Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Lethargy, Meniere's disease
Clinical narrative: Meniere's disease; Migraine; Extreme dizziness; Lethargy; Nausea; Fever; Stabbing pain in ears; stabbing pain in neck; Pain that radiated through her body like a jolt of lightning; Ringing in her right ear that will not stop; Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head; This spontaneous case was reported by an other health care professional and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine (well controlled) and Meniere's disease. Concurrent medical conditions included Drug allergy (Bactrim and Augmentin). Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX), IBUPROFEN (ADVIL [IBUPROFEN]), FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE HYDROCHLORIDE;PSEUDOEPHEDRINE HYDROCHLORIDE]), ERENUMAB (AIMOVIG [ERENUMAB]) and VALSARTAN.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head). On 20-Apr-2021, the patient experienced PAIN (Pain that radiated through her body like a jolt of lightning), TINNITUS (Ringing in her right ear that will not stop), EAR PAIN (Stabbing pain in ears) and NECK PAIN (stabbing pain in neck). On 22-Apr-2021, the patient experienced PYREXIA (Fever). On 23-Apr-2021, the patient experienced DIZZINESS (Extreme dizziness), LETHARGY (Lethargy) and NAUSEA (Nausea). On an unknown date, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant) and MIGRAINE (Migraine). At the time of the report, MENIERE'S DISEASE (Meniere's disease) and PYREXIA (Fever) outcome was unknown, MIGRAINE (Migraine), PAIN (Pain that radiated through her body like a jolt of lightning), TINNITUS (Ringing in her right ear that will not stop), EAR PAIN (Stabbing pain in ears), NECK PAIN (stabbing pain in neck) and HEADACHE (Headache so bad, headache lasted 6-18 hours, "ice pick headache, Stabbing pain in head) was resolving and DIZZINESS (Extreme dizziness), LETHARGY (Lethargy) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included migraine cocktail.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea and pyrexia are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache, nausea and pyrexia are consistent with the product safety profile