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Reporte zur Charge UJ841AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

10Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
AZ 2 CA 2 WA 1 NC 1 IN 1 MO 1 MI 1 KY 1

VAERS 2672682

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

schwer
Staat
WA
Alter
1,3
Geschlecht
M
Eingang
16.08.2023
Impfdatum
21.07.2023
Beginn
21.07.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dyspnoea Febrile convulsion Influenza virus test negative Oxygen saturation decreased Pyrexia SARS-CoV-2 test negative Staring Viral upper respiratory tract infection

Symptomtext

Shortly following, developed fever, then increased work of breathing tmax 100. Then blank/fixed stare, desaturated to 88% Transferred to ER, diagnosed with febrile seizure and viral URI, fever (7/21/23) 7/22/23: Rectal temp 104.1. Fever broke 7/23/22.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
Flu, covid tests negative 7/21/23.
Aktuelle Erkrankungen
Runny nose, Temp 100.2
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
n/a
Vorherige Impfungen
-

VAERS 2705867

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
NC
Alter
0,3
Geschlecht
M
Eingang
30.10.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered

Symptomtext

The child received two Hib vaccines. He received Pedvax HIB and Pentacel (Dtap, Hib, and IPV). Staff has been educated. Dr. has been notified. Employee with Regulatory Authority has been called. Dr. called and spoke with the childs mom to let her know of any signs and symptoms to watch for since the child received 2 doses of hib today.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2679881

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ841AA

gering
Staat
IN
Alter
17,0
Geschlecht
M
Eingang
07.09.2023
Impfdatum
12.07.2023
Beginn
12.07.2023
Tage bis Beginn
0,0
Dosis
UNK
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

17-year old patient was administered the pentacel vaccine with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 17-year-old patient was administered 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 12-Jul-2023, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength (lot: UJ841AA, Expiry date: 19-Feb-2024) via intramuscular route in the right arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was 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 2664239

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
MO
Alter
0,2
Geschlecht
F
Eingang
01.08.2023
Impfdatum
01.08.2023
Beginn
01.08.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event Wrong product administered

Symptomtext

Patient was to receive just Hib but instead was given Pentacel in addition to her scheduled vaccines of pediarix, rotavirus and Prevnar13 which caused her to have an extra dose of DTAP and IPV. Parents notified and no adverse reactions at time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
none
Allergien
n/a
Vorherige Impfungen
-

VAERS 2652098

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
AZ
Alter
0,3
Geschlecht
M
Eingang
03.07.2023
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: ja
Product preparation issue

Symptomtext

Patient was seen in office for vaccines, along with other patients due for the same vaccines. After patient was seen, it was found that there had been a vaccine preparation error with a pentacel. A Pentacel vaccine had not been correctly reconstituted with the Hib component Only the liquid component of the vaccine had been given. Due to the error being found after the fact, our office was not able to pinpoint which of the earlier patients had been affected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation issue
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2652093

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
AZ
Alter
0,4
Geschlecht
F
Eingang
03.07.2023
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: ja
Product preparation error Product preparation issue

Symptomtext

Patient was seen in office for vaccines, along with other patients due for the same vaccines. After patient was seen, it was found that there had been a vaccine preparation error with a pentacel. A Pentacel vaccine had not been correctly reconstituted with the Hib component Only the liquid component of the vaccine had been given. Due to the error being found after the fact, our office was not able to pinpoint which of the earlier patients had been affected.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2650641

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
28.06.2023
Impfdatum
28.06.2023
Beginn
28.06.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product administered to patient of inappropriate age Wrong product administered

Symptomtext

I roomed the patient for a Well Child Check, received report form nurse practitioner. to give the baby the vaccines. withdrew the wrong vaccines. ( pt. needed the pneumococcal 13 and gave them pneumococcal23). realized error after administration and nurse practitioner left. notified MA supervisor about the error. called patient to let them know about the error and the need for vaccination with pneumococcal 13, left voice message.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2616883

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
MI
Alter
0,2
Geschlecht
F
Eingang
18.04.2023
Impfdatum
13.04.2023
Beginn
13.04.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Single component of a two-component product administered

Symptomtext

MA who was administering the Pentacel did not mix both vials that come in the box. Patient was only given the liquid immunization and not the HIB portion.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Single component of a two-component product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NONE
Vorgeschichte
N/A
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2607973

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841aa

gering
Staat
CA
Alter
0,2
Geschlecht
M
Eingang
01.04.2023
Impfdatum
31.03.2023
Beginn
31.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Hypotonia Lethargy Pallor

Symptomtext

Pt is here for follow-up after a vaccine reaction yesterday. He was in his usual state of health. At his 2 month well check he received pentacel, prevnar, and rotateq. After the rotateq he developed gross pallor and lethargy without LOC. No choking. He had no anaphylactic sx. Vital signs were normal. Patient was observed for total of 30 minutes with slow but spontaneous return to baseline. He did well yesterday at home and had been feeding well. This morning he had another pallor episode lasting about 15 mins. His muscle tone seemed decreased. He gradually returned back to baseline.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Hypotonia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
thrush
Vorgeschichte
-
Andere Medikamente
gerber probiotic vitamin D mylicon
Allergien
none
Vorherige Impfungen
-

VAERS 2571790

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ841AA

gering
Staat
KY
Alter
1,5
Geschlecht
M
Eingang
31.01.2023
Impfdatum
25.01.2023
Beginn
25.01.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; DTaP-IPV component of PENTACEL was administered without the Hib component with no reported adverse event; Initial information was received on 25-Jan-2023 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 18 months old male patient, the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered 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. On 25-Jan-2023, the patient received a booster 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component (lot number: UJ841AA, expiry date: 19-Feb-2024) via intramuscular route in the right thigh for immunisation with no reported adverse event (product preparation error) and (incorrect dose administered) (latency: same day) No lab data reported. Action taken: not applicable. Outcome: 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.; Sender's Comments: 01462770:

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