Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Blood pressure fluctuation; chattering in jaw; sensation of a hair being on his face; voice has changed; inner shivering; can hear myself talking; weakness in both legs; Numbness in leg/left toes numb/bottom falls asleep; pins and needles in legs and feet; Anxiety; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in leg in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included covid-19 (received 3 COVID-19 vaccinations and states he did test positive for COVID (date not provided.)). Previously administered products included COVID-19 vaccine (on an unknown date received). On 08-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular). On 10-MAR-2025, 2 days after receiving Shingrix, the patient experienced numbness in leg (Verbatim: Numbness in leg/left toes numb/bottom falls asleep), pins and needles (Verbatim: pins and needles in legs and feet) and anxiety (Verbatim: Anxiety). On 11-MAR-2025, the patient experienced lower extremities weakness of (Verbatim: weakness in both legs), jaw movements disturbance (Verbatim: chattering in jaw), sensory disturbance (Verbatim: sensation of a hair being on his face), voice alteration (Verbatim: voice has changed), shivering (Verbatim: inner shivering) and autophony (Verbatim: can hear myself talking). On an unknown date, the patient experienced blood pressure fluctuation (Verbatim: Blood pressure fluctuation). The outcome of the numbness in leg, pins and needles, anxiety, lower extremities weakness of, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony were not resolved and the outcome of the blood pressure fluctuation was unknown. It was unknown if the reporter considered the numbness in leg, pins and needles, anxiety, lower extremities weakness of, blood pressure fluctuation, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony to be related to Shingrix. It was unknown if the company considered the numbness in leg, pins and needles, anxiety, lower extremities weakness of, blood pressure fluctuation, jaw movements disturbance, sensory disturbance, voice alteration, shivering and autophony to be related to Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The patient had dose of Shingrix and two days after receiving the vaccine his left leg felt numb and was tingling. On the third day the sensation of numbness and tingling was present in both legs. He began to experience muscle weakness and pain in both legs. The patient reports he was experiencing a chatter in his jaw, inner shivering, he can hear himself talking, he has the sensation a hair was on his face, his voice has changed (which he states might be due to the anxiety that he was now feeling,) states his bottom falls asleep and describes this a as feeling that have been driving too long. States when drive too long bottom, legs and feet might feel numb. States normally were able to walk around and that sensation goes away, however, the sensation of numbness, tingling and pain has not gone away no matter how long he attempts to walk it off. At the time of the call the patient states his left toes were numb. The patient states he has reported this to the vaccinating pharmacist at he scheduled an appointment with his primary care provider. He had an appointment with Cardiology and four appointments with Neurology. The neurologist did examination and conducted nerve tests and ruled out Guillain-Barre Syndrome. The patient states he was referred to the hospital where he had scans done and he was released. Diagnosis/comments/what images were taken from scans not provided. The patient was very concerned because he received Shingrix approximately one month ago from reporting date and the adverse events experienced have not resolved. The patient states he did not receive any other vaccination along with Shingrix vaccine. The patient states neurologist prescribed Gabapentin for symptoms of numbness, tingling and pain (dose/frequency not provided) but the patient states he has not taken the medication. The patient was concerned he would present with a case of Guillain-Barre Syndrome and was very anxious about his adverse events not resolving. This case was linked with case US2025041543 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025041543:Same reporter 1 of 2
Medical History/Concurrent Conditions: COVID-19 (received 3 COVID-19 vaccinations and states he did test positive for COVID (date not provided.))