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Reporte zur Charge UJ419AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

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

VAERS 1124660

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ419AA

mild
Staat
NM
Alter
0,5
Geschlecht
F
Eingang
22.03.2021
Impfdatum
18.02.2021
Beginn
18.02.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia

Symptomtext

RN administered Pentacel (Dtap/IPV component) in addition to fully reconstituted Pentacel (Dtap-IPV-HIB) vaccine. Provider and family were informed, no treatment indicated. Family reported low grade temp within 24 hours, no additional symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None known
Vorgeschichte
Congenital stenosis of lacrimal duct 09/08/2020 Infant of diabetic mother 08/11/2020 Rh incompatibility reaction 08/11/2020
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1154128

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ419AA

gering
Staat
WA
Alter
0,3
Geschlecht
F
Eingang
01.04.2021
Impfdatum
12.03.2021
Beginn
12.03.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation issue

Symptomtext

The patient was only given the liquid component of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00519175) and transmitted to Sanofi on 15-Mar-2021. This case involves a 4 months old female patient who was only given the liquid component of 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ419AA, expiry date: 08-Mar-2022) via intramuscular route in the right thigh for prophylactic vaccination on 12-Mar-2021 (Product preparation issue) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included oral ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day). The caller stated that a patient was given just the Diluent but not the vaccine and want to know what they need to do now and what were the recommendations. Recently a patient was only given the liquid component of PENTACEL. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTATEQ; PNEUMOCOCCAL VACCINE 13V
Allergien
-
Vorherige Impfungen
-