VAERS Reports UJ424AA

VAERS 1400223

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge *uj424aa

kritisch

Staat: MO
Alter: 0,2
Geschlecht: M
Eingang: 15.06.2021
Impfdatum: 07.06.2021
Beginn: 08.06.2021
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / LL

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

Cardiac arrest Death Respiratory arrest Skeletal survey normal Sudden infant death syndrome

Symptomtext

Patient was found asystolic and not breathing. Suspected cause of death was SIDS.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Cardiac arrest
Hospital-Tage: -
Labordaten: Post-mortem skeletal survey was negative for fractures.
Aktuelle Erkrankungen: Bronchiolitis/viral upper respiratory symptoms. COVID PCR was negative on 5/25/2021.
Vorgeschichte: None.
Andere Medikamente: None.
Allergien: None.
Vorherige Impfungen: -

VAERS 1387995

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ424AA

mild

Staat: PA
Alter: 3,0
Geschlecht: F
Eingang: 10.06.2021
Impfdatum: 04.06.2021
Beginn: 05.06.2021
Tage bis Beginn: 1,0
Dosis: 4
Route/Site: IM / RL

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

Injection site erythema Injection site swelling

Symptomtext

Swelling and redness at injection site(right thigh)

Weitere VAERSDATA-Felder

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

VAERS 2309804

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ424AA

gering

Staat: WA
Alter: 4,0
Geschlecht: M
Eingang: 06.06.2022
Impfdatum: 24.05.2022
Beginn: 24.05.2022
Tage bis Beginn: 0,0
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

expired dose of PENTACEL was administered with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE INACT (HEP A IN VAC) for Immunisation; and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (MEASLES, MUMPS AND RUBELLA) for Immunisation. On 24-May-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ424AA, expiration date: 21-May-2022, via intramuscular route in unknown administration site as prophylactic vaccination. On 24-MAY-2022 the patient was administered expired dose of pentacel with no reported adverse event (expired product administered) same day following the administration of suspect vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (expired dose of PENTACEL was administered with no reported adverse event). At time of reporting, the outcome was Unknown for the 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: -