Reporte zur Charge U66846AA

Symptomtext

injection site lump; injection site redness; injection site bruise; Patient got a subqutaneous injection instead of Intramuscular; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Media Information (under the reference 00826944). This case involves a 65-year-old female patient who experienced injection site lump (vaccination site mass), injection site redness (vaccination site erythema) and injection site bruise (vaccination site bruising) after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] she got a subqutaneous injection instead of Intramuscular (incorrect route of product administration). The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2021, the patient received a 0.5 mL total dosage form of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for Tuberculin (TB) skin test 0.5ML strength: standard except for Fluzone high dose, lot U66846AA, expiry date 16-Oct-2022] via subcutaneous route in the left arm for prophylactic vaccination. On 02-Oct-2021, the patient developed a non-serious injection site lump (vaccination site mass), injection site redness (vaccination site erythema), injection site bruise (vaccination site bruising) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was an actual medication error due to incorrect route of vaccine administration (latency same day). No other vaccine. It was reported "The caller stated that they administered ADACEL to a patient in the deltoid muscle of the arm on 21-Oct-2021. The caller stated that the patient called and reported injection site lump, brise and redness. She also said that the needle that was on the syringe did not go all the way in, so she believes she got a subqutaneous injection instead of Intramuscular." 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.