Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
found I had MENINGITIS within 2 weeks of hep B 2nd shot; ear infections; This serious case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, 2 weeks after receiving Hepatitis B vaccine, the patient experienced meningitis (Verbatim: found I had MENINGITIS within 2 weeks of hep B 2nd shot) (serious criteria GSK medically significant) and ear infection (Verbatim: ear infections). The outcome of the meningitis and ear infection were not reported. It was unknown if the reporter considered the meningitis and ear infection to be related to Hepatitis B vaccine. The company considered the meningitis to be unrelated to Hepatitis B vaccine. It was unknown if the company considered the ear infection to be related to Hepatitis B vaccine. Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that look at records and found had meningitis within 2 weeks of hepatitis B 2nd shot. Not to mention multiple ear infections following shots.; Sender's Comments: Meningitis is a listed event which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications, age of patient, relevant lab results, investigation details) is considered unrelated to GSK Hepatitis B vaccine.