Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Gait disturbance, Hypoacusis, Influenza like illness
Clinical narrative: Worsened tinnitus; Hearing is pertinently impacted; I am unsteady; stepping backwards; Body aches; Flu like symptoms; Fell ill; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), TINNITUS (Worsened tinnitus), BALANCE DISORDER (stepping backwards), PAIN (Body aches) and MALAISE (Fell ill) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ulcerative colitis (Pandemic Ulcerative colitis) in 1992, Migraine in 2016, Sinusitis in 2016, Tension in 2016, Osteopenia and Hiatal hernia. Concurrent medical conditions included Fibromyalgia (Tinnitus worse), Allergic reaction to drug (Prednisone) and Tinnitus aggravated (Tinnitus worse) since 1992. Concomitant products included CYCLOBENZAPRINE HCL from 2000 to an unknown date for Fibromyalgia, DIAZEPAM from 1980 to an unknown date for Fibromyalgia and Headache, FAMOTIDINE from 2017 to an unknown date for Hiatal hernia, LEVOTHYROXINE SODIUM (L THYROXINE) for Hypothyroidism, AZATHIOPRINE (IMURAN [AZATHIOPRINE]), FOLIC ACID from 2017 to an unknown date and MESALAMINE from 2017 to an unknown date for Ulcerative colitis, BIOTIN, VITAMIN E NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COD LIVER OIL [COD-LIVER OIL], VITAMIN D3, MAGNESIUM and PROBIOTICS NOS for an unknown indication.   On 21-Jan-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches). On 03-Mar-2021, the patient experienced BALANCE DISORDER (stepping backwards). On an unknown date, the patient experienced TINNITUS (Worsened tinnitus), MALAISE (Fell ill), HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady). On 22-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body aches) had resolved. At the time of the report, TINNITUS (Worsened tinnitus) and BALANCE DISORDER (stepping backwards) had not resolved, MALAISE (Fell ill) had resolved and HYPOACUSIS (Hearing is pertinently impacted) and GAIT DISTURBANCE (I am unsteady) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100-101 (High) body temperature 100-101 degrees.         No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Sig followup - Reporter's contact details updated i.e. email address. Patients demographics added, race and ethnicity updated, relevant medical history updated, Concomitant products added, Vaccine facility information updated, New events added, Narrative regenerated.