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Reporte zur Charge UJ834AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 2 CA 2 SC 2 NH 1

VAERS 2717923

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
NH
Alter
2,0
Geschlecht
M
Eingang
27.11.2023
Impfdatum
10.11.2023
Beginn
10.11.2023
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 error

Symptomtext

Medical Assistant recosntituted ACTHIB with sterile water instead of its diluent with no reported adverse event; Initial information was received on 17-Nov-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 years old male patient who experienced medical assistant recosntituted HIB (PRP/T) VACCINE [ACT-HIB] with sterile water instead of its diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Nov-2023, the patient received 0.5 ml of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ834AA and expiry 23-Feb-24) medical assistant recosntituted acthib with sterile water instead of its diluent with no reported adverse event (product preparation error) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization). 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 and Regulatory Authority 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2707637

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
CA
Alter
1,0
Geschlecht
M
Eingang
31.10.2023
Impfdatum
24.10.2023
Beginn
24.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product preparation error Single component of a two-component product administered

Symptomtext

MA administered diluent without mixing with vaccine powder. Patient left without showing any symptoms of adverse reactions. No adverse events.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NONE
Vorgeschichte
NA
Andere Medikamente
NA
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2701613

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
TX
Alter
1,0
Geschlecht
M
Eingang
25.10.2023
Impfdatum
25.10.2023
Beginn
25.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Wrong product administered

Symptomtext

INCORRECT VACCINE ADMINISTRATION 10/25/2023 @ 1:30PM- Staff SPOKE WITH MOM AND EXPLAINED ANY POSSIBLE REACTIONS AND MOM DID CONFIRM PATIENT DOING OK AS OF NOW, WILL FOLLOW UP WITH PATIENT AGAIN AND REPORT ANY CHANGES ASAP

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

VAERS 2696541

GLAXOSMITHKLINE BIOLOGICALS · DTAP + IPV (KINRIX) · Charge UJ834AA

gering
Staat
CA
Alter
1,8
Geschlecht
M
Eingang
16.10.2023
Impfdatum
13.10.2023
Beginn
01.10.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

NONE

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
TRIAMCINOLONE ACETONIDE 0.025% OINTMENT 1 APPLICATION EXTERNALLY TWICE A DAY
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2686167

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
SC
Alter
0,5
Geschlecht
F
Eingang
25.09.2023
Impfdatum
06.09.2023
Beginn
06.09.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C (with no reported adverse event); vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event); Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6-month-old female patient and is reported vaccine HIB (PRP/T) vaccine [ACT-HIB] who experienced excursion lasted for 19 hours and the thermometer showed the lowest cold reading as negative 2.2 c was deemed not suitable as of today and they just realized that the same vaccine had been administered (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, 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 (immunization). On 06-Sep-2023, the patient received a dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ834AA expiry date: 23-Feb-2024 via intramuscular route in the thigh not specified for Immunization and excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c (with no reported adverse event) (product storage error). On 06-SEP-2023 vaccine was deemed not suitable as of today and they just realized that the same vaccine had been administered (with no reported adverse event) (poor quality product administered) on the same day following the administration of HIB (PRP/T) Vaccine. Reported that they had a temperature excursion for ACTHIB on 30Aug2023. They had a hurricane coming and they didn't have an extra fridge to transfer the vaccine into, so someone packed the vaccines in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C. Action taken was not applicable. At time of reporting, the outcome was Unknown for the events. 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
PEDIARIX; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 2684863

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
SC
Alter
0,2
Geschlecht
M
Eingang
21.09.2023
Impfdatum
06.09.2023
Beginn
06.09.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event; the same vaccine had been administered to 2 patients with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2-months-old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post the excursion that lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c 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, 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 30-Aug-2023, suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ834AA; expiry date: 23-Feb-2024), was packed in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event (product storage error) (unknown latency). On 06-Sep-2023, the patient received 0.5 mL dose of same suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ834AA; expiry date: 23-Feb-2024) via intramuscular route in the thigh NOS (not otherwise specify) for immunization post temperature excursion with no reported adverse event (poor quality product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for both the events. 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
PEDIARIX; PREVNAR
Allergien
-
Vorherige Impfungen
-

VAERS 2684600

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ834AA

gering
Staat
TX
Alter
0,5
Geschlecht
M
Eingang
21.09.2023
Impfdatum
12.09.2023
Beginn
12.09.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Discontinued product administered

Symptomtext

Covid vaccine was administered before receiving notice to discard all bivalent covid vaccines

Weitere VAERSDATA-Felder
Praegender Schweregrund
Discontinued product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-