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Reporte zur Charge UJ842AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

7Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 3 TX 1 KY 1 MN 1

VAERS 2723172

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ842AA

gering
Staat
TX
Alter
0,8
Geschlecht
M
Eingang
12.12.2023
Impfdatum
09.12.2023
Beginn
09.12.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

No adverse events or reactions.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None per guardian
Vorgeschichte
None per guardian
Andere Medikamente
None per guardian
Allergien
No known allergies per guardian
Vorherige Impfungen
-

VAERS 2687473

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ842AA

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
27.09.2023
Impfdatum
19.07.2023
Beginn
19.07.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

A patient received PENTACEL and VAXELIS at the same time; This non-serious spontaneous safety report, with reference number 2023SA223707 was received by a partner on 20-JUL-2023 and forwarded to company on 23-JUL-2023 from a health professional. Due to the nature of the event, the causality between the events "A patient received PENTACEL and VAXELIS at the same time" and Vaxelis was not applicable. Further information is expected. Significant follow-up information was received by company on 14-AUG-2023, from an HCP. The case is maintained as non-serious. The causal relationship between Vaxelis and the reported event " A patient received PENTACEL and VAXELIS at the same time "was assessed as Not applicable due to the nature of the event. No further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2673686

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ842AA

gering
Staat
CA
Alter
1,1
Geschlecht
M
Eingang
18.08.2023
Impfdatum
18.08.2023
Beginn
18.08.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration

Symptomtext

Patient was given fourth dose in the series prematurely after incorrect interpretation of the vaccine chart.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
N/A
Allergien
-
Vorherige Impfungen
-

VAERS 2663475

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ842AA

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
31.07.2023
Impfdatum
19.07.2023
Beginn
19.07.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Vaccine coadministration

Symptomtext

patient received PENTACEL and VAXELIS at the same time with no reported adverse event; Initial information received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 4 months old female patient who received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (MENIGOCOCCAL PROTEIN), Pertussis vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus vaccine Toxoid (VAXELIS) at the same time 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), HIB vaccine CONJ (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (VERO), Tetanus Vaccine Toxoid (Vaxelis) and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) both for Prophylactic vaccination. On 19-Jul-2023, the patient received 0.5ml dose (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ842AA and expiry: 22-Feb-2024 via intramuscular route in the right vastus lateralis for immunization and at the same time the patient received Vaxelis with no reported adverse event (vaccine coadministration) (Latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event vaccine coadministration.

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

VAERS 2656651

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ842AA

gering
Staat
-
Alter
1,3
Geschlecht
M
Eingang
14.07.2023
Impfdatum
11.07.2023
Beginn
11.07.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

administered the liquid portion of the PENTACEL, but not the powder with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 15 months old male patient who was administered the liquid portion of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], but not the powder 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 pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination. On 11-Jul-2023, the patient received 0.5 mL dose 4 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ842AA; Expiry date: 22-Feb-2024) via intramuscular route in the left thigh for immunization, the liquid portion of the pentacel, but not the powder with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event administered the liquid portion of the pentacel, but not the powder 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 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649659

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj842aa

gering
Staat
KY
Alter
-
Geschlecht
U
Eingang
27.06.2023
Impfdatum
19.05.2023
Beginn
19.05.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

The patient received a dose of Vaxelis and a dose of Pentacel on 5/19/23; This non-serious spontaneous safety report, with Case ID: 02400302 (Interaction number 02400301), was received by partner on 05-JUN-2023 and forwarded to agency on 05-JUN-2023 from other health professional. The causality assessment between Vaxelis and the reported event "The patient received a dose of Vaxelis and a dose of Pentacel on 5/19/23" was assessed as not applicable due to the nature of the event. Further information is expected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2649063

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ842AA

gering
Staat
MN
Alter
-
Geschlecht
U
Eingang
24.06.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product lot number issue Single component of a two-component product administered

Symptomtext

only the Dtap-IPV being administered without HIB component with no reported adverse event; Initial information received on 19-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had only the DTAP-IPV being administered without HIB component with no reported adverse event for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ842AA, expiry date- 11-FEB-2024) (with an unknown dosage, strength) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient developed a event of only the DTAP-IPV being administered without HIB component with no reported adverse event (single component of a two-component product administered) (latency- same day)) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine. Reportedly, Due to patient safety concerns with the two different vials DTap-IPV (blue cap) and Hib (green cap) in one box with no attachment for administering staff to be alerted, we have always documented the lot numbers of both vials DTap-IPV and Hib separately to confirm both vials have been given in one dose. Now it has been noted both vials (blue cap and green cap) have the same lot number causing additional concerns for patient safety. Is there a reason for this change? Why are the vials not banded or shrink wrapper together? is Vaxelis going to soon replace the 15 month dose of Pentacel. Action taken was not applicable. 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-