Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | LC757 | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
lupus anticoagulant positive; Pulmonary embolism; left deltoid muscle swollen; residual breathing issues; rectangular patch on her left deltoid, patch was red/round red patch inner right leg above the ankle; round, red, itchy patch on her inner right leg above the ankle; rectangular patch on her left deltoid, patch was itchy/ itchy patch on her inner right leg above the ankle; This serious case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included depression. Concurrent medical conditions included obesity (Obesity), thyroid disorder (back issues) and hypertension (Hypertension). Concomitant products included lisinopril, spironolactone, clonidine, gabapentin, tramadol, sertraline hydrochloride (Zoloft), clonazepam, levothyroxine sodium (Synthroid) and tizanidine. On 10-OCT-2023, the patient received Shingrix (intramuscular, left arm). On 11-OCT-2023, 1 days after receiving Shingrix, the patient experienced muscle swelling (Verbatim: left deltoid muscle swollen) (serious criteria hospitalization). In OCT-2023, the patient experienced red rash (Verbatim: rectangular patch on her left deltoid, patch was red/round red patch inner right leg above the ankle) (serious criteria hospitalization), patchy rash (Verbatim: round, red, itchy patch on her inner right leg above the ankle) (serious criteria hospitalization), pruritus (Verbatim: rectangular patch on her left deltoid, patch was itchy/ itchy patch on her inner right leg above the ankle) (serious criteria hospitalization) and abnormal breathing (Verbatim: residual breathing issues) (serious criteria hospitalization). On 30-OCT-2023, the patient experienced pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria hospitalization and GSK medically significant). On 12-DEC-2023, the patient experienced lupus anticoagulant positive (Verbatim: lupus anticoagulant positive) (serious criteria hospitalization). The outcome of the pulmonary embolism, red rash, patchy rash, pruritus, muscle swelling and lupus anticoagulant positive were unknown and the outcome of the abnormal breathing was not resolved. It was unknown if the reporter considered the pulmonary embolism, red rash, patchy rash, pruritus, muscle swelling, lupus anticoagulant positive and abnormal breathing to be related to Shingrix. The company considered the pulmonary embolism, lupus anticoagulant positive and abnormal breathing to be unrelated to Shingrix. The company considered the red rash, patchy rash, pruritus and muscle swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JUL-2025 The patient received Shingrix administered. The patient states the day after the vaccination her entire left deltoid muscle was swollen. The patient states her deltoid muscle resembled that of a body builders muscles. She states she also had a 1 and 1/2 by 3 inches rectangular patch on her left deltoid. The patient states this patch was red and itchy. About 2 or 3 days after vaccination she noticed a round, red, itchy patch on her inner right leg above the ankle. On 30-October-2023 the patient went to the emergency department. She had a computed tomography scan of chest, ultrasound of right leg and lab work done. The patient states she was diagnosed with a pulmonary embolism that possibly originated in the saphenous vein of the right leg. Doctors stated the saphenous vein looked suspicious and could possibly reflect remnants of a blood clot. The ultrasound was negative for blood clot in deep veins of leg. The patient states she was admitted to the hospital for approximately 3 days and then released. The patient was referred to hematology on 12-December-2023 and blood work was done. Blood work for lupus anticoagulant was positive at that time. Blood work was taken again February-2024 and the lupus anticoagulant was negative. The patient states the lupus anticoagulant blood work was the only value that was out of range. The patient was not an anit-vaxxer. States she reported this adverse event to VAERS in January-2025 (approximately.) The patient wished that she had been referred to respiratory rehabilitation because she had residual breathing issues at the time of reporting.; Sender's Comments: A case of Rash erythematous, Rash, Pruritus and Muscle swelling, 2-3 days after receiving Shingrix, in a 54-year-old female patient. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and biological plausibility for Rash erythematous and Rash. A case of Pulmonary embolism, Antiphospholipid antibodies positive and Respiration abnormal, less than a month after receiving Shingrix, in a 54-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (Concurrent medical conditions included obesity and hypertension).
Hypertension (Hypertension); Obesity (Obesity); Thyroid disorder (back issues)
Medical History/Concurrent Conditions: Depression
LISINOPRIL; SPIRONOLACTONE; CLONIDINE; GABAPENTIN; TRAMADOL; ZOLOFT; CLONAZEPAM; SYNTHROID; TIZANIDINE
Test Name: lupus anticoagulant; Result Unstructured Data: (Test Result:unknown,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231212; Test Name: lupus anticoagulant; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan; Result Unstructured Data: (Test Result:pulmonary embolism,Unit:unknown,Normal Low:,Normal High:); Test Name: ultrasound; Result Unstructured Data: (Test Result:pulmonary embolism,Unit:unknown,Normal Low:,Normal High:); Comments: Blood work was taken again February 2024 and the lupus anticoagulant was negative. She had a CT scan of chest, ultrasound of right leg and lab work done.