Sex: F
Vaccine: COVID19
Symptoms: Head injury, Syncope
Clinical narrative: FAINTED; HIT HEAD; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (FAINTED) in an elderly 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 ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    The patient's past medical history included Psoriatic arthritis.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-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 ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced SYNCOPE (FAINTED) (seriousness criterion medically significant) and HEAD INJURY (HIT HEAD). At the time of the report, SYNCOPE (FAINTED) and HEAD INJURY (HIT HEAD) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant product use was reported.  The patient received all doses one in once. Humira (Adalimumab) was citrate free.  No treatment information was provided.  The reporter's causality with Humira (Adalimumab) for the events of hit head and fainted was not provided.  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 concerns an elderly female patient on treatment with Adalimumab for concurrent Psoriatic Arthritis, who experienced the unexpected, serious  (medically significant) event of Syncope on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. Patient experienced fainting and sustained a head injury as a consequence. Patient received a total of 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a 3rd dose approximately 8 months after.  Adalimumab may cause syncope as a serious adverse effect, thus, could be considered as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient on treatment with Adalimumab for concurrent Psoriatic Arthritis, who experienced the unexpected, serious  (medically significant) event of Syncope on an unknown date in the context of  receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. Patient experienced fainting and sustained a head injury as a consequence. Patient received a total of 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a 3rd dose approximately 8 months after.  Adalimumab may cause syncope as a serious adverse effect, thus, could be considered as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.