Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Feeling hot, Fibromyalgia
Clinical narrative: Pain; Weak; doesn't feel right; nervous system feels on edge; dizziness; post herpetic neuralgia exacerbated; condition agrrevated; fibromyalgia exacerbated; chilled and then warm; feeling warm; anxiety; fatigue/Tired; chills; flu like symptoms; severe injection site itching; injection site redness/ arm redness; This case was reported by a other health professional via call center representative and described the occurrence of anxiety in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date July 2020) for prophylaxis.   The patient's past medical history included shingles (5 years ago) and fibromyalgia. Previously administered products included Shingrix with an associated reaction of injection site pruritus (received 1st dose February 2019, refer case US2019AMR144671). Concurrent medical conditions included post herpetic neuralgia. Concomitant products included paracetamol (Tylenol).   On 29th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th July 2019, 1 days after receiving Shingrix, the patient experienced anxiety, fatigue, chills, influenza-like symptoms, injection site itching and injection site erythema. On an unknown date, the patient experienced pain in arm, weakness, feeling abnormal, nervous system disorder, dizziness, post herpetic neuralgia, condition aggravated, fibromyalgia worsened, feeling cold and feeling of warmth. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the anxiety, fatigue, chills, influenza-like symptoms and injection site itching were not recovered/not resolved and the outcome of the injection site erythema and pain in arm were recovered/resolved and the outcome of the weakness, feeling abnormal, nervous system disorder, dizziness, post herpetic neuralgia, condition aggravated, fibromyalgia worsened, feeling cold and feeling of warmth were unknown.  It was unknown if the reporter considered the anxiety, fatigue, chills, influenza-like symptoms, injection site itching, injection site erythema, pain in arm, weakness, feeling abnormal, nervous system disorder, dizziness, post herpetic neuralgia, condition aggravated, fibromyalgia worsened, feeling cold and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient reported that she had a history of shingles from 5 years ago and she ended up with post herpetic neuralgia that she got from shingles six years ago this November as well as fibromyalgia (bouts of it from years before). On 29Jul2019, the patient received her second Shingrix dose via intramuscular route in her left arm. The following day the patient developed anxiety, chills, flu-like symptoms, fatigue, severe injection site itching and redness, the events are reported to be ongoing.  The patient reported arm redness with pain and flu like symptoms that started two days later with itching. The patient claimed that she was very chilled and then warm, weak and tired and she doesn't feel right. The patient reported that her nervous system feels on edge at all times. The redness had resolved and the pain was gone now but she was still a little itchy at times. She was still very tired and doesn't feel herself with dizziness that was getting in the way of her daily activities.  It was reported that the post herpetic neuralgia and fibromyalgia had exacerbated after the second Shingrix shot.  The reporter consented to follow up.