Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain, Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 64-year-old male patient who received SHINGRIX. Previously experienced adverse reactions included burning sensation. Concurrent medical conditions included chronic herpes simplex (since 35 years ago; prior to generic valacyclovir and SHINGRIX) and restless legs syndrome (since 5 years of age; prior to valacyclovir and SHINGRIX; with pain since herpes simplex infection). Concomitant products included Valacyclovir, BYSTOLIC, MIRAPEX, alprazolam and oxycodone. On 5th April 2018, the patient received the 1st dose of SHINGRIX. On 5th April 2018, less than a day after receiving SHINGRIX, the patient experienced feeling hot, burning sensation, tiredness and influenza-like symptoms. In April 2018, the patient experienced difficulty sleeping and unexpected beneficial therapeutic response. On an unknown date, the outcome of the feeling hot, burning sensation and influenza-like symptoms were recovered/resolved and the outcome of the tiredness, difficulty sleeping and unexpected beneficial therapeutic response were unknown. It was unknown if the reporter considered the feeling hot, burning sensation, tiredness, influenza-like symptoms, difficulty sleeping and unexpected beneficial therapeutic response to be related to SHINGRIX. Additional details were provided as follows: The patient described his chronic herpes simplex viral infection was worse case relative to other people and did not know the exact type. For the last 15 years, the patient had been using suppressive therapy of generic Valacyclovir 1 gram daily. The patient usually took one-half of 1000 mg generic Valacyclovir tablet twice daily. And his current prescription bottle was labeled as valacyclovir substituted for VALTREX, but he did not know which manufacturer. The patient described that his herpes virus infection was always active. On most days, he had burning sensation feeling in his right leg's calf attributed to his herpes virus. The patient was having the burning sensation of his right calf on Thursday (5th April 2018) before the SHINGRIX vaccine was administered and very occasionally he might not feel the burning sensation on his right leg's calf. The burning sensation predominantly occurred in his right calf but sometimes travels to his left leg, his arms and wrists, and cheeks of his buttocks. After receiving the vaccine, the patient felt feverish and had a feeling of being tired described as his energy's being zapped like a flu-like symptom and he did not take his temperature. That night the burning sensation in the right leg's calf worsened but then resolved entirely by the date of reporting and also did not spread to any other part of his body because he had not any burning sensation, he also stopped using his valacyclovir therapy after the vaccine was administered. Because of eating peanut butter could also trigger the burning sensation, he ate some peanut butter and still had no burning sensation. The patient attributed the SHINGRIX to helped the burning sensation symptom disappeared by the date of reporting. The patient usually used between one and three oxycodone nightly for his chronic restless leg syndrome pain because he had not had as much pain since the vaccination, he had only needed to use one oxycodone nightly. The patient had chosen the vaccine after reading information about it per the Center of Disease Control, hoping it might a positive outcome on his herpes simplex. The reporters called back for the pharmacy address and phone information. The reporter was unaware of lot or expiration date for administered product. Since his diagnosis of herpes simplex infection, he had pain associated with his restless leg syndrome and that pain has historically awakened him at night also had difficulty sleeping last night, but the difference was that last night when he had trouble sleeping; he was awake described as with his eyes open but without pain.