VAERS 2415725
SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ648AA
- Staat
- CO
- Alter
- 6,0
- Geschlecht
- M
- Eingang
- 19.08.2022
- Impfdatum
- 02.08.2022
- Beginn
- 02.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- OT / LA
Symptomtext
redness and swelling in the injection site; redness and swelling in the injection site; PENTACEL to a child that is 6 years old; Initial information received on 12-Aug-2022 regarding an unsolicited valid non-serious case received from health professional. (GMI number: 01233778) This case involves a 6-year-old male child who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] and experienced redness and swelling in the injection site, redness and swelling in the injection site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant was administered. On 02-Aug-2022, the 6-year-old male child received suspect Pentacel vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (Lot: UJ648AA, expiry: 25-Feb-2023) for prophylactic vaccination (product administered to patient of inappropriate age, latency same day). First time product used: No On 02-AUG-2022, the patient developed a non-serious redness and swelling in the injection site (vaccination site erythema, vaccination site swelling) same day latency following the administration of vaccine. At time of report, product was discontinued. Action taken: Not applicable. No corrective treatment was received for the events (vaccination site erythema, vaccination site swelling). At time of reporting, the outcome was Unknown for all events. 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
- Injection site erythema
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -