VAERS Reports UJ339AAA

VAERS 1019802

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ339AAA

mild

Staat: IL
Alter: 0,3
Geschlecht: F
Eingang: 10.02.2021
Impfdatum: 08.02.2021
Beginn: 09.02.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: IM / RL

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

Rash Rash erythematous

Symptomtext

Patient developed rash and redness on both thighs that went down to her ankles. Rash and redness started the following day, and was gone by appointment on 2/10/2021

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: No
Vorgeschichte: None
Andere Medikamente: None
Allergien: No Known Allergies
Vorherige Impfungen: -

VAERS 1483683

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ339AAA

gering

Staat: -
Alter: -
Geschlecht: U
Eingang: 18.07.2021
Impfdatum: 12.07.2021
Beginn: 12.07.2021
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

patient gave an expired dose of PENTACEL vaccine today with no reported adverse event; Initial information received on 12-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (unknown demographics) who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 12-Jul-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ339AAA and expiry date: 05-Jul-2021) via an unknown route at an unknown administration site (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported that "one of our Medical Assistants gave an expired vaccine today. Does the vaccine need to be re-administered. Pentacel There is no more information for this report due to being a web case". At the time of reporting, no adverse event was reported. 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 1334957

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ339AAA

gering

Staat: OH
Alter: 1,7
Geschlecht: F
Eingang: 20.05.2021
Impfdatum: 04.05.2021
Beginn: 04.05.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Product preparation issue

Symptomtext

the liquid portion was not used; the powder portion was mixed with sterile water; aside from the patient not receiving the DTaP-IPV portion with no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598239). It was reported that a 20 month old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: lot UJ339AAA, expiry date: 07-May-2021) (Suspension For Injection) where the liquid portion was not used, the powder portion was mixed with sterile water; aside from the patient not receiving the dtap-ipv portion on 04-May-2021 via intramuscular route at an unknown administration site for prophylactic vaccination (product preparation issue). It was a case of actual medication error due to Inappropriate reconstitution technique. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR). At the time of report, no adverse event reported. 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: Product preparation issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13; MMR
Allergien: -
Vorherige Impfungen: -