Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: AFTER GETTING COVID 19 VACCINE/HAD A BAD REACTION; POST-TRAUMATIC STRESS DISORDER; ANXIETY; DEPRESSION; FEELS ITCHY FEW TIMES A WEEK IN GROIN AREA; HAD COVID 19 SEVERAL TIMES; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (AFTER GETTING COVID 19 VACCINE/HAD A BAD REACTION), POST-TRAUMATIC STRESS DISORDER (POST-TRAUMATIC STRESS DISORDER), ANXIETY (ANXIETY), DEPRESSION (DEPRESSION) and PRURITUS (FEELS ITCHY FEW TIMES A WEEK IN GROIN AREA) in a 58-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.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2020, the patient experienced COVID-19 (HAD COVID 19 SEVERAL TIMES). On an unknown date, the patient experienced IMMUNISATION REACTION (AFTER GETTING COVID 19 VACCINE/HAD A BAD REACTION), POST-TRAUMATIC STRESS DISORDER (POST-TRAUMATIC STRESS DISORDER), ANXIETY (ANXIETY), DEPRESSION (DEPRESSION) and PRURITUS (FEELS ITCHY FEW TIMES A WEEK IN GROIN AREA). At the time of the report, IMMUNISATION REACTION (AFTER GETTING COVID 19 VACCINE/HAD A BAD REACTION) and COVID-19 (HAD COVID 19 SEVERAL TIMES) had resolved, POST-TRAUMATIC STRESS DISORDER (POST-TRAUMATIC STRESS DISORDER), ANXIETY (ANXIETY) and DEPRESSION (DEPRESSION) had not resolved and PRURITUS (FEELS ITCHY FEW TIMES A WEEK IN GROIN AREA) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment medications were not reported.  Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the events of feels itchy few times a week in groin area, after getting COVID-19 vaccine/had a bad reaction, had COVID-19 several times, anxiety, depression and post-traumatic stress disorder was not provided.  Company comment: This spontaneous case concerns a 58-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. The patient reports he experienced COVID-19 several times, though it is unclear whether this was before or after vaccination. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old male patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. The patient reports he experienced COVID-19 several times, though it is unclear whether this was before or after vaccination. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.