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Reporte zur Charge UJ843AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

8Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NJ 4 MA 2 VA 1 PA 1

VAERS 2727404

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ843AB

gering
Staat
NJ
Alter
2,0
Geschlecht
M
Eingang
26.12.2023
Impfdatum
18.12.2023
Beginn
18.12.2023
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

patient was given only the DTAP-IPV liquid solution of the PENTACEL without the HIB component with no reported adverse event; Initial information received on 19-Dec-2023 regarding an unsolicited valid non-serious case received via consumer/non-healthcare professional. This case involves a 2-year-old male patient was given only the dtap-ipv liquid solution of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the hib component 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 7V (CRM197) (PREVNAR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. On 18-Dec-2023, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ843AB) via unknown route in unknown administration site for immunization and patient was given only the dtap-ipv liquid solution of the pentacel without the hib component with no reported adverse event (single component of a two-component product administered) (latency: same day). 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
PREVNAR; HEPATITIS B VACCINE; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2713280

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ843AB

gering
Staat
MA
Alter
26,0
Geschlecht
F
Eingang
13.11.2023
Impfdatum
07.11.2023
Beginn
07.11.2023
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product substitution error

Symptomtext

Tdap supply unavailable at time of visit. Support staff chose incorrect substitution (Pentacel) and administered. Staff administering discovered the error at time of administration/documentation. Staff notified provider at time of the event for review/risk assessment. Reporting completed. Patient notified. Patient advised to monitor for s/s of any changes/reaction and to follow up with any s/s changes, or complications. No adverse reaction reported by patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Blepharitis Seborrheic dermatitis of scalp
Vorgeschichte
Chronic Pain in right hip joint Chronic interstitial cystitis Dyspareunia IBS Anxiety
Andere Medikamente
ketoconazole 2 % shampoo clobetasoL 0.05 % scalp solution
Allergien
Penicillins
Vorherige Impfungen
-

VAERS 2667862

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ843AB

gering
Staat
VA
Alter
1,5
Geschlecht
M
Eingang
08.08.2023
Impfdatum
03.08.2023
Beginn
03.08.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Product preparation error

Symptomtext

administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; administered only diluent (DTaP-IPV) at first/diluent not mixed with powder/physician then instructed MA to give a complete Pentacel by mixing a powder with another Pentacel DTaP-IPV diluent/received extra DTaP-IPV with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old male patient who was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] dtap-ipv diluent/received extra dtap-ipv with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Aug-2023, the patient received a dose 4 with dosage 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ843AB, Expiry date: 24-Feb-2024 with unknown strength) via unknown route at unknown site as Immunization. On 03-Aug-2023 the patient was administered only diluent (dtap-ipv) at first/diluent not mixed with powder/physician then instructed ma to give a complete pentacel by mixing a powder with another pentacel dtap-ipv diluent/received extra dtap-ipv with no reported adverse event (product preparation error) and (extra dose administered) same day following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine. It was reported "the patient received extra DTaP-IPV. The record shows the injection site as the left thigh. It does not specify which dose or if both were given in the left thigh. No other vaccines were administered to the patient today." Action taken: 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 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2659974

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ843AB

gering
Staat
MA
Alter
0,3
Geschlecht
F
Eingang
24.07.2023
Impfdatum
11.07.2023
Beginn
17.07.2023
Tage bis Beginn
6,0
Dosis
2
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Haematochezia Irritability Mucous stools Occult blood positive

Symptomtext

Blood and mucous in stool, increased irritability around bowel movements. Positive occult blood test of stool at visit 7/17/23. F/U 7/19/23 - Negative occult blood in stool, still some fussiness Phone f/u 7/24/23 - fully resolved, back to normal self

Weitere VAERSDATA-Felder
Praegender Schweregrund
Haematochezia
Hospital-Tage
-
Labordaten
Occult blood testing x 1 on 7/17/23 and 7/19/23
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
Vitamin D supplement, 400 IU daily
Allergien
none
Vorherige Impfungen
-

VAERS 2656650

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ843AB

gering
Staat
PA
Alter
0,5
Geschlecht
M
Eingang
14.07.2023
Impfdatum
11.07.2023
Beginn
11.07.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Single component of a two-component product administered

Symptomtext

only the liquid component of the vaccine was administered to a patient with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered only the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Jul-2023, the patient was administered a dose of 0.5 ml once of the liquid component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ843AB; expiry date: 24-Feb-2024; strength: standard) (single component of a two-component product administered) (latency: same day) via unknown route in the left thigh for Immunization. There are no adverse event(s) in this case. It was reported, "Nurse called saying that the lyophilized component of PENTACEL wasn't reconstituted using the liquid component, so only the liquid component of the vaccine was administered to a patient. Nurse asked how many Hib's are necessary for the whole series and what should they do next? Nurse also asked if they can use a standalone Hib component to make up for the dose?" 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
-

VAERS 2656647

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ843AB

gering
Staat
NJ
Alter
0,3
Geschlecht
M
Eingang
14.07.2023
Impfdatum
07.07.2023
Beginn
07.07.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

administered Pentacel to a patient, after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTaP-IPV component with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional (nurse). This case involves a 4 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] to a patient and after giving shot nurse realized she was not able to reconstitute Hib component of vaccine, patient only received DTAP-IPV component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. There were no concomitant vaccines administered. On 07-Jul-2023, the patient only received DTAP-IPV component at a dose of 0.5ml (dose 2) of suspect Diphtheria/Tetanus/5 HYBRID AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ843AB and expiry: 24-Feb-2024 (strength: standard and frequency: once) via unknown route in the thigh NOS for immunization and after giving shot nurse realized she was not able to reconstitute HIB component of vaccine, patient only received DTAP-IPV component with no reported adverse event (single component of a two-component product administered) (Latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event single component of a two-component 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2653817

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ843AB

gering
Staat
NJ
Alter
0,3
Geschlecht
M
Eingang
07.07.2023
Impfdatum
07.07.2023
Beginn
07.07.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LG
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue

Symptomtext

The vaccine was not reconstituted so the DTAP/IPV portion of the vaccine was given without any Hib. No side effects were noted at the time of vaccination. Patient was well appearing.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2652848

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ843AB

gering
Staat
NJ
Alter
-
Geschlecht
F
Eingang
05.07.2023
Impfdatum
02.07.2023
Beginn
02.07.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Unevaluable event

Symptomtext

N/A

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MULTIVITAMINS
Allergien
NKA
Vorherige Impfungen
-