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
off-label use; interchange of vaccine products; booster; post viral fatigue; excessive menstruation; shingles; genital herpes; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency. the reporter is the patient. regulatory number: gb-mhra-webcovid-202202171147341540-gtayj. other case identifier(s): gb-mhra-adr 26612527. a 51 year-old female patient received bnt162b2 (comirnaty) (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "genital herpes" (unspecified if ongoing), notes: not had that in approx 10 years. the patient's concomitant medications were not reported. patient has not had symptoms associated with covid-19. vaccination history included: astra zeneca (dose 1, my first 2 doses were astra zeneca and i did not notice irregularities after that), for covid-19 immunisation; astra zeneca (dose 2, my first 2 doses were astra zeneca and i did not notice irregularities after that), for covid-19 immunisation. the following information was reported: off label use (medically significant), outcome "unknown", described as "off-label use"; interchange of vaccine products (medically significant), outcome "unknown", described as "interchange of vaccine products"; immunisation (medically significant), outcome "unknown", described as "booster"; heavy menstrual bleeding (medically significant) with onset 13jan2022, outcome "recovered" (06feb2022), described as "excessive menstruation"; herpes zoster (medically significant) with onset 11jan2022, outcome "recovering", described as "shingles"; post viral fatigue syndrome (medically significant) with onset 20jan2022, outcome "not recovered", described as "post viral fatigue"; genital herpes (medically significant) with onset nov2021, outcome "recovered", described as "genital herpes". in the period of 3 months following this booster patient has had genital herpes (very soon after vaccine and not had that in approx 10 years) then shingles and extreme post-viral fatigue, plus a 25-day period. she has been unable to work for over a month. she wondered if there was any connection. her first 2 doses were astra zeneca and she did not notice irregularities after that. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). relevant investigations or tests conducted: "all blood tests came back fine - thyroid, liver, blood count and white blood cells etc". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test; blood test: fine, notes: fine - thyroid, liver, blood count and white blood cells etc. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected
- Données de laboratoire
test name: blood test; result unstructured data: test result:fine; comments: fine - thyroid, liver, blood count and white blood cells etc; test name: covid-19 virus test; result unstructured data: test result:no - negative covid-19 test
- Liste des symptômes
heavy menstrual bleeding herpes zoster interchange of vaccine products sars-cov-2 test immunisation blood test off label use genital herpes post viral fatigue syndrome
- 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