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Reporte zur Charge UJ589AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

3Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IN 1 MA 1 IL 1

VAERS 2644342

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ589AA

gering
Staat
IN
Alter
1,0
Geschlecht
F
Eingang
13.06.2023
Impfdatum
01.12.2022
Beginn
01.12.2022
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 Medication error No adverse event

Symptomtext

gave acthib vaccine to a patient in december that was expired in october with no reported adverse event; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] given in december that was expired in october with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Dec-2022 , the patient was given 0.5 ml dose once (1X) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection, (lot UJ589AA: Expiry date: Oct-2022; strength not reported) via unknown route in unknown administration site for Immunization that was expired in october with no reported adverse event (expired product administered) (latency: same day). Action taken : not applicable. Outcome : Unknown. 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 2147465

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ589AA

gering
Staat
MA
Alter
0,5
Geschlecht
F
Eingang
27.02.2022
Impfdatum
21.02.2022
Beginn
21.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue Product reconstitution quality issue

Symptomtext

mixed vaccine with sterile water instead of diluent /reconstituted ACTHIB vaccine with sterile water diluent with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who got mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 21-Feb-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE at a dose of 0.5 mL once (lot-UJ589AA,25-Oct-2022) via intramuscular route in unknown administration site for immunization. On 21-FEB-2022 the patient developed a non-serious event "mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event" (product reconstitution quality issue)(latency-Same day) following the administration of HIB (PRP/T) VACCINE. It was reported "reconstituted ACTHIB vaccine with sterile water diluent instead of 0.4% saline." Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the event mixed vaccine with sterile water instead of diluent /reconstituted acthib vaccine with sterile water diluent with no reported adverse event.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2128690

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ589AA

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
21.02.2022
Impfdatum
20.01.2022
Beginn
20.01.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

reconstituted with sterile water with no reported adverse event; Initial information was received on 14-Feb-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and unknown gender patient who reported reconstitution of vaccine HIB (PRP/T) Vaccine [ACT-HIB] with sterile water 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 Measles, mumps and rubella vaccine (live) (MMR vaccine) as prophylactic vaccination. On 20-Jan-2022, the patient received a dose of suspect HIB (PRP/T) Vaccine (formulation: Powder and solvent for solution for injection, dose: 0.5 ml, 4th dose, lot: UJ589AA, Expiration date: 25Oct2022) (frequency,strength: unknown) via intramuscular route in the right thigh as prophylactic vaccination On 20-JAN-2022 the patient reported reconstitution with sterile water with no reported adverse event (product preparation error) (latency: same day) of HIB (PRP/T) Vaccine. Action Taken: not applicable. At time of reporting, the outcome was Unknown for the event reconstituted with sterile water 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR VACCINE
Allergien
-
Vorherige Impfungen
-