Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Decreased appetite, Dysstasia, Hypertension, Injection site pain
Clinical narrative: Both leg tingling sensation which starts from both feet and radiates to the middle of both the thighs; blood pressure was high; the waist pain feels like shingles-type pain, as doctor has not diagnosed her with shingles; Right sided pain in her waist area / pain does radiate to the left side of her waist/ stabbing pain; right sided pain in her waist area which has gotten worse with time with cramps; muscle pain; difficult to stand up straight; nausea; decrease in appetite; Injection site pain; left arm being sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in her left shoulder and back many years ago).   On 29th January 2020, the patient received the 1st dose of Shingrix. On 29th January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, nausea and decreased appetite. On 31st January 2020, the patient experienced pain localized, cramp, muscle pain, difficulty in standing and low back pain. On 10th February 2020, the patient experienced blood pressure high. On 17th February 2020, the patient experienced tingling sensation. The patient was treated with oxycodone. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved and the outcome of the nausea, decreased appetite and pain localized were not recovered/not resolved and the outcome of the cramp, muscle pain, difficulty in standing, blood pressure high, tingling sensation and low back pain were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, nausea, decreased appetite, pain localized, cramp, muscle pain, difficulty in standing, blood pressure high, tingling sensation and low back pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix vaccine in her left deltoid at her doctor's office. The vaccine lot number was not available. On the same day, she had injection site pain with left arm being sore for about 4 to 5 days which then resolved. The patient also complained of nausea which started from day 1 and this had not improved with decrease in appetite. Around 31st January 2020, she started to experience right sided pain in her waist area which had gotten worse with time with cramps and the pain did radiate to the left side of her waist. The patient could only sleep on the right side and also she was finding it difficult to stand up straight. She was seen by the healthcare professional on 10th February 2020 and was started on oxycodone, which had decreased the waist pain somewhat but she still experienced stabbing pain on the right side of her waist. The patient also stated, when she was at the doctor's office, her blood pressure was high. She stated the waist pain felt like shingles type pain but the doctor had not diagnosed her with shingles. The patient stated from around the 17th February 2020, she started to experience both leg tingling sensation which started from both feet and radiate to the middle of both the thighs. She did take X-ray and MRI and no significant findings were noted. The patient consented to follow up. No additional information provided.