VAERS Reports UJ575AA

VAERS 2471428

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AA

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Staat: KS
Alter: -
Geschlecht: U
Eingang: 07.10.2022
Impfdatum: 23.09.2022
Beginn: 23.09.2022
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 Medication error No adverse event

Symptomtext

administering act-hib to a patient but the diluent portion of the act-hib was expired with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had received hib (prp/t) vaccine [Act-Hib] but the diluent portion of the Act-Hib was expired with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2022, the patient had received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection total (Lot # UJ575AA Expiration Date (Product): 07-OCT-2022 Lot # UJ575AA Expiration Date (Diluent): 20-SEP-2022) (dose, strength unknown) via unknown route in unknown administration site for Immunization but the diluent portion of the act-hib was expired with no reported adverse event (expired product administered) (latency same day). Action: not applicable. Outcome: Unknown 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 2322115

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj575aa

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Staat: IL
Alter: 0,2
Geschlecht: F
Eingang: 16.06.2022
Impfdatum: 15.04.2022
Beginn: 15.04.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Expired product administered

Symptomtext

Pediarix vaccine expired on 04/04/2022. Pediarix vaccine was given on 4/15/2022. Patient had no adverse reactions from expired vaccine.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: NKDA
Vorherige Impfungen: -

VAERS 1940703

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AA

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Staat: CO
Alter: 0,3
Geschlecht: F
Eingang: 10.12.2021
Impfdatum: 09.12.2021
Beginn: 10.12.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein

Body temperature increased Extra dose administered Feeling abnormal Lethargy

Symptomtext

pt was given 2 doses of the HIB by mistake due to combo vaccine. pt develped high temperature, lethargy and increased fussiness

Weitere VAERSDATA-Felder

Praegender Schweregrund: Body temperature increased
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1913589

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AA

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Staat: MI
Alter: 1,0
Geschlecht: F
Eingang: 01.12.2021
Impfdatum: 29.11.2021
Beginn: 29.11.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Circumstance or information capable of leading to medication error Extra dose administered

Symptomtext

Pt was here on 11/22/2021 for Well Child and was given ActHib in addition to other imms due. Mom and pt came back on 11/29/2021 for remainder of imms to be given. Normal Clinical staff for provider was busy so I checked to see what was due. Documentation showed ActHib, Hep A and flu was due. When asked, mom declined flu. I pulled up ActHib and HepA. Normal clinical staff took over as they were not busy any more. I showed her the Documentation and what was due, we verified what was pulled up and ready to administer and she gave the injections. While recording the administration in system, she was alerted the ActHib was not due and was an invalid dose. Upon further investigation, we noticed ActHib was recorded in system as being given but documentation did not reflect that. Contacted Health Dept and explained to her the issue. She said there should be no problem other than maybe being more painful at the injection site. This was reported back to appropriate provider and then mom was notified by RMA.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Circumstance or information capable of leading to medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: none
Allergien: NKDA
Vorherige Impfungen: -

VAERS 1692832

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ575AA

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Staat: NY
Alter: 0,4
Geschlecht: F
Eingang: 11.09.2021
Impfdatum: 30.07.2021
Beginn: 30.07.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Inappropriate schedule of product administration No adverse event

Symptomtext

Vaccine was administered too early/ no AE; Initial information was received on 02-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00752429) and transmitted to Sanofi on 02-Sep-2021. This case involves a five-month-old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] too early with no adverse event (Inappropriate schedule of product administration). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided On 30-Jul-2021, the patient received a 0.5 mL (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ575AA and expiry date not provided] via intramuscular route in unknown administration site for prophylactic vaccination. It was reported, "Caller calling regarding dosing schedule of ACT-HIB. Caller than placed MD on the phone for more information. Dr. stated she is requesting to know when to give the next shot due to the child getting the shot too early Dr. stated the child got the first shot on 6/30/21 and the next dose on 7/30/21. Caller is wanting to know if a repeated dose needs to be given. Doctor did not provide all info needed due to just wanting the answer to the question she had. MD was provided information on dosing too early." Product used: Used. First time product used: Yes. Still using product: No. It was a case of actual medication error due to Drug dose administration interval too short (latency was on same day). At the time of reporting, patient had 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 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: Inappropriate schedule of product administration
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -