Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain in extremity, Pruritus, Rash, Somnolence
Clinical narrative: Developed six canker sores on the right side of her mouth / 15 or 20 canker sores started on the left side of her mouth; Arm was sore the next day after receiving the vaccination; Round, red, hard, swollen area below the injection site; Round, red, hard, swollen area below the injection site; Round, red, hard, swollen area below the injection site/bump; Could not move arm; Flu-like symptoms; Tired; rash developed to the right of the swollen; she slept 13 hours; Itching; Stinging tongue; This case was reported by a consumer via call center representative and described the occurrence of aphthous stomatitis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had it twice before). Concurrent medical conditions included diabetes.   On 6th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th August 2019, 1 days after receiving Shingrix, the patient experienced pain in arm and influenza-like symptoms. On 8th August 2019, the patient experienced erythema, induration, swelling and injected limb mobility decreased. On 10th August 2019, the patient experienced rash. In August 2019, the patient experienced stinging tongue. On 2nd September 2019, the patient experienced sleepiness. On an unknown date, the patient experienced aphthous stomatitis, tiredness and pruritus. On an unknown date, the outcome of the aphthous stomatitis, pain in arm, erythema, induration, swelling, injected limb mobility decreased, influenza-like symptoms, tiredness, rash, sleepiness and stinging tongue were recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the aphthous stomatitis, pain in arm, erythema, induration, swelling, injected limb mobility decreased, influenza-like symptoms, tiredness, rash, sleepiness, pruritus and stinging tongue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her arm was sore the next day after receiving the vaccination. Two days after receiving the vaccination, four inches below the injection site, she had a round, red, hard, swollen area. She could not sleep on her arm, and she could not move it. After four days, a rash developed to the right of the swollen, hard area. Over three days, the rash spread down the inside part of the elbow down to just below the elbow. All symptoms resolved after two weeks. She had flu-like symptoms that started the day after receiving the vaccine and these symptoms lasted for two days. She reports she was still tired she slept 13 hours yesterday. She developed six canker sores on the right side of her mouth one week after receiving the Shingrix vaccine, and it took about a week for them to start to heal. As they started to heal, 15 or 20 canker sores started on the left side of her mouth. They are healing but she has had them for two weeks.  The patient had stings on the end of her tongue that she says usually indicate that a canker sore was coming. The stings had there for two days but no canker sores have developed. She said that the stings are sensitive areas on her tongue. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. This report 1 of 2 reported by the consumer.