Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face, Tinnitus, Tremor, Vertigo
Clinical narrative: woke up with vertigo / room spinning / equilibrium was off because the spinning of the room was so fast /; it takes them hours (3 or 4 hours) to go back to sleep / equilibrium was off because the spinning of the room was so fast; Puffiness in their cheek; some drainage staying under their eye; causes her to have tremors; can't hear because it's so loud / Moderate to severe hearing loss; throwing up; Low pitch tone ringing in the ear / pitch got higher and louder / seemed to go down a little bit; Aches; Sore arms; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (can't hear because it's so loud / Moderate to severe hearing loss) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051(D or 0)224) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Movement disorder (Movement Disorder in neck) and Tremor of hands. Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose) on 24-Feb-2021, Pfizer vaccine (2nd dose) on 05-Mar-2021, Pfizer vaccine (1st booster) on 04-Nov-2021 and Pfizer vaccine (2nd booster) on 12-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Asthma, Drug allergy (Sulfur allergy) and Allergy to antibiotic (Allergy to Vibramycin). Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA) for Asthma, TRIHEXYPHENIDYL for Movement disorder, CLONAZEPAM for Tremor of hands.    On 31-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 31-Oct-2022, the patient experienced MYALGIA (Aches) and PAIN IN EXTREMITY (Sore arms). On 01-Nov-2022, the patient experienced TINNITUS (Low pitch tone ringing in the ear / pitch got higher and louder / seemed to go down a little bit). On an unknown date, the patient experienced DEAFNESS (can't hear because it's so loud / Moderate to severe hearing loss) (seriousness criterion medically significant), VERTIGO (woke up with vertigo / room spinning / equilibrium was off because the spinning of the room was so fast /), INSOMNIA (it takes them hours (3 or 4 hours) to go back to sleep / equilibrium was off because the spinning of the room was so fast), SWELLING FACE (Puffiness in their cheek), EYE DISORDER (some drainage staying under their eye), TREMOR (causes her to have tremors) and VOMITING (throwing up). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, DEAFNESS (can't hear because it's so loud / Moderate to severe hearing loss), TINNITUS (Low pitch tone ringing in the ear / pitch got higher and louder / seemed to go down a little bit), VERTIGO (woke up with vertigo / room spinning / equilibrium was off because the spinning of the room was so fast /), INSOMNIA (it takes them hours (3 or 4 hours) to go back to sleep / equilibrium was off because the spinning of the room was so fast), SWELLING FACE (Puffiness in their cheek), EYE DISORDER (some drainage staying under their eye), TREMOR (causes her to have tremors), MYALGIA (Aches), PAIN IN EXTREMITY (Sore arms) and VOMITING (throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: it's so loud they are scoring moderate and severe for the hearing test (could not hear)..         Treatment medication also reported as Antibiotic and Steroid for the puffiness in their cheek. The patient had rehab exercises and was alone so there were things she could not do.  Company comment: This spontaneous case concerns a 68 year old female with no relevant medical history who experienced the unexpected, serious (medically significant) event of deafness that occurred in the context of receiving a dose of mRNA1273 bivalent BA .4/5 as fifth dose in the COVID-19 vaccine series. Tinnitus and vertigo were reported as additional events in the case and may be in association with deafness. The patient received 4 doses of COVID-19 vaccine Comirnaty (interchange of vaccine products) (revaccination with different COVID-19 vaccine), the latest given approximately 5 months 19 days prior to the current dose of mRNA1273 bivalent BA.4/5. The patient reportedly had low pitch ringing tone in her ears post vaccination. She also complained of having problems with her equilibrium and hearing. The patient eventually consulted a health care provider for the symptoms and underwent hearing test where she was assessed to have moderate to severe hearing loss. Further details on the clinical course and additional treatment were not provided. The patient's elderly age may be considered as a risk factor for deafness, tinnitus and vertigo. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment.   This case was linked to US-MODERNATX, INC.-MOD-2022-675058 (Linked Report).; Sender's Comments: This spontaneous case concerns a 68  year old female with no relevant medical history who experienced the unexpected, serious (medically significant) event of deafness that occurred in the context of receiving a dose of mRNA1273 bivalent BA .4/5 as fifth dose in the COVID-19 vaccine series. Tinnitus and vertigo were reported as additional events in the case and may be in association with deafness. The patient received 4 doses of COVID-19 vaccine Comirnaty (interchange of vaccine products) (revaccination with different COVID-19 vaccine), the latest given approximately 5 months 19 days prior to the current dose of mRNA1273 bivalent BA.4/5. The patient reportedly had low pitch ringing tone in her ears post vaccination. She also complained of having problems with her equilibrium and hearing. The patient eventually consulted a health care provider for the symptoms and underwent hearing test where she was assessed to have moderate to severe hearing loss. Further details on the clinical course and additional treatment were not provided. The patient's elderly age may be considered as a risk factor for deafness, tinnitus and vertigo. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgment. US-MODERNATX, INC.-MOD-2022-675058:Reporter's case