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Reporte zur Charge UJ207AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
HI 1 SD 1

VAERS 1387846

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ207AA

gering
Staat
HI
Alter
3,0
Geschlecht
M
Eingang
10.06.2021
Impfdatum
18.05.2021
Beginn
18.05.2021
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 No adverse event

Symptomtext

An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00609798) and transmitted to Sanofi on 20-May-2021. This case involves a 3 years old male patient who received fourth dose 0.5 mL HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (frequency: once, batch number: UJ207AA and expiry date : 30-Apr-2021 via an intramuscular route at an right thigh administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination. Reporter want to know what need to know and which actions to take for the affected donors. Caller requested information to provide to mother of patient. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1384853

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ207AA

gering
Staat
SD
Alter
2,0
Geschlecht
F
Eingang
09.06.2021
Impfdatum
21.05.2021
Beginn
21.05.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Inappropriate schedule of product administration No adverse event

Symptomtext

a patient was administered an expired dose of ACT-HIB vaccine/ No AE; a two years old patient was administered a second dose of ACT-HIB vaccine/ No AE; Initial information received on 21-May-2021 regarding an unsolicited valid non-serious case received from nurse via phone via Medical Information (Reference number- 00611667). This case involves a two years old female patient who was administered an expired 0.5 ml second dose of suspect vaccine HIB (PRP/T) VACCINE [ACT-HIB] Frequency: Once, Strength: Standard [lot UJ207AA, expiry date 30-Apr-2021] via intramuscular route in the right thigh on 21-May-2021 for prophylactic vaccination (expired product administered and inappropriate schedule of product administration). The patient's medical history, medical treatments, vaccinations 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], PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) [PCV13] and INFLUENZA VACCINE [FLU] vaccine for prophylactic vaccination. It was an actual medication error case due to expired vaccine used and drug dose administration interval too long (latency: same day). Potential Product Technique Complain: No, Caller stated that she gave and expired ACT-HIB vaccine to patient. Caller would like to know what to do at this point. Confirmed nurse question about an expired dose of ACTHIB that was given. Nurse explained what happened and provider told her to repeat the ACT-HIB dose. Patient was in late with her vaccines. No further information was provided. 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 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 CONJ 13V (CRM197); FLU
Allergien
-
Vorherige Impfungen
-