Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | 2 | — | OT |
epilepsy after taking ipol; Initial information received on 18-Jul-2025 regarding an unsolicited valid serious case received from a other health professional. This case was linked to US-SA-2025SA209387 (master case). This case involves a 5 months old male patient who had epilepsy after receiving IPV (Vero) [Ipol]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Epilepsy in Nov-2017 from 4 months age. Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel); Hib Vaccine Conj (Tet Tox) (Act Hib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) all for Immunisation. On an unknown date in 2017, The patient also received (dose 1) of suspect IPV (Vero), Suspension for injection unknown strength and expiry date), lot number not reported via unknown route in unknown administration site for immunisation. On an unknown date, The patient also received (dose 2) of suspect IPV (Vero), Suspension for injection unknown strength and expiry date), lot number not reported via unknown route in unknown administration site for immunisation . On 21-Jun-2021, the patient received 0.5ml (Dose 3) of suspect IPV (Vero) (once) Suspension for injection, lot RIG101M (unknown strength and expiry date) via subcutaneous route in left arm for immunisation. On an unknown date in Nov-2017, the patient developed epilepsy after taking ipol (epilepsy) (Latency Few day to months approximately) following the first dose administration of IPol. Reportedly, Patient had epilepsy after taking Pentacel. Patient has been epileptic since he's 4 months old and it lasted "forever". They first noticed it since Nov-2017. Some epileptic episodes were noted when he was given with these vaccines. The patient is on treatment since he's 4 months old. He tried different drugs but caller declined to provide as they're "not really pertinent Action taken was not applicable. An unknown corrective treatment was received for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 23-Jul-2025,This case involves a 5 month old male patient who had epilepsy after receiving IPV (Vero) [Ipol]. Further information regarding tolerance, allergic history, medical history and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. Furthermore, Concomitant medications included Diphtheria Vaccine Toxoid, Hib Vaccine Conj (Tet Tox), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Mrc 5), Tetanus Vaccine Toxoid (Pentacel); Hib Vaccine Conj (Tet Tox) (Act Hib) and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Daptacel) all for Immunisation could be the confounding factor for the event US-SA-2025SA209387:IPOL US-SA-2025SA209519:IPOL
PENTACEL; Act hib; Daptacel