Received Jul 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | 947900 | IM / LA |
Chronic Inflammatory Demyelinating Polyneuropathy; Guillain-Barré Syndrome; Numbness; Initial report received on 06-Jul-2026, 07-Jul-2026, and 08-Jul-2026. A caregiver (husband of patient) reported that a 48-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced numbness and was subsequently diagnosed with Guillain-Barré Syndrome then chronic inflammatory demyelinating polyneuropathy. No medical history was reported. The patient had no preexisting conditions and was very active and healthy. Concomitant medications included an unspecified oral contraceptive (years). On 04-Apr-2026, dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 947900, expiration date 22-May-2028; NDC number not available)] was administered intramuscularly in the left deltoid. Concomitant vaccines included a dose of a diphtheria tetanus and pertussis vaccine [DTaP (lot number, expiration date, route, and site not provided)] was administered. Vaccines were administered at a pharmacy. On an unspecified date, following vaccination, the patient began experiencing symptoms of numbness. On 27-Apr-2026, 24 days after receiving HEPLISAV-B, the numbness worsened, prompting the patient to visit the emergency department. The patient was admitted to the hospital. The patient has been hospitalized twice. Treatment included intravenous immunoglobulin, plasmapheresis, intravenous steroid (not specified), and VYVGART (efgartigimoid alfa). On 01-May-2026, the patient was diagnosed with Guillain-Barré Syndrome. On 02-May-2026, the patient was discharged. On 29-Jun-2026, the patient was diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP). The reporter noted that "the patient has undergone several treatments for this condition" and that the patient has had 3 previous admissions. At the time of reporting, the conditions were reported as not improving. The patient did not receive the second dose of Heplisav-B. No additional information was reported. Company Comment: The company assessed the events of Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy as serious. As only limited information has been obtained to date (lack of EMG, nerve conduction studies, neurologic exam and results of CSF), the relationship between HEPLISAV-B and the reported events cannot be assessed. Based on the Brighton Collaboration case definition for Guillain-Barré syndrome (bilateral paralysis of limbs and interval between onset and nadir of weakness is 12 hours to 28 days and subsequent clinical plateau), this is not a case of GBS. The incidence of chronic inflammatory polyneuropathy is 0.15-10.6 per 100,000 person-years, and has insidious onset (>=8 weeks of progressive symptoms). Other contributory factors include concomitant administration of a DTaP vaccine. The event of Guillain-Barré syndrome is unlisted per HEPLISAV-B IB, SmPC and SPC and listed per HEPLISAV-B USPI. The event of chronic inflammatory demyelinating polyneuropathy is unlisted per HEPLISAV-B IB, USPI, SPC and SmPC.; Sender's Comments: The company assessed the events of Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy as serious. As only limited information has been obtained to date (lack of EMG, nerve conduction studies, neurologic exam and results of CSF), the relationship between HEPLISAV-B and the reported events cannot be assessed. Based on the Brighton Collaboration case definition for Guillain-Barré syndrome (bilateral paralysis of limbs and interval between onset and nadir of weakness is 12 hours to 28 days and subsequent clinical plateau), this is not a case of GBS. The incidence of chronic inflammatory polyneuropathy is 0.15-10.6 per 100,000 person-years, and has insidious onset (>=8 weeks of progressive symptoms). Other contributory factors include conccomitant administration of a DTaP vaccine. The event of Guillain-Barré syndrome is unlisted per HEPLISAV-B IB, SmPC and SPC and listed per HEPLISAV-B USPI. The event of chronic inflammatory demyelinating polyneuropathy is unlisted per HEPLISAV-B IB, USPI, SPC and SmPC.