Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tinnitus is so loud, more on the left than the right; Felt achy; Headache; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (Tinnitus is so loud, more on the left than the right), MYALGIA (Felt achy) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006A21A, 052E21A, 030M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Migraine, Vertigo and COVID-19 on 12-Jan-2022. Previously administered products included for Product used for unknown indication: Influenza vaccine in September 2021. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Latex allergy, Drug allergy (NSAIDs allergy), Iodine allergy, Food allergy (Food allergies), Tinnitus (Mild Tinnitus for close to 10 yrs., recent change in status reported as worse tinnitus) and Immunocompromised (had been receiving IgG for many years).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced TINNITUS (Tinnitus is so loud, more on the left than the right). 02-May-2022, the patient experienced MYALGIA (Felt achy) and HEADACHE (Headache). On 03-May-2022, MYALGIA (Felt achy) and HEADACHE (Headache) had resolved. At the time of the report, TINNITUS (Tinnitus is so loud, more on the left than the right) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient stated that the patient was immunocompromised because the patient had been receiving IgG for many years. The patient's immunologist wanted the patient to wait until this week to get the booster. The patient took the second booster and had minimal side effects. The patient had headaches and felt achy, but it only lasted 24 hours. The patient stated the patient had mild tinnitus for close to 10 years, but the patient had grown accustomed to it.  After 6 hours of taking the vaccine, the patient's tinnitus was so loud, that the patient could not tell if the patient was yelling or talking, and it was driving the patient insane. It was more on the left than the right.  The patient stated that the patient had not yet seeked medical care for the AE caused and the patient had experienced a similar event in the past. Reportedly, the patient said their symptoms had worsened.  The patient's height reported as 5 feet 2 inch.  No treatment information was provided.   This case was linked to MOD-2022-560535 (Patient Link).