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Reporte zur Charge UJ182AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OH 1 FL 1

VAERS 1279446

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ182AAA

gering
Staat
-
Alter
-
Geschlecht
M
Eingang
02.05.2021
Impfdatum
22.03.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
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 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional and a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00559372) and transmitted to Sanofi on 13-Apr-2021. This case involves a 01-year old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered) (lot number: UJ182AAA and expiration date: unknown and lot number: U6685AA and expiration date: 08-Mar-2021] at 0.5 ml dose via intramuscular route in the right thigh for prophylactic vaccination. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP). It was an actual medication error due to expired vaccine used (latency: unknown). At the time of reporting, patient had no adverse event. It was not reported if the patient received a corrective treatment. Disclaimer: 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
PENTACEL; DTAP
Allergien
-
Vorherige Impfungen
-

VAERS 1272209

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ182AAA

gering
Staat
OH
Alter
1,0
Geschlecht
F
Eingang
29.04.2021
Impfdatum
31.03.2021
Beginn
31.03.2021
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 No adverse event

Symptomtext

expired dose of ACTHIB was administered with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case from consumer or non-healthcare professional (MI Inquiry number: 00559284). It was reported that expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ182AAA, expiry date: 08-Mar-2021) (Suspension For Injection) was administered to a one-year-old female patient via an intramuscular route for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS A VACCINE (HEPATITIS A). At the time of report, no adverse event 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 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. . Initial information received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 1 years old female patient who experienced expired dose of acthib was administered with no reported 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. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 31-Mar-2021, the patient received a dose dose of suspect HIB (PRP/T) VACCINE lot UJ182AAA via intramuscular route in unknown administration site. On 31-MAR-2021 the patient developed a non-serious expired dose of acthib was administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE. (Other relevant tests included No lab data.) Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event (expired dose of ACTHIB was administered with no reported adverse event). At time of reporting, the outcome was Not Applicable for the event expired dose of acthib was 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.; Sender's Comments: 00559372:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PENTACEL; MMR; VARICELLA VACCINE; DTAP; HEPATITIS A
Allergien
-
Vorherige Impfungen
-

VAERS 1169021

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ182AAA

gering
Staat
FL
Alter
0,8
Geschlecht
M
Eingang
05.04.2021
Impfdatum
12.03.2021
Beginn
12.03.2021
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

A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00517090) and transmitted to Sanofi on 12-Mar-2021. This case involves a 10-month-old male patient who received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AAA and expiry date: 08-Mar-2021) via an unknown route in left thigh for prophylactic vaccination on 12-Mar-2021. The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE on 12-Mar-2021 for prophylactic vaccination. This was a case of actual medication error due to expired vaccine used (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 holders 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
INFLUENZA VACCINE
Allergien
-
Vorherige Impfungen
-