Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Inappropriate schedule of product administration, Incomplete course of vaccination, Pustule
Clinical narrative: Medium size pustles; Patient reportes it was a medium ize pustle,that is dry but very bright red; Eruption on the cheek bone area; Tenderness; shingles / suspected vaccination failure; shingles; 2nd dose on September 3rd 2020; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) (batch number 9E995) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 23JK5) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received zostavax vaccine on 18th May 2013 at a local pharmacy).   On 03-SEP-2020, the patient received the 2nd dose of Shingrix (left arm). On 21-MAY-2019, the patient received the 1st dose of Shingrix (left arm). On 03-SEP-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose on September 3rd 2020). On 10-NOV-2023, the patient experienced vaccination failure (Verbatim: shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced pustule (Verbatim: Medium size pustles), erythema (Verbatim: Patient reportes it was a medium ize pustle,that is dry but very bright red), eruption facial (Verbatim: Eruption on the cheek bone area) and tenderness (Verbatim: Tenderness). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not resolved and the outcome of the pustule, erythema, eruption facial and tenderness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pustule, erythema, eruption facial and tenderness to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pustule, erythema, eruption facial and tenderness to be related to Shingrix and Shingrix.   Additional Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.   Follow up information received on 13-NOV-2023 Patient reported she had her 1st dose of Shingrix in her left arm a different retail pharmacy and received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. Patient reported that was developed mild case of shingles on the same spot-on 10th November 2023. Patient reported that this was the 5th time she had shingles. It was always on the same spot. Patient reported that it was not severe, nor it was spreading, only one spot. Patient reported it was medium size pustule, that was dry but very bright red. It was one eruption on the cheek bone area, and it was very tender. Patient provided consent to follow up with healthcare professional. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting Summary of changes: Patient details, product details, event details and narrative were updated.