Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging head, Mood altered, Ocular hyperaemia
Clinical narrative: equilibrium went off,imbalance; eyes were bloodshot red; ringing in the ear, tinnitus , ringing is very loud and disruptive; decline in the activity of the hearing , couldn't hear ringing at high pitch; Left side of head is clogged feels like it had weight, feels heavy.; Killing my mood and production; No sleep, cant sleep with ringing in the ear.; Interfering with job, sleep and daily activity.; extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch) and HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE and ALPRAZOLAM for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.). On an unknown date, the patient experienced BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch), HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.), MOOD ALTERED (Killing my mood and production), INSOMNIA (No sleep, cant sleep with ringing in the ear.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with job, sleep and daily activity.). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, BALANCE DISORDER (equilibrium went off,imbalance), OCULAR HYPERAEMIA (eyes were bloodshot red), TINNITUS (ringing in the ear, tinnitus , ringing is very loud and disruptive), HYPOACUSIS (decline in the activity of the hearing , couldn't hear ringing at high pitch), HEAD DISCOMFORT (Left side of head is clogged feels like it had weight, feels heavy.), MOOD ALTERED (Killing my mood and production), INSOMNIA (No sleep, cant sleep with ringing in the ear.), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfering with job, sleep and daily activity.) and HEADACHE (extremely large headache, which lasted over a month, could not get rid of it/Never experienced headache until the Moderna shot.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: abnormal (abnormal) supposed to be at 20 and patient was at 40. On an unknown date, Magnetic resonance imaging head: normal (normal) nnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to ER and gave pain medication and left her in dark room. Left the ER because she did not like drugs in her body. Patient reports that her headache was so bad her eyes were bloodshot red. Patient went to neurologist and got inner ear test - which noticed that there was a decline in the activity of the hearing and there was some imbalance. Left side of head was clogged feels like it had weight, feels heavy. Patient reported neurology also performed an MRI of the brain MRI (normal). Patient stated neurologist referred her an ENT.Went to ENT and had hearing test. Patient stated her test results showed that she couldn't hear ringing at high pitch supposed to be at 20 and patient was at 40. The results was looking at hearing and going to see about a hearing aid. We have to go through the steps. Patient never experienced headache until the Moderna shot. No sleep, can't sleep with ringing in the ear. Never experienced that in whole life.   This case was linked to MOD-2021-359515 (Patient Link).