Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abnormal sensation in eye, Corneal disorder, Corneal scar, Eye swelling, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in October, 2014, resulting in scar tissue in her left cornea). Previously administered products included SHINGRIX (1st dose received in left arm intramuscularly on 13th March 2018). On 25th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 25th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and screaming. On 8th July 2018, the patient experienced eye swelling, forehead headache, shingles, corneal scar, vision decreased, bloodshot eye, corneal deformity, unspecified and abnormal sensation in eye. The patient was treated with antivirals for systemic use (Drug Name Unknown). On an unknown date, the outcome of the eye swelling, forehead headache, shingles, corneal scar, vision decreased, bloodshot eye, corneal deformity, unspecified, abnormal sensation in eye and screaming were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the eye swelling, forehead headache, shingles, corneal scar, vision decreased, injection site pain, bloodshot eye, corneal deformity, unspecified, abnormal sensation in eye and screaming to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to physician. The patient received first dose of SHINGRIX without any complications. On Monday, the patient received SHINGRIX into left arm. On 8th July 2018 Sunday, 13 days after vaccination the patient woke up and she said that her left eye felt funny. As the day progressed her left eye became red inside and swollen. Later that evening she developed a headache in the upper left area of her forehead. She at this point noted that this reminded her of when she had shingles previously in October 2014. With the previous shingles outbreak she had shingles in her left eye and in the left side of her head, also resulting in a headache. The patient called her physician and was told that was probably not shingles but they could not see her until the next day. On 9th July 2018 Monday, the patient went to ophthalmologist and was told that the situation with her eye was strange and her cornea looked different. The ophthalmologist referred her to the cornea specialist at the practice. The cornea specialist told her that she had shingles. She was put on an antiviral medication. On 28th August 2018, the patient saw the specialist, and her visibility was decreased due to the additional scar tissue on her cornea (there was already scar tissue on the cornea from the previous shingles outbreak). The patient reported that her left arm was sore after the injection, and the injection of the medication was painful (she screamed when the injection was administered). At the time of this report, the soreness had decreased however, her left arm hurts at the injection site when she raises it up over her head. The reporter gave permission for her physician to be contacted.