Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Thrombosis, Treatment noncompliance, X-ray
Clinical narrative: Clot; Stroke; Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back; Problem with walking; Got mad and walked out of hospital byhimself; Nauseous; Pins and needles sensation; Felt chilly; Dizzy; Whole body(left side) went numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back) (seriousness criterion hospitalization), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), PARAESTHESIA (Pins and needles sensation) and NAUSEA (Nauseous). On 07-May-2021, the patient experienced THROMBOSIS (Clot) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (Problem with walking) and TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself). The patient was hospitalized on 07-May-2021 due to CEREBROVASCULAR ACCIDENT and THROMBOSIS. At the time of the report, SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot), CEREBROVASCULAR ACCIDENT (Stroke), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), GAIT DISTURBANCE (Problem with walking), PARAESTHESIA (Pins and needles sensation), TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Blood test: unknown (Inconclusive) Unknown. On 07-May-2021, Computerised tomogram: unknown (Inconclusive) Unknown. On 07-May-2021, Magnetic resonance imaging: unknown (Inconclusive) Unknown. On 07-May-2021, X-ray: unknown (Inconclusive) Unknown.         Company comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded.   The causality assessment for the event of Treatment noncompliance remains Not applicable.   This case was linked to MOD-2021-133656 (Patient Link).; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273.  The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded.   The causality assessment for the event of Treatment noncompliance remains Not applicable.