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Reporte zur Charge UJ358AAB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 1

VAERS 1528279

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ358AAB

gering
Staat
CA
Alter
1,3
Geschlecht
M
Eingang
05.08.2021
Impfdatum
28.07.2021
Beginn
28.07.2021
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

A patient received a expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00701286) and transmitted to Sanofi on 28-Jul-2021. This case involves a 16-month-old male patient who received an expired 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 28-Jul-2021, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot UJ358AAB and expiry date: 27-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination (expired product administered). This was a case of actual medication error due to Expired vaccine used (latency same day). At time of reporting, no adverse events were 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
DAPTACEL; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 1337142

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ358AAB

gering
Staat
-
Alter
0,5
Geschlecht
M
Eingang
21.05.2021
Impfdatum
21.05.2021
Beginn
21.05.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Product administered to patient of inappropriate age Wrong product administered

Symptomtext

no adverse reaction, pt was given the wrong vaccine pt was given PPV 23 and pt was supposed to be given PCV 13

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
administered the wrong vaccination but no harm to pt
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-