Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | Y1D54P2 | SC / LA |
lump on her arm, It's like a 1-inch lump and it's a little red; experienced a dull ache in the area; lump on her arm, It's like a 1-inch lump; given with IMOVAX subcutaneously, instead of intramuscular, with no reported adverse event; Initial information received on 17-Apr-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (pharmacist). This case involves a 26-year-old female patient who had a lump on her arm, it's like a 1-inch lump, experienced a dull ache in the area after receiving RABIES (HDC) VACCINE (IMOVAX RABIES) subcutaneously instead of intramuscular route with no reporter adverse event. On 13-Apr-2026, the patient received 0.5 (dose 2) dose of suspect taking rabies vaccine (IMOVAX RABIES) powder and solvent for suspension for injection (strength: standard) frequency: once, via subcutaneous route instead of intramuscular route with no reported event for immunization (Incorrect route of product administration) (latency: same day) (batch: Y1D54P2, expiry: 30-Sep-2027)]. The patient noticed a lump on her arm, it's like a 1-inch lump and it's a little red (Vaccination site erythema) (vaccination site mass) and experienced a dull ache in the area (Vaccination site pain) (onset: 16-Apr-2026, latency: 3 days) (batch: Y1D54P2, expiry: 30-Sep-2027). It was reported "Pharmacist said that the patient didn't even realize that she had the lump on there until yesterday, 16-Apr-2026, which is 3 days after the injection. It was because she was applying lotion on her arm and then, that's when she felt it. Patient took Ibuprofen and pharmacist advised her to continue taking it to help with the swelling and ice the area if it's painful. Pharmacist asked if we have further advise to manage the adverse reaction. Patient reported that it is tolerable and she just called to report it and ask the pharmacist what to do aside from taking Ibuprofen. The patient didn't say that it's intolerable that she needs an emergency. Pharmacist said that this was supposedly the second dose of the patient that was given on 13-Apr-2026. The patient received her first dose correctly which is intramuscular". Action taken: not applicable Corrective treatment: The patient was advised to continue taking Ibuprofen to help with the swelling and to ice the area if painful as an corrective treatment for all the events Event outcome: Unknown for all the 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 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.
Comments: NONE