Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Insomnia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: SHUFFLING GAIT; OTOTOXICITY; VISION CHANGES; INSOMNIA; MALAISE; THROBBING OR SHOOTING HEAD PAIN/ INTERMITTENT HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. Initial information was processed along with the additional information received on 25-May-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional alcohol user (stopped drinking recently; originally a 1-2 drinks per week). The patient had no medical history. The patient had no vaccines prior series of negative COVID-19 tests to visit mother in long term care facility. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 total, administered on 28-MAR-2021 13:00 in left arm for prophylactic vaccination. No concomitant medications were reported. 10 days post vaccination on 06-APR-2021, the patient experienced brain inflammation which felt like pressure in head and ears, vision changes like unable to read for long and pressure sensation in ear /clogged ears like descending in airplane. On the same day the patient experienced intense head pressure\changes in head pressure, intense tinnitus/sounds amplified in head, dizziness, insomnia, throbbing or shooting head pain/ intermittent headache, malaise and fatigue. The patient stated that the symptoms were debilitating and felt changes in the head pressure. On an unspecified date the patient went to ENT physician to rule out other possible causes and was diagnosed with ototoxicity. The patient have eliminated coffee, alcohol and spicy food to settle down neuroinflammation. The patient was tired and in bed for most of the day. The left leg was seem to shuffling while walking. On an unspecified date the patient was referred to a neurologist for follow-up appt on shuffling gait. Currently, tinnitus and head pressure fluctuate. Pressure in head have subsided, and she was hopeful that this would eventually resolved. Weird pressure sensation in ear and occasional shooting pain was also reported. The patient was relatively healthy and was doing routinely exercises. On 07-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and PCR (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, had not recovered from vision changes, throbbing or shooting head pain/ intermittent headache, malaise, and insomnia, and the outcome of ototoxicity and shuffling gait was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180326. The suspected product quality complaint has been confirmed to be voided does not meet PQC criteria based on the PQC evaluation/investigation performed.; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-ototoxicity. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).