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Reporte zur Charge UJ525AAB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
AL 2 AZ 1 TX 1 NH 1

VAERS 2408270

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ525AAB

gering
Staat
AZ
Alter
-
Geschlecht
U
Eingang
11.08.2022
Impfdatum
-
Beginn
22.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Fall

Symptomtext

patient was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event involving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ525AAB and expiry date: 11-Jul-2022) via unknown route in unknown administration site for Immunization. It was reported that the patient developed a non-serious event was administered the vaccine, the same form listed an exp date for the product of 11-Jul-2022 with no reported adverse event (expired product administered) (onset date: 22-Jul-2022, latency: same day) following the administration of HIB (PRP/T) VACCINE. They received the vaccination report for the patient and the expiry date listed falls about 11 days before the vaccination was administered. They were asking if we can confirm the expiration date based on the lot number of the product, and how to proceed from here. Reporter does not have the actual product so they cannot see the date on the package, it was located at another pharmacy that administered the vaccine. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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 guidelines. 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 2391111

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ525AAB

gering
Staat
AL
Alter
1,1
Geschlecht
M
Eingang
26.07.2022
Impfdatum
13.07.2022
Beginn
13.07.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

Pt was inadvertently given a vaccine that was 2 days beyond it's expiration date. Patient's mother was informed. Patient had no signs or symptoms of a adverse reaction.

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

VAERS 2387777

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ525AAB

gering
Staat
AL
Alter
1,0
Geschlecht
M
Eingang
24.07.2022
Impfdatum
13.07.2022
Beginn
13.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired ACT-HIB was inadvertently given to a child with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid non-serious case from a healthcare professional. This case involves a 1-year-old male patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given to a child 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 Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. On 13-Jul-2022, the patient received 0.5ml total dose of suspect HIB (PRP/T) VACCINE strength: standard (lot: UJ525AAB; Expiration Date: 11-Jul-2022), Drug Treatment Duration: not applicable, via intramuscular route in the right thigh for Immunization and on the same day expired HIB (PRP/T) VACCINE was inadvertently given to a child with no reported adverse event (expired product administered). It was reported, the caller is wanting to know what to do. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. At time of reporting, the outcome was 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 guidelines. 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 1794432

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ525AAB

gering
Staat
TX
Alter
-
Geschlecht
F
Eingang
18.10.2021
Impfdatum
12.10.2021
Beginn
12.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

ACT-HIB was reconstituted with store water instead of the diluent it came with, no reported adverse event; Initial information received on 12-Oct-2021 regarding an unsolicited valid non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00809033. This case involves a one years old female patient who was received HAEMOPHILUS TYPE B (HIB) VACCINE[ACT-HIB] (product preparation error). The patient's medical history, past medical treatments, vaccinations and family history were not provided.. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) and WATER FOR INJECTION (STERILE WATER) for Immunisation. On 12-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ525AAB and expiry number:11-JUL-2022 via intramuscular route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to Wrong solution used in drug reconstitution (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 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
INFANRIX; STERILE WATER
Allergien
-
Vorherige Impfungen
-

VAERS 1779482

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ525AAB

gering
Staat
NH
Alter
0,3
Geschlecht
M
Eingang
12.10.2021
Impfdatum
12.10.2021
Beginn
12.10.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Wrong product administered

Symptomtext

Patient was seen in office for 4 month visit. Patient received 4 month vaccines, parents requested not to have Hep B administered. Patient should have received DTAP and IPV, however accidentally received Pediarix (DTAP, HepB, IPV) and IPV separately.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-