Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Syncope, Therapeutic response shortened
Clinical narrative: Orthostatic collapse; Feeling abnormal; Wearing off effect; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Orthostatic collapse) in an elderly 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 ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Orthostatic collapse) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling abnormal) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, SYNCOPE (Orthostatic collapse) had not resolved and FEELING ABNORMAL (Feeling abnormal) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna  were missed to be booked-in.  Company Comment: This spontaneous case concerns an elderly, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the unexpected, serious (medically significant) event of syncope and other unexpected, non-serious events. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was reported as unspecified date in 2019 and the event onset dates were not provided, hence, the onset latency could not be assessed. The events occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient felt fine the week after receiving Humira and on the second week, he 'fell apart'. No further details were provided. It was also reported that the patient collapsed after receiving the second dose of the mRNA-1273 vaccine. Treatment information was not provided. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly, male patient with history of co-suspect administration of Humira (adalimumab) for Psoriatic Arthritis, who experienced the unexpected, serious (medically significant) event of syncope and other unexpected, non-serious events. The events occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was reported as unspecified date in 2019 and the event onset dates were not provided, hence, the onset latency could not be assessed. The events occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset dates were not provided, hence, the onset latency could not be assessed. It was reported that the patient felt fine the week after receiving Humira and on the second week, he 'fell apart'. No further details were provided. It was also reported that the patient collapsed after receiving the second dose of the mRNA-1273 vaccine. Treatment information was not provided. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.