Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Ophthalmic herpes zoster, Ophthalmoplegia, Pain, Pain in extremity
Clinical narrative: needle-like pain in /right foot/ like walking on glass/horrendous, needle-like pain in the bottom of the right foot; being unable to walk on right foot as it feels like walking on glass/ mobility decreased; lid of the eye seemed to be paralyzed/ unable to open the eye; essentially blind in their left eye; shingles of the eye; corneal ulceration; Eye pain/ front and rear of the left eye/horrific pain; Unable to open eye; sensitivity to light / hindered their ability to work/unable to tolerate any type of light; feel scratchy eye; vision is blurry and reduced as if there is patch that covering; Vision reduced; Hindered their ability to work; This case was reported by a consumer via call center representative and described the occurrence of extraocular palsy in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date unknown) for prophylaxis.   Co-suspect products included acyclovir unknown for corneal ulcer.   On 1st August 2021, the patient received the 1st dose of Shingrix. On 12th August 2021, the patient started acyclovir at an unknown dose and frequency. On 10th August 2021, 9 days after receiving Shingrix and not applicable after starting acyclovir, the patient experienced extraocular palsy (serious criteria GSK medically significant), blind left eye (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), corneal ulcer (serious criteria GSK medically significant), eye pain, eyelid function disorder, photophobia, eye scratch, blurred vision, vision decreased and inability to work. On 15th August 2021, the patient experienced foot pain and unable to walk. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)) and antiinfectives, ophthalmic (nos) (Antibiotic Eye Drops (Name Unknown)). The action taken with acyclovir was unknown. On an unknown date, the outcome of the extraocular palsy, ophthalmic herpes zoster and eyelid function disorder were unknown and the outcome of the blind left eye, corneal ulcer, foot pain, photophobia, eye scratch, blurred vision, vision decreased, inability to work and unable to walk were not recovered/not resolved and the outcome of the eye pain was recovering/resolving.   It was unknown if the reporter considered the extraocular palsy, blind left eye, ophthalmic herpes zoster, corneal ulcer, foot pain, eye pain, eyelid function disorder, photophobia, eye scratch, blurred vision, vision decreased, inability to work and unable to walk to be related to Shingrix. It was unknown if the reporter considered the foot pain and unable to walk to be related to acyclovir.  Additional details were provided as follows: The case was reported by the patient herself. The patient received Shingrix in right arm and 9 days after the vaccination, the patient reported onset of eye pain. The patient stated that experienced pain in the front and rear of the left eye that got progressively worse and patient was essentially blind in their left eye at the onset of symptoms. The reporter stated that the patient was unable to tolerate any type of light without experiencing horrific pain. The patient stated that eye continued to feel scratchy and vision was blurry and reduced,as if there were a patch covering the eye. The patient also experienced ongoing sensitivity to light and patient was unable to withstand light emanating from a computer monitor,which has hindered their ability to work. On 11 August 2021, the patient visited to doctor and the doctor discovered a corneal ulceration in the left eye, doctor initially stated it appeared to be shingles of the eye. On 12 August 2021, the patient again visited to doctor and the doctor stated corneal ulceration was a side effect of Shingrix vaccine as a scratch on the cornea would have been almost or completely healed on that second visit. The patient was prescribed steroid eye drops and acyclovir to treat the corneal ulceration. The patient also took antibiotic eye drops for treatment. The reporter stated that after receiving the treatments the eye pain was improved by 85 percent. After receiving treatments the patient also stated that on 15th August 2021, 14 days after receiving Shingrix and 3 days after receiving Acyclovir and steroid eye drops, the patient experienced onset of horrendous,needle-like pain in the bottom of the right foot and stated unable to walk on right foot,as it felt like walking on glass. The reported stated foot pain was ongoing, but not continuous throughout the day. The patient was advised by doctor not to proceed with second dose of Shingrix until eye was completely healed. The patient stated that she saw the eye doctor at the day of reporting and had 9 more days of treatment of acyclovir,steroid eye drops and antibiotic eye drops. The reporter consented to follow up.