Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Deafness, Fatigue, Hypersensitivity, Unevaluable event
Clinical narrative: Hearing loss; ALLERGIES; congestion; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 65-year-old female 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-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) 1 dosage form. In 2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), HYPERSENSITIVITY (ALLERGIES) and UNEVALUABLE EVENT (congestion). At the time of the report, DEAFNESS (Hearing loss) had not resolved, HYPERSENSITIVITY (ALLERGIES) and FATIGUE (fatigue) outcome was unknown and UNEVALUABLE EVENT (congestion) was resolving.            No relevant concomitant medications were reported.   The patient had some congestion and allergies. She was placed on a steroid and antibiotic. She had received  allergy injections. She did not take injection on the same day as Skyrizi. She had hearing loss and also had  aids. She had fatigue with the second Covid-19 vaccine injection.  The reporter's causality for the events of hearing loss, allergies, congestion and fatigue was not provided. RA's opinion is that the events of hearing loss, allergies and congestion are not assessable. RA's opinion is that there is no reasonable possibility that the event fatigue are related to skyrizi(risankizumab).  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of DEAFNESS on an unknown date in the context of  receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as the date of event onset was not provided.  Outcome of the event was reported as not resolved. Patient previously  received a dose  of mRNA-1273 vaccine given as first dose 28 days prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-620452 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious  (medically significant) event of DEAFNESS on an unknown date in the context of  receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as the date of event onset was not provided.  Outcome of the event was reported as not resolved. Patient previously  received a dose  of mRNA-1273 vaccine given as first dose 28 days prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.