Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2T92N | — |
Transient ischemic attack; Peripheral polyneuropathy; This serious case was reported by a consumer via other manufacturer and described the occurrence of transient ischemic attack in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 52F7M, expiry date 15-JUN-2026) and (batch number 2T92N, expiry date 15-JUN-2026) for prophylaxis. The patient's past medical history included alcohol use, cholecystectomy (in 2010) and plastic surgery (in 2001, tummy tuck). Concurrent medical conditions included anxiety (in 2001), arthritis (in 2000), depression (in 2001), thyroid disorder (in 1994), hay fever, hypercholesterolemia, asthma, blood pressure high, penicillin allergy (Anaphylaxis and Hives) and rhinitis. Additional patient notes included patient height was 1.651 m. Concomitant products included atomoxetine hydrochloride (Strattera), buspirone hydrochloride (Buspar), levocetirizine dihydrochloride (Allegra), guanfacine hydrochloride (Guanfacine Hcl), montelukast sodium (Singulair), progesterone (Progesteron), rosuvastatin calcium, thyroid, testosterone, buspirone, rosuvastatin calcium (Crestor), amlodipine, mirabegron (Myrbetriq), macrogol, salbutamol (Albuterol), atorvastatin, estradiol, prazosin, semaglutide, bupropion hydrochloride (Wellbutrin Xl), salbutamol sulfate (Albuterol Sulfate) and guanfacine hydrochloride (Intuniv). Family history included arthritis (mother and father) and diabetes (father). On 12-NOV-2024, the patient received Shingrix. In NOV-2024, less than a week after receiving Shingrix, the patient experienced transient ischemic attack (Verbatim: Transient ischemic attack) (serious criteria hospitalization and GSK medically significant) and polyneuropathy (Verbatim: Peripheral polyneuropathy) (serious criteria hospitalization and GSK medically significant). The patient was treated with acetylsalicylic acid (Aspirin). The outcome of the transient ischemic attack and polyneuropathy were not reported. It was unknown if the reporter considered the transient ischemic attack and polyneuropathy to be related to Shingrix. The company considered the transient ischemic attack and polyneuropathy to be unrelated to Shingrix. Additional Information: GSK receipt date: 24-FEB-2025 The patient recived Shingrix vaccine and experienced transient ischemic attack and peripheral polyneuropathy. The reporter mentioned that the patient developed numbness/tingling left side of face. The phone call completed, or visit completed within 48 hours of Discharge on 18th November 2024. They received discharge summary and hospital records for reviewed. The medication reconciliation was completed. The education provided for disease and illness self-management, independent living and activities of daily living. The patient was in office for routine follow up. Patient would like to discuss hospital admission 22nd November 2024 to 23rd November 2024 for stroke-like symptoms. The suspect patient might had a TIA (transient ischemic attack) as the inpatient team discharged her on ASA and statin. Patient was still having numbness and tingling in her left lower extremity and left face. The possible patient's hormone replacement therapy of estrogen, progesterone and testosterone could had caused occult clotting leading to a TIA. The medication Dispense History from 27th November 2023 to 25th November 2024. The patient reports that she had never smoked. She had never used smokeless tobacco. She reported that she did not currently use alcohol after a past usage of about 1.0 standard drink of alcohol per week. The neurological positive for numbness. The reporter mentioned the problem list the bronchiectasis without complication. The patient had an iron deficiency pulmonary infection due to Mycobacterium avium complex. Allergic shiners and allergic rhinitis with postnasal drip. The drug-induced constipation was anxiety and depression. The urinary incontinence vegetarian acquired hypothyroidism and facial paresthesia. The clock draw test, recall 3 words and mini-cog score was not recorded. The Influenza, Pneumococcal and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination declined by patient. The current long-term use of postmenopausal hormone replacement therapy.; Sender's Comments: Transient ischaemic attack and Polyneuropathy are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Anxiety (in 2001); Arthritis (in 2000); Asthma; Blood pressure high; Depression (in 2001); Hay fever; Hypercholesterolemia; Penicillin allergy (Anaphylaxis and Hives); Thyroid disorder (in 1994)
Medical History/Concurrent Conditions: Alcohol use; Arthritis (mother and father); Cholecystectomy (in 2010); Diabetes (father); Plastic surgery (in 2001, tummy tuck); Rhinitis; Comments: patient height was 1.651 m
STRATTERA; BUSPAR; Allegra; GUANFACINE HCL; SINGULAIR; PROGESTERON; ROSUVASTATIN CALCIUM; THYROID; TESTOSTERONE; BUSPIRONE; CRESTOR; AMLODIPINE; MYRBETRIQ; MACROGOL; ALBUTEROL; ATORVASTATIN; ESTRADIOL; PRAZOSIN; SEMAGLUTIDE; WELLBUTRIN XL;
Test Date: 202411; Test Name: BP; Result Unstructured Data: (Test Result:112/72,Unit:unknown,Normal Low:,Normal High:); Comments: location: left arm; Test Date: 202411; Test Name: BMI; Result Unstructured Data: (Test Result:25.33 kilogram per meter square,Unit:unknown,Normal Low:,Normal High:); Test Date: 202411; Test Name: temperature; Result Unstructured Data: (Test Result:36.4,Unit:degree C,Normal Low:,Normal High:); Comments: 97.6 degree F; Test Date: 202411; Test Name: pulse; Result Unstructured Data: (Test Result:83,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240724; Test Name: Depression screening; Result Unstructured Data: (Test Result:1,Unit:unknown,Normal Low:,Normal High:); Test Date: 202411; Test Name: Spo2; Test Result: 98 %; Test Date: 202411; Test Name: Respiratory rate; Result Unstructured Data: (Test Result:16,Unit:unknown,Normal Low:,Normal High:); Comments: Physical examination: Vitals and nursing note reviewed. Constitutional: Appearance: She is not ill-appearing or toxic-appearing. HENT: Head: Normocephalic and atraumatic. Right Ear: Tympanic membrane, ear canal and external ear normal. There is no impacted cerumen. Left Ear: Tympanic membrane, ear canal and external ear normal. There is no impacted cerumen. Nose: Nose normal. General: No scleral icterus. Right eye: No discharge. Left eye: No discharge. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary Effort: No respiratory distress. Breath sounds: No stridor. No wheezing, rhonchi or rales. Chest:Chest wall: No tenderness. Abdominal:General: Bowel sounds are normal. Musculoskeletal: General: No tenderness. Normal range of motion. Cervical back: Normal range of motion. Right lower leg: No edema. Left lower leg: No edema. Skin: Coloration: Skin is not pale. Findings: No erythema or rash. Neurological: Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit. Sensory: No sensory deficit (pt can feel my palpation of her face and lower extremities) Gait: Gait normal. Deep Tendon Reflexes: Reflexes normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. LabComments: BP 15-NOV-24: location: left arm, temperature 15-NOV-24: 97.6 degree F