Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tremor, White blood cell count increased
Clinical narrative: Fatigue; Severe prolonged inflammatory reaction; Daily fever to 103.5; Rigors; Asthenia; Pain; Leukocytosis over 16,000; Anemia to 9.9 gm Hgb; Hyponatremia of 129; Albumin falling to 3.3; This case was reported by a other health professional and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GH33, expiry date 13th October 2023) for prophylaxis.   The patient's past medical history included inflammatory reaction. Previously administered products included Reclast infusion with an associated reaction of inflammation (dose received over 6 years ago prior to the reporting). Concurrent medical conditions included diffuse scleroderma. Concomitant products included nebivolol hydrochloride (Bystolic).   On 28th January 2023, the patient received Shingrix (intramuscular) .5 ml. On 3rd February 2023, 6 days after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), rigors (serious criteria hospitalization), asthenia (serious criteria hospitalization), pain (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), anemia (serious criteria hospitalization), hyponatremia (serious criteria hospitalization) and albumin decreased (serious criteria hospitalization). On an unknown date, the patient experienced fatigue (serious criteria hospitalization) and inflammatory reaction (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the rigors, asthenia, pain, leukocytosis, anemia, hyponatremia, albumin decreased and fatigue were not recovered/not resolved and the outcome of the inflammatory reaction was unknown.   It was unknown if the reporter considered the fever, rigors, asthenia, pain, leukocytosis, anemia, hyponatremia, albumin decreased, fatigue and inflammatory reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The patient was self-reported this case. The report was submitted by public. This report was submitted by the online direct entry reporting system.  The reporter reported that the patient received Shingrix vaccine. The reporter stated that on 3rd February 2023, 6 days after received Shingrix vaccine the patient was hospitalized due to she experienced daily fever to 103.5 with rigors, asthenia, pain with leukocytosis to over 16,000, anemia to 9.9 gm hemoglobin and hyponatremia of 129 with albumen falling to 3.3. The reporter reported that the patient done with the blood cultures and urine culture which was showed no growth. The reporter stated that the patient experienced similar severe prolonged inflammatory reaction to reclast infusion 6 years ago. The patient received IV antibiotics on 7th February 2023 as a treatment with rules out of sepsis. The reporter reported that the patient gradual return to a febrile state but thre asthenia and fatigue persist to still the date. The reporter did consent to follow up. Additional supportive information: The event severe prolonged inflammatory reaction coded as per the reporter mentioned that suffered similar severe prolonged inflammatory reaction to Reclast infusion 6 years ago.