Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Hypoacusis, Migraine, Ocular hyperaemia
Clinical narrative: Red veins in eye whites predominant; 2 types of mild hearing loss/ now some hearing loss; Tinnitus; redness/ flush, like redness, on her body/redness on her face/chest and neck and legs were all red; like I had sunburn all over my body; flush/ the flush appeared on my face & body-chest, neck, everywhere when pressed lightens; Migraine; tachycardia/ high heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), ERYTHEMA (redness/ flush, like redness, on her body/redness on her face/chest and neck and legs were all red), SUNBURN (like I had sunburn all over my body), FLUSHING (flush/ the flush appeared on my face & body-chest, neck, everywhere when pressed lightens) and MIGRAINE (Migraine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M2DA and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 (All test negative.  symptoms of lung COVID) on 15-Mar-2020. Concurrent medical conditions included Postural orthostatic tachycardia syndrome since 2020 and Tinnitus (Tinnitus increased with second dose, about 2 weeks after second Moderna dose) since March 2021. Concomitant products included MAGNESIUM, COLECALCIFEROL (D3), ZINC, VITAMIN C [ASCORBIC ACID] and ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ERYTHEMA (redness/ flush, like redness, on her body/redness on her face/chest and neck and legs were all red), FLUSHING (flush/ the flush appeared on my face & body-chest, neck, everywhere when pressed lightens), MIGRAINE (Migraine) and TACHYCARDIA (tachycardia/ high heart rate). 17-Feb-2021, the patient experienced SUNBURN (like I had sunburn all over my body). On 03-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced OCULAR HYPERAEMIA (Red veins in eye whites predominant) and HYPOACUSIS (2 types of mild hearing loss/ now some hearing loss). On 18-Feb-2021, TACHYCARDIA (tachycardia/ high heart rate) had resolved. At the time of the report, TINNITUS (Tinnitus) had not resolved, ERYTHEMA (redness/ flush, like redness, on her body/redness on her face/chest and neck and legs were all red), SUNBURN (like I had sunburn all over my body) and FLUSHING (flush/ the flush appeared on my face & body-chest, neck, everywhere when pressed lightens) was resolving, MIGRAINE (Migraine) had resolved and OCULAR HYPERAEMIA (Red veins in eye whites predominant) and HYPOACUSIS (2 types of mild hearing loss/ now some hearing loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she stopped all supplements except vitamin D3, but there was no change in flushing and redness. There was some minimal flushing She consulted with an audiologist on an unspecified date, and was told that the mild hearing loss could have been due to inflammation from vaccine and may require surgery. She has a follow up with ENT (ear, nose, throat) doctor on an unspecified date. No treatment information was not provided.   This case was linked to MOD-2021-089491 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Added patient's demographics, physician correspondence, medical history, concomitant medications, events(migraine, ocular hyperemia, hypoacusis and tachycardia). Events outcome updated.; Sender's Comments:  MOD-2021-089491: