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Reporte zur Charge UJ389ABA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 1387909

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ389ABA

gering
Staat
OH
Alter
1,5
Geschlecht
F
Eingang
10.06.2021
Impfdatum
28.05.2021
Beginn
28.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

HCP accidentally grabbed Pentacel instead of Daptacel by mistake and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious was received from other healthcare professional via Medical Information (Reference number- 00620295) and transmitted to Sanofi on 28-May-2021. This case involves an 18 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389ABA and expiry date: 09-Oct-2021) via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) (wrong product administered) for prophylactic vaccination as administrator accidentally grabbed wrong vaccine by mistake on 28-May-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation. The reporter asked if receiving the extra Ipol and ActHIB will harm the patient. Reporter also asked what side effects she should look out for. As it turned out it was also time for the ActHIB, however the next Ipol vaccine is not due until ages 4-6 years of age. They stated that Stated that a patient was given pentacel but the patient only needed the dTap. It was an actual medication error case due to wrong vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event. 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
HEPATITIS A VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1340542

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ389ABA

gering
Staat
NY
Alter
1,3
Geschlecht
F
Eingang
22.05.2021
Impfdatum
12.05.2021
Beginn
12.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

A patient received Daptacel and Pentacel on same day, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598259) and transmitted to Sanofi on 12-May-2021. This case involves a 15-month-old female patient who received 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ389ABA and expiry date not reported) via an unknown route in the right thigh, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via an unknown route in the left thigh for prophylactic vaccination on 12-May-2021 (extra dose administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect PREVNAR [PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)] (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination. This was a case of actual medication error case due to extra dose administered (latency same day). 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 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-