Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hypoacusis, Illness, Myalgia
Clinical narrative: sick for few days; Fever; Hearing loss; both ears became blocked; I did not have good hearing/I am not hearing as well/my hearing has been blocked; When I was lying on my side my left ear would flutter and make noise; when she lays on the right side of the body her left ear flutters; Head strain; Achy all over; Upset stomach; Dry mouth; Hot and cold; Dehydrated; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lactose intolerant. Concomitant products included FERROUS SULFATE (IRON NATURE MADE) from 01-Jan-2018 to an unknown date for Anemic, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2018 to an unknown date for Dry eyes, CALCIUM from 01-Jan-2018 to an unknown date for Lactose intolerance, MULTIVITAMINS [VITAMINS NOS] from 01-Jan-2018 to an unknown date for an unknown indication.   On 23-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DRY MOUTH (Dry mouth), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DEHYDRATION (Dehydrated), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Achy all over). On 01-Jun-2021, the patient experienced EAR CONGESTION (both ears became blocked), HYPOACUSIS (I did not have good hearing/I am not hearing as well/my hearing has been blocked), TINNITUS (When I was lying on my side my left ear would flutter and make noise), EAR DISCOMFORT (when she lays on the right side of the body her left ear flutters) and HEADACHE (Head strain). On 28-Jun-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (sick for few days) and PYREXIA (Fever). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) from 08-Jun-2021 to 15-Jun-2021 for Adverse event, at a dose of UNK, tid; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) from 18-Jun-2021 to 25-Jun-2021 for Adverse event, at a dose of UNK, qd; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) from 18-Jun-2021 to 25-Jun-2021 for Adverse event, at a dose of UNK, qd; IBUPROFEN (ADVIL [IBUPROFEN]) from 14-Jul-2021 to 20-Jul-2021 for Adverse event, at a dose of 600 mg three times a day; PHENYLEPHRINE HYDROCHLORIDE (SYNEPHRINE [PHENYLEPHRINE HYDROCHLORIDE]) (nasal) from 05-Aug-2021 to 07-Aug-2021 for Adverse event, at a dose of UNK, tid and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) from 09-Sep-2021 to 11-Sep-2021 for Adverse event, at a dose of UNK, tid. On 24-May-2021, ABDOMINAL DISCOMFORT (Upset stomach), DRY MOUTH (Dry mouth), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DEHYDRATION (Dehydrated), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (Achy all over) had resolved. At the time of the report, DEAFNESS (Hearing loss), EAR CONGESTION (both ears became blocked), HYPOACUSIS (I did not have good hearing/I am not hearing as well/my hearing has been blocked), TINNITUS (When I was lying on my side my left ear would flutter and make noise) and EAR DISCOMFORT (when she lays on the right side of the body her left ear flutters) had not resolved and ILLNESS (sick for few days), PYREXIA (Fever) and HEADACHE (Head strain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Nasoendoscopy: normal (normal) normal. On 28-Jun-2021, Acoustic stimulation tests: abnormal (abnormal) Hearing loss. patient heard less sound. blocked ear feeling was causing hearing loss. On 20-Aug-2021, Nasoendoscopy: normal (normal) Normal. On 01-Sep-2021, Computerised tomogram: normal (normal) Normal. On an unknown date, Acoustic stimulation tests: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was  prescribed antibiotics for sinus infection and also took allergy medication. Patient has gone through multiple office exams, nose exam via camera.  Patient has issues with her hearing and everything is negative except for a hearing test.  This case concerns a 49 Y/O F with serious unexpected deafness, and non-serious ear congestion, hypoacusis, tinnitus, illness, abdominal discomfort, dry mouth, ear discomfort, feeling of body temperature change, dehydration, fatigue, pyrexia, chills, myalgia, headache. Latency 1 day after 2nd dose. Outcome unknown. Rechallenge not applicable. Reporter causality not provided. Possibly related based on temporal association. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-319984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Patient demographics updated, new medical history lactose intolerance added,  Added event hearing loss , hot and cold, fatigue, dehydration, headache, myalgia. treatment medication added, concomitant drugs indication and dosage text updated, lab test added, event outcome and event start date updated. On 16-Sep-2021: Follow-up information included non significant information - Narrative updated.; Sender's Comments: This case concerns a 49 Y/O F with serious unexpected deafness, and non-serious ear congestion, hypoacusis, tinnitus, illness, abdominal discomfort, dry mouth, ear discomfort, feeling of body temperature change, dehydration, fatigue, pyrexia, chills, myalgia, headache. Latency 1 day after 2nd dose. Outcome unknown. Rechallenge not applicable. Reporter causality not provided. Possibly related based on temporal association. The benefit-risk relationship of mRNA-1273 is not affected by this report.