VAERS 2708001
UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ859AA
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- F
- Eingang
- 01.11.2023
- Impfdatum
- 19.10.2023
- Beginn
- 19.10.2023
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / RL
Symptomtext
stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; stated that PENTACEL was mixed with the solution part of the ACT-HIB and was administered incorrectly with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received via nurse. This case involves a 1-year-old female patient and the reporter stated that diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination. On 19-Oct-2023, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ859AA, 02-Apr-2024) via intramuscular route in the right thigh for Immunization and reporter stated that pentacel was mixed with the solution part of the act-hib and was administered incorrectly with no reported adverse event (product preparation error and poor quality product administered) (latency: same day) It was reported, preparation and administration of PENTACEL that was mixed with a saline diluent of ACT-HIB. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- DAPTACEL
- Allergien
- -
- Vorherige Impfungen
- -