Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Glue ear/Ear filling; Feeling bad/Feeling Terrible; Sinus infection; Ear aches; chest tightness; Streptococcal sore throat; Chills; Fever; General body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of OTITIS MEDIA CHRONIC (Glue ear/Ear filling) in a 37-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.    The patient's past medical history included COVID-19 in December 2020, Fever in December 2020, Myalgia in December 2020 and Plaque psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced PAIN (General body pain) and PYREXIA (Fever). In March 2022, the patient experienced CHILLS (Chills). In May 2022, the patient experienced PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat). On an unknown date, the patient experienced OTITIS MEDIA CHRONIC (Glue ear/Ear filling) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling bad/Feeling Terrible), SINUSITIS (Sinus infection), EAR PAIN (Ear aches), CHEST DISCOMFORT (chest tightness) and HEADACHE (headache). At the time of the report, OTITIS MEDIA CHRONIC (Glue ear/Ear filling), FEELING ABNORMAL (Feeling bad/Feeling Terrible), PAIN (General body pain), EAR PAIN (Ear aches), CHEST DISCOMFORT (chest tightness), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown, SINUSITIS (Sinus infection) and PHARYNGITIS STREPTOCOCCAL (Streptococcal sore throat) was resolving and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: This is a spontaneous case concerning a 37-year-old female patient with plaque psoriasis on treatment with risankizumab, who experienced the serious (medically significant) unexpected event otitis media chronic, on an unknown date after the first dose of mRNA-1273.  Event was described as glue ear/ ear filling and ear pain was also reported as an event. Clinical course, diagnostic tests and treatment details were not provided. Other reported non-serious events include sinusitis, pharyngitis streptococcal and chest discomfort, among others. Concomitant medication risankizumab remains a co-suspect for the event. Events seriousness captured as per IME  list. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Concomitant products were not provided. Treatment medication were not reported. 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.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Follow-up contains updated information on medical history, suspect details, new event, event onset date and outcome. Sender's Comments: Company comment: This is a spontaneous case concerning a 37-year-old female patient with plaque psoriasis on treatment with risankizumab, who experienced the serious (medically significant) unexpected event otitis media chronic, on an unknown date after the first dose of mRNA-1273.  Event was described as glue ear/ ear filling and ear pain was also reported as an event. Clinical course, diagnostic tests and treatment details were not provided. Other reported non-serious events include sinusitis, pharyngitis streptococcal and chest discomfort, among others. Concomitant medication risankizumab remains a co-suspect for the event. Events seriousness captured as per IME  list. The benefit-risk relationship of mRNA-1273 is not affected by this report.