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VAERS Report 2156956

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: fc9001


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-06-23
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

maternal exposure during breast feeding; maternal exposure during breast feeding; this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency for a sponsored program. regulatory number: gb-mhra-ycvm-202106280855089900-p2q4s. other case identifier(s): gb-mhra-adr 26630205, gb-pfizer inc-202200328147 (mother/baby case). a 27 year-old female patient (not pregnant) received bnt162b2 (bnt162b2), administration date 23jun2021 (lot number: fc9001) as dose 1, single for covid-19 immunisation. relevant medical history included: "breast feeding" (ongoing). the patient's concomitant medications were not reported. the following information was reported: off label use (medically significant), product use issue (medically significant) and all described as "maternal exposure during breast feeding". clinical course: patient has not had symptoms associated with covid-19 and not had a covid-19 test. patient was not pregnant. patient last menstrual period date 08nov2020. since the vaccination, patient has not tested for covid-19. patient was not enrolled in clinical trial. the reporter assessment of the causal relationship of the events with the suspect product (comirnaty) was not provided at the time of this report. since no determination has been received, the case is managed based the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on the information in the case report, a possible causal relationship between the reported events and the suspect drug bnt162b2 cannot be completely excluded. the impact of this report on the benefit/risk profile of the pfizer drug is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate

Données de laboratoire
na
Liste des symptômes
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