VAERS Reports UJ648AB

VAERS 2599056

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648AB

gering

Staat: TX
Alter: 1,0
Geschlecht: M
Eingang: 18.03.2023
Impfdatum: 08.03.2023
Beginn: 08.03.2023
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 preparation error

Symptomtext

acthib was given with normal saline instead of being reconstituted with the diluent provided with no reported adverse event; Initial information received on 08-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient to whom hib (prp/t) vaccine [Act-Hib] was given with sodium chloride [Normal Saline] instead of being reconstituted with the diluent provided with no reported adverse event while receiving vaccine and while treated with The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis a vaccine (Hepatitis A), pneumococcal vaccine conj 13v (crm197) (Prevnar 13) and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination. On 08-Mar-2023 the patient developed a non-serious event of acthib Powder and solvent for solution for injection (strength was unknown,dose:0.5ml, intramuscular in Left thigh, lot: UJ648AB and expiry date: 16-Mar-2023 for Immunization) was given with normal saline instead of being reconstituted with the diluent provided with no reported adverse event (product preparation error) (Latency: same day). Action taken : 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 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: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: NORMAL SALINE
Allergien: -
Vorherige Impfungen: -

VAERS 2593793

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ648AB

gering

Staat: TX
Alter: 1,0
Geschlecht: M
Eingang: 09.03.2023
Impfdatum: 09.03.2023
Beginn: 09.03.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / RL

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

No adverse event Poor quality product administered Product preparation error

Symptomtext

The MA reconstituted sterile diluent with the Acthib powder instead of the sodium chloride diluent and administered vaccine to patient. The patient did not have any symptoms. After the patient left the clinic is when it was realized how the Acthib was mixed. The manufacture was called and went over the incident & the outcome was that the vaccine given was not valid and would have to be repeated. The manufacture stated that Acthib could be given again as the same day of event. The parent was called and informed of the even that took place & brought the patient back for proper administration of Acthib. Staff has been trained in reducing healthcare related medical errors by ensuring patient identification, verifying allergies, double checks doses, and ensures other patient safety functions occur as medications are administered to patients.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -