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Reporte zur Charge UJ143AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
UT 2 NY 1 OR 1 FL 1 CA 1

VAERS 2147470

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
NY
Alter
0,3
Geschlecht
M
Eingang
27.02.2022
Impfdatum
22.02.2022
Beginn
22.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Patient received an expired ACTHIB vaccination with no adverse event; Initial information received on 22-Feb-2022 regarding an unsolicited valid non-serious case from patient. This case involves a 3 months old male patient who received an expired ACT-HIB vaccination no adverse event while receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Pertusis vaccine acellular, Tetanus vaccine toxoid (Daptacel); and Rotavirus vaccine for Immunization. On 22-Feb-2022, the patient received 0.5 ml dose of HIB (PRP/T) Vaccine once (lot number: UJ143AA and expiry dates: 03-May-2021)via intramuscular route in the thigh nos for immunization. On 22-FEB-2022 the patient received an expired ACT-HIB vaccination with no adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine. Action taken was not applicable. 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 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 1416724

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
OR
Alter
0,1
Geschlecht
F
Eingang
22.06.2021
Impfdatum
07.06.2021
Beginn
07.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

was given a expired dose of Acthib with no reported adverse event; Initial information was received on 16-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (GMI Inquiry number: 00644081). It was reported that a one-month-old female patient was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Suspension For Injection) (lot number: UJ143AA, expiry date: 22-Mar-2021] via an intramuscular route at right thigh 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 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE (HEPATITIS A). 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
PREVNAR; PROQUAD; HEPATITIS A
Allergien
-
Vorherige Impfungen
-

VAERS 1261842

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
UT
Alter
1,0
Geschlecht
F
Eingang
27.04.2021
Impfdatum
02.04.2021
Beginn
02.04.2021
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

ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559740) and transmitted to Sanofi on 13-Apr-2021. This case is linked to cases 2021SA124061 and 2021SA133014 (same reporter). This case involves an 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 02-Apr-2021. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. No other vaccines received by patient. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021. At the time of reporting, No specific 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 1261841

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
UT
Alter
1,0
Geschlecht
F
Eingang
27.04.2021
Impfdatum
08.04.2021
Beginn
08.04.2021
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 Medication error

Symptomtext

ActHIB mixed/ reconstituted with diluent that expired on 22Mar2021 and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00559563) and transmitted to Sanofi on 13-Apr-2021. This case is linked to case 2021SA124250 and 2021SA133014 (same reporter). This case involves a 1 years old female patient who was administered with expired 0.5 mL dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiry date: 22-Mar-2021) via intramuscular route in the left thigh (expired product administered) for prophylactic vaccination on 08-Apr-2021. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. No other vaccines received by patient. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021. At the time of reporting, No specific 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 1255773

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
FL
Alter
0,5
Geschlecht
M
Eingang
25.04.2021
Impfdatum
07.04.2021
Beginn
07.04.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Product preparation issue

Symptomtext

patient received ACT-HIB which was reconstituted with expired diluent/no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 06-Apr-2021 from a health care professional (medical assistant) (Reference number- 00550125) and transmitted to Sanofi on 07-Apr-2021. This case involves a 6 month-old male patient who was vaccinated with 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with expired diluent (batch number UJ143AA; expiry date 03-May-2021 and expiry date of diluent 22-Mar-2021) via an unknown route at an unknown administration site on 07-Apr-2021 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. It was also reported that "MA(medical assistant) also asked if all of the Act-HIB vaccines they had in that box with the expired diluent would also be considered not viable. MA confirmed that the Act-HIB and diluent were from the same brand new box, and vial used was the first vial taken from the box. MA was requesting letter stating different expiration dates should be expected for the Act-HIB and the diluent. MA suddenly had to go saying they had patients in the middle of the call. Attempted to call back MA for AE(adverse event) information but the front desk stated that she was still assisting patients and just asked a number she can call back". Additional description of event Adverse events: "MA explained that the expiration date for the Act-HIB itself and the diluent were different. The expiration date for Act-HIB in the vial was 03-May-2021 and the expiration date for diluent was 22-Mar-2021. Initial Response: It was discussed with MA that it was not atypical for the expiration dates to differ. It was discussed, dose administered was not considered valid as Act-HIB was reconstituted with expired diluent. MA also asked if having the expired diluent means all Act-HIB vaccines in the same box were no longer viable for use and use of alternate diluent was discussed. MA requested to her information that it was not atypical for the expirations to differ". It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event information was obtained from the consumer who received the vaccine. Result of assessment was not 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 1224942

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AA

gering
Staat
CA
Alter
1,3
Geschlecht
M
Eingang
18.04.2021
Impfdatum
23.03.2021
Beginn
23.03.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error

Symptomtext

15 month old patientan expired dose of Acthib with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00533747) and transmitted to Sanofi on 23-Mar-2021s. This case involves a 15 months old male patient who received 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiration date: 22-Mar-2021) via intramuscular route in the right deltoid (expired product administered) on 23-Mar-2021. Medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. It was actual medication error due to expired vaccine used (on same day). It was reported that after administration they noticed that it expired yesterday. At the time of report, the patients experienced 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 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
PREVNAR; DTAP
Allergien
-
Vorherige Impfungen
-