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Reporte zur Charge UJ805AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

11Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
LA 2 TX 2 WI 2 GA 2 PR 1 AR 1 NC 1

VAERS 2663995

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

mild
Staat
LA
Alter
0,2
Geschlecht
F
Eingang
31.07.2023
Impfdatum
15.06.2023
Beginn
17.06.2023
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Diarrhoea Faeces discoloured Gastrointestinal pathogen panel Rotavirus test positive Vomiting

Symptomtext

Patient seen on 6/24/2023 c/o black, watery stool X3 weeks with csome vomiting after feedings Ordered GI Panel through test. Resutes came back 07/25/2023 positie ROTAVIORUS

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
GI panel
Aktuelle Erkrankungen
05/23/23 GE Refkux & Seborrhea Dermatitis
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
nkda
Vorherige Impfungen
-

VAERS 2646869

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

mild
Staat
PR
Alter
0,3
Geschlecht
M
Eingang
19.06.2023
Impfdatum
12.06.2023
Beginn
12.06.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Discomfort Fatigue Pyrexia Rash

Symptomtext

Fever, Tiredness, Discomfort and Rash.

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

VAERS 2715662

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

gering
Staat
TX
Alter
0,2
Geschlecht
M
Eingang
20.11.2023
Impfdatum
09.11.2023
Beginn
09.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect dose administered

Symptomtext

As per CDC guidelines, avoid using two 50mg doses for infants weighing (?11 pounds), because 50mg doses should be reserved only for infants weighing (<11 pounds), for example those born during the season who will be at increased risk for severe RSV illness because of their young age. Furthermore, providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant, and health care settings currently experiencing shortages of Beyfortus should prioritize 100mg doses to infants at the highest risk for severe RSV disease. Patient was monitored for 30 minutes after vaccines were administered and did not show any sign of pain, discomfort or adverse reaction. Patient tolerated administration well and was sent home.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
None.
Aktuelle Erkrankungen
None.
Vorgeschichte
None.
Andere Medikamente
Tylenol was given by mother to child before vaccine appointment.
Allergien
None.
Vorherige Impfungen
-

VAERS 2703561

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ805AA

gering
Staat
LA
Alter
1,1
Geschlecht
F
Eingang
27.10.2023
Impfdatum
16.10.2023
Beginn
16.10.2023
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 Product preparation error

Symptomtext

due to not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 months old female patient and stated that the product was not properly reconstituting the lyophilized component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] using the liquid vaccine component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2023, it was reported that only the lyophilized component of PENTACEL was administered to a patient and was not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event (product preparation error) (Suspension for injection) (latency: same day) (lot UJ805AA) (Frequency = once) (Strength = standard) via unknown route in unknown administration site for immunization. It was reported that "Medical assistant stated that the lyophilized component was mixed with a sterile diluent the clinic uses to dilute MMR vaccine. There was no mention of the specific sterile diluent that was used. No further information provided. Sales representative mentioned that the clinic wanted to know what to do next with the situation." Action taken: Not applicable. Outcome: Unknown 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2673627

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ805AA

gering
Staat
WI
Alter
1,8
Geschlecht
F
Eingang
18.08.2023
Impfdatum
31.07.2023
Beginn
31.07.2023
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 Single component of a two-component product administered

Symptomtext

patient only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 22 months old female patient who only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Jul-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ805AA, expiry date: 17-Feb-2024 via intramuscular route at unknown administration site for immunization (strength: unknown), patient only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event (single component of a two-component product administered) (latency same day). Action taken: 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 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2671542

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

gering
Staat
WI
Alter
1,8
Geschlecht
F
Eingang
15.08.2023
Impfdatum
31.07.2023
Beginn
31.07.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect product formulation administered

Symptomtext

During an inventory count on 8/8/23, it was discovered that a patient was only given the liquid part of the Pentacel Vaccine (Dtap/IPV/Hib). The liquid part contains the Dtap/IPV, this is to be mixed with a separate vial of powdered Hib. We were able to trace back the lot number and were able to identify who the patient was that this happened to. A call was placed to the manufacturer on 8/14/23 and it was noted that the Dtap and IPV will count as doses, but that the Hib will need to be redone. Parents will be called and notified of the error.

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

VAERS 2656649

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ805AA

gering
Staat
GA
Alter
6,0
Geschlecht
F
Eingang
14.07.2023
Impfdatum
07.07.2023
Beginn
07.07.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

inadvertently administered Pentacel to a 6 year old with no reported adverse event; Initial information received on 10-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 years old female patient who was inadvertently administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past vaccination(s) included DTP on 05-Aug-2017 and 26-Apr-2022 and IPV (2). The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/merck) (Proquad); and hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination. On 07-Jul-2023, the patient received 0.5 mL dose 3 of suspect diphtheria/ tetanus/ 5 hybrid ac pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (batch number: UJ805AA; Expiry date: 17-Feb-2024) via intramuscular route in the right deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event inadvertently administered pentacel to a 6 year old 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 2649067

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ805AA

gering
Staat
TX
Alter
0,3
Geschlecht
U
Eingang
24.06.2023
Impfdatum
14.06.2023
Beginn
14.06.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Wrong product administered

Symptomtext

pentacel instead of acthib was administered in error with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old and unknown gender patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] instead of HIB (PRP/T) vaccine [ACT-HIB] 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 Rotavirus Vaccine for Prophylactic vaccination, chlorphenamine maleate, naphazoline hydrochloride (Flucur). On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection lot UJ805AA expiry date: 17-feb-2024 via intramuscular route in the right thigh for prophylactic vaccination (immunization) instead of HIB (PRP/T) VACCINE in error with no reported adverse event (wrong product administered) on the same day. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event pentacel instead of acthib was administered in error 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 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; FLUCUR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2648365

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

gering
Staat
GA
Alter
0,3
Geschlecht
F
Eingang
22.06.2023
Impfdatum
20.06.2023
Beginn
20.06.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Inappropriate schedule of product administration Product preparation issue

Symptomtext

The patient needed Polio, DTAP, and HIB. The provider opted to use the combination vaccination Pentacel. During the preparation of the Pentacel vaccine the DTAP and Polio component was drawn up but not combined with the HIB component. The patient was then administered the DTAP and Polio only. The patient's guardian was notified that the patient is missing the HIB component of vaccination. The patient has been scheduled for June 30, 2023 to receive the missing HIB vaccination.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2640953

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

gering
Staat
AR
Alter
0,3
Geschlecht
M
Eingang
05.06.2023
Impfdatum
25.05.2023
Beginn
25.05.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Incorrect product formulation administered No adverse event

Symptomtext

Hib portion of vaccine was not added to DTAP + IPV portion of vaccine. No adverse reactions. Patient to return to clinic for HIB vaccine. Web-IZ updated to reflect only DTaP and IPV administered.

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

VAERS 2638413

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ805AA

gering
Staat
NC
Alter
0,5
Geschlecht
F
Eingang
30.05.2023
Impfdatum
02.05.2023
Beginn
02.05.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Underdose

Symptomtext

Pt inadvertently given inadequate dose of Moderna vaccine, no signs or symptoms of adverse reaction noted

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
soothe drops
Allergien
none
Vorherige Impfungen
-