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Reporte zur Charge UJ162AB

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

9Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
IL 6 MI 1 IN 1

VAERS 930495

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

mild
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
08.01.2021
Impfdatum
04.01.2021
Beginn
04.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site swelling Irritability

Symptomtext

Swelling of thigh at injection site and fussy

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NKA
Vorgeschichte
NKA
Andere Medikamente
Vitamin D
Allergien
NKA
Vorherige Impfungen
-

VAERS 930458

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

mild
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
08.01.2021
Impfdatum
05.01.2021
Beginn
05.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site swelling

Symptomtext

Swelling at injection site

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NKA
Vorgeschichte
NKA
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 930371

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

mild
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
08.01.2021
Impfdatum
05.01.2021
Beginn
05.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Discomfort Injection site swelling Irritability

Symptomtext

Patient had swelling of left leg from hip to thigh as well as fussy and uncomfortable

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKA
Vorherige Impfungen
-

VAERS 1340538

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
MI
Alter
0,5
Geschlecht
M
Eingang
22.05.2021
Impfdatum
26.04.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

he gave a 2 day old expired PENTACEL vaccine to a patient with no reported adverse event; Initial information was received on 06-May-2021 regarding an unsolicited valid non-serious case from a other health professional in the (GMI Inquiry number: 00590857). It was reported that on 26-Apr-2021, a six month old male patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) (lot number: UJ162AB, expiry date: 24-Apr-2021) which was expired 2 days ago via intramuscular at an unknown administration site for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13). At the time of report, 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 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1255767

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
IN
Alter
0,4
Geschlecht
F
Eingang
25.04.2021
Impfdatum
01.03.2021
Beginn
01.03.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

a patient received only the liquid portion of Pentacel/ No AE; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797). This case is linked to case 2021SA128613 (same reporter). This case involves a five months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 01-Mar-2021 for prophylactic vaccination (product preparation issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique (latency: same day). Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none. Reporter relationship: HCP. Product used: Used. At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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 1255764

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
-
Alter
0,6
Geschlecht
F
Eingang
25.04.2021
Impfdatum
25.03.2021
Beginn
25.03.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

only the liquid portion of Pentacel with no reported adverse event; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case received from an other health care professional (HCP) via Medical Information (Reference number- 00542797). This case is linked to case 2021SA110128 (same reporter). This case involves a seven months old female patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] 0.5 ml third dose (batch number: UJ162AB, expiry date: 24-APR-2021, frequency: once, strength: standard) via an unknown route in unknown administration site on 25-Mar-2021 for prophylactic vaccination (product preparation issue). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique (latency: same day). Potential Product Technique Complain: No, Description: Stated that the liquid portion of Pentacel was given to two children and want to know what to do. HCP who reports two patients received the liquid portion of Pentacel. She stated they are unsure which patient received the incorrect dose and asks what to do about potentially giving an extra dose. Treatment: none. Emergency Room/ Doctor Visit and date: none. At the time of report 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 holders compliance with the requirements set out in 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
HEPATITIS B VACCINE; PREVNAR 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1051622

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
24.02.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Peripheral swelling

Symptomtext

severe swelling in the leg from knee to hip; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient (unknown demographic) who experienced severe swelling in the leg from knee to hip (swelling), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. It is unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ162AB and expiry date: not reported) (Suspension for injection) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious severe swelling in the leg from knee to hip (swelling) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown.

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

VAERS 934165

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
11.01.2021
Impfdatum
08.01.2021
Beginn
08.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Feeling abnormal Peripheral swelling

Symptomtext

Mother called in with patient having left thigh swollen and extremely fussy.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Feeling abnormal
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NKA
Vorgeschichte
NKA
Andere Medikamente
Taking Omeprazole 2 MG/ML Suspension 0.7 ml Orally Once a day, Taking Diflucan 10 MG/ML Suspension Reconstituted 3 ml po qd x 1 1.5 ml po qd x 13 days. Orally Once a day, stop date 01/14/2021,
Allergien
NKA
Vorherige Impfungen
-

VAERS 930426

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ162AB

gering
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
08.01.2021
Impfdatum
04.01.2021
Beginn
04.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Irritability Peripheral swelling

Symptomtext

Pt had left thigh swollen from hip to knee. Pt very fussy

Weitere VAERSDATA-Felder
Praegender Schweregrund
Irritability
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
NKA
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-