Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, IVth nerve paralysis, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Felt worst; Balance issues that persist until today as a sequelae; diagnosed with stroke with cranial four nerve palsy; Cranial four nerve palsy; Spent all day in bed; Sore in the left arm; Lack of energy; Tiredness; First dose of Shingrix at the beginning of 2020 and second dose on 5/23/2023; This serious case was reported by a consumer via call center representative and described the occurrence of stroke in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at the beginning of 2020).   On 23-MAY-2023, the patient received the 2nd dose of Shingrix (left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced loss of energy (Verbatim: Lack of energy) (serious criteria hospitalization) and tiredness (Verbatim: Tiredness) (serious criteria hospitalization). On 23-MAY-2023, the patient experienced pain in arm (Verbatim: Sore in the left arm) (serious criteria hospitalization) and drug dose administration interval too long (Verbatim: First dose of Shingrix at the beginning of 2020 and second dose on 5/23/2023). On 26-MAY-2023, the patient experienced feeling bad (Verbatim: Felt worst) (serious criteria hospitalization). On 27-MAY-2023, the patient experienced stroke (Verbatim: diagnosed with stroke with cranial four nerve palsy) (serious criteria hospitalization and GSK medically significant), cranial nerve palsy (Verbatim: Cranial four nerve palsy) (serious criteria hospitalization and GSK medically significant) and bedridden (Verbatim: Spent all day in bed) (serious criteria hospitalization). On an unknown date, the patient experienced balance difficulty (Verbatim: Balance issues that persist until today as a sequelae) (serious criteria hospitalization). The outcome of the stroke, cranial nerve palsy and pain in arm were resolved and the outcome of the balance difficulty was not resolved and the outcome of the loss of energy and tiredness were resolved (duration 2 days) and the outcome of the bedridden and feeling bad were not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the stroke, cranial nerve palsy, balance difficulty, loss of energy, tiredness, pain in arm, bedridden and feeling bad to be related to Shingrix.     It was unknown if the company considered the stroke, cranial nerve palsy, balance difficulty, loss of energy, tiredness, pain in arm, bedridden and feeling bad to be related to Shingrix.   Additional Information: GSK date: 16-JUN-2023 The reporter was the patient as he developed sore in the left arm same day he received dose, that was a Tuesday, that lasted a couple of days then tiredness and lack of energy for another two days. Then on Friday same week he felt worst and spent all day in bed the following day Saturday.  Patient went to emergency room on Sunday where he was diagnosed with stroke with cranial four nerve palsy.  The reporter mentioned he stayed hospitalized for two days, then discharged to home.  Patient was reporting balance issues that persisted until today as a sequelae. Emergency room visit required. Consented to follow up.