severe headache; chills; strong immune response; surrounding tissue is inflamed and swollen; surrounding tissue is inflamed and swollen; her upper left arm swelled; there are red blotches near vaccine site down to palms and hands; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE-MEDIATED ADVERSE REACTION (strong immune response), SWELLING (surrounding tissue is inflamed and swollen), INFLAMMATION (surrounding tissue is inflamed and swollen), PERIPHERAL SWELLING (her upper left arm swelled) and RASH MACULAR (there are red blotches near vaccine site down to palms and hands) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high. Concurrent medical conditions included Menopause and Tinnitus (when blood pressure is elevated it feels like a pulse sensation in ears). Concomitant products included PLANTAGO OVATA FIBRE (FIBER SUPPLEMENT) and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM SUPPLEMENT WITH VITAMIN D) for Menopause.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (strong immune response), SWELLING (surrounding tissue is inflamed and swollen), INFLAMMATION (surrounding tissue is inflamed and swollen), PERIPHERAL SWELLING (her upper left arm swelled), RASH MACULAR (there are red blotches near vaccine site down to palms and hands), TINNITUS (tinnitus in both ears), LYMPHADENOPATHY (States the lymph nodes under armpit are swollen one lymph node is size of golf ball.), HEADACHE (severe headache) and CHILLS (chills). On 20-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (experiencing nausea that was ongoing for 3-4 days). On 20-Nov-2021 at 6:00 PM, the patient experienced BEDRIDDEN (States she was in bed due to symptoms from 6pm Saturday until Tuesday night). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 pills every 6 hours. In November 2021, TINNITUS (tinnitus in both ears), HEADACHE (severe headache), CHILLS (chills) and NAUSEA (experiencing nausea that was ongoing for 3-4 days) had resolved. On 23-Nov-2021, BEDRIDDEN (States she was in bed due to symptoms from 6pm Saturday until Tuesday night) had resolved. At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (strong immune response), SWELLING (surrounding tissue is inflamed and swollen), INFLAMMATION (surrounding tissue is inflamed and swollen), PERIPHERAL SWELLING (her upper left arm swelled), RASH MACULAR (there are red blotches near vaccine site down to palms and hands) and LYMPHADENOPATHY (States the lymph nodes under armpit are swollen one lymph node is size of golf ball.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-396702, MOD-2021-396654 (Patient Link).