Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
aches; Fatigue; Fever; feeling unwell; This non-serious case was reported by a physician and described the occurrence of fever in a 39-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included tingling, pain, shingles, vesicles (posterior right arm, right leg, genital area), fatigue, colitis (suspected), polyp, colonoscopy (done on 13-JUN-2024, colonoscopy recall 2-3 years no colitis), renal stone (kidney stone analysis done on DEC-2019), cardiac ablation (for cardiac arrhythmia on 15-MAY-2005), cardiac arrhythmia, alcohol use (current, 1-2 times per year, 15-MAY-2020) and computerized tomogram abnormal. Previously administered products included Valtrex and Valganciclovir (received in JUL-2020). Concurrent medical conditions included systemic lupus erythematosus, asthma, cytomegalovirus infection (chronic), immunocompromised, mouth ulcer, genital ulceration, nausea, fever, hypotension, vomiting, sepsis, therapeutic drug monitoring, transaminitis, urinary tract infection, allergic to cats and dust allergy. Concomitant products included hydroxychloroquine, valaciclovir (Valacyclovir), salbutamol (Albuterol Hfa), azathioprine, biotin, loratadine, tizanidine, colecalciferol (Vitamin D3) and cyanocobalamin. Family history included heart disease, unspecified (patient's father), fibromyalgia (patient's mother) and hypertension (patient's mother). On 05-SEP-2024, the patient received the 1st dose of Shingrix. In SEP-2024, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: Fever), feeling unwell (Verbatim: feeling unwell), pain (Verbatim: aches) and fatigue (Verbatim: Fatigue). The patient was treated with paracetamol (Tylenol). In SEP-2024, the outcome of the pain and fatigue were resolved. The outcome of the fever and feeling unwell were resolving. It was unknown if the reporter considered the fever, feeling unwell, pain and fatigue to be related to Shingrix. It was unknown if the company considered the fever, feeling unwell, pain and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025024878 Additional Information: GSK Receipt Date:16-APR-2025 The patient used B-12 1000 mcg oral tablet, 1000 mcg is equal to 1 Tab, PO, Daily (Once Daily) as concomitant. The place of vaccination in VAERS details was reported as mercy one trees medical cende. The patient experienced reaction from Shingrix injection. Fevers 99.9 today on 26-SEP-2024 it was (99-100.6) The pain present but no actual or suspected pain. The patient was 39-year-old who presents for an acute visit for fevers after Shingles vaccine. Reported after getting the Shingrix vaccine on 05-SEP-2024 she developed a fever and generally feeling unwell. She stated for the first 2 days she ran a fever as high as 101.8 then after that had further low grade fevers. She had aches and fatigue. Only tries to use Tylenol sparingly. No further mediation changes. She was feeling a bit better. No sores or outbreaks at this time. On 06-FEB-2025, the patient who presented for her second Shingles vaccine. Last visit she was evaluated with an acute visit for fevers after Shingles vaccine and stated she did feel bad a few days after her vaccine she did not feel well and had fevers on and off for some time but does need her second vaccine prior to starting Benlysta per. She presented here for her second Shingles vaccine. She went to last week. She does have a dry hacky cough but no chest pain or SOB (shortness of breath). TB test in December 2024 negative. She was immunocompromised with SLE and intermittent outbreaks of oral and genital ulcers but was currently stable on evaluation today. She would also like to continue towards using less valacyclovir and even some day discontinuing her suppressive therapy, however she had been doing well at this time therefore they would continue current regimen, no recent outbreak. Patient would also like to discuss shingles vaccine and they did discuss at last visit, she checked with her insurance and was covered as she was immunocompromised. Previously in history, before receiving vaccine, when she had her outbreaks, she had get vesicles to her posterior right arm, right leg and genital area at times. Typically when she was more stressed. Reported that she has had to take the abortive therapy a couple times over the year but again tries not to unless only necessary. She continues her daily suppressive Valtrex and not missing doses. She does not have side effects. Today she denies any current outbreaks to her arm, leg or genital area. Continues regular labs per Rheumatology and reported as stable. Now also following GI (gastrointestinal) Dr. for evaluation for suspected colitis. Last 2-3 small polyps. Colonoscopy recall 2-3 years no colitis. Several days after received Shingrix, the patient experienced feeling unwell. Less than 3 weeks after received Shingrix, the patient experienced pain and fatigue. For tolerance of the 2nd dose refer linked case US2025024878, reported by the same reporter.; Sender's Comments: US-GSK-US2025024878:case for 2nd dose
Allergic to cats; Asthma; Cytomegalovirus infection (chronic); Dust allergy; Fever; Genital ulceration; Hypotension; Immunocompromised; Mouth ulcer; Nausea; Sepsis; Systemic lupus erythematosus; Therapeutic drug monitoring; Transaminitis; Urinary tract infection; Vomiting
Medical History/Concurrent Conditions: Alcohol use (current, 1-2 times per year, 15-MAY-2020); Cardiac ablation (for cardiac arrhythmia on 15-MAY-2005); Cardiac arrhythmia; Colitis (suspected); Colonoscopy (done on 13-JUN-2024, colonoscopy recall 2-3 years no colitis); Computerized tomogram abnormal; Fatigue; Fibromyalgia (patient's mother); Heart disease, unspecified (patient's father); Hypertension (patient's mother); Pain; Polyp; Renal stone (kidney stone analysis done on DEC-2019); Shingles; Tingling; Vesicles (posterior right arm, right leg, genital area)
HYDROXYCHLOROQUINE; VALACYCLOVIR; ALBUTEROL HFA; AZATHIOPRINE; BIOTIN; LORATADINE; TIZANIDINE; VITAMIN D3; CYANOCOBALAMIN
Test Date: 202409; Test Name: Diastolic Blood Pressure; Result Unstructured Data: (Test Result:126,Unit:unknown,Normal Low:,Normal High:); Comments: unit: mm hg; Test Date: 202409; Test Name: BP Extremity; Result Unstructured Data: (Test Result:RUE,Unit:unknown,Normal Low:,Normal High:); Test Date: 202409; Test Name: Systolic Blood Pressure; Result Unstructured Data: (Test Result:126,Unit:unknown,Normal Low:,Normal High:); Comments: unit: mm hg; Test Date: 202409; Test Name: BMI; Result Unstructured Data: (Test Result:242,Unit:unknown,Normal Low:,Normal High:); Comments: unit: kg/m2; Test Date: 202409; Test Name: BSA; Result Unstructured Data: (Test Result:1.8,Unit:unknown,Normal Low:,Normal High:); Test Date: 202409; Test Name: Body temperature; Result Unstructured Data: (Test Result:36.2,Unit:degree C,Normal Low:,Normal High:); Test Date: 202409; Test Name: Body temperature; Result Unstructured Data: (Test Result:99.9,Unit:unknown,Normal Low:,Normal High:); Test Date: 202409; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.8,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240926; Test Name: Body temperature; Result Unstructured Data: (Test Result:99 to 100.6,Unit:unknown,Normal Low:,Normal High:); Test Date: 202409; Test Name: Body temperature; Result Unstructured Data: (Test Result:97.1,Unit:degree F,Normal Low:,Normal High:); Test Date: 202409; Test Name: Pulse rate; Test Result: 71 bpm; Test Date: 202412; Test Name: TB test; Test Result: Negative ; Test Date: 202409; Test Name: Pulse ox; Test Result: 99 %; Comments: Temperature Source : Temporal Scanner BP source: Manual LabComments: Diastolic Blood Pressure 15-SEP-24: unit: mm hg, Systolic Blood Pressure 15-SEP-24: unit: mm hg, BMI 15-SEP-24: unit: kg/m2