Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphasia, Arthralgia, Cerebrovascular accident, Decreased appetite, Gait disturbance
Clinical narrative: FLARE UP OF STIFFNESS; FLARE UP OF PAIN; stroke affected speech; stroke affected walking; FLARE UP OF JOINTS SWELLING; FLARE UP OF RIGHT KNEE PAIN; Stroke; 1st dose of Moderna on 20-MAR-2021 and 2nd dose on 13-APR-2021; LOSS APPETITE; LOST 35 POUND; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 64-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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.    Concurrent medical conditions included Rheumatoid arthritis and Plaque psoriasis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-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) Dose 1. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Dose 2(Citrate free, Solution for injection in pre-filled pen). On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna on 20-MAR-2021 and 2nd dose on 13-APR-2021). In 2021, the patient experienced DECREASED APPETITE (LOSS APPETITE) and WEIGHT DECREASED (LOST 35 POUND). On 10-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (FLARE UP OF JOINTS SWELLING), MUSCULOSKELETAL STIFFNESS (FLARE UP OF STIFFNESS), PAIN (FLARE UP OF PAIN), APHASIA (stroke affected speech), GAIT DISTURBANCE (stroke affected walking) and ARTHRALGIA (FLARE UP OF RIGHT KNEE PAIN). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and MUSCULOSKELETAL STIFFNESS (FLARE UP OF STIFFNESS) had not resolved and JOINT SWELLING (FLARE UP OF JOINTS SWELLING), DECREASED APPETITE (LOSS APPETITE), WEIGHT DECREASED (LOST 35 POUND), PAIN (FLARE UP OF PAIN), APHASIA (stroke affected speech), GAIT DISTURBANCE (stroke affected walking), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna on 20-MAR-2021 and 2nd dose on 13-APR-2021) and ARTHRALGIA (FLARE UP OF RIGHT KNEE PAIN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: LOST 35 POUND.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporter's causality for the events of STROKE, LOSS APPETITE and LOST 35 POUND with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events of FLARE UP OF JOINTS SWELLING, FLARE UP OF STIFFNESS, FLARE UP OF PAIN and FLARE UP OF RIGHT KNEE PAIN with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication 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 is a spontaneous case concerning a 64-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, approximately 3 months after receiving the second dose of mRNA-1273 vaccine. The patient had stroke which affected the speech and walking. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Inappropriate schedule of product administration was also reported as the two dose of mRNA-1273 were given on a 24-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old male patient with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, approximately 3 months after receiving the second dose of mRNA-1273 vaccine. The patient had stroke which affected the speech and walking. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had not resolved at the time of the report. Inappropriate schedule of product administration was also reported as the two dose of mRNA-1273 were given on a 24-day interval. The benefit-risk relationship of mRNA-1273 is not affected by this report.