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Reporte zur Charge U7251AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MT 2

VAERS 2616527

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7251AA

gering
Staat
MT
Alter
0,7
Geschlecht
F
Eingang
18.04.2023
Impfdatum
28.03.2023
Beginn
28.03.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Poor quality product administered

Symptomtext

ACT-HIB was mixed with an expired diluent and was administered to a patient with no reported AE; Initial information was received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 8 months old female patient who stated act-hib was mixed with an expired diluent and was administered to a patient with no reported ae after receiving 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 POLIO VACCINE INACT 3V (VERO) (Ipol [POLIO VACCINE INACT 3V (VERO)]) and pneumococcal vaccine 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation. On 28-Mar-2023, the patient received a Dose 2 of 0.5 ml Total of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot U7251AA/UJ647AA, expiration date: 05-Mar-2023/30-Mar-2023) Strength: standard via intramuscular route in Left Quadracipe for prophylactic vaccination (Immunisation). On 28-Mar-2023, the patient developed a non-serious event of ''act-hib was mixed with an expired diluent and was administered to a patient with no reported ae'' (Poor quality product administered) (same day) following the administration of HIB (PRP/T) vaccine. Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the 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 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 2603148

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7251AA

gering
Staat
MT
Alter
1,0
Geschlecht
M
Eingang
24.03.2023
Impfdatum
14.03.2023
Beginn
14.03.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

acthib was administered with an expired diluent with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from nurse. This case involves a 1 years old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) both for Prophylactic vaccination. On 14-Mar-2023, the patient received a dose of 0.5 ml dose 3 of suspect ACT-HIB (Powder and solvent for solution for injection) (Lot: HIB: UJ646AA, DILUENT: U7251AA, Expiry date: HIB: 01APR2023, DILUENT: 05MAR2023) (strength: standard; frequency: once) via intramuscular route in the right thigh for immunization. On 14-Mar-2023 the patient was administered ACT-HIB with an expired diluent with no reported adverse event (expired product administered) (latency: same day). It was reported that Caller with question on whether dose needs repeating. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the 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 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
-