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Reporte zur Charge UJ143AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NV 2

VAERS 1235846

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AAA

gering
Staat
NV
Alter
1,5
Geschlecht
F
Eingang
21.04.2021
Impfdatum
29.03.2021
Beginn
29.03.2021
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

Patient received expired dose of Act-Hib/no AE; Initial information regarding an unsolicited valid non-serious case was received on 01-APR-2021 from a health care professional via Global Medical Information (Reference number- 00544865) and transmitted to Sanofi on 01-APR-2021. This case is linked to case 2021SA108007(same reporter). This case involves a 18 month-old female patient who was vaccinated with 0.5 mL(total) expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch number UJ143AAA; expiry date 22-Mar-2021; frequency: once; strength: standard) via an intramuscular route at the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered). 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); DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vacciantion. Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-HIB and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, Still using product: No. At the time of reporting, no adverse event was reported. 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 holders 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
PROQUAD; PEDIARIX; HEPATITIS A
Allergien
-
Vorherige Impfungen
-

VAERS 1230977

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ143AAA

gering
Staat
NV
Alter
0,5
Geschlecht
M
Eingang
19.04.2021
Impfdatum
29.03.2021
Beginn
29.03.2021
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

Symptomtext

a patient received an expired dose of ACT-HIB vaccine/ No AE; Initial information received on 29-Mar-2021 and additional information received on 01-Apr-2021 regarding an unsolicited valid non-serious case received from a Other Health Care Professional via nurse via physician via Medical Information (Reference number- 00539890). This case is linked to case 2021SA112593 (same reporter, sibling). This case involves a 6 months old male patient who received an expired 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] batch number: UJ143AAA, expiry date: 22-Mar-2021, Frequency: once, Strength: standard via intramuscular route in the left vastus lateralis on 29-Mar-2021 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination respectively. It was an actual medication error due to expired vaccine used (latency: same day). Potential Product Technique Complain: No, Caller stated that they gave two different children the product that had expired. Caller wanted to know what should they do. Outbound call made at 1:09 pm on 30-Mar-2021. No response. Voicemail left with case and contact number. Nurse called previously about Act-Hib and is looking for guidance on how to proceed. Treatment: The clinic calling the manufacturer for guidance. Product used, Still using product: No. 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 holders 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
PEDIARIX; PREVNAR
Allergien
-
Vorherige Impfungen
-