Zurueck zur Suche

Reporte zur Charge U6890AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 1 VA 1

VAERS 1129887

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6890AA

gering
Staat
CA
Alter
2,0
Geschlecht
F
Eingang
24.03.2021
Impfdatum
19.02.2021
Beginn
19.02.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation error

Symptomtext

they gave a Pentacel without the Diluent ,No AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Global Medical Information(Reference number- 00487716) and transmitted to Sanofi on 22-FEB-2021. This case involves a 2 year old female patient who received DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) without the Diluent, (batch number U6890AA,expiry date 22-mar-2022 ) via Intramuscular route in unknown administration site for prophylactic vaccination on 19-Feb-2021(Product preparation issue). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of an actual medication error due to active ingredient not added to diluent(latency same day). At the time of report, 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 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
Product preparation error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1025315

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6890AA

gering
Staat
VA
Alter
0,6
Geschlecht
M
Eingang
12.02.2021
Impfdatum
27.01.2021
Beginn
27.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

A patient received only the liquid portion of Pentacel without reconstituting, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Regulatory Authority (Reference number- 00448757) and transmitted to Sanofi on 27-Jan-2021. This case involves a seven-month-old male patient who received only the liquid portion of pentacel without reconstituting the Hib powder portion (product preparation issue), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) and NA (sodium). On 27-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6890AA and expiry date: 08-Mar-2022) via an unknown route in right thigh for prophylactic vaccination. This was a case of actual medication error due to inappropriate reconstitution technique (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 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR; ROTAVIRUS VACCINE; FLUZONE QUADRIVALENT; NA
Allergien
-
Vorherige Impfungen
-