Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blister, Herpes zoster, Post herpetic neuralgia, Quality of life decreased
Clinical narrative: constant nerve pain now, destructive to my life/ nerve pain PHN; anxiety; This ongoing issue has been very destructive to my life; Large blisters; constant shingle outbreaks, breaking point for overall health/6+ times is now a breaking point for me/ outbreak on left butt check; This case was reported by a consumer and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number p7n2h, expiry date unknown) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased, hypothyroidism and osteoarthritis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), rosuvastatin, levothyroxine (Levothyroxin) and meloxicam.   On 26th November 2021, the patient received the 2nd dose of Shingrix. On 27th November 2021, 1 days after receiving Shingrix, the patient experienced shingles. On 7th December 2022, the patient experienced blister. On an unknown date, the patient experienced post herpetic neuralgia, anxiety and quality of life decreased. The patient was treated with clonazepam, valaciclovir (Valacyclovir) and gabapentin. On an unknown date, the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved and the outcome of the anxiety, quality of life decreased and blister were unknown.   It was unknown if the reporter considered the shingles, post herpetic neuralgia, anxiety, quality of life decreased and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-FEB-2023 Reporter's comments: The patient self-reported this case. The patient never had any issues until she got Shingrix shots.  If she would had knew that, she was going to have the shingles just about every month then she would had not gotten the shots for preventing shingles, following the physician orders.  This ongoing issue had been very destructive to her life with the constant nerve pain now, along with never knowing when it would arise again. Six plus times was now a breaking point for her with the anxiety and overall health (constant shingle outbreaks). The symptoms were treated. The reporter gave permission to contact. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Adverse event (AE) outcome captured conservatively and clarification was raised to confirm the same.   Follow-up information received on 22-FEB-2023 Reporter's comment: On 27th November 2021, patient had the outbreak of infection on left butt cheek which was seen and confirmed by doctor on 30th November 2021 to be shingles.  On 20th February 2022, the patient saw other doctor for the same outbreak. On 23rd March 2022, the doctor already gave her refills for any outbreaks due to covid. On 8th May 2022, the doctor did not want to see her due to covid, so just called in to provided with prescription. On 9th May 2022, she had the prescription so she started it.  On 10th May 2022, she called doctor but couldn't get herself in, thus started prescription immediately. On 11th May 2022, she called doctor but couldn't get herself in until 11th July 2022, but as she had already started prescription, she could not get a swab. On 12th July 2022, she just started to take prescription as the outbreak hit fast and hard with blisters within hours. On 27th December 2022, she contacted the doctor but no vacation was given, so she started to take the medication. On 3rd February 2023, she started medication immediately. When she got the shingles, she needed to get on medication as soon as possible or goes right into small blisters within 12 hours of that they were large blisters. Doctors already had made sure she had refills of the valacyclovir 1 gram tablet 3 times for 7 days. She then had to even take gabapentin 400 mg capsule 3 times daily for the nerve pain (post herpetic neuralgia). Reporters were added. Shingrix second dose was added as suspect product. Event blister was added Treatment Gabapentin drug was added. Summary of changes: General tab, Product tab, Event tab and narrative updated.