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Reporte zur Charge UJ465AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

5Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 2 OH 1 CA 1 VA 1

VAERS 2031880

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AA

kritisch
Staat
OH
Alter
0,2
Geschlecht
M
Eingang
13.01.2022
Impfdatum
28.12.2021
Beginn
30.12.2021
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Death

Symptomtext

Healthcare Professionals are unsure of adverse events. Family called into office to say that patient had passed away on 12/30/2021. Patient was evaluated on 12/28/2021 by Dr. at 2 month check up and then received 2 month vaccines at same time. Please contact family for more information regarding adverse event.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none known
Vorgeschichte
none known
Andere Medikamente
poly-vi-sol drops
Allergien
none known
Vorherige Impfungen
-

VAERS 1818894

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj465aa

mild
Staat
CA
Alter
0,2
Geschlecht
M
Eingang
26.10.2021
Impfdatum
26.10.2021
Beginn
26.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Cyanosis Pallor Rash

Symptomtext

Baby developed rash on the thighs and on the abdomen and Baby looked pale and lips turned slightly purple and baby got her color back after 3-4 minutes and initial O2sat was 85 and wen t up to Sat: 100 % and HR: 140/mt and baby returned to normal color and rash disappeared Possible immediate allergic reaction to vaccines Called EMS and baby is sent to ER for observation

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
umbilical hernia Macrocephaly
Andere Medikamente
none
Allergien
no known
Vorherige Impfungen
-

VAERS 2322961

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AA

gering
Staat
MI
Alter
0,8
Geschlecht
M
Eingang
17.06.2022
Impfdatum
25.05.2022
Beginn
25.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired dose of pentacel administered to a patient with no reported adverse event; Initial information received on 02-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 9-month-old male patient who administered expired dose of pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunisation. On 25-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine unknown: strength and formulation, lot UJ465AA, expiry date: 21-MAY-2022, frequency: once, via intramuscular route in the left thigh as immunization. On 25-MAY-2022 the patient developed a non-serious event expired dose of pentacel administered to a patient with no reported adverse event (expired product administered) latency: same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (expired product administered). At time of reporting, the outcome was Unknown for the event expired 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2306885

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AA

gering
Staat
MI
Alter
0,7
Geschlecht
F
Eingang
02.06.2022
Impfdatum
25.05.2022
Beginn
25.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Patient was inadvertently given an expired vaccine that was not physically taken out from inventory. No adverse effects have been report from patient's mother as of today. Staff member that gave the vaccine has not yet contacted the mother yet but is planning to do so. Sanofi has been contacted and recommended that vaccine be given again as soon as possible.

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

VAERS 1950824

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ465AA

gering
Staat
VA
Alter
3,0
Geschlecht
M
Eingang
15.12.2021
Impfdatum
02.12.2021
Beginn
02.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

the diluent was given without the actual drug mixed into it/ no AE; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case received from physician via call center via Medical Information (MI) (Reference number- 00883763). This case involves a 3-year-old male patient who received the diluent portion without mixing of actual drug (powder) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Product preparation issue). The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination. On 02-Dec-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (diluent: lot number: UJ465AA and expiry date: 21-May-2021) (Powder: lot number: U6940BA and expiry date: 21-May-2021) via an intramuscular route in the right arm for prophylactic vaccination. It was an actual medication error case due to Inappropriate reconstitution technique (latency: same day). It was reported "he diluent was given without the actual drug mixed into it, Is there any harm in that? Should they proceed with giving another dose immediately?; Nurse asking if the diluent was just given , Will I need to give the vaccine again and is there any harm for just giving the diluent?" 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 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
HEPATITIS A; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-