VAERS 1349705
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ416AA
- Staat
- NY
- Alter
- 0,4
- Geschlecht
- F
- Eingang
- 26.05.2021
- Impfdatum
- 15.05.2021
- Beginn
- 15.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- OT / LL
Symptomtext
a patient received a dose of Pentacel vaccine that had been at a temperature of greater than 77 F for 12 hours/ No AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case received from a Nurse educator via physician via Medical Information (Reference number- 00603828). This case involves a five months old female patient who received a 0.5 ml third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that had been at a temperature of greater than 77 f for 12 hours lot UJ416AA, expiry date: 22-MAR-2022, frequency: once, strength: standard via intramuscular route in the left thigh (left quadriceps) on 15-May-2021for prophylactic vaccination (product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via oral route for prophylactic vaccination respectively. It was an actual medication error due to incorrect product storage (latency same day). Potential Product Technique Complain: No. At the time of report no adverse event was reported. No causality not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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
- Medication error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PREVNAR; ROTATEQ
- Allergien
- -
- Vorherige Impfungen
- -