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Reporte zur Charge UJ611AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
PA 2 FL 1 MI 1

VAERS 2541544

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ611AA

gering
Staat
PA
Alter
1,2
Geschlecht
M
Eingang
23.12.2022
Impfdatum
15.12.2022
Beginn
15.12.2022
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

Symptomtext

expired ACTHIB administered to a patient with no reported AE; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 14 months old male patient who reported that expired acthib administered to a patient with no reported ae after 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 measles vaccine LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), rubella vaccine LIVE (WISTAR RA 27/3), VARICELLA zoster vaccine live (OKA/MERCK) (Proquad); hepatitis a vaccine (HEPATITIS A); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13). On 15-Dec-2022, the patient received a dose of 0.5 ml suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (Frequency: once, lot UJ611AA) via intramuscular route in the right thigh. for prophylactic vaccination(immunization) On 15-Dec-2022 the patient developed a non-serious event of expired acthib administered to a patient with no reported ae (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine. Action taken : not applicable. It was not reported if the patient received a corrective treatment for the event (expired Acthib administered to a patient with no reported AE). At time of reporting, the outcome was Not Recovered for the event expired acthib administered to a patient with no reported ae. 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 2535341

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ611AA

gering
Staat
PA
Alter
1,2
Geschlecht
M
Eingang
16.12.2022
Impfdatum
15.12.2022
Beginn
15.12.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
SYR / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

RN admistered Act HIB vaccine on 12/15/22 to patient, the vaccine had expired on 12/13/22. RN realized this error after administration. RN immediately notified doctor as well as patient mom. RN let pt. mom know that pt. may need another dose of vaccine depending on manufacturer protocol. Pt. mom expressed understanding. RN called manufacturer who clarified that another dose of Act HIB will need to be administered and can that can be done as soon as today. RN will call pt. mom to let her know. RN documented in pt. chart as well as followed facility protocol.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
benzocaine
Vorherige Impfungen
-

VAERS 2518296

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ611AA

gering
Staat
FL
Alter
1,0
Geschlecht
M
Eingang
28.11.2022
Impfdatum
21.11.2022
Beginn
21.11.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

patient received a dose of ACTHIB administered with an expired diluent with no reported adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves 1 year old male patient who was administered a dose of HIB (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunisation. On 21-Nov-2022, the patient received 0.5 mL of dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot: UJ611AA; expiry date: 13-Dec-2022) via intramuscular route in unknown administration site for Immunization, administered with an expired diluent with no reported adverse event (expired product administered) (latency: same day). Action taken: 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
DTAP
Allergien
-
Vorherige Impfungen
-

VAERS 2440323

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ611AA

gering
Staat
MI
Alter
1,0
Geschlecht
F
Eingang
12.09.2022
Impfdatum
31.08.2022
Beginn
31.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient to whom experienced HIB (PRP/T) VACCINE [ACT-HIB] vaccine administered post excursion after low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HIB VACCINE (HIB) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 31-Aug-2022, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE, (lot UJ611AA exp date: 30-Nov-2022) via intramuscular route in the left thigh as immunization. on unknown date low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event" (product storage error) occurs and on 31-Aug-2022 (latency: same day) the patient was administered post excursion with no reported adverse event (poor quality product administered). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event vaccine. 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.; Sender's Comments: US-SA-2022SA370866: US-SA-2022SA371948: US-SA-2022SA372086: US-SA-2022SA372095: US-SA-2022SA372123: US-SA-2022SA372180: US-SA-2022SA372199: US-SA-2022SA372581: US-SA-2022SA373167: US-SA-2022SA373534: US-SA-2022SA371333: US-SA-2022SA372584: US-SA-2022SA371564:

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; HIB; VARICELLA VACCINE; PNEUMOCOCCAL CONJUGATE VACCINE; HEPATITIS A
Allergien
-
Vorherige Impfungen
-