Age: 35.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster disseminated, Product administered to patient of inappropriate age, Pyrexia, Rash, Urticaria
Clinical narrative: Low grade fever; Rash/Rash were worsening; Hives/hives across her chest, torso and to both arms/ Hives were worsening; she was diagnosed with disseminated zoster; She received her second Shingrix dose on 8-MAY-2024; Inappropriate age at vaccine administration; This serious case was reported by a pharmacist via call center representative and described the occurrence of low grade fever in a 35-year-old female patient who received Herpes zoster (Shingrix) (batch number LL5C2, expiry date 18-APR-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 08-MAY-2024, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 06-FEB-2024, the patient received the 1st dose of Shingrix. On 06-FEB-2024, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 08-MAY-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: She received her second Shingrix dose on 8-MAY-2024). On 14-MAY-2024, the patient experienced low grade fever (Verbatim: Low grade fever) (serious criteria hospitalization), rash (Verbatim: Rash/Rash were worsening) (serious criteria hospitalization) and hives (Verbatim: Hives/hives across her chest, torso and to both arms/ Hives were worsening) (serious criteria hospitalization). In MAY-2024, the patient experienced herpes zoster disseminated (Verbatim: she was diagnosed with disseminated zoster) (serious criteria hospitalization and GSK medically significant). The patient was treated with triamcinolone acetonide (Kenalog), hydrocortisone, methylprednisolone (Medrol Dosepak), valaciclovir (Valacyclovir), prednisone and aciclovir (Acyclovir). The outcome of the low grade fever, rash, hives, herpes zoster disseminated, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the low grade fever, rash, hives and herpes zoster disseminated to be related to Shingrix.     The company considered the low grade fever, rash, hives, herpes zoster disseminated, inappropriate age at vaccine administration and inappropriate age at vaccine administration to be unrelated to Shingrix. The company considered the low grade fever, rash, hives, herpes zoster disseminated and inappropriate age at vaccine administration to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2024 This case was self-reported by patient. The patient did not had an adverse reaction with her first Shingrix dose. The patient received 2nd dose of Shingrix vaccine and six days after vaccination, she developed a low grade fever, rash and hives across her chest, torso and to both arms. On 16th May the patient went to urgent care because the rash and hives were worsening. She was given Kenalog intramuscular (IM) in the urgent care and topical hydrocortisone to use as needed. On 17th May 2024, she saw her physician due to continued worsening of the rash, hives and started on a Medrol dose pack. On 18th May 2024, she was switched from Medrol to oral prednisone and valacyclovir. At evening, on 18th May 2024, she went to the emergency room and was admitted to the hospital for two days.  While hospitalized she received (intravenous) IV acyclovir.  Less than a week after 2nd dose, in the hospital, she was diagnosed with disseminated zoster.  She was discharged to home with oral acyclovir and oral prednisone.  Nothing else was reported.  The patient received both dose of Shingrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments: Herpes zoster disseminated is an unlisted event which is considered unrelated to GSK vaccine Shingrix. Pyrexia, Rash  and Urticaria are  listed events which, due to the following criteria (Herpes zoster) are considered unrelated to GSK vaccine Shingrix.