Age: 71.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 71-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Co-suspect products included Tetanus vaccine. Concurrent medical conditions included blood pressure high. Concomitant products included ibuprofen, REQUIP and muscle relaxants. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and Tetanus vaccine (intramuscular). On 2nd May 2018, less than a day after receiving SHINGRIX and Tetanus vaccine, the patient experienced allergic reaction (serious criteria life threatening and other: as per reporter), general body pain (serious criteria life threatening and other: as per reporter) and fever (serious criteria life threatening and other: as per reporter). On 3rd May 2018, the patient experienced muscle rigidity (serious criteria life threatening and other: as per reporter), heart rate increased (serious criteria life threatening and other: as per reporter), passed out (serious criteria GSK medically significant, life threatening and other: as per reporter), increased blood pressure (serious criteria life threatening and other: as per reporter), difficulty in standing and crying. The patient was treated with TORADOL. In May 2018, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the allergic reaction, difficulty in standing and crying were unknown and the outcome of the general body pain, muscle rigidity, heart rate increased, fever and increased blood pressure were recovering/resolving. The reporter considered the allergic reaction, general body pain, muscle rigidity, heart rate increased, difficulty in standing and crying to be possibly related to SHINGRIX. It was unknown if the reporter considered the passed out, fever and increased blood pressure to be related to SHINGRIX and Tetanus vaccine. It was unknown if the reporter considered the allergic reaction, general body pain, muscle rigidity and heart rate increased to be related to Tetanus vaccine. The reporter considered the difficulty in standing and crying to be possibly related to Tetanus vaccine. Additional details were provided as follows: The reporter was a pharmacy technician reporting an event on behalf of a patient who received SHINGRIX. The reporter was also the daughter of the patient. The patient received allergic medication, blood pressure medication, and stomach pills concomitantly. She also received Ibuprofen occasionally. The patient experienced body pain and fever on the vaccination day, but the next day it was worse. The reporter stated that the next day (3rd May 2018), while the patient was at work, the pain got worse and she could barely stand up and was crying because the pain was so bad. The patient experienced a high fever, intense body pain, high blood pressure, high heart rate and she passed out. The reporter stated that the patient went to the emergency room and was given TORADOL and sent home. On the day of reporting, the patient went to visit her doctor and her doctor informed her that she had an allergic reaction to the SHINGRIX vaccine and the vaccine caused her muscles to seize up. The reporter stated that the patient's doctor believed that the tetanus vaccine increased the patient's pain. The patient received tetanus vaccine at her doctor's office, so limited information was available regarding the tetanus vaccine. The reporter stated that the patient's doctor advised her to be on bed rest for a week to recover. The physician's information was not available at the time of the call. The reported batch number WX952 of SHINGRIX, did not exist and was updated to NX952, as per sales database.