Page breadcrumb nav

VAERS Report 2156655

Case Report Section

Détails du rapport Vaer

Âge: 0

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: MENINGOCOCCAL B (BEXSERO)

Type : Meningococcal group b vaccine, rDNA absorbed

Fabricant: NOVARTIS VACCINES AND DIAGNOSTICS

Lot: unknown


Nom: ROTAVIRUS (ROTARIX)

Type : Rotavirus vaccine, live, oral

Fabricant: GLAXOSMITHKLINE BIOLOGICALS

Lot: unknown


Nom: DTAP+IPV+HEPB+HIB (INFANRIX HEXA)

Type : Diphtheria and tetanus toxoids and acellular pertussis adsorbed + inactivated poliovirus + hepatitis B + haemophilus B conjugate vaccine

Fabricant: GLAXOSMITHKLINE BIOLOGICALS

Lot: unknown


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-02-21
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

gerd worsened severely; case received by gsk via regulatory authority on 27th february 2022 this case was reported by a consumer via regulatory authority and described the occurrence of oesophageal reflux aggravated in a 1-month-old female patient who received men b nvs (bexsero) for prophylaxis. co-suspect products included meningococcal b recom vaccine + aloh + omv pre-filled syringe device (meningococcal b vaccine pre-filled syringe device) injection syringe for prophylaxis, dtpa-hbv-ipv+hib (infanrix hexa) for prophylaxis and rota (rotarix) for prophylaxis. concurrent medical conditions included gastroesophageal reflux disease. concomitant products included folic acid. on 21st february 2022, the patient received bexsero (unknown), meningococcal b vaccine pre-filled syringe device, infanrix hexa (unknown) and rotarix (oral). on 21st february 2022, less than a day after receiving bexsero, meningococcal b vaccine pre-filled syringe device, infanrix hexa and rotarix, the patient experienced oesophageal reflux aggravated (serious criteria other: serious as per reporter). on an unknown date, the outcome of the oesophageal reflux aggravated was not recovered/not resolved. it was unknown if the reporter considered the oesophageal reflux aggravated to be related to bexsero, meningococcal b vaccine pre-filled syringe device, infanrix hexa and rotarix. this report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. additional details were reported as follows: the intensity of event oesophageal reflux aggravated was severe. concomitant products included infant gaviscon (nos), however it was retained in narrative as it may cause report failure. initial information was received from a consumer via regulatory authority on 27th february 2022: oesophageal reflux aggravated. case narrative: gastroesophageal reflux disease (gerd) worsened severely adverse reaction did not occur as a result of an exposure during pregnancy

Données de laboratoire
na
Liste des symptômes
gastrooesophageal reflux disease condition aggravated
Patient décédé?
Non
Date de décès
N/A
Anomalie congénitale
false
Vaccin administré par :
Unknown
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
gastroesophageal reflux disease