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Reporte zur Charge UJ527AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OH 2 OR 1

VAERS 2404217

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ527AA

gering
Staat
OH
Alter
1,3
Geschlecht
F
Eingang
08.08.2022
Impfdatum
29.07.2022
Beginn
29.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

expired dose of pentacel being administered with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 months old female patient who was administered expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Pentacel) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and varicella zoster vaccine (Varicella vaccine) for Prophylactic vaccination. On 29-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml total (lot UJ527AA, expiry date: 22-Jul-2022, lot: U6986AA, expiry date: 22-Jul-2022) via intramuscular route in unknown administration site for immunisation. On 29-Jul-2022 the expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) was being administered with no reported adverse event (expired product administered)to the patient (same day latency). Action taken: Not applicable. Outcome: Unknown for the event expired dose of pentacel being administered with no reported 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2298868

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ527AA

gering
Staat
OR
Alter
0,2
Geschlecht
F
Eingang
27.05.2022
Impfdatum
27.05.2022
Beginn
27.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Administration error: prevnar 20 given instead of prevnar 13. Prevnar 20 lot: FJ2605

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1864362

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ527AA

gering
Staat
OH
Alter
0,5
Geschlecht
M
Eingang
12.11.2021
Impfdatum
27.10.2021
Beginn
27.10.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

Patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference number 0083849). This case involves a 6 months old male patient who was given the dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], but not the acthib portion (product preparation issue). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE (lot numbers and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date. On 27-Oct-2021, the patient received a 0.5 ml third standard dose in total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once , lot UJ527AA and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination (the caller stated that she had the same lot and expiration date for both components of the PENTACEL vaccine). It was an actual medication error case due to inappropriate reconstitution technique (same day latency). It was reported "Nurse reported that a patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion. The caller would like to speak with someone about obtaining the diluent portion of ActHIB. Caller declined to provide her email address. I referred the caller to the PENTACEL reconstitution video. I spoke with a Pasteur Customer Service Representative and they will contact the caller." No treatment required post administration was provided to the patient. At time of reporting, no adverse event was reported and the outcome was unknown for the 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
-
Allergien
-
Vorherige Impfungen
-