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Reporte zur Charge UJ359AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MD 1 IL 1

VAERS 1653337

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ359AA

gering
Staat
MD
Alter
0,6
Geschlecht
M
Eingang
29.08.2021
Impfdatum
24.07.2021
Beginn
24.07.2021
Tage bis Beginn
0,0
Dosis
3
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 administered with no adverse event; Initial information received 05-Aug-2021regarding an unsolicited valid non-serious case from the other health professional via Global Medical Information (Reference number- 00712064). This case involves a seven-month-old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 24-Jul-2021, the patient received a third dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AA and expiry date: 11 Jun 2021) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was also reported that, "expired ACTHIB was administered and wanted to know if it's safe for the consumer. Should the consumer be re-vaccinated?" At 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PEDIARIX; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 1489862

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ359AA

gering
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
21.07.2021
Impfdatum
12.07.2021
Beginn
12.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

A child received an expired dose of ACTHIB yesterday with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via regulatory authority (Reference number- 00678904) and transmitted to Sanofi on 12-Jul-2021. This case involves a 2 months old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] yesterday (Expired product administered) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination. On 12-Jul-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ359AA, expiry date: 11-Jul-2021) (Diluent- Lot: U6872AA, Expiration date: 01-Feb-2022, dose of diluent 0.6 ml) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported that "Nurse called to report that an expired dose of a vaccine had been administered today (12JUL2021). The vaccine expired 11-Jul-2021. The caller would like to know if this dose is valid or if the child should be revaccinated?" 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTATEQ; PREVNAR; PEDIARIX
Allergien
-
Vorherige Impfungen
-

VAERS 1483681

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ359AA

gering
Staat
-
Alter
67,0
Geschlecht
U
Eingang
18.07.2021
Impfdatum
12.07.2021
Beginn
12.07.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Product administered to patient of inappropriate age

Symptomtext

This case involves a 67 years old patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered). The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) and POLIO VACCINE (POLIO) (lot number and expiration date not reported) via unknown route and unknown site of administration for prophylactic vaccination. On 12-Jul-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (total, lot UJ359AA and expiry date: 11-Jul-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error case due to expired vaccine used and inappropriate age at vaccine administration (product administered to patient of inappropriate age and expired product administered, latency: same day). The reporter was with the question that what does she do. At the time of reporting, it was unknown whether the patient experienced any 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
PREVNAR; TENIVAC; POLIO
Allergien
-
Vorherige Impfungen
-