Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypoacusis, Tinnitus
Clinical narrative: with the most recent bivalent booster, she has ringing in both ears; reduces my hearing, it was real loud loud and is affecting her hearing; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (with the most recent bivalent booster, she has ringing in both ears) and HYPOACUSIS (reduces my hearing, it was real loud loud and is affecting her hearing) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot (2 weeks before Moderna bivalent) in 2022. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood cholesterol abnormal, Macular degeneration (status such as improvement or worsening was reported as Stable.) since 2019, Drug allergy (allergy to Meloxicam) and Fruit allergy (allergy to Blueberries). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol abnormal, BEVACIZUMAB for Macular degeneration, LEVOTHYROXINE SODIUM (SYNTHROID) and TRETINOIN for an unknown indication.    On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced TINNITUS (with the most recent bivalent booster, she has ringing in both ears) and HYPOACUSIS (reduces my hearing, it was real loud loud and is affecting her hearing). At the time of the report, TINNITUS (with the most recent bivalent booster, she has ringing in both ears) and HYPOACUSIS (reduces my hearing, it was real loud loud and is affecting her hearing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal at 118/75.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient received the dose number one of Moderna on 29-Jan-2021 (Dose: 0.5 mL and Lot number: 010M20A). The patient received the dose number two of Moderna on 26-Feb-2021 (Dose: 0.5 mL and Lot number: 013A21A). The patient received the dose number three of Moderna on 26-Oct-2021 (Lot number: 939904). The patient received the dose number four of Moderna on 11-May-2022 (Expiration date: 02-Jun-2022and Lot number: 004M21A). It was reported that after each shot, she has experienced ringing in her ears, which she never had before. She states that when the vaccine starts to wear off, the ringing in her ears stop. With the first 4 doses, the ringing was only in one ear. But with the most recent bivalent booster, she has ringing in both ears. After her 4th dose, the ringing in her ears lasted for about 4 months and it was very loud. It started getting better, but the tinnitus came right back after she got the bivalent booster on 14-OCT-2022. This time it was really loud and was affecting her hearing. She read online that ringing could be caused due to high blood pressure but her most recent blood pressure was normal at 118/75. She also read that dehydration could be a cause, but she said that she drinks a lot of water so it cannot be that. patient not had COVID positive test or diagnosis. Recent change in status such as improvement or worsening: Stable Patient had been to the hearing doctor for her symptoms. The patient did not experience a similar event in the past. The outcome was reported as ongoing, reduces her hearing. The symptoms Improves over time between each shot, but came back whenever she gets another Moderna shot. No treatment medications were reported.   This case was linked to MOD-2022-661336, MOD-2022-661339 (Patient Link).