Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 75-year-old female patient who received SHINGRIX. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 3 years ago and within maybe six or eight months experienced painful, sore itchy rash on her lower back and left buttock, which was diagnosed as mild shingles) and Vitamin K. Concurrent medication conditions included type II diabetes mellitus (since prior to vaccinations), allergy to plants (Balsam or Peru) and multiple allergies (since prior to vaccinations). Concomitant products included CLARINEX, COZAAR, Vitamin D3, Aspirin, folic acid, Probiotics, Warfarin, HUMALOG, LANTUS, TOPROL and mexiletine. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, 3 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash and papular rash. On 15th May 2018, the patient experienced burning in eyes. The patient treated with betamethasone. On an unknown date, the outcome of the itchy rash, erythematous rash, popular rash and burning in eyes were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, erythematous rash, popular rash and burning in eyes to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient could not recall exactly what year but said might be three years before reporting date she had a shingles vaccine of unknown manufacturer to prevent shingles. The vaccine was dispensed by her pharmacy and administered at her prescriber's office. She could not recall further specific administation or dosing details. Within maybe six or eight months after receiving that vaccine, the patient experienced symptoms and the rash was diagnosed by her dermatologist as mild shingles. An infectious disease specialist also diagnosed the rash as shingles. She was taking an unknown antiviral medication for the rash, when she went to the emergency room at that time due to an elevated international normalized ratio (INR) described as being greater than 7. The emergency room physicians also saw the rash and said it was shingles. She was given vitamin K to lower her INR in the emergency room. She thought the antiviral therapy was a 10 day course. The painful rash eventually resolved, and she thought the vaccine caused that symptom. the patient received SHINGRIX at her pharmacy just below her left shoulder on her left arm. The patient noticed a rash on her face like she had broken out, and her legs were itching as well as her arms. In the morning of reporting day, after showering she also noticed the rash on her neck and chest in addition to her face, arms, and legs. The rash was described as bothersome, itching, raised, red, and irritated spots of skin that look like the beginning of acne. There were no pustules or pimples or any signs of infection. The spots were not as large on her arms and legs as on her chest and face and nose. There was more redness of the rash on her face and chest than legs. The rash on her chest goes from her neck and down towards her breasts going towards her underarm, not under the arm. The rash was above her wrists to her elbows and from the knees down to her ankles on her legs. On the day of reporting, 4 days after vaccination, the symptoms were worse, and her eyes were irritated and burning. The itching was coming and going and was not constant. On the day of reporting, the patient's nose was itching as well as her shoulder, and the area of her legs above where she currently seen the rash was not itching, so she did not know if the rash might be expanding. The patient though the previous mild shingles was caused by the previous shingles vaccine but did not know if her current symptoms were caused by SHINGRIX. The same healthcare professional prescribed SHINGRIX as well as the previous shingles vaccine. The same dermatologist examined the current rash on the reporting date as well as her previous shingles and said the current rash did not look like that of shingles but of unknown origin yet to be determined. The patient had not yet started to use the Betamethasone cream, which the dermatologists ordered for the current rash. The reporter gave permission to contact the reporter or her prescribing physician. No further dosing details were provided regarding the SHINGRIX vaccine either. This case has been linked to US2018086795 and US2018086793, reported by the same reporter.