Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Tinnitus
Clinical narrative: then I feel warmth in my ear; condition aggravated; Persistent side effect of Nausea; Migraine; Frontal headache; Ringing in ears more on left ear/pattern feel is some ringing on ear; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear), FEELING HOT (then I feel warmth in my ear), MIGRAINE (Migraine), CONDITION AGGRAVATED (condition aggravated) and HEADACHE (Frontal headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Open angle glaucoma since 04-Aug-2018, Penicillin allergy, Sulfonamide allergy (sulfa allergy) and Drug allergy (Erythromycin allergy). Concomitant products included LATANOPROST (XALATAN) from 04-Aug-2018 to an unknown date for Open angle glaucoma.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear). 27-Mar-2021, the patient experienced HEADACHE (Frontal headache). On 14-Jul-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced FEELING HOT (then I feel warmth in my ear), CONDITION AGGRAVATED (condition aggravated) and NAUSEA (Persistent side effect of Nausea). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at a dose of UNK, bid; METHYLPREDNISOLONE from 20-Apr-2021 to 23-Apr-2021 for Frontal headache, at a dose of 4 milligram; NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLIN) on 04-May-2021 for Tinnitus, at a dose of 25 milligram and VENLAFAXINE HCL on 14-Mar-2021 at a dose of 37.5 milligram once. At the time of the report, TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear), MIGRAINE (Migraine) and HEADACHE (Frontal headache) had not resolved and FEELING HOT (then I feel warmth in my ear), CONDITION AGGRAVATED (condition aggravated) and NAUSEA (Persistent side effect of Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Acoustic stimulation tests: normal (normal) No auditory cause for tinnitus. ENT specialist suggested seeking help from headache clinic.. On 12-Mar-2021, Computerised tomogram: negative (Negative) CT scan done at radiology office. On 14-Apr-2021, Fibrin D dimer: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 : Patient demographics like body weight, race, ethnicity, lab tests, Medical history were added , concomitant medication and treatment medication were  added,New event  Migraine was added. On 14-Jul-2021: Follow up received on 14-JUL-2021:event Migraine  outcome was updated to Not recovered.