Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, White blood cell count
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received SHINGRIX. The patient's past medical history included mononucleosis. Concurrent medical conditions included borderline diabetes (in the past several years before the date of reporting), bronchiectasis (prior to SHINGRIX vaccination) and genital herpes (3 years before the date of reporting). Concomitant products included VENTOLIN HFA, Aspirin, atorvastatin calcium, montelukast sodium, omeprazole, metoprolol succinate and fish oil. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 4 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness, weakness, nausea, feeling unwell and genital herpes. The patient was treated with valaciclovir hydrochloride. On an unknown date, the outcome of the influenza-like symptoms, tiredness, nausea and feeling unwell were not recovered/not resolved and the outcome of the weakness was unknown and the outcome of the genital herpes was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to SHINGRIX. The reporter considered the tiredness, weakness, nausea and genital herpes to be related to SHINGRIX. Additional details were provided as follows: The reporter did not attribute any symptom to her VENTOLIN HFA therapy which was mentioned during the concomitant therapy discussion. The dose of the series of the SHINGRIX vaccine was administered at a senior fair on a Saturday about three or four Saturdays before the date of reporting sometime in April 2018 at hotel which was having a senior fair. Across the street there was a pharmacy, and some of the pharmacist came over to the senior fair to administer SHINGRIX vaccinations. About 4 hours after having the SHINGRIX vaccine, the patient had flu-like symptoms described as extreme tiredness and weakness with a bit described as a twinge of nausea. The patient described that these flu-like symptoms were better described as feeling like she did when she had mononucleosis like when she was a teenager. The nausea was stronger the day of the injection. Those symptoms lasted between two and one-half to three days and then resolved. She felt fine for about a week and then suddenly felt sick again and described as the same symptoms returning. These symptoms have occurred each day and have not yet resolved at the time of reporting. Might a week after those symptoms returned she had an outbreak of two vaginal herpes. The symptoms have made it harder to work part-time. Due to herpes and this feeling of illness, the patient decided to cancel her colonoscopy and endoscopy appointments which had been made around the time she got the vaccine or might a week later. She had no relief of these daily symptoms. Sometime earlier in the week of reporting date because of the symptoms, she went to her primary care physician who ordered a blood glucose check and herpes blood test. Later one night in the week of reporting date she went to the emergency room because of the symptoms. She was diagnosed as having a herpes vaginal outbreak and was given generic VALTREX medication for the outbreak. The day before the day of before of reporting day, she went to urgent care about 10:30 pm that night because she was still feeling sick with these symptoms. Further bloodwork including white blood cell count, a mononucleosis test, and other unknown blood tests were ordered. She could still felt the herpes outbreak and it was almost gone. The reporter gave consent to contact her healthcare provider and herself.