VAERS Reports UJ581AA

VAERS 1857200

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ581AA

mild

Staat: OK
Alter: 0,3
Geschlecht: M
Eingang: 04.11.2021
Impfdatum: 27.10.2021
Beginn: 27.10.2021
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / LL

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

Rash erythematous

Symptomtext

While getting child dress after shots, mother noticed red rash on forehead top head. patient was seen by physician and was watched in office for. 20min. at that time Rash had almost disappeared. no breathing issues. 10.-28-21 checked on Pt. No Problems.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash erythematous
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1974380

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ581AA

gering

Staat: IN
Alter: -
Geschlecht: M
Eingang: 23.12.2021
Impfdatum: 13.12.2021
Beginn: 13.12.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Medication error Product preparation error

Symptomtext

This case involves a 14 months old male patient who had HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) powder which not mixed with sodium chloride diluent; mixed with sterile diluent for live virus vaccine (product preparation error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (lot and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination. On 13-Dec-2021, the patient received a dose of suspect ACT-HIB (Solution, 0.5 ml, total, once, lot UJ581AA and expiration date: 14-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to wrong diluent used (same day latency). It was reported "Nurse reports that they had an ACTHIB administration error, states that ACTHIB powder was not mixed with the sodium chloride diluent that comes in the box, states ACTHIB powder was mixed with sterile diluent for live virus vaccine. Nurse asks if there are any recommendations in this situation and if there could be any harm to the patient. Nurse states that the patient did not require any treatment after receiving ACTHIB; states the parents have not yet been notified, but to their knowledge the patient has not required any treatment" 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: Medication error
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: FLULAVAL
Allergien: -
Vorherige Impfungen: -