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Reporte zur Charge UJ437ABB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NY 1 WA 1

VAERS 1653306

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ437ABB

gering
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
3
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

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
-

VAERS 1416556

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ437ABB

gering
Staat
WA
Alter
1,3
Geschlecht
M
Eingang
22.06.2021
Impfdatum
09.06.2021
Beginn
09.06.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation error Product preparation issue

Symptomtext

ActHib vial was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the ActHib vaccine and administered to the patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via physician via regulatory authority (GMI) (reference number- 00636420 and 00636271) and transmitted to Sanofi on 10-Jun-2021. This case involves a 15 month old male patient who received 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] [lot number: UJ437ABB, expiry date: 03-May-2022, total, drug interval dosage: once] via intramuscular route at the right thigh, on 09-Jun-2021, for prophylactic vaccination which was inadvertently mixed with a Merck vaccine diluent, rather than the diluent that is supplied with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13). It was a case of actual medication error due to wrong diluent used. (Latency: on the same day) At the time of report, reporter wanted to know the recommendations on what to do will be upon that ACT-HIB was reconstituted with the wrong diluent, that for a Merck vaccine, rather than the supplied diluent, and then administered to the patient and additionally asked how to proceed. At the time of report, reporter wanted to the protocol/side effect of giving Hib reconstituted with Merck diluent and wanted to know if patient need to revaccinated. At the time of report, no adverse event reported. At the time of report, event outcome was not applicable. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-