Détails du rapport Vaer
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
hives; anxiety; tears; distressing; itchy rash; primary immunisation: non-pfizer vaccine; booster: comirnaty; primary immunisation: non-pfizer vaccine; booster: comirnaty; rash started on inner thighs, then stomach, back few on arms, armpits, and chest; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority (ra). the reporter is the patient. regulatory number: gb-mhra-webcovid-202202161216487260-yambq (ra). other case identifier(s): gb-mhra-adr 26609880 (ra). a 59 year-old female patient received bnt162b2 (comirnaty), administration date 15dec2021 (lot number: fk9712) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "blood pressure" (unspecified if ongoing). the patient had no symptoms associated with covid-19 and was not enrolled in clinical trial. concomitant medication(s) included: amlodipine taken for blood pressure abnormal; perindopril taken for blood pressure abnormal. vaccination history included: covid-19 vaccine (dose 2; manufacturer unknown), for covid-19 immunisation; covid-19 vaccine (dose 1; manufacturer unknown), for covid-19 immunisation. the following information was reported: off label use (medically significant), interchange of vaccine products (medically significant) all with onset 15dec2021, outcome "unknown" and all described as "primary immunisation: non-pfizer vaccine; booster: comirnaty"; rash pruritic (medically significant) with onset 23dec2021, outcome "not recovered", described as "itchy rash"; urticaria (medically significant), outcome "unknown", described as "hives"; anxiety (medically significant), outcome "not recovered", described as "anxiety"; rash (medically significant) with onset dec2021, outcome "not recovered", described as "rash started on inner thighs, then stomach, back few on arms, armpits, and chest"; tearfulness (medically significant), outcome "unknown", described as "tears"; emotional distress (medically significant), outcome "unknown", described as "destressing". the events "itchy rash", "hives" and "rash started on inner thighs, then stomach, back few on arms, armpits, and chest" were evaluated at the physician office visit. the clinical course was reported as follows: rash started on inner thighs, then stomach, back few on arms, armpits, and chest. doctor advised taking cetirizine twice a day, had been 11 weeks now, rash not so severe but on 1 dose of cetirizine at night, managing with oatmeal baths, anti-itch creams, moisturizers and low histamine diet. all this has been researched by her together with a support group. it had been very distressing and caused anxiety and tears. would not of had a booster if she had known the outcome was hives. the patient had not been tested positive for covid-19 since having the vaccine. the patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. therapeutic measures were taken as a result of rash pruritic, urticaria, rash. no follow-up attempts are possible. no further information is expected
- Données de laboratoire
test name: covid-19 virus test; test result: negative
- Liste des symptômes
anxiety rash rash pruritic urticaria interchange of vaccine products emotional distress sars-cov-2 test off label use tearfulness
- 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