Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injected limb mobility decreased, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pain (pain due to cervical C3 C4 not aligned). Previously administered products included RECLAST (for osteoporosis) and PROZAC. Concurrent medical conditions included osteoporosis, herpes simplex type ii, short-bowel syndrome and headache (due to head injury 20 years ago goes to physical therapy for this condition). Concomitant products included Valacyclovir, VALIUM, Cholestyramine and FIORICET. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, 4 hrs after receiving SHINGRIX, the patient experienced erythema of extremities, inflammation localized, headache, chills, diarrhea and fever. In May 2018, the patient experienced injected limb mobility decreased and pain. On 25th May 2018, the patient experienced blood test abnormal. The patient was treated with Acetaminophen and ALEVE. On 17th May 2018, the outcome of the fever was recovered/resolved. On 21st May 2018, the outcome of the erythema of extremities and inflammation localized were recovered/resolved. On 22nd May 2018, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the injected limb mobility decreased, headache, chills and pain were recovered/resolved and the outcome of the blood test abnormal was unknown. The reporter considered the erythema of extremities, inflammation localized, injected limb mobility decreased, headache, chills, diarrhea, fever and pain to be related to SHINGRIX. It was unknown if the reporter considered the blood test abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient stated that 4 to 5 hours after receiving the SHINGRIX, she noticed 8 inches of bright red inflammation on her right arm that resolved after 6 days. The patient stated that she could not move her right arm for 2 to 3 days. The patient stated that approximately 4 to 5 hours after receiving the SHINGRIX, she experienced a headache and chills and these symptoms resolved after 2 to 3 days, also 4 to 5 hours after receiving SHINGRIX she experienced diarrhea that lasted approximately 1 week. The patient reported that that she also experienced a fever that spiked at 102 F that evening and eventually her body temperature went down to normal and spiked again the next day. The patient stated that the next day her fever did not reach 102 degree F and the fever resolved in approximately 2 days. The patient mentioned that she used acetaminophen and ALEVE for the fever. The patient reported that 10 days after receiving the vaccine, she went to her hematologist to have blood work completed and her doctor mentioned that she had an antibody reaction (not specified) and had some abnormal blood chemistries the patient said that she would had the blood work redone at a later date, she also said that her doctor advised her not to get the 2nd dose of SHINGRIX. The patient said that the package insert should warn that this severe reaction could happen. The patient had denied permission to contact their physician. The patient did not want her doctor involved at all.