Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Fatigue, Injection site erythema, Injection site pain, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included double vision. Concurrent medical conditions included ocular myasthenia (prior to SHINGRIX vaccine). On 4th May 2018, the patient received SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, double vision, fatigue, injection site pain and malaise. On an unknown date, the outcome of the injection site erythema, fatigue, injection site pain and malaise were recovered/resolved and the outcome of the double vision was unknown. The reporter considered the injection site erythema, double vision, fatigue, injection site pain and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. He was a retired physician who no longer practices. He did not have any dosing specifics beyond that this was the first dose in the series. He called to inquire if GSK has any data about worsened double vision in ocular myasthenia gravis patients who have received SHINGRIX. The product information was discussed during the call, and the reporter was referred to his responsible health care professional during the call regarding his inquiry and additional inquiry of whether or not he should continue with the SHINGRIX series. The symptoms of redness and soreness of his arm at the injection site, malaise, and fatigue all started within a couple of days of having been vaccinated, peaked at three or four days and resolved within seven to eight days following the date of vaccination. All of those symptoms were not concerning. He had a prior history before vaccination of having double vision which manifests due to his ocular myasthenia gravis. This previous double vision was described as occurring several times during the day and lasting for a few seconds to a couple of minutes or so. His double vision deepened which was described as its having worsened considerably after having the SHINGRIX vaccine. This double vision worsened after day two following the SHINGRIX and lasted about five or six days to the point where he could no longer drive. And then this symptom faded and started getting better, and now his double vision was back to his normal pre-vaccination levels of double vision. He routinely wears glasses with prisms in the lenses to straighten out his vision. His glasses were ineffective in helping his vision while having the worsened double vision after the SHINGRIX vaccination. He had been worried about potential permanence of this symptom of worsened double vision while it was occurring. He given permission to contact the health care professional. He received the vaccination at a clinic which but could not for certain provide the name of the clinic during the call or the zip code. He given address of that clinic the that the only number he had for his responsible physician and the same as for the clinic. The details of the vaccination place was provided.