Détails du rapport Vaer
Âge: N/A
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
Fabricant: PFIZER
Lot: elo739
- Date de réception du rapport
- 2022-03-04
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-01-24
- Date d’apparition
- 250
- Nombre de jours (date d’apparition – date de vaccination)
- 250
- Description de l’événement indésirable
-
itchy skin; severe rash and random skin eruptions; regulatory authority vaccine monitor this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority for a sponsored program. regulatory number: gb-mhra-ycvm-202101271028554990. other case identifier(s): gb-mhra-adr 26630081. a 83 year-old male patient received bnt162b2 (bnt162b2), administration date 24jan2021 (lot number: elo 739) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "hypertension" (unspecified if ongoing). concomitant medication(s) included: tenoret taken for hypertension, start date: 07jul1980. vaccination history included: bnt162b2 (dose 1), for covid-19 immunisation; bnt162b2 (dose 2), for covid-19 immunisation. unsure if patient has had symptoms associated with covid-19 not had a covid-19 test. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial the following information was reported: pruritus (medically significant) with onset oct2021, outcome "not recovered", described as "itchy skin"; rash (medically significant) with onset oct2021, outcome "unknown", described as "severe rash and random skin eruptions". the events "itchy skin" and "severe rash and random skin eruptions" were evaluated at the physician office visit. clinical course: the patient developed the severe rash and random skin eruptions after his pfizer booster jab last october for which he was seen by his gp. he experienced severe itching notably on the trunk. for the record, he had no reactions after the first 2 jabs (also pfizers). no follow-up attempts are possible. no further information is expected.; sender's comments: based on temporal association, there is reasonable possibility of causal association between the reported events and the suspect drug bnt162b2. the impact of this report on the benefit/risk profile of the pfizer drug 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
-
na
- Liste des symptômes
-
pruritus rash
- 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