Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: CSF protein, Headache, Lumbar puncture, Meningitis aseptic, Psoriasis
Clinical narrative: Psoriasis flare-up; Headache; Aseptic meningitis; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS ASEPTIC (Aseptic meningitis) in a 54-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third 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. In April 2021, the patient experienced HEADACHE (Headache). In 2021, the patient experienced MENINGITIS ASEPTIC (Aseptic meningitis) (seriousness criterion medically significant). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, MENINGITIS ASEPTIC (Aseptic meningitis), PSORIASIS (Psoriasis flare-up) and HEADACHE (Headache) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CSF protein: abnormal. On an unknown date, Lumbar puncture: Protein in spinal fluid.         No concomitant medications were reported.  It was reported that, the patient had protein in spinal fluid, and plaque psoriasis flare up/break out on forehead. In Mar-2021, the patient had a follow up visit with first neurologist. Within a couple of days or shortly after the first vaccine, the patient developed a headache which never had before. The headaches continued twenty-four by seven and then saw a neurologist who diagnosed the patient with aseptic meningitis. They did not know the exact cause, but it was not bacterial. The patient had been out of work for six months now. The patient went to see another neurologist who told it was not aseptic meningitis and did not know what was caused of headaches and prescribed another medication to treat headaches. The patient had been suffering with daily headaches since shortly after his first covid vaccine.  The patient was due for Skyrizi injection on 25-Dec-2021 and missed it. The patient had started to break out on forehead after being almost a month late on his injection. The patient stated that this was always the first place he breaks out.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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 spontaneous case reported by a consumer, concerns a 54 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of Aseptic meningitis, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of Psoriasis flare up and headache. Patient had previously received 2 primary doses with Moderna  vaccine, with no adverse events reported. Within a couple of days after the first vaccine, the patient developed a headache and was diagnosed with Aseptic meningitis by a Neurologist. On an unknown date, Lumbar puncture showed abnormal proteins in CSF fluid. The exact cause was not known, but it was not bacterial. Six months later another neurologist denied it as aseptic meningitis and the cause of headache was not known The patient had been suffering with daily headaches since shortly after his first covid vaccine. It was reported that the patient had received RISANKIZUMAB for chronic plaque psoriasis and the patient had plaque psoriasis flare up/break out on forehead after missing Risankizumab for a month. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2022: Live  Follow-up document received includes: onset date of suspect and co-suspect, lab data, additional event and outcome of event was updated.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 54 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of Aseptic meningitis, unknown days after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of Psoriasis flare up and headache. Patient had previously received 2 primary doses with Moderna  vaccine, with no adverse events reported. Within a couple of days after the first vaccine, the patient developed a headache and was diagnosed with Aseptic meningitis by a Neurologist. On an unknown date, Lumbar puncture showed abnormal proteins in CSF fluid. The exact cause was not known, but it was not bacterial. Six months later another neurologist denied it as aseptic meningitis and the cause of headache was not known The patient had been suffering with daily headaches since shortly after his first covid vaccine. It was reported that the patient had received RISANKIZUMAB for chronic plaque psoriasis and the patient had plaque psoriasis flare up/break out on forehead after missing Risankizumab for a month. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The events had not. resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.