Zurueck zur Suche

Reporte zur Charge UJ137AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OH 1 AR 1

VAERS 1266081

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ137AAA

gering
Staat
OH
Alter
1,3
Geschlecht
F
Eingang
28.04.2021
Impfdatum
16.04.2021
Beginn
16.04.2021
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

A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00564905) and transmitted to Sanofi on 16-Apr-2021. This case involves a 15-month-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB]( lot UJ137AAA and expiry date: 06-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 16-Apr-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination. The caller wanted to know the efficacy and if there are any issues since that expired vaccine was given. 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 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 1149928

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ137AAA

gering
Staat
AR
Alter
0,2
Geschlecht
F
Eingang
31.03.2021
Impfdatum
11.03.2021
Beginn
11.03.2021
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

2 month old female patient administered expired dose of Act-HIB with no reported adverse event; Initial information received on 12-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 month old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, 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) for Immunisation; PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 11-Mar-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ137AAA and expiry date: 06-Mar-2021) via an intramuscular route in the Vastus Lateralis for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that the ActHIB injection was given and it had expired by 5 days and wants to know if any side effects will be had by patient. The patient has not experienced any adverse event (AE) as a result of this. Reporter relationship: health care professional (HCP) Product used: used Still using product: no was Device used: yes 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 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; PNEUMOCOCCAL VACCINE; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-