Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch; really tired; big knot where the shot was administered; area itched like crazy; soreness in arm; bad headache in the front part of head; gets whoozy; brain fog / missing words; Stress; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch), DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words) and STRESS (Stress) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus. Concurrent medical conditions included Gastritis. Concomitant products included TRAZODONE for Sleep disorder due to a general medical condition, THYROID (ARMOUR THYROID), ZINC, MAGNESIUM, CALCIUM, FLUOXETINE HYDROCHLORIDE (PROZAC) and VITAMIN C [ASCORBIC ACID] for an unknown indication, VITAMIN D NOS and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE, SODIUM BICARBONATE (PEPPERMINT INDIGESTION).   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words), STRESS (Stress) and HEADACHE (bad headache in the front part of head). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), VACCINATION SITE MASS (big knot where the shot was administered) and VACCINATION SITE PRURITUS (area itched like crazy). On 18-Apr-2021, the patient experienced TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch) and FATIGUE (really tired). At the time of the report, PAIN IN EXTREMITY (soreness in arm), TINNITUS (tinnitus seemed to be louder / tinnitus had an additional layer of sound / tinnitus kicked up and is nonstop / now getting a high pitch joined in the whishing and sometimes a low pitch), DIZZINESS (gets whoozy), FEELING ABNORMAL (brain fog / missing words), STRESS (Stress), VACCINATION SITE MASS (big knot where the shot was administered), VACCINATION SITE PRURITUS (area itched like crazy), FATIGUE (really tired) and HEADACHE (bad headache in the front part of head) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient Has inflammation in the intestines. Patient is on a low fodmap diet for food triggers and lactose is one of the triggers.  No treatment information was provided  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-089247, US-MODERNATX, INC.-MOD-2021-089281 (E2B Linked Report). This case was linked to MOD-2021-089264 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089247: US-MODERNATX, INC.-MOD-2021-089281: