Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Pyrexia, Rash, Skin mass
Clinical narrative: pain from the left shoulder blade spread to the left rib cage; diagnosed with shingles; rash on left shin; the same location as the rash, subcutaneous nodes on the left shin; acute pain in her left shoulder blade; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for shingles, gabapentin for pain, prednisone for product used for unknown indication and ibuprofen for shoulder blade pain.   The patient's past medical history included shingles (first case of Shingles in 1980's (when she was in her 20's)) and shingles (second case of Shingles 2019). Previously administered products included Zostavax (received in 2013). Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 29th May 2021 09:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, the patient started Valacyclovir 1 g 3 times daily (3 g daily). On 18th June 2021, the patient started gabapentin at an unknown dose and frequency. On 8th June 2021, the patient started prednisone at an unknown dose and frequency. On 4th June 2021, the patient started ibuprofen 400 mg 3 times daily (1200 mg daily). On 29th May 2021, 8 hrs after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced fever and chills. On 3rd June 2021, the patient experienced shoulder blade pain. On 7th June 2021, the patient experienced shingles, rash and subcutaneous nodule. On 8th June 2021, the patient experienced cough. On 15th June 2021, the patient experienced rib pain. On 18th June 2021, the patient experienced ankle swelling and pain. The action taken with Valacyclovir was unknown. Gabapentin was discontinued. The action taken with prednisone was unknown. Ibuprofen was discontinued on 6th June 2021. On 30th May 2021, the outcome of the fever and chills were recovered/resolved. On 13th June 2021, the outcome of the cough was recovered/resolved. On 22nd June 2021, the outcome of the ankle swelling was recovered/resolved. On an unknown date, the outcome of the shingles, subcutaneous nodule, rib pain and pain were not recovered/not resolved and the outcome of the shoulder blade pain and rash were recovered/resolved.   It was unknown if the reporter considered the shingles, fever, chills, rash, subcutaneous nodule, cough, rib pain, ankle swelling and pain to be related to Shingrix. The reporter considered the shoulder blade pain to be unrelated to Shingrix. It was unknown if the reporter considered the ankle swelling and pain to be related to Valacyclovir.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Covid 19 vaccine 3 months before the date of reporting. The patient received Shingrix in the left arm. On 3rd Jun 2021, 5 days after receiving Shingrix, the patient developed acute pain in her left shoulder blade. The patient did not associate this pain with the Shingrix vaccine. On 4th, 5th and 6th June 2021, the patient took OTC Ibuprofen (400mg three times a day) and on 7th June 2021, the patient developed a rash on her left shin and in the same location as the rash, subcutaneous nodes on the left shin and stopped the Ibuprofen. On June 8th, the patient went to the healthcare professional (HCP) who prescribed a 6 days Prednisone Taper (no dosage noted). The patient developed a slight cough while on prednisone that resolved on 13th June 2021 when the Prednisone taper ended. On 15th June 2021, the pain from the left shoulder blade spread to the left rib cage and the patient went back to HCP who diagnosed her with Shingles. The HCP started her on Valcyclovir 1 gram three times a day for 7 days. The HCP started her on Gabapentin for shingles pain on 18th June 2021. On 22nd June 2021, the patient stopped the Gabapentin due to swelling in her ankles. The patient was currently not on any medication for the shingles pain. The HCP offered a 12-day Prednisone taper on June 22nd, but the patient declined the medication. The reporter does not wish to share her address or date of birth. The reporter gave permission to contact via phone only. The reporter does not give permission to contact HCP. It was unknown if the reporter considered the shingles, rash, subcutaneous nodule, cough, rib pain, ankle swelling and shingles pain to be related to Ibuprofen. It was unknown if the reporter considered the shingles, cough, rib pain, ankle swelling and shingles pain to be related to Prednisone taper. It was unknown if the reporter considered the ankle swelling to be related to Gabapentin.   Upon a medical review performed following changes were made on 13th July 2021: The COVID 19 vaccine was updated as medical history instead of concomitant drug. Cough and ankle swelling were deleted as event because they occurred after treatment with non-GSK products. Event pain was deleted.