VAERS Reports UJ658AAA

VAERS 2405870

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ658AAA

mild

Staat: MD
Alter: 0,2
Geschlecht: F
Eingang: 09.08.2022
Impfdatum: 02.08.2022
Beginn: 02.08.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LL

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

Crying Irritability Skin discolouration Vomiting

Symptomtext

PATIENT WOKE FROM HER NAP IRRITABLE APPROXIMATELY 4 HRS AFTER RECEIVING VACCINES. SHE HAS ONE EPISODE OF EMESIS, AND HAD PURPLE COLORATION TO HER RIGHT LEG BELOW THE KNEE THE LASTED 5-10 MINUTES SO PARENT TOOK PATIENT TO ER. PATIENT WAS AFEBRILE, WELL APPEARING, TOLERING FEEDS, AND NO DISCOLORATION TO THE LEG WITH BRISK CAP REFILL. PATIENT WAS GIVEN TYLENOL IN THE ER. NO LAB WORK WAS DONE. EXTREME FUSSINESS AND CRYING LASTED 45 MINUTES. LEFT LEG WAS THE SITE WHERE VACCINES WERE GIVEN.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Vomiting
Hospital-Tage: -
Labordaten: NONE
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: VITAMIN D
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2599059

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ658AAA

gering

Staat: OH
Alter: -
Geschlecht: U
Eingang: 18.03.2023
Impfdatum: 08.03.2023
Beginn: 08.03.2023
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 No adverse event

Symptomtext

an expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient of unknown age and unknown gender and it was reported an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant and family history were not provided. On 08-Mar-2023, an expired dose of 0.5 mL of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (1X; batch/lot number: UJ658AAA and expiry date: 31-Jan-2023; strength, route: unknown) in unknown administration site for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: same day). Action taken: Not applicable. 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 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 2595040

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ658AAA

gering

Staat: NY
Alter: 0,3
Geschlecht: F
Eingang: 11.03.2023
Impfdatum: 03.03.2023
Beginn: 03.03.2023
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: OT / -

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

Expired product administered Medication error

Symptomtext

patient was given a dose of PENTACEL today and the vaccine expired on 31Jan2023,with no reported adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 4 months old female patient who was given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] today and the vaccine expired on 31jan2023,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 PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. On 03-Mar-2023, the patient received dose 2 at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength: standard) (lot number: UJ658AAA, expiry date: 31-Jan-2023) via unknown route in unknown administration site for Immunization and on the same day, patient was given a dose of pentacel today and the vaccine expired on 31jan2023,with no reported adverse event (expired product administered). It was reported, reporter stated that she is the manager in the office. Caller states that she is calling about PENTACEL and the expiration date. Caller asking if the company has any information regarding this. No further information provided by the reporter. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. At time of reporting, the outcome was 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 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: PREVNAR
Allergien: -
Vorherige Impfungen: -