VAERS 1653306
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ434ABA
- Staat
- NY
- Alter
- 2,0
- Geschlecht
- M
- Eingang
- 29.08.2021
- Impfdatum
- 27.07.2021
- Beginn
- 27.07.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / -
Symptomtext
A temperature excursion of unopened PENTACEL and ACT-HIB at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes, the patient had been given ACTHIB post-excursion/ No AE; Initial information was received on 05-Aug-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via phone (under Global medical information (GMI) Inquiry Number: 00712270 and 00712270). This case involves a 25 months old male patient. This case involves a temperature excursion of unopened DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] lot UJ434ABA, expiry date: 08-MAR-2022 and HIB (PRP/T) VACCINE [ACT-HIB] at 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes that occurred 11-Jun-2021, and the patient had been given ACT-HIB vaccine post-excursion (product storage error). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination. On 27-Jul-2021, the patient received a 0.5 ml third dose of suspect HIB (PRP/T) VACCINE lot UJ437ABB, expiry date: 03-MAY-2022, frequency: once, strength: standard via intramuscular route in the left thigh for prophylactic vaccination. Emergency Room/ Doctor visit and date: 27-Jul-2021. It was a case of an actual medication error due to product storage error temperature too low (latency: same day). It was reported "Medical assistant reported temperature excursion for unopened: PENTACEL and ACTHIB reported several temperature excursions: first was 46.7 Fahrenheit for total excursion of 30 minutes, second was 46.5 Fahrenheit for total excursion of 30 minutes and third was 46.5 degrees Celsius for total excursion of 30 minutes cause of temperature excursions is unknown. Medical assistant asking for stability information. Caller reports she had called previously regarding a temperature excursion. Caller states that she needs to report another temperature excursion that occurred 11-Jun-2021, temperature excursion was for unopened: PENTACEL and ACTHIB temperature excursion was 30.7 Fahrenheit for total excursion of 1 hour and 30 minutes. Caller does report that a patient has been given ACT-HIB post-excursion. Product used, First time product used: No". At the time of reporting, no adverse event was 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 by the regulatory authority. 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
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- HEPATITIS A VACCINE
- Allergien
- -
- Vorherige Impfungen
- -