Symptomtext
lump at the injection site; injection site bruise; injection site redness; patient got a subcutaneous injection instead of intramuscular route; needle that was on the syringe did not go all the way in; Initial information received on 11-Nov-2021 regarding an unsolicited valid non-serious case received from a non-healthcare professional (under reference: US-SA-SAC20211116001392). This case involves adult female patient who experienced lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) also got a subcutaneous injection instead of intramuscular route (incorrect route of product administration) and needle that was on the syringe did not go all the way in (wrong technique in product usage process) when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On 21-Oct-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection, lot number: U6846AA and expiry date: 16-OCT-2022) via subcutaneous route in deltoid muscle of the arm for prophylactic vaccination. It was an actual medication error due to inappropriate route of vaccination and wrong technique in product usage process (same day). On an unknown date the patient developed a non-serious lump at the injection site (vaccination site mass), injection site bruise (vaccination site bruising), injection site redness (vaccination site erythema) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient believes that the needle did not go into the muscle. It was reported "The caller would like to know if they need to repeat the injection. The caller also would like advice regarding how to treat the lump at the injection site." Laboratory details were not reported. It was not reported if the patient received a corrective treatment for the events. At the time of reporting, the outcome was unknown for all the events. The reporter assessed the causal relationship for events (vaccination site mass, vaccination site bruising, vaccination site erythema, incorrect route of product administration) with the ADACEL as not 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.
