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
i felt faint; heavy periods/i had very heavy bleeding during menstruation following the vaccine; delayed period/my period was also delayed.; 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-202202171203273890-gby49 (ra). other case identifier(s): gb-mhra-adr 26612541 (ra). a 38 year-old female patient (not pregnant) received bnt162b2 (comirnaty), administration date 02jan2022 (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. vaccination history included: bnt162b2 (dose 1, lot-unknown), for covid-19 immunisation; bnt162b2 (dose 2, lot-unknown), for covid-19 immunisation. the following information was reported: syncope (medically significant), outcome "unknown", described as "i felt faint"; menstruation delayed (medically significant) with onset 05jan2022, outcome "recovered" (31jan2022), described as "delayed period/my period was also delayed."; heavy menstrual bleeding (medically significant) with onset 31jan2022, outcome "unknown", described as "heavy periods/i had very heavy bleeding during menstruation following the vaccine". the event "i felt faint" was evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: pregnancy: (01jan2022) negative; sars-cov-2 test: (01jan2022) negative, notes: no - negative covid-19 test. patient had a very heavy bleeding during menstruation following the vaccine, to the point that she considered going to a&e when she felt faint. her period was also delayed. patient took home pregnancy tests due to the delayed period and they were negative. patient last menstrual period date was on 31jan2022. patient has not had symptoms associated with covid-19. patient was not pregnant and was not currently breastfeeding. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. the reported events did not relate to possible inflammation of the heart (myocarditis or pericarditis). no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected
- Données de laboratoire
test date: 20220101; test name: pregnancy; test result: negative ; test date: 20220101; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test
- Liste des symptômes
heavy menstrual bleeding syncope sars-cov-2 test pregnancy menstruation delayed
- 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