Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Didn't feel good), SOMNOLENCE (Fell asleep all day), PERIPHERAL SWELLING (Arm was swollen), PAIN IN EXTREMITY (Arm was sore) and FEELING ABNORMAL (Kept feeling worse and worse after 1st dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Didn't feel good) and SOMNOLENCE (Fell asleep all day). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Arm started itching at the injection site). On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN (Burning at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). On an unknown date, the patient experienced FEELING ABNORMAL (Kept feeling worse and worse after 1st dose) and FATIGUE (Patient experienced fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 10-Mar-2021, SOMNOLENCE (Fell asleep all day) had resolved. On 11-Mar-2021, MALAISE (Didn't feel good) had resolved. On 12-Mar-2021, PERIPHERAL SWELLING (Arm was swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), FEELING ABNORMAL (Kept feeling worse and worse after 1st dose), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Arm started itching at the injection site), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN (Burning at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and FATIGUE (Patient experienced fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. The patient post receiving their first dose didn't feel good after they went home. The patient fell asleep all day and their arm were sore on the second day for a couple of days. Their arm also started itching at the injection site and later they noticed their injection site was red and was a red rash, burning, hot, and itching.  On 08-May-2021, the patient reported that their arm was also swollen and experienced fatigue as well post receiving the first dose of vaccine. Reportedly, the patient informed that they won't take the 2nd dose as their doctor suggested and reported that they kept feeling worse and worse after the 1st dose. No Concomitant product use was reported. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up information was received on 09 May 2021. Added additional events arm was swollen, kept feeling worse and worse and fatigue. Updated the action taken of the suspect drug and updated the event description.