Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Confusional state, Deafness, Ear infection, Gait disturbance
Clinical narrative: Neuropathy; Difficulty in walking; Confusion; Sciatica; Deaf; Bell's palsy; Ear infection; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Deaf), NEUROPATHY PERIPHERAL (Neuropathy) and BELL'S PALSY (Bell's palsy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included GABAPENTIN for an unknown indication.   On 06-Mar-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 milligram. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SCIATICA (Sciatica). In 2021, the patient experienced DEAFNESS (Deaf) (seriousness criterion medically significant), BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and EAR INFECTION (Ear infection). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), GAIT DISTURBANCE (Difficulty in walking) and CONFUSIONAL STATE (Confusion). At the time of the report, DEAFNESS (Deaf), NEUROPATHY PERIPHERAL (Neuropathy) and EAR INFECTION (Ear infection) was resolving, BELL'S PALSY (Bell's palsy) and SCIATICA (Sciatica) outcome was unknown and GAIT DISTURBANCE (Difficulty in walking) and CONFUSIONAL STATE (Confusion) had not resolved.            The patient has other concomitant therapy of Antibiotic oil. Treatment medication was not provided by the reporter.  The reporter's causality for Imbruvica for the event(s) of ear infection in both ears/one is worse than other/causing him to be deaf onset in 2021, bells palsy, ear ache, confusion, hard time walking and ear infection in both ears/one is worse than other/causing him to be deaf onset in 2021 was not provided. the reporter's causality for the event(s) of sciatic pain after the injections with imbruvica(ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of NEUROPATHY with imbruvica(ibrutinib) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns a 77-year-old male patient with no relevant medical history, who experienced the expected, serious  (medically significant) adverse event of special interest Bell's palsy, and unexpected serious (medically significant) events of Deafness, and Neuropathy peripheral on unspecified dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact dates of vaccination and onset dates of the events were not provided. Patient experienced an ear infection in both ears, with one ear worse than the other ear that caused ear ache and deafness. Outcome of the event Bell's palsy was reported as unknown, and the events Deafness, and Neuropathy peripheral as resolving. Patient received 2 doses of RNA-1273 vaccine within the same month at an unknown interval.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old male patient with no relevant medical history, who experienced the expected, serious  (medically significant) adverse event of special interest Bell's palsy, and unexpected serious (medically significant) events of Deafness, and Neuropathy peripheral on unspecified dates in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as exact dates of vaccination and onset dates of the events were not provided. Patient experienced an ear infection in both ears, with one ear worse than the other ear that caused ear ache and deafness. Outcome of the event Bell's palsy was reported as unknown, and the events Deafness, and Neuropathy peripheral as resolving. Patient received 2 doses of RNA-1273 vaccine within the same month at an unknown interval.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.