Détails du rapport Vaer
Âge: 59 ans
Genre: Female
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
Fabricant: PFIZER
Lot: ff2752
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-08-04
- Date d’apparition
- 0
- Nombre de jours (date d’apparition – date de vaccination)
- 0
- Description de l’événement indésirable
-
skin rash on forearms and trunk after dose 2 of covid vaccine. similar reaction after dose 1; 1st dose on 23jun2021, 2nd dose on 04aug2021; farmatse-2020 this is a non-interventional study report from the regulatory authority-web. regulatory number: it-minisal02-844386. a 59 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 04aug2021 (lot number: ff2752) at the age of 59 years as dose 2, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: comirnaty (dose 1, 0.45 ml - concentrate for injection solution - intramuscular - glass vial), administration date: 23jun2021, for covid-19 vaccination, reaction(s): "rash over arms/rash trunk". the following information was reported: rash (medically significant) with onset 04aug2021, outcome "recovered", described as "skin rash on forearms and trunk after dose 2 of covid vaccine. similar reaction after dose 1"; inappropriate schedule of product administration (non-serious) with onset 04aug2021, outcome "unknown", described as "1st dose on 23jun2021, 2nd dose on 04aug2021". therapeutic measures were taken as a result of rash. clinical course: admission to pso (patient safety organization) and somm. di urbason ev in physiological saline, pantoprazole ev in physiological the reporter's assessment of the causal relationship of the "skin rash on forearms and trunk after dose 2 of covid vaccine. similar reaction after dose 1" 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. sender's comment: follow up already obtained from the reporter; no additional info available. no follow-up attempts are possible. no further information is expected.; sender's comments: the causal association of reported rash in relation to bnt162b2 cannot be excluded based on known drug safety profile. case will be reassess pending new information.,linked report(s) : it-pfizer inc-202200319664 same patient, different event/dose number
- Données de laboratoire
-
na
- Liste des symptômes
-
rash inappropriate schedule of product administration
- Patient décédé?
- Non
- Date de décès
- N/A
- Anomalie congénitale
- false
- Vaccin administré par :
- Other
- Vaccin acheté par :
- Inconnu
- Visite d’un patient à l’urgence?
- Non
- Patient hospitalisé?
- Non
- Séjour à l’hôpital
- Non
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Non
- Allergies:
-
na
- Maladie actuelle
-
na