VAERS Reports UJ669AAA

VAERS 2604114

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ669AAA

mild

Staat: AZ
Alter: 0,7
Geschlecht: F
Eingang: 27.03.2023
Impfdatum: 21.02.2023
Beginn: 22.02.2023
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LL

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

Injection site erythema Injection site swelling Injection site warmth

Symptomtext

Mother contacted RN. Day after vaccinations received pt. developed red, swollen, warm to touch right thigh. PCV13 was given on this thigh. She also mentioned that the same reaction happened to the same thigh with the previous vaccines given, which PCV13 was given on that same thigh. I advised to put some thing cool on the area of the thigh and the redness and swelling will go down. I advised to go see a Dr. if the redness and swelling do not subside.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: No
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: Mother stated the same reaction to same thigh prior to this event.

VAERS 2624412

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ669AAA

gering

Staat: AZ
Alter: 1,0
Geschlecht: M
Eingang: 01.05.2023
Impfdatum: 20.09.2022
Beginn: 20.09.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: IM / LL

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

Product preparation error

Symptomtext

PATIENT CAME IN FOR VACCINES 09/20/2022, RN ONLY ADMINISTERED DILUENT. HIB COMPONENT WAS NOT MIXED IN. PATIENTS MOTHER WAS INFORMED AND CORRECT VACCINATION WAS ADMINISTERED 04/04/2023.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product preparation error
Hospital-Tage: -
Labordaten: NONE
Aktuelle Erkrankungen: NONE
Vorgeschichte: NONE
Andere Medikamente: UNKNOWN
Allergien: NONE
Vorherige Impfungen: -

VAERS 2583323

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ669AAA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 17.02.2023
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: OT / -

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

Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event; One patient was administered ACTHIB after not being suitable to use post temperature excursion with no adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and gender patient who was administered haemophilus type B (HIB) vaccine [ACT-HIB] after not being suitable to use post temperature excursion and reporter reported temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot number: UJ669AAA, expiry date: 07-Apr-2023) (With unknown strength, route and at unknown administration site) for immunization. On an unknown date, caller reported that temperature excursion was caused by the door to the refrigerator being left open with no reported adverse event (product storage error) (unknown latency) and one patient was administered acthib after not being suitable to use post temperature excursion with no adverse event (poor quality product administered) (latency: same day). No lab data were reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for both events. 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: -
Allergien: -
Vorherige Impfungen: -