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Reporte zur Charge UJ382AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
OR 1 HI 1 SD 1 ID 1

VAERS 2020335

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ382AA

gering
Staat
OR
Alter
4,0
Geschlecht
F
Eingang
10.01.2022
Impfdatum
08.04.2021
Beginn
08.04.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation issue

Symptomtext

This case involves a 4 years old female patient who received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib 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 MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination. On 08-Apr-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ382AA via intramuscular route in unknown administration site. On 08-APR-2021 the patient developed a non-serious received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib (product preparation error) 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 (received the PENTACEL vaccine on 08Apr2021 but did not use the proper diluent for the ACT-HIB). At time of reporting, the outcome was Unknown for the event received the pentacel vaccine on 08apr2021 but did not use the proper diluent for the act-hib. 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
MENACTRA; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1776005

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ382AA

gering
Staat
HI
Alter
0,2
Geschlecht
M
Eingang
11.10.2021
Impfdatum
06.10.2021
Beginn
06.10.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Patient received a dose of Pentacel on 06OCT2021 that expired on 01OCT2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00801434) and transmitted to Sanofi on 06-Oct-2021. This case involves a 2-month-old male patient received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] on 06oct2021 that expired on 01oct2021 (expired product administered). Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. On 06-Oct-2021, the patient received first 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ382AA and expiry date: 01-Oct-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered). It was reported "Caller wished to report this event and receive information on how to proceed". This case was an actual medication error due to expired vaccine used (latency: same day). At the time of reporting, no 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTAVIRUS VACCINE; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 1656381

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj382aa

gering
Staat
SD
Alter
0,7
Geschlecht
F
Eingang
30.08.2021
Impfdatum
30.08.2021
Beginn
30.08.2021
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered Incorrect product formulation administered

Symptomtext

EXPIRED HEPATITIS B VACCINE GIVEN TO PT PENTACEL DILUTANT GIVEN TO PT WITHOUT IMMUNE MIXED IN.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
none
Vorgeschichte
no
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 976981

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ382AA

gering
Staat
ID
Alter
0,2
Geschlecht
M
Eingang
27.01.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

received a dose of Pentacel after it was exposed to a temperature excursion of 22.7?F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418447) and transmitted to Sanofi on 06-Jan-2021. This case is linked with 2021SA005526, 2021SA006645 (same reporter). This case involved a 2 months old male patient who received a 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ382AA, expiration date: 01-Oct-2021) once via unknown route at left vastus lateral for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked. It was an actual medication error due to product storage error temperature too low. The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. The reporter wanted to know how they should proceed and if they should revaccinate the patient. Doctor/emergency room visit on 05-Jan-2021. No adverse event reported to the patient at the time of reporting. 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
Product storage error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-