Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Balance disorder, Diarrhoea, Electromyogram abnormal, Fatigue, Gait disturbance
Clinical narrative: Hands became numb/ feet became numb; Hands became numb and tingling; Unsteady and tired; super tired and unsteady walking/standing; Unsteady when standing or walking.; Guillian Barre Syndrome; killer headache; Massive diarrhea; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 04-NOV-2022, the patient received the 1st dose of Shingrix (left arm) and Flu vaccine (right arm). On 12-DEC-2022, 38 days after receiving Shingrix and Flu vaccine, the patient experienced headache (Verbatim: killer headache). In DEC-2022, the patient experienced diarrhea (Verbatim: Massive diarrhea). On 18-FEB-2023, the patient experienced guillain barre syndrome (Verbatim: Guillian Barre Syndrome) (serious criteria GSK medically significant), unsteadiness (Verbatim: Unsteady when standing or walking.) and walking difficulty (Verbatim: super tired and unsteady walking/standing). In APR-2023, the patient experienced tiredness (Verbatim: Unsteady and tired). In JUN-2023, the patient experienced numbness of limbs (Verbatim: Hands became numb/ feet became numb) and tingling (Verbatim: Hands became numb and tingling). The patient was treated with immunoglobulins nos (Ivig). In DEC-2022, the outcome of the diarrhea was resolved (duration 1 day). The outcome of the guillain barre syndrome, headache, numbness of limbs, unsteadiness, tingling, tiredness and walking difficulty were unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingrix. It was unknown if the reporter considered the headache, numbness of limbs, unsteadiness, tingling, tiredness, walking difficulty and diarrhea to be related to Shingrix and Flu vaccine. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.     The company considered the guillain barre syndrome to be possibly related to Shingrix. It was unknown if the company considered the headache, numbness of limbs, unsteadiness, tingling, tiredness, walking difficulty and diarrhea to be related to Shingrix and Flu vaccine. It was unknown if the company considered the guillain barre syndrome to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter was a patient. The reporter reported that she administered dose of Shingrix and Flu vaccine on a same day. The reporter reported that she had a killer headache after both the vaccination and stated that day 42 from when she had the Shingrix vaccination was on 16th December 2022. The reporter reported that the week after December 2022 she had one day only of massive diarrhea. The patient was unsteady when standing or walking, she went to the emergency department because she was unsteady and tired. However, one dose of IVIG was given at the emergency department. The reporter reported that she felt better until June 2023. Reporter reported that the 1st week of June her hands became numb and tingling and the second week of June her feet became numb, on 27 June 2023, the patient had an appointment with a neurologist and was officially diagnosed with Guillian Barre Syndrome. The reporter stated the diagnosis was determined by EMG that was performed, the patient had IVIG administered on 8, 9, 10, 11 July and her last dose would be on 12 July 2023. The reporter stated that she believed her diagnosis was delayed due to the sporadic onset of symptoms and she believed there was a chance it could be connected with receiving the Shingrix vaccine. The reporter did consent to follow up.