Received Jun 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Queasy; Fever; Fatigue; Headache; Anorexia; whole-body aches; Skin sensitisation; Painful arm; Flat in bed for 36 hrs/Flat in bed for 24 hrs; chills; Suspected vaccination failure; Shingles on her upper left back and one day of discomfort with this outbreak; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) solution for injection for prophylaxis. Concurrent medical conditions included autoimmune disorder (Immunocompromised unspecified origin), gastroesophageal reflux disease, cortisol (Mild autonomous cortisol secretion), hormone replacement therapy, hypothyroidism, allergic reaction, pollen allergy and food allergy (patient does not know what triggers the allergy). Concomitant products included levothyroxine sodium (Synthroid), famotidine, estradiol (Estrogen), progesterone, estradiol (Estrogen), montelukast sodium (Singulair), cetirizine hydrochloride (Zyrtec), loratadine (Claritin) and magnesium glycinate. On an unknown date, the patient received the 2nd dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on her upper left back and one day of discomfort with this outbreak). On an unknown date, the patient experienced queasy (Verbatim: Queasy), fever (Verbatim: Fever), fatigue (Verbatim: Fatigue), headache (Verbatim: Headache), anorexia (Verbatim: Anorexia), general body pain (Verbatim: whole-body aches), skin sensitization (Verbatim: Skin sensitisation), pain in arm (Verbatim: Painful arm), bedridden (Verbatim: Flat in bed for 36 hrs/Flat in bed for 24 hrs) and chills (Verbatim: chills). The patient was treated with Antivirals. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 2 weeks) and the outcome of the queasy, fever, fatigue, headache, anorexia, general body pain, skin sensitization, pain in arm, bedridden and chills were resolved. It was unknown if the reporter considered the vaccination failure, shingles, queasy, fever, fatigue, headache, anorexia, general body pain, skin sensitization, pain in arm, bedridden and chills to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 01-JUN-2026 and 02-JUN-2026 The patient received a 2-shot SHINGRIX series in 2018 and completed the series within the prescribed time frame. Seven years later, in June of 2025, the patient contracted shingles to her upper left back, which the patient described as mild, lasting about 2 weeks. The patient reported only one day of discomfort with this outbreak. The patient took antiviral medication, which helped immediately, and the blisters healed in about 2 weeks or so. The patient waited almost a year after the shingles infection before receiving another Shingrix vaccination. The patient's reactions for first dose, 2018 were queasy, fever, fatigue, headache, loss of appetite, chills, skin sensitive to touch all-over, whole-body pain, pain in arm like someone had punched the patient. The patient was flat in bed for 36 hours. The patient had reactions for second dose, 2018 all the same symptoms at the same severity, but did not last as long. The patient was in bed for 24 hours. The patient always had a very strong reaction to the vaccine. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided upon follow-up with the reporter.; Sender's Comments: A case of Vaccination failure, on an unknown time after vaccination with the 1st and 2nd doses of Shingrix, in a 60-year-old female patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought. US-GSK-US2026AMR075429:case for 2nd dose US-GSK-US2026AMR075433:case for 3nd dose
Allergic reaction; Autoimmune disorder (Immunocompromised unspecified origin); Cortisol (Mild autonomous cortisol secretion); Gastroesophageal reflux disease; Hormone replacement therapy; Hypothyroidism
Medical History/Concurrent Conditions: Food allergy (patient does not know what triggers the allergy); Pollen allergy
SYNTHROID; FAMOTIDINE; ESTROGEN; PROGESTERONE; ESTROGEN; SINGULAIR; ZYRTEC; Claritin; MAGNESIUM GLYCINATE
Test Name: C-reactive protein; Result Unstructured Data: (Test Result:Elevated,Unit:unknown,Normal Low:,Normal High:)