Received Jul 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
Inadequate rabies titers; Initial information received on 26-Jun-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 41-year-old female patient who experienced inadequate rabies titers after receiving RABIES (HDC) VACCINE [RABIES-IMOVAX] The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 29-Sep-2025, the patient received a 1 dose frequency (single total) dose of RABIES (HDC) VACCINE [RABIES-IMOVAX] powder and solvent for suspension for injection (batch/lot number: unknown, expiry: unknown) (strength: unknown) via intramuscular route in an unknown vaccination site for Pre-exposure Prophylaxis - Booster Dose [Prophylaxis]. The patient, a veterinary technician, stated that she had a rabies booster on record from September 2025, which was a Sanofi rabies vaccine. Rabies titer testing in June 2026 showed that she did not have adequate titers (Decreased immune responsiveness, onset: Jun-2026, latency: approximately 9 months). She contacted Sanofi, but they were not able to replace the booster. Because she could not safely continue without adequate rabies protection, she sought assistance from another manufacturer for a replacement vaccine. Relevant laboratory test results included: Rabies Antibody (CPL) - In Jun-2026, result: below detection limit (< 0.1 IU/mL). The Rabies Neutralizing Antibody Titration (RFFIT) was performed at (withheld) Rabies Laboratory. In humans, a result of 0.5 IU/mL or higher is considered an acceptable response to rabies vaccination according to World Health Organization (WHO) guidelines. Action taken: Not applicable. Therapy was not ongoing at the time of this report (last dose: 29-Sep-2025). Corrective treatment: Unknown. Event outcome: Outcome for inadequate rabies titers (Decreased immune responsiveness) was unknown.
Comments: NONE