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VAERS Report 2156570

Case Report Section

Détails du rapport Vaer

Âge: N/A

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: unknown


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

heavy menstrual bleeding; off label use/maternal exposure during breast feeding; drug use in unapproved population/maternal exposure during breast feeding; irregular periods; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority. the reporter is the patient. regulatory number: gb-ra-vac-202202111924006420-bzy3n (ra). other case identifier(s): gb-mhra-adr 26595195 (ra). a 37 year-old female patient received bnt162b2 (comirnaty) (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "breast feeding" (ongoing). there were no concomitant medications. vaccination history included: covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunization; covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunization. the following information was reported: menstruation irregular (medically significant) with onset 06dec2021, outcome "recovered", described as "irregular periods"; heavy menstrual bleeding (medically significant), outcome "recovered", described as "heavy menstrual bleeding"; off label use (non-serious), outcome "unknown", described as "off label use/maternal exposure during breast feeding"; product use issue (non-serious), outcome "unknown", described as "drug use in unapproved population/maternal exposure during breast feeding". the patient had heavier periods since the booster. one was a week after her last period about 5 days after the booster. it was bright red blood and very heavy.the patient did not think this reaction occurred as a result of a mistake made in the administration of the vaccine. it was also reported that the has been no more bleeding at the time of the report. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected. sender's comments: linked report(s) : gb-pfizer inc-202200323081 baby case

Données de laboratoire
na
Liste des symptômes
menstruation irregular heavy menstrual bleeding product use issue off label use
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
breast feeding