Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Central nervous system inflammation, Migraine, Tinnitus
Clinical narrative: Tinnitus/tinnitus worsened/The vaccine triggered chronic tinnitus; Migraines/Migraines worsened/The vaccine triggered migraines; Neuroinflammation; Contracted COVID-19/Subsequent infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TINNITUS (Tinnitus/tinnitus worsened/The vaccine triggered chronic tinnitus), MIGRAINE (Migraines/Migraines worsened/The vaccine triggered migraines) and CENTRAL NERVOUS SYSTEM INFLAMMATION (Neuroinflammation) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Tozinameran (Comirnaty) for an unknown indication.    The patient's past medical history included Headache (Few migraines). Concurrent medical conditions included Tinnitus (Tinnitus briefly earlier in the year prior to the first Moderna vaccine.) and Migraine (Few migraines).   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and second dose of Tozinameran (Comirnaty) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus/tinnitus worsened/The vaccine triggered chronic tinnitus) (seriousness criterion disability), MIGRAINE (Migraines/Migraines worsened/The vaccine triggered migraines) (seriousness criterion disability), CENTRAL NERVOUS SYSTEM INFLAMMATION (Neuroinflammation) (seriousness criterion medically significant) and COVID-19 (Contracted COVID-19/Subsequent infection). At the time of the report, TINNITUS (Tinnitus/tinnitus worsened/The vaccine triggered chronic tinnitus) and MIGRAINE (Migraines/Migraines worsened/The vaccine triggered migraines) had not resolved and CENTRAL NERVOUS SYSTEM INFLAMMATION (Neuroinflammation) and COVID-19 (Contracted COVID-19/Subsequent infection) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered TINNITUS (Tinnitus/tinnitus worsened/The vaccine triggered chronic tinnitus) and MIGRAINE (Migraines/Migraines worsened/The vaccine triggered migraines) to be related. No further causality assessments were provided for CENTRAL NERVOUS SYSTEM INFLAMMATION (Neuroinflammation) and COVID-19 (Contracted COVID-19/Subsequent infection).    Concomitant medication was not provided. Patient received a Moderna vaccine during the first roll out. The vaccine triggered chronic tinnitus and migraines that have continued, and she was classified as having a persistent disability (tinnitus) and permanent disability (migraines). She contracted Covid over a year following Moderna vaccine and a Pfizer booster, the tinnitus and migraines worsened. Within the span of about one and half years, there was an onset of severe tinnitus and migraines with the Moderna vaccine (stage 1), which worsened when she contracted Covid (stage 2), and the tinnitus and migraines had remained at that baseline to this date. Over time, her neurologist determined the cause as neuroinflammation related to the initial vaccine and subsequent infection.  Treatment information was not reported. Reporter believed that the reaction was likely due to the higher dose compared to Pfizer. Subsequent doses of the Pfizer vaccine did not bump her tinnitus and migraines higher.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2024: Live follow-up received and updated references.; Reporter's Comments: Company comment: The medical history of Headache and Tinnitus, and event COVID-19 could be confounders for the events. The benefit-risk relationship of product is not affected by this report.