Received Jul 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | OT |
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | OT |
insomnia; hallucinations; anorexia; heart palpitation/heart palpitations, shaking really bad; shaking really bad, like bad tremors; tinnitus/ringing in the ears and stuff like that; chest pain/chest was having a lot of pain in it; Initial information received on 08-Jul-2025 regarding an unsolicited valid serious case received from a nurse. This case involves Adult female patient who experienced insomnia, hallucinations, anorexia, chest pain/chest was having a lot of pain in it, heart palpitation/heart palpitations, shaking really bad, tremors and tinnitus/ringing in the ears and stuff like that while receiving vaccines Rabavert and Rabies (HDC) Vaccine[Imovax Rabies]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Mar-2025 the patient received (2 doses) one of 0 mg of suspect Rabies (HDC) Vaccine, Powder and solvent for suspension for injection frequency: once, via intramuscular route and other one unknown dose of suspect Rabies vaccine inact (chick embryo) not produced by Sanofi Pasteur, unknown formulation, via unknown route, both with (lot number, expiry date and strength not reported) via unknown route in unknown administration site for vaccination. Information on the batch number could not be requested corresponding to the one at time of event occurrence On an unknown date In Mar-2025 the patient had insomnia, hallucinations (hallucination), anorexia (decreased appetite), chest pain/chest was having a lot of pain in it (chest pain), heart palpitation/heart palpitations, shaking really bad (palpitations), tremors (tremor) and tinnitus/ringing in the ears and stuff like that (tinnitus) (latency: few days approximately following the first dose of both the suspects). Reportedly, patient received 2 doses of the rabies vaccination one which is RabAvert and then another one through Imovax. She had pretty bad reaction to we're not sure which one it was because she got, and have to figure out what order they went in but not sure which one it was. Action taken was not applicable for all the events for both the suspects It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness criteria: Medically significant for the event hallucination and hospitalized for all the events. No follow-up is possible as Reporter cannot be contacted by Sanofi; Sender's Comments: Sanofi company comment dated 10-Jul-2025: This case involves Adult female patient who experienced insomnia, hallucinations, anorexia, chest pain/chest was having a lot of pain in it, heart palpitation/heart palpitations, shaking really bad, tremors and tinnitus/ringing in the ears and stuff like that while receiving vaccines Rabavert and Rabies (HDC) Vaccine[Imovax Rabies]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.