Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus in her right ear/Pulsatile Tinnitus; tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.; heart rate fluctuations; hand cramps; bloody eyes; insomnia; two panic attacks due to this situation; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus), SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps) and OCULAR HYPERAEMIA (bloody eyes) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Dust allergy and Allergy to plants (Allery to olive trees). Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for Birth control, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Multiple allergies, ASCORBIC ACID (VIT C), VITAMIN B NOS and MAGNESIUM for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 experienced TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus), SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus) had not resolved and SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (Tinnitus in her right ear/Pulsatile Tinnitus) to be possibly related. No further causality assessments were provided for SLEEP DISORDER (tinnitus on her right ear since 4 months ago which ,volume is still high,and was causing her sleeping issues.), HEART RATE IRREGULAR (heart rate fluctuations), MUSCLE SPASMS (hand cramps), OCULAR HYPERAEMIA (bloody eyes), INSOMNIA (insomnia) and PANIC ATTACK (two panic attacks due to this situation).    Concomitant medication included supplements. The patient visited urgent care twice, and had checked with the primary physician and ear, nose, throat specialist (ENT). The patient was prescribed with prescriptions for allergies (Zyrtec and Flunase) but it did not work.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow-up information received. Added medical history, events, concomitant medications, updated reporter causality of tinnitus