Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: hearing test done which showed mild sensorineural hearing loss of left ear.; More than 35 days after the first dose without receiving the second dose; Muscle pain; Joint pain; Has developed tinnitus in both ears/ringing in both ears that is getting worse over time; This spontaneous case was reported by a nurse and describes the occurrence of DEAFNESS NEUROSENSORY (hearing test done which showed mild sensorineural hearing loss of left ear.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Bactrim), Allergy to antibiotic (Allergy to macrobid) and Sulfonamide allergy.    On 05-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced TINNITUS (Has developed tinnitus in both ears/ringing in both ears that is getting worse over time). On 01-Feb-2021 at 7:00 AM, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced DEAFNESS NEUROSENSORY (hearing test done which showed mild sensorineural hearing loss of left ear.) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, DEAFNESS NEUROSENSORY (hearing test done which showed mild sensorineural hearing loss of left ear.) outcome was unknown, TINNITUS (Has developed tinnitus in both ears/ringing in both ears that is getting worse over time), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: mild sensorineural hearing loss of left ear (abnormal) Hearing test done which showed mild sensorineural hearing loss of left ear.. On an unknown date, Laboratory test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered TINNITUS (Has developed tinnitus in both ears/ringing in both ears that is getting worse over time) to be probably related. No further causality assessments were provided for DEAFNESS NEUROSENSORY (hearing test done which showed mild sensorineural hearing loss of left ear.), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose).    No concomitant medications was reported. No treatment drug details was reported. Weight of the patient was reported as 152, units not specified. Patient visited specialist for her event and they stated they have no treatment for ringing in the ears.  Since she had a bad reaction to vaccination, she does not want to get the second vaccine and she is having to make a decision on what to do. Patient have been referred to endocrinology. Patient was facing employer COVID-19 mandate which is terrifying because if not vaccinated by November 12, Patient will lose her job.  Company Comment: This is a case of product dose omission issue in a 57 year old female patient, with no relevant medical history reported, who experienced serious unexpected event of deafness neurosensory after first dose of mRNA-1273. The re-challenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up received contains Significant information. Secondary reporter is added. Laboratory data is added. Events Deafness neurosensory, Myalgia and Arthralgia are added. Narrative is updated. On 29-Oct-2021: Follow up received contains No New Information.; Sender's Comments: This is a case of product dose omission issue in a 57 year old female patient, with no relevant medical history reported, who experienced serious unexpected event of deafness neurosensory after first dose of mRNA-1273. The re-challenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.