Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Ocular hyperaemia, Skin lesion, Stomatitis, Tongue ulceration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old male patient who received SHINGRIX. Concurrent medical conditions included atrial fibrillation. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th February 2018, 4 days after receiving SHINGRIX, the patient experienced headache and exhaustion. On 14th February 2018, the patient experienced nasal irritation. On 15th February 2018, the patient experienced eyes tearing, eye red, eye pain, shingles and corneal irritation. In February 2018, the patient experienced eye disorder. On 17th February 2018, the patient experienced skin lesion. On 1st March 2018, the patient experienced blepharospasm. On 8th March 2018, the patient experienced increased blood pressure. On 9th March 2018, the patient experienced sores mouth and tongue ulceration. In March 2018, the patient experienced visual acuity decreased. On an unknown date, the patient experienced nerve pain. The patient was treated with Valacyclovir, gabapentin, Nasal ointment (Medication unknown), Antibacterial Eye Drops, Prednisone Eye Drops and atropine sulfate. On an unknown date, the outcome of the headache, nasal irritation, eye red, skin lesion, nerve pain, increased blood pressure, eye disorder and visual acuity decreased were unknown and the outcome of the eyes tearing, eye pain, shingles, exhaustion, sores mouth and tongue ulceration were not recovered/not resolved and the outcome of the corneal irritation was recovering/resolving and the outcome of the blepharospasm was recovered/resolved. The reporter considered the headache, nasal irritation, eyes tearing, eye red, eye pain, shingles, corneal irritation, blepharospasm, nerve pain, increased blood pressure, exhaustion, eye disorder, sores mouth and tongue ulceration to be related to SHINGRIX. It was unknown if the reporter considered the skin lesion and visual acuity decreased to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. This case was previously reported to physician. The patient required emergency visit. At 15:30, the patient went to his pharmacy and received the SHINGRIX vaccine in left arm. After 4 days of receiving SHINGRIX, the patient developed headache on the left side of his head that radiated down to his left eye. On 13th February 2018, the headache continued and nothing he took provided the relief. After 6 days of receiving SHINGRIX, he had an irritation in his nose and thought it was a sinus infection. He went to his clinic and was told it was not a sinus infection but was provided with a nasal ointment. After 7 days of receiving SHINGRIX, he woke up and his left eye was tearing, bright red, and very painful like someone had stuck a stick in his eye. He went back to the clinic and was told that it might be shingles. He was sent to an eye care center and evaluated by a Doctor of Optometry. Tests were performed and he was told he had an irritated cornea and prescribed antibacterial eye drops. After 9 days of receiving SHINGRIX (on Saturday), lesions started to break out on the left side of his forehead, left side of his nose, and the left side of his head around the hairline by his part. He spoke to the ophthalmologist on call and was told to go to the emergency room (ER) to get antiviral medications. At the ER, he was present for 4 hours and the ER physician did tests and started him on an antiviral medication. On 19th February 2018 (Monday), he called the eye clinic to alert them to what had happened over the weekend. He was told to continue the antibacterial eye drops because he had white matter in his eyes (less than a month after vaccination) and an appointment was scheduled for 21st February 2018. On 21st February 2018, he went to the eye doctor and was told he had shingles and told to stop the other antiviral medication and start on Valacyclovir, three capsules daily and Prednisone eye drops, one drop four times daily. On 1st March 2018 (21 days after receiving SHINGRIX), he went back to the OD and was told there was no improvement in his cornea and the dose of prednisone eye drop was doubled to one drop eight times daily and to use refresh eye lubricant. He was also prescribed atropine sulfate because his iris was spasming which caused it to close. On 8th March 2018 (28 days after receiving SHINGRIX), he went to see the eye doctor again and was told to stop the atropine because his iris looked better. He was told to get an appointment with a nerve specialist to help treat the nerve pain in his eye, forehead and top of head (less than a month after vaccination). He went to his cardiologist on the same day for a routine check and it was noted that his blood pressure was elevated due the nerve pain. The cardiologist contacted an infectious disease physician to take a look at the reporter's husband while he was in the office. The infectious disease physician prescribed Gabapentin and scheduled an appointment for 16th March 2018. The patient took Gabapentin on 8th March 2018 and 9th March 2018, and had not noticed any relief in the pain yet. After 29 days of receiving SHINGRIX, it was noted that he was getting sores on the left side of his mouth and tongue. His eye continued to tear and he could not read out of his eye without a magnifying glass (less than a month after vaccination). It was reported that, prior to the shingles outbreak, his left eye was good (20 by 20 vision) with his right eye measuring 20 by 50. The reporter stated that, her husband had been exhausted the whole time since vaccination because he was up half of the night due to the eye pain. The reporter and patient gave permission for the physicians to be contacted and provided the contact information.