Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Pruritus, Vaccination site erythema
Clinical narrative: Insomnia; Chest pain; arm was burning; whole area of the muscle part is swollen; tenderness/soreness in the arm; pain down the armpits; Headache; muscle part was hot; itching; Rash on the muscle part; still feeling dizzy/lightheadedness; red on the muscle part; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (muscle part was hot), PRURITUS (itching), VACCINATION SITE RASH (Rash on the muscle part), DIZZINESS (still feeling dizzy/lightheadedness) and VACCINATION SITE ERYTHEMA (red on the muscle part) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM from 01-Jan-2018 to an unknown date for Bone loss, ACETYLSALICYLIC ACID (LOW DOSE ASPIRIN) from 01-Jan-2018 to an unknown date for Cardiac disorder, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) from 04-Apr-2021 to an unknown date for Eye disorder, 10 STRAIN PROBIOTIC from 01-Jan-2021 to an unknown date for Gastric disorder, LISINOPRIL from 01-Jan-2018 to an unknown date, CARVEDILOL from 01-Jan-2018 to an unknown date, RABEPRAZOLE from 01-Jan-2018 to an unknown date, GEMFIBROZIL from 01-Aug-2016 to an unknown date and BERBERINE, SUCRALFATE (SUCRALFATE AND BERBERINE) from 01-Apr-2021 to an unknown date for an unknown indication.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE WARMTH (muscle part was hot), PRURITUS (itching), VACCINATION SITE RASH (Rash on the muscle part), DIZZINESS (still feeling dizzy/lightheadedness), VACCINATION SITE ERYTHEMA (red on the muscle part) and NAUSEA (Nausea). On 06-Sep-2021, the patient experienced INSOMNIA (Insomnia), CHEST PAIN (Chest pain), BURNING SENSATION (arm was burning), VACCINATION SITE SWELLING (whole area of the muscle part is swollen), VACCINATION SITE PAIN (tenderness/soreness in the arm), AXILLARY PAIN (pain down the armpits) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Burning sensation, at a dose of 1 dosage form; PARACETAMOL (TYLENOL [PARACETAMOL]) for Rash, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (muscle part was hot), PRURITUS (itching), VACCINATION SITE RASH (Rash on the muscle part), DIZZINESS (still feeling dizzy/lightheadedness), VACCINATION SITE ERYTHEMA (red on the muscle part), NAUSEA (Nausea), INSOMNIA (Insomnia), CHEST PAIN (Chest pain), BURNING SENSATION (arm was burning), VACCINATION SITE SWELLING (whole area of the muscle part is swollen), VACCINATION SITE PAIN (tenderness/soreness in the arm), AXILLARY PAIN (pain down the armpits) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE WARMTH (muscle part was hot), PRURITUS (itching), VACCINATION SITE RASH (Rash on the muscle part), DIZZINESS (still feeling dizzy/lightheadedness), VACCINATION SITE ERYTHEMA (red on the muscle part) and NAUSEA (Nausea) to be possibly related. No further causality assessments were provided for INSOMNIA (Insomnia), CHEST PAIN (Chest pain), BURNING SENSATION (arm was burning), VACCINATION SITE SWELLING (whole area of the muscle part is swollen), VACCINATION SITE PAIN (tenderness/soreness in the arm), AXILLARY PAIN (pain down the armpits) and HEADACHE (Headache).    Onn 09-Sep-2021, the physician treated the symptoms by putting a warm towel at the site of vaccination and the patient got a Benadryl shot and was prescribed with a steroid. The patient was given another Benadryl shot on 10-Sep-2021. The patient was still having symptoms and not been recovering well and the patient had to visit the primary physician. The physician continued to check the patient on Sundays.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Significant follow up Appended : Event start dates and reporter causality updated