Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Rash, Rash macular, Swelling face, Tinnitus
Clinical narrative: Ramsey Hunt Syndrome; couldn't hear out of her right ear / still cannot hear out of the ear; humming, tingling feeling her right ear / felt like a bee in her ear /  buzzing and she can't fully hear out of her ear; humming/ felt like a bee in her ear/buzzing; a mass on the right side of her face; rash on her face /  nasty, bubbly rash that broke open and a mass on the right side of her face /  rash spots this morning on her body; face swelled / swelling is starting to go down on her face; face swelled and was numb all over /  entire face went numb / left side of her nose and mouth were completely numb/novicane in her face; blisters on her right arm; shooting nerve pain / still has the nerve pain in her face today/kneecap to the top of her right foot that felt like electricity; facial paralysis; shingles; This case was reported by a consumer and described the occurrence of ramsay-hunt syndrome in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (experienced bad chickenpox when patient was a child). Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 25th January 2021, refer case: US2021090801). Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 31st March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 6th April 2021, 6 days after receiving Shingrix, the patient experienced ramsay-hunt syndrome (serious criteria GSK medically significant), no hearing (serious criteria GSK medically significant), tingling and ear buzzing. In April 2021, the patient experienced facial paralysis (serious criteria GSK medically significant), shingles, spot-like rash, facial swelling, numbness facial, blister, nerve pain and mass. The patient was treated with valaciclovir hydrochloride (Valtrex) and steroids nos (Steroids). On an unknown date, the outcome of the ramsay-hunt syndrome, no hearing, facial paralysis, shingles, tingling, spot-like rash, facial swelling, numbness facial, blister, nerve pain, ear buzzing and mass were recovering/resolving.   The reporter considered the ramsay-hunt syndrome, no hearing, facial paralysis, shingles, tingling, spot-like rash, facial swelling, numbness facial, blister, nerve pain, ear buzzing and mass to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient had no history of shingles although she had a bad case of chickenpox as a child. The patient received the second dose of Shingrix in her left arm. After the second shot she felt a humming, tingling feeling her right ear and it felt like a bee in her ear. The patient couldn't hear out of her right ear and she still could not hear out of the ear. This feeling was started on 6th April 2021. The patient had a rash on her face and her face swelled and was numb all over and it felt like she had novicane in her face. The patient had a nasty, bubbly rash that broke open and a mass on the right side of her face. She also had blisters on her right arm. The patient had shooting nerve pain from ear to ear and down her kneecap to the top of her right foot that felt like electricity. The patient still experinced the nerve pain in her face today. Her entire face went numb and on Sunday, 18th April 2021, the patient went to the emergency room. The parts of her face were still numb today. Everything to the left side of her nose and mouth were completely numb. She was released from the ER the same day and diagnosed with shingles. The patient's condition got worse on 21st April 2021 and she went to the physician and was diagnosed with Ramsey Hunt Syndrome which she attributes to the Shingrix vaccine. For 7 days she did not get treatment for her side effects because they thought it was initially poison ivy. The patient was treated with Valtrex and Steroids and she has finished her first round of Valtrex. The patient still had a few more rash spots this morning on her body but the swelling was starting to go down on her face. The patient still had the buzzing and she could not fully hear out of her ear still. The patient was feeling that her condition was improving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090801:same reporter