Sex: F
Vaccine: COVID19, UNK
Symptoms: Cerebrovascular accident, Hypoaesthesia, Hypophagia, Pain in extremity, Thyroid cancer
Clinical narrative: Stroke; Thyroid cancer; numb hands; Oral intake reduced; Weight loss; Hand pain; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THYROID CANCER (Thyroid cancer), HYPOAESTHESIA (numb hands), HYPOPHAGIA (Oral intake reduced), WEIGHT DECREASED (Weight loss) and PAIN IN EXTREMITY (Hand pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), THYROID CANCER (Thyroid cancer) (seriousness criterion medically significant), HYPOAESTHESIA (numb hands) (seriousness criterion medically significant), HYPOPHAGIA (Oral intake reduced) (seriousness criterion medically significant), WEIGHT DECREASED (Weight loss) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), THYROID CANCER (Thyroid cancer), HYPOAESTHESIA (numb hands), HYPOPHAGIA (Oral intake reduced), WEIGHT DECREASED (Weight loss) and PAIN IN EXTREMITY (Hand pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Weight Lost.   No concomitant medication information was provided. It was unknown if patient was enrolled in a covid-19 Vaccine trial. No treatment medication was provided.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a elderly female patient with relevant medical condition of moderate to severe Ulcerative colitis treated with Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident and unexpected serious (medically significant) events of Thyroid cancer reported as possible thyroid cancer, Hypoaesthesia reported as numbness in hand, Hypophagia described as oral intake reduced, Weight decreased, and Pain in extremity reported as hand pain,  in the context of the three doses of mRNA-1273 vaccine given on unknown dates. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Ulcerative colitis could be a confounding factor for weight loss and reduced oral intake, while the co-suspect drug Adalimumab remains as a confounders for stroke and cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Significant follow-up appended-Events added; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a elderly female patient with relevant medical condition of moderate to severe Ulcerative colitis treated with Adalimumab, who experienced the unexpected serious (medically significant) adverse event of special interest Cerebrovascular accident and unexpected serious (medically significant) events of Thyroid cancer reported as possible thyroid cancer, Hypoaesthesia reported as numbness in hand, Hypophagia described as oral intake reduced, Weight decreased, and Pain in extremity reported as hand pain,  in the context of the three doses of mRNA-1273 vaccine given on unknown dates. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Ulcerative colitis could be a confounding factor for weight loss and reduced oral intake, while the co-suspect drug Adalimumab remains as a confounders for stroke and cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.