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
booster caused hormonal imbalance; irregular periods; prolonged periods/ irregular periods; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency (ra). the reporter is the patient. other case identifier(s): gb-mhra-vac-202202112306076300-ivesj (ra), gb-mhra-adr 26596261 (ra). a 44 year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 26nov2021 (batch/lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose number unknown; manufacturer unknown), for covid-19 immunization. the following information was reported: heavy menstrual bleeding (medically significant) with onset 23dec2021, outcome "not recovered", described as "prolonged periods/ irregular periods"; hormone level abnormal (medically significant), outcome "unknown", described as "booster caused hormonal imbalance"; menstruation irregular (medically significant) with onset 23dec2021, outcome "not recovered", described as "irregular periods". the events "prolonged periods/ irregular periods", "booster caused hormonal imbalance" and "irregular periods" were evaluated at the physician office visit. the patient underwent the following laboratory tests and procedures: computerised tomogram: no cancer. therapeutic measures were taken as a result of heavy menstrual bleeding, hormone level abnormal, menstruation irregular. clinical course was reported as following: patient had booster jab on the 26nov2021. patient's period started on the 23dec2021. patient's period usually lasts 7 days but she was still bleeding at the time of this report. gp has prescribed norethisterone which was not helping to stop, and patient have had a scan to rule out cancer. nothing was found. it appears the booster caused hormonal imbalance no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected
- Données de laboratoire
test name: ct scan; result unstructured data: test result:no cancer
- Liste des symptômes
hormone level abnormal menstruation irregular heavy menstrual bleeding computerised tomogram
- 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