VAERS Reports UJ320AA

VAERS 1315011

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ320AA

mild

Staat: OR
Alter: 1,0
Geschlecht: F
Eingang: 13.05.2021
Impfdatum: 12.05.2021
Beginn: 13.05.2021
Tage bis Beginn: 1,0
Dosis: 4
Route/Site: IM / RL

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

Injection site discolouration Injection site pain Injection site swelling Injection site warmth

Symptomtext

Lower extremity swelling and purple discoloration with warmth (per mom). Happened about 24 hrs after injections. Legs seemed painful and patient was very fussy. Symptoms started at 6am and I saw baby at 10:30am. Legs were only very mildly swollen with no real erythema or discoloration.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site discolouration
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 1440129

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ320AA

gering

Staat: VA
Alter: 1,0
Geschlecht: F
Eingang: 01.07.2021
Impfdatum: 23.06.2021
Beginn: 23.06.2021
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / RL

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

Expired product administered No adverse event

Symptomtext

Patient was given expired vaccine today/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Medical Information (Reference number- 00653605) and transmitted to Sanofi on 23-Jun-2021. This case involves a one-year-old female patient who was vaccinated 4th and final dose with 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB].(once) (lot number UJ320AA, expiry date 13-Jun-2021) via intramuscular route in right thigh on 23-Jun-2021 for prophylactic vaccination and reported that was given expired vaccine today with no adverse event (expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used (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 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 1017437

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ320AA

gering

Staat: FL
Alter: 0,7
Geschlecht: M
Eingang: 09.02.2021
Impfdatum: 04.02.2021
Beginn: 05.02.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: SYR / LL

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

Skin irritation

Symptomtext

Left side the mom noticed a sore developed and then it became a circular burn about the size of a quarter.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Skin irritation
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: circumcision prior to vaccine and was put sleep for that
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -