Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Product administered at inappropriate site, Skin discolouration, Swelling
Clinical narrative: Genital herpes once or twice a year during stressful time / gotten the vaccine she has had 1 to 2 episodes a month; Bruising, raised area and soreness at the sight right away; Raised area and soreness at the sight right away; discoloation; soreness; fatigue; headache; Shot was given on the backside of her left arm in the fatty part below her shoulder; she was taking just 1 a day,   but then was told by her doctor to take valacyclovir twice a da; the herpes rersolved but then returns; This case was reported by a consumer via call center representative and described the occurrence of genital herpes in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for genital herpes.  The patient's past medical history included genital herpes (once or twice a year during stressful time).   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Valacyclovir 1 g once daily (1 g daily). On an unknown date, the dose was changed to 1 g twice daily (2 g daily). On an unknown date, less than 6 months after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the genital herpes, contusion, swelling, skin discoloration, pain, fatigue, headache, vaccine administered at inappropriate site, underdose and lack of drug effect were unknown.   It was unknown if the reporter considered the genital herpes, contusion, swelling, skin discoloration, pain, fatigue and headache to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the pharmacist did not seem to be aware of where to give the shot, so it was given on the backside of her left arm in the fatty part below her shoulder, which led to inappropriate site of vaccine administration. She stated that she was told this could help with her genital herpes, which she stated was once or twice a year during stressful time. She noted she had gotten the vaccine she has had 1 to 2 episodes a month. She was being treated with Valacylovir (manufacturer unknown). She reported that she was taking just 1 a day, but then was told by her doctor to take valacyclovir twice a day, which led to underdose.  She stated that the herpes resolves, but then returns, which led to lack of drug effect. The prescribing information was reviewed for indications and dosage and administration and common adverse events seen.  She was referred to her doctor. The doctor noted she had bruising, raised area and soreness at the sight right away. She noted she also had fatigue and headache after the vaccine.   Follow up information received from physician on 23rd April 2020: The patient was under care and no longer with the practice. Called to reviewer and officer but unable to add patient discovery.