Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Malaise, Nausea, Neuritis
Clinical narrative: severe immune response effecting the vestibular system; severe immune response effecting the vestibular system/vestibular neuritis; Overall malaise; ringing in both ears; ragging headache; fever; chills; nausea; hypersomnia from 7-jan-2021 to 9-jan-2021; fatigue/ haven't been able to drive or work since; heaviness; dizziness; vestibular neuritis; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (severe immune response effecting the vestibular system) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (esterase induced.) since 1970 and Drug allergy (Sulfa, PCN). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, ESTRADIOL (ESTRACE) for Hormone replacement therapy, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Reflux gastritis, VITAMIN D NOS for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced NEURITIS (vestibular neuritis), HEAD DISCOMFORT (heaviness), DIZZINESS (dizziness) and FATIGUE (fatigue/ haven't been able to drive or work since). On 07-Jan-2021, the patient experienced HYPERSOMNIA (hypersomnia from 7-jan-2021 to 9-jan-2021), HEADACHE (ragging headache), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). On 08-Jan-2021, the patient experienced TINNITUS (ringing in both ears). On 09-Jan-2021, the patient experienced MALAISE (Overall malaise). On 26-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (severe immune response effecting the vestibular system) (seriousness criterion medically significant) and VIIITH NERVE INJURY (severe immune response effecting the vestibular system/vestibular neuritis). The patient was treated with Rehabilitation therapy for Anaphylactic reaction and Rehabilitation therapy for VIIIth nerve injury. On 09-Jan-2021, HYPERSOMNIA (hypersomnia from 7-jan-2021 to 9-jan-2021) and PYREXIA (fever) had resolved. At the time of the report, ANAPHYLACTIC REACTION (severe immune response effecting the vestibular system), VIIITH NERVE INJURY (severe immune response effecting the vestibular system/vestibular neuritis), NEURITIS (vestibular neuritis), TINNITUS (ringing in both ears), HEAD DISCOMFORT (heaviness), DIZZINESS (dizziness), MALAISE (Overall malaise), HEADACHE (ragging headache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue/ haven't been able to drive or work since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10 Jan 2021 visited Dr. prescribed with antivert and steroids, no improvement prescribed antibiotics and referred to ENT. ENT diagnosed severe immune response to Moderna vaccine effecting the vestibular septum. Started rehab therapy for 2 weeks. Conducted a VNG (Videonystagmography) test ,She was diagnosed with vestibular neuritis secondary to the COVID 19 vaccine. Treatment medication included shot of solumedrol, Zpack, Medrol dose pack.  Company Comment: This case concerns a 57-year-old female with a serious expected event of anaphylactic reaction, and nonserious unexpected VIIIth nerve injury, neuritis, tinnitus, head discomfort, dizziness, hypersomnia, malaise, and expected pyrexia, chills, headache, nausea. Event latency 21 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21 Apr 2021,Sig FU/ Events added, concomitant medications added, patient demographics updated.; Sender's Comments: This case concerns a 57-year-old female with a serious expected event of anaphylactic reaction, and nonserious unexpected VIIIth nerve injury, neuritis, tinnitus, head discomfort, dizziness, hypersomnia, malaise, and expected pyrexia, chills, headache, nausea. Event latency 21 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.