Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site pain, Laboratory test normal, Movement disorder
Clinical narrative: she woke up from a nap and could not move; Joint pain/ joints hurt badly/ joints felt like they were going to break; Muscle pain; Stomach pain and torso pain; stomach and Torso burning sensation; Dehydration/felt really dehydrated; Low-grade fever; Headache; started having vertigo; Unable to walk on her own; Could not stand up straight; Quarter-size blister right above her right buttock; Pain in her right hip area and radiating down her right leg; viral infection; Shingles/ on-going shingles flare-up; Condition aggravated; Injection site soreness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of viral infection in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (Shingles outbreaks since she was 20 years old), stress and anxiety. Concomitant products included acyclovir.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th May 2019, immediately after receiving Shingrix, the patient experienced viral infection, shingles, condition aggravated, injection site pain, fatigue, blister and pain. On 16th May 2019, the patient experienced movement disorder, joint pain, muscle pain, stomach pain, stomach burning sensation of, dehydration, low grade fever, headache, vertigo, unable to walk and difficulty in standing. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the viral infection and condition aggravated were unknown and the outcome of the shingles, injection site pain, fatigue, movement disorder, joint pain, muscle pain, stomach pain, stomach burning sensation of, dehydration, low grade fever, headache, vertigo, unable to walk, difficulty in standing, blister and pain were recovered/resolved.   It was unknown if the reporter considered the viral infection, shingles, condition aggravated, injection site pain, fatigue, movement disorder, joint pain, muscle pain, stomach pain, stomach burning sensation of, dehydration, low grade fever, headache, vertigo, unable to walk, difficulty in standing, blister and pain to be related to Shingrix.  Additional details were received as follows: The patient had a long history of shingles outbreaks.  The patient received Shingrix in right deltoid. Right after receiving Shingrix, the patient experienced soreness at injection site and fatigue.  The patient had an outbreak of shingles at the time when she got her 1st dose of shingrix and was taking Acyclovir to treat it. Her shingles were brought on by stress and anxiety and presented with a quarter-size blister right above her right buttock with pain in her right hip area and radiating down her right leg.  One week after the Shingrix, she woke up from a nap and could not move, her joints hurt badly, her insides hurt badly (specifically stomach area and torso which she described as burning), felt really dehydrated but was able to drink and maintained food intake, low-grade fever, headache, fatigue, started having vertigo, was unable to walk on her own or stand up straight and her joints felt like they were going to break. Then the patient went to emergency department. They ran all tests and saw nothing abnormal. The patient was told she had a viral infection and was discharged.  The patient stated that, all these reactions occurred while she had the on-going shingles flare-up. She reported that these side effects started subsiding after the third day. Two weeks before the reporting date, the patient again experienced all the same side effects described above but without the vertigo and soreness at injection site.  At the same time, the patient again had another shingles flare-up which she treated again with Acyclovir.   The patient went to emergency department and all tests were normal. She took Ibuprofen and Tylenol to help with pain and fever.  The patient wanted to know if the side effects were from Shingrix and whether she needed to get the 2nd dose. The patient was informed about side effects per package insert and referred to her physician. The patient consented to follow up and provide details of her physician.