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Reporte zur Charge U6899AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
GA 1 UT 1

VAERS 1793450

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6899AA

gering
Staat
GA
Alter
0,2
Geschlecht
F
Eingang
16.10.2021
Impfdatum
30.09.2021
Beginn
30.09.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue Underdose

Symptomtext

just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event; just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component), with no reported adverse event;Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a nurse and consumer/ non-healthcare professional via Media Information (under reference 00794305). This case involves a 2 months old female patient who just received the liquid vial (dtap-ipv component) and it was not mixed with the powder (hib component) of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] [product preparation issue][vaccine underdose]. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 30-Sep-2021, the patient received a first dose of suspect PENTACEL (VERO) [Total, lot number for Powder vial (Hib component): UJ425AA, lot number for Liquid vial (DTaP-IPV component): U6899AA and expiration date: 21-May-2022] via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to Inappropriate reconstitution technique and vaccine underdose(same day latency). It was reported "Nurse states that she has questions about PENTACEL if only half was given. Nurse states that just the liquid vial (DTaP-IPV component) was given to the patient and it was not mixed with the powder (Hib component). Nurse asking if she should give the shot again after mixing it or if she should just give a Hib." At time of reporting, no adverse event 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1692822

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6899AA

gering
Staat
UT
Alter
0,2
Geschlecht
M
Eingang
11.09.2021
Impfdatum
31.08.2021
Beginn
31.08.2021
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

one of the medical assistants gave the Ipol and dtap portion of the pentacel vaccine without giving the hib portion with no reported adverse event; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves a 2-month-old male patient whom "one of the medical assistants gave the IPOL and DTAP portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine without giving the HIB portion" (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. On 31-Aug-2021, the patient received a dose of 0.5 ml suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6899AA, expiry date 05-Feb-2022 via intramuscular route in the left thigh for prophylactic vaccination. It was reported, "Caller stated that a 2-month-old patient was given the Ipol and dtap portion of product and not the Acthib. Caller wanted to know if the ActHIB can be given separately. She also wanted to know if there was any concerns of not given the product with acthib." It was a case of actual medication error due to inappropriate reconstitution technique (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 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-