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| Table |
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| Age | Count | Percent |
| 17-44 Years | 1 | 100% |
| TOTAL | 1 | 100% |
| Case Details |
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: Thrombosis; Paraesthesia; Headache; Inappropriate age at vaccine administration; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis), PARAESTHESIA (Paraesthesia) and HEADACHE (Headache) in a 17-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) unknown. On 02-Apr-2021, the patient experienced THROMBOSIS (Thrombosis) (seriousness criteria hospitalization prolonged and medically significant), PARAESTHESIA (Paraesthesia) (seriousness criterion hospitalization prolonged), HEADACHE (Headache) (seriousness criterion hospitalization prolonged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, THROMBOSIS (Thrombosis), PARAESTHESIA (Paraesthesia) and HEADACHE (Headache) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication use was not provided. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the thrombosis, headache and paresthesia, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Event added tp reflect that the patient was below age specified in label. Events seriousness per assessment by Authority and per IME list; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the thrombosis, headache and paresthesia, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Event added tp reflect that the patient was below age specified in label. Events seriousness per assessment by Authority and per IME list | ||||||||||||||||
Link To This Search Result:
https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&SYMPTOMS[]=Cerebral+venous+sinus+thrombosis+%2810083037%29&SYMPTOMS[]=Cerebral+venous+thrombosis+%2810008138%29&SYMPTOMS[]=Coagulopathy+%2810009802%29&SYMPTOMS[]=Deep+vein+thrombosis+%2810051055%29&SYMPTOMS[]=Disseminated+intravascular+coagulation+%2810013442%29&SYMPTOMS[]=Embolism+%2810061169%29&SYMPTOMS[]=Idiopathic+thrombocytopenic+purpura+%2810021245%29&SYMPTOMS[]=Immune+thrombocytopenia+%2810083842%29&SYMPTOMS[]=Immune+thrombocytopenic+purpura+%2810074667%29&SYMPTOMS[]=Ischaemic+stroke+%2810061256%29&SYMPTOMS[]=Myocardial+infarction+%2810028596%29&SYMPTOMS[]=Petechiae+%2810034754%29&SYMPTOMS[]=Pulmonary+embolism+%2810037377%29&SYMPTOMS[]=Purpura+%2810037549%29&SYMPTOMS[]=Thrombocytopenia+%2810043554%29&SYMPTOMS[]=Thrombosis+%2810043607%29&SYMPTOMS[]=Vasculitis+%2810047115%29&VAX=COVID19&VAXMAN=MODERNA&WhichAge=range&LOWAGE=12&HIGHAGE=18
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