Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, COVID-19
Clinical narrative: Bell's palsy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in an adult 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE).   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, BELL'S PALSY (Bell's palsy) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported. The patient was exposed to covid-19. The patient experienced COVID-19 and Bell's palsy after vaccination. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Bell's palsy, COVID-19 was assessed as Not reported for cosuspect SKYRIZI. No treatment medications were reported. 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 is a spontaneous case, reported by a consumer, concerning an adult male patient with current medication of Rizankizumab, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, and unexpected non-serious adverse event of special interest COVID-19, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 25 days which falls within the recommended vaccine dosing schedule. It was reported that the patient was exposed to COVID-19. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drug Rizankizumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an adult male patient with current medication of Rizankizumab, who experienced the expected serious (medically significant) adverse event of special interest Bell's palsy, and unexpected non-serious adverse event of special interest COVID-19, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 25 days which falls within the recommended vaccine dosing schedule. It was reported that the patient was exposed to COVID-19. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The co-suspect drug Rizankizumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.