Détails du rapport Vaer
Âge: 22 ans
Région : Outside US
- Patient décédé?
- Renseignements sur les vaccins
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
- Date de réception du rapport
- Date à laquelle le formulaire est complèté
- Date de vaccination
- Date d’apparition
- Nombre de jours (date d’apparition – date de vaccination)
- Description de l’événement indésirable
loss of sphincters; fever 39 centigrade; vomiting; weakness; diarrhea; this is a non-interventional study report from the agency regulatory authority-web. regulatory number: it-minisal02-843983. a 22 year-old female patient received bnt162b2 (comirnaty), intramuscular, administered in arm right, administration date 03may2021 12:17 (lot number: ew6327) at the age of 22 years as dose 2, 0.3 ml single for covid-19 immunisation. relevant medical history included: "multiple sclerosis" (unknown if ongoing). the patient's concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1; manufacturer unknown), for covid-19 immunisation. on 03may2021, the patient experienced fever 39 centigrade, vomiting, weakness, diarrhea. the events was reported as serious for being medical significant. in the 20 days following the vaccine the patient has a clinical relapse with loss of sphincters on 23may2021. the patient underwent the following laboratory tests and procedures: body temperature: (03may2021) 39 centigrade. the outcome of the events was resolving. the reporter's assessment of the causal relationship of the "fever", "vomiting", "weakness", "diarrhea" and "loss of sphincters" with the suspect product(s) bnt162b2 was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on the close temporal association the possibility of causal association between the reported events and the suspect drug bnt162b2 cannot be ruled out. the impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate
- Données de laboratoire
test date: 20210503; test name: body temperature; result unstructured data: test result:39 centigrade
- Liste des symptômes
diarrhoea vomiting asthenia pyrexia incontinence body temperature
- Patient décédé?
- Date de décès
- Anomalie congénitale
- Vaccin administré par :
- Vaccin acheté par :
- Visite d’un patient à l’urgence?
- Patient hospitalisé?
- Séjour à l’hôpital
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Maladie actuelle