VAERS Reports U5654AA

VAERS 1313260

SANOFI PASTEUR · TDAP (ADACEL) · Charge U5654AA

mild

Staat: TX
Alter: -
Geschlecht: M
Eingang: 13.05.2021
Impfdatum: 08.05.2018
Beginn: 08.05.2018
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / -

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

Rash

Symptomtext

Rash; Initial information regarding an unsolicited valid non-serious case was received from the Physician via Medical Information (Reference number- 00577192) and transmitted to Sanofi on 26-Apr-2021. This case involves a male patient (demographics not reported) who had rash while after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 08-May-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5654AA; expiry date: 27-Apr-2019) via unknown route in unknown administration site for prophylactic vaccination. On 08-MAY-2018 the patient developed a non-serious rash on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The reporter stated, the patient has had a rash ever since he received the vaccine and believed it may have been caused by the vaccine. The reporter wanted to know if there are any known issues with this vaccine. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the event was not recovered.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1653343

SANOFI PASTEUR · TDAP (ADACEL) · Charge U5654AA

gering

Staat: CO
Alter: 11,0
Geschlecht: F
Eingang: 29.08.2021
Impfdatum: 29.09.2017
Beginn: 29.09.2017
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: OT / RL

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

Expired product administered

Symptomtext

vaccine was given to patient that was supposedly expired with no reported adverse event; Initial information received on 06-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional via Global Media Information (under the reference 00714462). This case involved a 11 years old female patient who was given an DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] that was supposedly expired (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (lot and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination.. On 29-Sep-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot U5654AA and EXP: 04/27/2017) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine use (same day latency). It was reported that "patient was administered Adacel intramuscularly into the right lower thigh on 29 Sep 2017. The lot number for the Adacel was U5654AA. The expiration date that was recorded was 27 Apr 2017, which, if correct, would mean that the patient had received an expired dose of Adacel. However, the reporter thinks that the expiration date may have been recorded incorrectly, and the Adacel might actually have had a later expiration date. Reporter was calling to check and see what the expiration date is for Adacel given lot". At time of reporting, the outcome was unknown for the reported 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: MENACTRA; HPV VACCINE
Allergien: -
Vorherige Impfungen: -