VAERS 1528281
SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ358AA
- Staat
- WV
- Alter
- 3,0
- Geschlecht
- M
- Eingang
- 05.08.2021
- Impfdatum
- 29.07.2021
- Beginn
- 29.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RL
Symptomtext
patient received an expired dose of ACTHIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00702980) and transmitted to Sanofi on 29-Jul-2021. This case involves a 3-year-old male patient received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX). Medical history, medical treatment, vaccination and family history were not provided. On 29-Jul-2021, the patient received a 0.5 mL first dose of suspect HIB (PRP/T) VACCINE [total, once, strength: standard, UJ358AA, expiry date: 27-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination (expired product administered). (Latency: on the same day) It was a case of actual medication error due to expired vaccine use. It was reported that, "nurse practitioner asked for information regarding administration of expired dose". At the time of report, no adverse event reported. 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
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS A; PREVENAR 13; PEDIARIX
- Allergien
- -
- Vorherige Impfungen
- -