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Reporte zur Charge UJ529AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
VA 3 AZ 1 MI 1

VAERS 1726417

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AA

schwer
Staat
VA
Alter
0,5
Geschlecht
F
Eingang
23.09.2021
Impfdatum
21.09.2021
Beginn
21.09.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: nein
Blood test Computerised tomogram Electroencephalogram Lumbar puncture Pyrexia Seizure

Symptomtext

Multiple seizures with fever starting evening after receiving vaccine. Has continued to have multiple seizures daily, is attempting to be stabilized on antiseizure medication

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure
Hospital-Tage
2,0
Labordaten
CT scan, LP, multiple blood tests, continuous EEG
Aktuelle Erkrankungen
No illness
Vorgeschichte
Polysyndactyly
Andere Medikamente
Vitamin D supplements, Fe supplements
Allergien
none
Vorherige Impfungen
-

VAERS 1059492

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AA

mild
Staat
AZ
Alter
2,0
Geschlecht
F
Eingang
27.02.2021
Impfdatum
24.02.2021
Beginn
25.02.2021
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Cellulitis Injection site erythema Injection site warmth

Symptomtext

Pt. had large, red, hot development at site of injection that became increasingly large, red and hard 3 days post vaccine. It was over 4 inches in diameter. Pt. given Rocephin injection for potential cellulitis.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Rash on buttocks
Vorgeschichte
No Known
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 2028580

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AA

gering
Staat
MI
Alter
1,0
Geschlecht
M
Eingang
12.01.2022
Impfdatum
10.01.2022
Beginn
11.01.2022
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Wrong product administered

Symptomtext

Pentacel given when only HIB was due. Provider spoke with parent - no known adverse reaction

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

VAERS 1941973

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AA

gering
Staat
VA
Alter
0,2
Geschlecht
M
Eingang
11.12.2021
Impfdatum
01.12.2021
Beginn
01.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

patient received only the liquid DTAP-IPV portion, no AE; Initial information received on 01-Dec-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and nurse via Agency (under reference number 00880090). This case involves a 2 months old male patient who received only the liquid dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue). The patient's medical history, medical treatment(s) and family history were not provided. No other vaccines/ concomitants were given to patient. On 01-Dec-2021, the patient received a 0.5ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number UJ529AA and expiry date 22-Jul-2022, 30-Jun-2022, standard, once) via intramuscular route in the right leg for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique (same day latency). It was reported "Registered Nurse (RN) calling on PENTACEL. Caller states a patient received only the liquid DTAP-IPV portion of the vaccine and would like to know if that is a valid dose? Caller would also like to know if they can still administer the ACTHIB portion separately? Agent directed caller to visit pentacel.com for vaccine preparation guidance." At time of reporting, no adverse event reported. 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 1756423

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ529AA

gering
Staat
VA
Alter
-
Geschlecht
M
Eingang
02.10.2021
Impfdatum
23.09.2021
Beginn
23.09.2021
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 Product preparation issue

Symptomtext

received the DTaP-IPV liquid component of pentacel but not the HIB lyophilized powder component; pentacel was not reconstituted with no reported adverse event; Initial information received on 23-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information number: 00782515. This case involves a Four months old male patient who was received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue). The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 23-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number: UJ529AA and expiry date: 22-JUL-2022 via intramuscular route in the left thigh Prophylactic vaccination respectively. It was case of an actual medication error due to product preparation issue (latency: same day). It was reported that "Office Manager reports that a 4-month old patient received the DTaP-IPV liquid component of PENTACEL but not the HIB lyophilized powder component; PENTACEL was not reconstituted. Caller would like to know if the patient can receive ACTHIB separately. Caller was encouraged to view the PENTACEL Reconstitution video". At the time of reporting, no adverse event was reported. 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
PREVNAR 13; ROTATEQ
Allergien
-
Vorherige Impfungen
-