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Reporte zur Charge UJ390AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 2

VAERS 1387908

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ390AAA

gering
Staat
TX
Alter
0,5
Geschlecht
M
Eingang
10.06.2021
Impfdatum
24.05.2021
Beginn
24.05.2021
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

Patient was given PENTACEL and a separate DTAP vaccine (INFANRIX) with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00613527) and transmitted to Sanofi on 24-May-2021. This case involves a 6 months old male patient who received a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiration date: 12-Oct-2021) via intramuscular route in the right thigh and a separate dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number and expiry date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination on 24-May-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Immunisation. The reporter asked for what to look out for and if the patient will be ok. They also questioned on the duplicate DTAP dose and what they need to do and what to expect. It was an actual medication error case due to extra dose 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS B [HEPATITIS B VACCINE]
Allergien
-
Vorherige Impfungen
-

VAERS 1313071

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ390AAA

gering
Staat
TX
Alter
0,2
Geschlecht
F
Eingang
13.05.2021
Impfdatum
03.05.2021
Beginn
03.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

Vaccine was reconstituted the hib with sterile water, instead of the diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00585910) and transmitted to Sanofi on 03-May-2021. This case involves a two-month-old female patient who received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiry date: 29-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination, which was reconstituted the hib part with sterile water, instead of the diluent on 03-May-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. The reporter wanted to know that the revaccination should be needed or not. 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 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
HEPATITIS B VACCINE; PREVNAR; ROTATEQ
Allergien
-
Vorherige Impfungen
-