Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Joint stiffness, Muscle tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included guillain barre syndrome (had Guillain-Barre syndrome about 15 years ago). Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 22nd April 2021 and also experienced injection site pain, sluggishness and pain in arm, refer case US2021250234). Concurrent medical conditions included lower extremities weakness of (has some slight weakness in her left leg). On 21st June 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st June 2021, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. In July 2021, the patient experienced stiff joint, muscle tightness, decrease in coordination, ataxia, weakness of limbs, leg pain and pain ankle. On an unknown date, the patient experienced condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/ resolved and the outcome of the stiff joint, muscle tightness, ataxia, weakness of limbs, leg pain and pain ankle were not recovered/not resolved and the outcome of the decrease in coordination and condition aggravated were unknown. The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, stiff joint, muscle tightness, decrease in coordination, ataxia, weakness of limbs, leg pain, pain ankle and condition aggravated to be related to Shingrix. Additional details were provided are as follows: The patient self-reported this case. The patient had a history of Guillian Barr Syndrome (about 15 years ago) and was recovered other than some slight weakness in her left leg. The patient received a dose of Shingrix in left deltoid and immediately had soreness at injection site that lasted several days. Less than a day after receiving the vaccination, the patient had swollen upper left arm. About a month ago, after receiving the vaccination, the patient had experienced weakness of the legs and arms, tightness in her ankles and legs, stiffness of her joints, ataxia, pain in her ankles and legs and a loss of coordination. In 2021, less than 6 months after receiving vaccination, the patient got increased weakness in her left leg and the weakness spread to her right leg and both arms. The reporter stated that these side effects felt exactly the same as the effects of Guillian Barr Syndrome when she had previously been diagnosed. The reporter called to ask if the Shingrix vaccine could reactive Guillian Barr Syndrome. The reporter did not have any further healthcare professional's contact information. The reporter consented to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2021250234:Same patient, different dose.