VAERS Reports UJ667ABA

VAERS 2576608

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ667ABA

mild

Staat: WA
Alter: 1,0
Geschlecht: U
Eingang: 09.02.2023
Impfdatum: 20.01.2023
Beginn: 20.01.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Injection site erythema Injection site induration Injection site irritation Injection site swelling Rash Skin texture abnormal Vaccination error

Symptomtext

No additional AEs reported; Caller reported VARIVAX and PROQUAD were administered at the same visit.; This solicited report has been received from a registered nurse, regarding a 12-months old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. On 20-JAN-2023, the patient was administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (lot number: W024552, which was determined to be valid, with an expiration date on 31-JAN-2024) and also a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number: W021741, which was determined to be valid, with an expiration date on 10-JUL-2024), both on the same visit at a dos of 0.5 milliliter subcutaneously as prophylaxis (strengths, schemes and anatomical locations of administration were not reported) (overdose). No additional adverse event was reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2623337

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge UJ667ABA

gering

Staat: CO
Alter: 1,8
Geschlecht: F
Eingang: 28.04.2023
Impfdatum: 10.04.2023
Beginn: 10.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / -

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

Expired product administered

Symptomtext

On the afternoon of 04/10/2023 the clinic MA unknowingly administered an expired of Hib vaccine. HIB vaccine lot number was UJ667ABA with and expiration date of 04/07/2023. The manufacturer is Sanofi Pasteur. The vaccine was to be taken off the shelf by 04/07/2023. The patient?s guardian was contacted and another appointment for re-administration was scheduled. Procedures have been put in place in order to avoid further incidents. A two-point check will be conducted prior to administration. MA will check the expiration date from the vial and compare it to the box. MA will also make a note in our Pharmacy book were vaccine lot numbers and expiration dates are kept. Moving forward a list of upcoming vaccine expiration dates will be printed weekly in order to quickly remove them from the inventory, therefore adding another safety net to the process at hand. We updated our policy for administration and documentation of vaccines. Team members now must print a copy of report for vaccines needed, compare to what we have on stock; highlight which vaccines need to be administered and finally pull them from our fridge. After pulling the vaccine MA needs to do two-step check comparing vial and the box to make sure there are no discrepancies

Weitere VAERSDATA-Felder

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

VAERS 2622869

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ667ABA

gering

Staat: NV
Alter: 0,3
Geschlecht: F
Eingang: 28.04.2023
Impfdatum: 20.04.2023
Beginn: 20.04.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / -

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

Expired product administered No adverse event

Symptomtext

expired diluent of the vaccine was administered to a patient with no reported adverse event; Initial information received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who experienced expired diluent of the vaccine was administered with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Apr-2023, the patient received a 0.5 ml (total) (dose 2) dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ667ABA (diluent expiry: 07-Apr-2023) via intramuscular route in unknown administration site as immunization. On 20-Apr-2023, the patient developed a non-serious event expired diluent of the vaccine was administered to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine. No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event expired diluent of the vaccine was administered to a patient with no reported 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: -
Allergien: -
Vorherige Impfungen: -

VAERS 2621907

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ667ABA

gering

Staat: WA
Alter: -
Geschlecht: U
Eingang: 27.04.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
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

administered ACTHIB with an expired diluent with no reported adverse event; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age/gender patient who involved in administered haemophilus type b (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), concomitant medications and family history were not provided. On an unknown date, the patient received 0.5 ml total dose of suspect haemophilus type b (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number: UJ667ABA, expiry date: 15-May-2023) with an expired diluent (Lot Number:U7261AA, expiration date: 07-Apr-2023) (strength, route, administration site: Unknown) for Immunization (immunization) with no reported adverse event (expired product administered) (latency: same day). No lab data reported. Action taken: not applicable. Outcome: Unknown for the event administered acthib with an expired diluent with no reported 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 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: -