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