Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: COVID vaccine made him sicker; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID vaccine made him sicker) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION COMPLICATION (COVID vaccine made him sicker). At the time of the report, VACCINATION COMPLICATION (COVID vaccine made him sicker) had resolved.            No concomitant product was reported. On an unknown date, the patient felt like Humira was not working. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality of event with Humira was reported as no reasonable possibility. 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 a 54 year old male patient, with no medical history reported, who experienced the unexpected, non serious event of VACCINATION COMPLICATION (COVID vaccine made him sicker) unknown days after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient received the 1 dose of m RNA1273 vaccine at an interval of about 01 month between the 2 doses. Concurrent medical conditions included Psoriatic arthritis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection at an unspecified dose for Psoriatic Arthritis, which is a confounder. On an unknown date, the patient felt like Humira was not working. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 54 year old male patient, with no medical history reported, who experienced the unexpected, non serious event of VACCINATION COMPLICATION (COVID vaccine made him sicker) unknown days after receiving the second dose of mRNA-1273 Vaccine in the covid 19 vaccination series. Patient received the 1 dose of m RNA1273 vaccine at an interval of about 01 month between the 2 doses. Concurrent medical conditions included Psoriatic arthritis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) injection at an unspecified dose for Psoriatic Arthritis, which is a confounder. On an unknown date, the patient felt like Humira was not working. Details of risk factors, other co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.