Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Cerebrovascular accident, Cough, Fatigue, Pain
Clinical narrative: STROKE; WOKE UP AROUND MORNING ONE AM WITH PAIN; FATIGUE; Cough; ARTHRITIS IN RIGHT KNEE; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (STROKE), PAIN (WOKE UP AROUND MORNING ONE AM WITH PAIN) and FATIGUE (FATIGUE) in a 71-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) for Ulcerative colitis.    The patient's past medical history included Stroke (she was at the hospital) in 2020. Concurrent medical conditions included Ulcerative colitis and Blood pressure high. Concomitant products included LOSARTAN POTASSIUM for Blood pressure.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In 2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (STROKE) (seriousness criteria hospitalization and medically significant), PAIN (WOKE UP AROUND MORNING ONE AM WITH PAIN) (seriousness criterion hospitalization), FATIGUE (FATIGUE) (seriousness criterion hospitalization), COUGH (Cough) and ARTHRITIS (ARTHRITIS IN RIGHT KNEE). The patient was hospitalized from 15-Jun-2021 to 21-Jun-2021 due to CEREBROVASCULAR ACCIDENT, FATIGUE and PAIN. The patient was treated with NYSTATIN (STATIN [NYSTATIN]) at an unspecified dose and frequency; ACETYLSALICYLIC ACID at an unspecified dose and frequency and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. In 2021, CEREBROVASCULAR ACCIDENT (STROKE) had resolved. At the time of the report, PAIN (WOKE UP AROUND MORNING ONE AM WITH PAIN), FATIGUE (FATIGUE) and COUGH (Cough) outcome was unknown, ARTHRITIS (ARTHRITIS IN RIGHT KNEE) had not resolved and PYREXIA (Fever) had resolved.            The patient had a stroke and she was at the hospital. She was hospitalized from 15-Jun-2021 to till 21-Jun-2021. She had been having fatigue and weak legs. She was unable to talk, unable to use her right side. She could not use her right hand well due to stroke. Her right knee was strong and had no fever. Her cholesterol was all good. She was taking different blood pressure medication because, the last one was caused a cough. Unknown blood pressure medication was also considered as co suspect. In 2021, she had a fever after getting the Covid 19 booster. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The formulation for Humira was reported as Solution for injection in pre-filled pen.  Lab tests blood work, Echocardiogram and magnetic resonance Imaging were performed but results are unknown.  The reporter's causality for the event(s) of FATIGUE, WOKE UP AROUND MORNING ONE AM WITH PAIN and COUGH was not provided. The reporter's causality for the event(s) of STROKE, ARTHRITIS IN RIGHT KNEE and FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The events of FATIGUE, STROKE and WOKE UP AROUND MORNING ONE AM WITH PAIN are not assessable. There was no reasonable possibility that the events of COUGH, ARTHRITIS IN RIGHT KNEE and FEVER are related to HUMIRA(ADALIMUMAB).  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 71-year-old female patient with medical history of blood pressure high and stroke, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of Cerebrovascular accident, the unexpected, serious (hospitalization) events of Pain, Fatigue and the unexpected, non-serious adverse event of special interest of Arthritis. The events Cerebrovascular accident, Pain and Fatigue occurred approximately 3 months prior to receiving the second dose of mRNA-1273 vaccine. The patient had been having fatigue and weak legs, unable to talk, unable to used her right side and could not use her right hand well due to stroke. The event Arthritis occurred on unknown date. It should be noted that the patient received the first dose of mRNA-1273 vaccine on unknown date. The event Cerebrovascular accident resolved within the same year. At the time of the report, the outcome of the events Pain and Fatigue were unknown and the event Arthritis had not resolved. Medical history of blood pressure high and stroke remain as risk factors for the event of Cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with medical history of blood pressure high and stroke, who experienced the unexpected, serious (hospitalization and medically significant) adverse event of special interest of Cerebrovascular accident, the unexpected, serious (hospitalization) events of Pain, Fatigue and the unexpected, non-serious adverse event of special interest of Arthritis. The events Cerebrovascular accident, Pain and Fatigue occurred approximately 3 months prior to receiving the second dose of mRNA-1273 vaccine. The patient had been having fatigue and weak legs, unable to talk, unable to used her right side and could not use her right hand well due to stroke. The event Arthritis occurred on unknown date. It should be noted that the patient received the first dose of mRNA-1273 vaccine on unknown date. The event Cerebrovascular accident resolved within the same year. At the time of the report, the outcome of the events Pain and Fatigue were unknown and the event Arthritis had not resolved. Medical history of blood pressure high and stroke remain as risk factors for the event of Cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.