Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Guillain-Barre Syndrome /difficulty walking /Leg pain; physical, emotional, and financial distress; incapacitated for 2 months /resulting in lost income, personal trips/ medical expenses; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cataract operation (had cataract surgery) and respiratory disorder (had respiratory illness). Previously administered products included Shingrix (received 1st dose on 28-NOV-2023). Concurrent medical conditions included small fiber neuropathy (had since 2016). In JAN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre Syndrome /difficulty walking /Leg pain) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter), emotional distress (Verbatim: physical, emotional, and financial distress) (serious criteria other: Serious as per reporter) and activities of daily living impaired (Verbatim: incapacitated for 2 months /resulting in lost income, personal trips/ medical expenses) (serious criteria other: Serious as per reporter). The patient was treated with IMMUNOGLOBULINS. The outcome of the guillain barre syndrome, emotional distress and activities of daily living impaired were resolving. It was unknown if the reporter considered the guillain barre syndrome, emotional distress and activities of daily living impaired to be related to Shingrix. The company considered the guillain barre syndrome, emotional distress and activities of daily living impaired to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025AMR031874 Additional Information: GSK Receipt Date: 13-MAR-2025 This case was received from the legal department to report the adverse event regarding the Shingrix vaccine. The complainant had filed a complaint against the doctor, intemist/rheumatologist for Reckless Imprudence resulting in Serious Physical Injury. The complaint arised from the administration of a Shingrix vaccine by the respondent in October 2023, which was intended to prevent shingles. The complainant alleged that Doctor, failed to properly inform her of the vaccines potential risks and side effects and did not take her medical history into account before administering the vaccine. The patient received the first dose of the Shingrix vaccine and were no reported issues after the first dose. The patient mentioned having recently experienced a respiratory illhess and undergoing cataract surgery. The patient received the second dose in January 2024, the complainant began experiencing severe pain and difficulty walking, which she promptly reported to doctor. Despite being advised by the doctor to go to the hospital, the complainant's condition worsened, leading to multiple hospital confinements at under the care of various doctors. A diagnosis of small fiber neuropathy secondary to varicella zoster vaccination was made and further treatment was suggested, including expensive intravenous immunoglobulin therapy (IVIG). The complainant later consulted additional neurologists who diagnosed her with Guillain-Barre Syndrome (GBS), a known side effect of the Shingrix vaccine. The respondent (doctor), allegedly failed to properly manage the patients condition, even though she had been informed of the sufferings and inquiries regarding the adverse effects. The doctor also allegedly attempted to refer the complainant to another specialist, instead of addressing the complications caused by the vaccine herself. As a result of the adverse effects, the complainant claimed to have suffered severe physical, emotional, and financial distress. She was incapacitated for over two months, resulting in lost income, personal trips, and significant medical expenses, totaling nearly one million pesos. In counter affidavit the doctor stated that, the complainant has been a patient of hers since 2016. In October 2023, she offered the complainant the recombinant herpes zoster (Shingrix) vaccine as a preventive measure for shingles, which the patient agreed to. After the second dose, the patient complained of leg pain, which was not accompanied by other severe symptoms like weakness, fever or rash. Respondent guided the patient to seek care at the Emergency Room and referred her to her cardiologist and neurologist. Despite the patient's concerns, respondent continued to offer support and coordinated with specialists for further evaluation. After a hospital admission and medical tests, it was determined that complainant had small fiber neuropathy, a condition not unusual in older adults. The Respondent (doctor) clarified that there was no clear medical evidence linking the condition to the vaccine, as small fiber neuropathy had been present in the patient since 2016. The patient condition improved, and she was discharged after receiving pain management. Respondent made efforts to ensure that the complainant received appropriate care, including securing urgent consultations with another neurologist and responding promptly to her concerns, even while traveling. Respondent also reported the case to the vaccine manufacturer (GSK) for investigation into the potential adverse effects of the vaccine. The complaint suggested that doctor actions, or lack thereof, amounted to negligence and inadequate response to a serious medical issue, potentially strengthening the case for reckless imprudence.; Sender's Comments: Guillain-Barre syndrome, Emotional distress and Loss of personal independence in daily activities are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR031874:same patient case
Small fiber neuropathy (had since 2016)
Medical History/Concurrent Conditions: Cataract operation (had cataract surgery); Respiratory disorder (had respiratory illness)