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Reporte zur Charge UJ351AAB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
FL 1 IN 1 MD 1

VAERS 1935260

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ351AAB

gering
Staat
FL
Alter
75,0
Geschlecht
M
Eingang
09.12.2021
Impfdatum
24.11.2021
Beginn
24.11.2021
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

Symptomtext

patient received an expired Act-Hib with no reported adverse event; Initial information received on 29-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist and other health care professional via regulatory agency (under reference 00875926). This case involves a 75 year old male patient who received 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 vaccination included MENINGOCOCCAL VACCINE and PNEUMOCOCCAL VACCINE (lot numbers and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On 24-Nov-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE (once, lot UJ351AAB and expiry date: 09-Aug-2021) via unknown route in an unknown administration site for prophylactic vaccination (it was stated that they did not document). It was an actual medication error due to expired vaccine used (same day latency). It was reported "The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The caller reported that a patient received an expired Act-Hib and she wanted to know what to do now." 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 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 1744265

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ351AAB

gering
Staat
IN
Alter
0,3
Geschlecht
F
Eingang
29.09.2021
Impfdatum
30.08.2021
Beginn
30.08.2021
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

Symptomtext

ACT-HIB vaccine was given post expiration with no reported adverse event;Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case received from another health care professional and consumer non health care professional via Medical Information number: 00780823. This case involves a Four months old female patient who who was administered an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatments, vaccinations, family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID VACCINE [DTAP] and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. On 30-Aug-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE batch number: UJ351AAB and expiry date: 09-AUG-2021 via intramuscular route in unknown administration site for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "that Medical assistant transferred. Obtained report details from medical assistant. Medical assistant asking if there are any studies regarding expired ACTHIB being administered. Medical assistant asking if the ACTHIB needs to be revaccinated. Medical assistant also asking why Merck would have different information for PedvaxHIB. Note: Contact Name and Contact Details obtained. Obtained and verified email address from medical assistant". At time of reporting, the patient 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
DTAP; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 1653376

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ351AAB

gering
Staat
MD
Alter
1,0
Geschlecht
F
Eingang
29.08.2021
Impfdatum
16.08.2021
Beginn
16.08.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired dose of ACTHIB was administered to a patient, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Global Medical Information (GMI) (Reference number- 00725700) and transmitted to Sanofi on 16-Aug-2021. This case involves a one-year-old female patient who was administered 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) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination. On 16-Aug-2021, the patient received a fourth dose (0.5ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ351AAB; expiry date: 09-Aug-2021) via intramuscular route in the right deltoid for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Caller states that an expired dose of ACT-HIB was administered to a patient on 16AUG2021 and needed to report it. Caller sought information on how to proceed." No adverse events were reported at the time of this report. The outcome of the event was reported as 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 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; DAPTACEL
Allergien
-
Vorherige Impfungen
-