Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Gait disturbance, Musculoskeletal stiffness, Urticaria
Clinical narrative: broke into hives; cannot walk; muscles were stiff; diarrhea; throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (cannot walk) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine normal (Inconclusive) CT Scan was fine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. An ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criterion hospitalization), GAIT DISTURBANCE (cannot walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine (Inconclusive) fine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. Treatment information included  an ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.