Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Depression, Fatigue, Feeling abnormal
Clinical narrative: Stroke; Hypertension; Temporomandibular joint syndrome; Sickness; Foggy feeling in head; Depressed state; General body pain; still having issues with smell and taste as of 25 Mar 2022; still having issues with smell and taste as of 25 Mar 2022; Headache; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 64-year-old 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) injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Rheumatoid arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), HYPERTENSION (Hypertension), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), ILLNESS (Sickness), FEELING ABNORMAL (Foggy feeling in head), DEPRESSION (Depressed state), PAIN (General body pain), OLFACTORY DYSFUNCTION (still having issues with smell and taste as of 25 Mar 2022), TASTE DISORDER (still having issues with smell and taste as of 25 Mar 2022), HEADACHE (Headache) and FATIGUE (Exhaustion). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), HYPERTENSION (Hypertension), TEMPOROMANDIBULAR JOINT SYNDROME (Temporomandibular joint syndrome), ILLNESS (Sickness), FEELING ABNORMAL (Foggy feeling in head), DEPRESSION (Depressed state), PAIN (General body pain), OLFACTORY DYSFUNCTION (still having issues with smell and taste as of 25 Mar 2022), TASTE DISORDER (still having issues with smell and taste as of 25 Mar 2022), HEADACHE (Headache) and FATIGUE (Exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.         No concomitant and treatment medications were reported.  Her physician switched to another medication of infusions.  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. A 64-year-old female patient treated with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of cerebrovascular accident (AESI). Onset date of the event was not provided, latency cannot be assessed. Patient stated that, after receiving the second covid vaccine she was advised to go to hospital in ambulance as the blood pressure was up. She was having a stroke. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. In addition, on an unknown date, patient experienced non serious events of depression, general body pain, fatigue, headache, temporomandibular joint syndrome, foggy feeling in head, olfactory disfunction and taste disorder. Relevant medical history of COVID-19 could be a contributory factor for olfactory disfunction and taste disorder. Rheumatoid arthritis could be a contributory factor for general body pain, fatigue and temporomandibular joint syndrome. Adalimumab is a confounding factor for cerebrovascular accident. 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. A 64-year-old female patient treated with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of cerebrovascular accident (AESI). Onset date of the event was not provided, latency cannot be assessed. Patient stated that, after receiving the second covid vaccine she was advised to go to hospital in ambulance as the blood pressure was up. She was having a stroke. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. In addition, on an unknown date, patient experienced non serious events of depression, general body pain, fatigue, headache, temporomandibular joint syndrome, foggy feeling in head, olfactory disfunction and taste disorder. Relevant medical history of COVID-19 could be a contributory factor for olfactory disfunction and taste disorder. Rheumatoid arthritis could be a contributory factor for general body pain, fatigue and temporomandibular joint syndrome. Adalimumab is a confounding factor for cerebrovascular accident. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.