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Reporte zur Charge UJ784AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NH 2 HI 1 DC 1 IL 1

VAERS 2699489

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ784AA

gering
Staat
HI
Alter
0,2
Geschlecht
F
Eingang
20.10.2023
Impfdatum
13.10.2023
Beginn
13.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

given ACT-HIB on 13Oct2023, but the vaccine was already 6 days past its expiration date (with no reported adverse event); Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was given act-hib on 13oct2023, but the vaccine was already 6 days past its expiration date (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 rotavirus vaccine live reassort oral 5V (Rotateq), diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (vero), tetanus vaccine toxoid (Pediarix) and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination. On 13-Oct-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ784AA, expiry date: 07-Oct-2023 via intramuscular route in the left thigh for immunization (strength: unknown) but the vaccine was already 6 days past its expiration date (with no reported adverse event) (expired product administered) (latency same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired product administered. 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
ROTATEQ; PEDIARIX; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 2694001

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ784AA

gering
Staat
NH
Alter
1,1
Geschlecht
M
Eingang
11.10.2023
Impfdatum
09.10.2023
Beginn
09.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Expired ActHIB vaccine administered on 10/9/23. Saline diluent expired 10/7/2023. ActHIB expired 10/8/2023

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
n/a
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2687849

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ784AA

gering
Staat
NH
Alter
2,0
Geschlecht
M
Eingang
28.09.2023
Impfdatum
28.09.2023
Beginn
28.09.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Wrong product administered

Symptomtext

patient given Tdap instead of Dtap during visit. Parent contacted; patient okay no reaction/symptoms.

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

VAERS 2659311

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ784AA

gering
Staat
DC
Alter
1,0
Geschlecht
F
Eingang
21.07.2023
Impfdatum
14.07.2023
Beginn
14.07.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

The provider ordered Dtap, IPV, Hib, Hep B and MMRV but did not specify what brand (combination) to give. The medical assistant confirmed the order and asked if Kinirix (Dtap-IPV) could be used. The provider confirmed the use of Kinirix. The MA gave the vaccine. The MA reported the error on 7/14/23 and the case was reviewed by the lead physician with the provider and MA. Corrective action was taken to ensure the provider writes/documents the specific brand of vaccine or combination of vaccine to be given when writing vaccine orders. The MA was re-educated on the requirement not proceed with any order that is not written with the brand or combination identified, to follow the manufacturer instruction and limitations on age printed on the vaccine box and to contact the lead doctor if she has any question about a vaccine. The patient's mother was notified of the error on 7/17/23. The mother has not reported the patient having any symptoms or signs of any consequence from the vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
None reported
Vorgeschichte
None
Andere Medikamente
None reported
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2641741

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ784AA

gering
Staat
IL
Alter
0,5
Geschlecht
M
Eingang
06.06.2023
Impfdatum
28.04.2023
Beginn
29.04.2023
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Haematochezia Imaging procedure Ultrasound abdomen normal

Symptomtext

Within 24 hours of vaccine administration, Patient developed grossly bloody stools. The bloody stools lasted approximately 2 weeks following vaccine administration. Other causes of bloody stools have thus far been ruled out. A GI consult is pending to clarify source of bleeding.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Haematochezia
Hospital-Tage
-
Labordaten
Ultrasound on 5/1 did not demonstrate intussusception. Scan did not reveal diverticulum.
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
vitamin D
Allergien
none
Vorherige Impfungen
-