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Reporte zur Charge UJ327AAB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WI 2 PA 1 NJ 1

VAERS 1033342

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AAB

mild
Staat
PA
Alter
1,2
Geschlecht
F
Eingang
16.02.2021
Impfdatum
15.02.2021
Beginn
16.02.2021
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Urticaria

Symptomtext

Patient's father called into the office around 1:00pm on 2/16/21 stating that patient has broken out in hives across her chest and abdominal area.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None.
Vorgeschichte
None.
Andere Medikamente
None.
Allergien
No Known Drug Allergies.
Vorherige Impfungen
-

VAERS 1653380

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AAB

gering
Staat
WI
Alter
3,0
Geschlecht
F
Eingang
29.08.2021
Impfdatum
16.08.2021
Beginn
16.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

The patient was administrated with an expired Act-hib vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via consumer/non-healthcare professional via Global Medical Information (Reference number- 00726333) and transmitted to Sanofi on 16-Aug-2020. This case involves a 3-year-old female patient who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 16-Aug-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB, expiry: 28-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported "stated that an expired ACT-HIB was given and wants to know what the recommendations would be on the vaccine. stated that she does not have that information" 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 1574243

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AAB

gering
Staat
WI
Alter
3,0
Geschlecht
F
Eingang
16.08.2021
Impfdatum
16.08.2021
Beginn
16.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Gave this vaccine with 2 other immunizations. When I went to chart on the vaccine given I could not find a Lot number. I spoke with the staff member that enters all vaccines and lot numbers, and this is when I realized the HIB vaccine expired on 06/28/2021.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NKA
Vorherige Impfungen
-

VAERS 1466138

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ327AAB

gering
Staat
NJ
Alter
1,5
Geschlecht
M
Eingang
13.07.2021
Impfdatum
29.06.2021
Beginn
29.06.2021
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

Symptomtext

18 month old male patient received expired dose of ACT-HIB vaccine, no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 month old male patient who was vaccinated with an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation. On 29-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ327AAB and expiry date: 28-Jun-2021) (Frequency: once) via an intramuscular route at an unknown administration site (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was also reported that the caller reported giving an ACT-HIB vaccine to a patient. That was within 24 hours after expiration date. No email was provided by caller. Patient Information Patient age greater 1 year enter as 2 month, 4 month etc. Many pediatric vaccines need month for age. Dosage Information: Frequency -once o Therapy Date: From Date of immunization To - leave blank-given 29Jun2021 by caller Route - route and site- intramuscularly 0.5ml Dose - 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ml Strength = standard except for Fluzone HD- standard o Indications -Immunization or TB skin test-immunization. Pregnancy- not applicable Last menstrual period, Due date, AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry. 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
DAPTACEL
Allergien
-
Vorherige Impfungen
-