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Reporte zur Charge UJ357AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 2 FL 1 MO 1

VAERS 2238004

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AAA

gering
Staat
FL
Alter
-
Geschlecht
U
Eingang
16.04.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
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

It is reported as a medication error due to administration of the vaccine after expiry (with no adverse event); Initial information was received on 08-APR-2022 regarding an unsolicited valid non-serious case received from a non-health care professional via call center. This case involves an unknown age and unknown gender patient who experienced it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event) while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) vaccine (lot UJ357AAA and expiry- 26-JUL-2021) (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for immunization. On an unknown date the patient developed a non-serious "it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event)" (expired product administered) following the administration of HIB (PRP/T) vaccine. Action taken: not applicable. Action taken: not applicable. Outcome: unknown 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1674427

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AAA

gering
Staat
TX
Alter
1,5
Geschlecht
F
Eingang
04.09.2021
Impfdatum
23.08.2021
Beginn
23.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 23-Aug-2021 from an Other health care professional via Agency (Reference number- 00736347) and transmitted to Sanofi on 23-Aug-2021. This case involves an 18-month-old female patient who was given an expired HIB (PRP/T) VACCINE [ACT-HIB] (Expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP). On 23-Aug-2021, the patient received a 0.5 ml (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ357AAA and expiry date 26-Jul-2021] via intramuscular route in left thigh for prophylactic vaccination. It was reported, "A dose of ACT-HIB was given to a child which was expired. Caller is want to know what to do". It was a case of actual medication error due to expired vaccine used (latency was on the same day). At the time of reporting, patient had 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 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
DTAP
Allergien
-
Vorherige Impfungen
-

VAERS 1653354

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AAA

gering
Staat
MO
Alter
1,0
Geschlecht
M
Eingang
29.08.2021
Impfdatum
10.08.2021
Beginn
10.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Patient received an expired dose of ACTHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (GMI) (Reference number- 00718295) and transmitted to Sanofi on 10-Aug-2021. This case involves a 12-month-old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for immunization. On 10-Aug-2021, the patient received a third 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ357AAA and expiry date: 26-Jul-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was reported that "Caller states her son went in for 12 month checkup and immunizations and they gave him expired ACTHIB. Patient received "4 sticks" in total." It was an actual medication error case due to expired vaccine used (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 by the regulatory authority. 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
VARICELLA VACCINE; MMR; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 1391212

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ357AAA

gering
Staat
TX
Alter
0,2
Geschlecht
M
Eingang
11.06.2021
Impfdatum
18.05.2021
Beginn
18.05.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

The vaccine was reconstituted with "sterile diluent"; sterile water instead of co-packed 0.4% saline with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via physician via (Reference number- 00607391) and transmitted to Sanofi on 19-May-2021. This case involves a 2 month old male patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], which was reconstituted with sterile diluent; sterile water instead of co-packed 0.4% saline (lot UJ357AAA, expiry; 25-Jan-2022) via intramuscular route in left leg for prophylactic vaccination on 18-May-2021 (Product preparation error) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was a case of an actual medication error due to Wrong diluent used (latency same day) The caller stated that they used the incorrect dilute for ACTHIB and administered it to a patient. The caller would like to know what steps to take now. But the nurse who prepared the vaccine reconstituted it with sterile diluent; sterile water instead of co-packed 0.4% saline. The vaccine will be repeated No adverse effects 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13
Allergien
-
Vorherige Impfungen
-