Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: lightheadedness; can't think how she used to; gets confused; couldn't comprehend a story she had to read at work; forgetting things like looking for cell phone with cell phone (flashlight on) in hand, looking for glasses which were already on her head; back pain; spinal pain; right foot cramping in the middle of the night & that ankle would turn to the right in a locked position; vision getting worse; Lost hearing in 1 ear; shortness of breath; sleep apnea; chest pain; Got really sick/sick for a few hours weekly; muscle pain; headache; nausea; ankle pain/joint pain; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Lost hearing in 1 ear) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chest pain (chest pain about once every other year before the vaccine).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath), SLEEP APNOEA SYNDROME (sleep apnea), CHEST PAIN (chest pain), ILLNESS (Got really sick/sick for a few hours weekly), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (ankle pain/joint pain) and FATIGUE (fatigue). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Lost hearing in 1 ear) (seriousness criterion medically significant), DIZZINESS (lightheadedness), THINKING ABNORMAL (can't think how she used to), CONFUSIONAL STATE (gets confused), COGNITIVE DISORDER (couldn't comprehend a story she had to read at work), MEMORY IMPAIRMENT (forgetting things like looking for cell phone with cell phone (flashlight on) in hand, looking for glasses which were already on her head), BACK PAIN (back pain), SPINAL PAIN (spinal pain), MUSCLE SPASMS (right foot cramping in the middle of the night & that ankle would turn to the right in a locked position) and VISUAL IMPAIRMENT (vision getting worse). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at a dose of 1 dosage form and TIZANIDINE for Adverse event, at a dose of 1 dosage form. At the time of the report, DEAFNESS UNILATERAL (Lost hearing in 1 ear) had resolved and DYSPNOEA (shortness of breath), SLEEP APNOEA SYNDROME (sleep apnea), CHEST PAIN (chest pain), DIZZINESS (lightheadedness), THINKING ABNORMAL (can't think how she used to), CONFUSIONAL STATE (gets confused), COGNITIVE DISORDER (couldn't comprehend a story she had to read at work), MEMORY IMPAIRMENT (forgetting things like looking for cell phone with cell phone (flashlight on) in hand, looking for glasses which were already on her head), BACK PAIN (back pain), SPINAL PAIN (spinal pain), MUSCLE SPASMS (right foot cramping in the middle of the night & that ankle would turn to the right in a locked position), VISUAL IMPAIRMENT (vision getting worse), ILLNESS (Got really sick/sick for a few hours weekly), MYALGIA (muscle pain), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (ankle pain/joint pain) and FATIGUE (fatigue) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment medication also included Breo.  The reporter stated she failed a lung test at end of March. She did not think the shortness of breath is related to her heart. Some symptoms were ongoing.  This case concerns a 6o-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of deafness unilateral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 6o-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of deafness unilateral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.