Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site mass, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of head tightness in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included cilostazol for peripheral arterial disease. The patient's past medical history included flashing lights (had the flashes of light 2 other times in her life). Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included multiple allergies, blood pressure high, migraine, pain in hip, leg pain and peripheral arterial disease. Concomitant products included atenolol and irbesartan. On 14th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, the patient started cilostazol 50 mg once daily (50 mg daily). On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 15th March 2019, the patient experienced head tightness, tiredness and flashing lights. In March 2019, the patient experienced injection site lump and mobility decreased. Cilostazol was discontinued on 20th March 2019. On an unknown date, the outcome of the head tightness, pain in arm and injection site lump were not recovered/not resolved and the outcome of the tiredness and mobility decreased were unknown and the outcome of the flashing lights was recovered/resolved. It was unknown if the reporter considered the head tightness, tiredness, flashing lights, pain in arm, injection site lump and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: On 11th March 2019, the cardiologist also stopped Cilostazol, which was started 10 days before the time of reporting for her peripheral arterial disease. The Cilostazol was started to see if it would help with the pain in her hips and legs. On last Thursday, the patient received a dose of SHINGRIX on the right arm. The patient experienced pain in her arm, from the date of vaccination that was still just slightly tender at the time of reporting and had a small lump at the injection site still. Less than a week after vaccination, the patient experienced injection site lump and arm mobility decreased. The patient noted that, the patient could hardly lift her arm over the weekend. One day after vaccination, the patient experienced tiredness, head tightness and light flashes. On Friday, the patient experienced extreme tired and caused her to stay in bed all day Saturday. On Friday, the patient had head tightness and still feels tight, but the patient noted it could be from allergies. The patient also noted flashes of lightning bolts in both eyes, mostly in her peripheral vision that she noticed on Friday and through Tuesday. It was lasted for about 20 seconds to a minute but only occurring about once a day. The patient saw her eye physician due to the flashes and the eye physician referred her to her cardiologist thought possibly related to her blood pressure medications. The patient noted that, she had been on those for years. The patient saw her cardiologist based on the eye physician appointment and had her starting a 24-hour blood pressure monitoring tomorrow to see if the patient was experiencing any spikes. On Tuesday, 19th March 2019, the patient took last dose of Cilostazol. The patient had a minimized flash on 20th March 2019 but had not any at the time of reporting. The patient noted that, the patient had the flashes of light 2 other times in her life and that was thought to be possibly migraines because after the flashes she had migraine headache. But the patient told that, this occurrence was more like tightness in her head and not a migraine. The patient required emergency room visit. It was unknown if the reporter considered the head tightness, tiredness, flashing lights, pain in arm, injection site lump and mobility decreased to be related to Cilostazol. The reporter consented to follow up.