Sex: F
Vaccine: PPV
Symptoms: Hyperlipidaemia, Hypertension, Hypothyroidism, Immunoglobulin therapy, Large intestine polyp
Clinical narrative: hemoptysis; Melanoma resection - left face (2013); right forearm (pending 2022); Hypothyroidism; There appears to be symmetric weakness of her lower extremities that does not affect her upper extremities or the rest of her body; She exhibits difficulty getting up from seated position, and needs a cane to walk, but is able to do leg presses.; At various times including last few months has short-term burning sensation over left thigh but her predominant symptom is weakness; She had a muscle biopsy done in August 2022 which showed moderately severe myofiber atrophy; Hyperlipidemia; Bilateral LE varicose veins; Hiatal Hernia (small); Diverticulosis; Colonoscopy - 2/17/23 divertic, small polyp; Osteopenia fem necks; Hypertension; In Sept 2021 she was taken off Keytruda due to possible pneumonitis; myopathy; In February she started developing difficulty walking, "feels like I am walking on a waterbed or trampoline."; Ataxic Gait "like I am walking on a trampoline"; This spontaneous report has been received from a physician via employee from the ask line referring to a female patient in her 70s. Information of concurrent conditions, medical history, concomitant medications and drug reactions/allergies was not reported.   On an unknown date, the patient administered therapy unspecified (manufacture unknown) (strength, formulation, dose, frequency, lot number, expiration date, route of administration and indication were unknown). Employee could not confirm the product patient was taking, but stated physician called the ask line, so employee assumed the product was pembrolizumab (KEYTRUDA).  On an unknown date, the patient was experiencing myopathy. It was unknown if patient sought any medical attention, received treatment or any lab/diagnostic tests were performed. Action taken with therapy unspecified (manufacture unknown) for the event was not reported. The outcome of the event was unknown.   The causality assessment between the suspect product and event was not provided.  This report was considered as non-valid due to therapy unspecified.  Follow up information has been received from a physician on 22-FEB-2023, referring to a currently 75 years old retired non-pregnant female patient, who was a former smoker and tobacco user without known drug allergy. The patient's historical surgeries included tonsillectomy and partial hysterectomy. She denies dizziness, vertigo, lower extremity pain, headache, bowel or bladder incontinence or retention. Concomitant therapies included hydrochlorothiazide (+) losartan potassium (HYZAAR), simvastatin, levothyroxine sodium (SYNTHROID), famotidine and simeticone.   The patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (strength, dose, route, lot# and expiration date were not provided) the first dose on 17-DEC-2012 and the second dose on 12-DEC-2018.   The patient, who was previously in very good health, was diagnosed with stage 4 poorly differentiated lung adenocarcinoma in July 2020 when she presented to local hospital with hemoptysis (also reported as hospitalized hemoptysis 29-JUL-2020 to 31-JUL-2020),   On 20-JUL-2020, the patient started therapy with pembrolizumab (KEYTRUDA) powder for injection (strength, dose, frequency, route, lot# and expiration date were not provided) for stage 4 poorly differentiated lung adenocarcinoma.   On an unknown date, the patient developed hypertension, hyperlipidaemia, hypothyroidism, bilateral varicose vein of lower extremities (varicose vein surgeries - multiple), diverticulosis and melanoma left face, right forearm (melanoma resection - left face (2013), right forearm (pending 2022)) (malignant neoplasm progression).   In February 2021, she started developing difficulty walking, ataxic gait "feels like I am walking on a waterbed or trampoline". In July 2021, the patient started developing myopathy, which was confirmed by biopsy and electromyography (EMG). Dual x-ray absorptiometry (DEXA) on 07-SEP-2021 showed osteopenia femoral necks. In September 2021, she was taken off pembrolizumab (KEYTRUDA) due to possible pneumonitis. There appeared to be symmetric weakness of her lower extremities that did not affect her upper extremities or the rest of her body. She exhibited difficulty getting up from seated position, and needs a cane to walk, but was able to do leg presses. At various times including last few months she had short-term burning sensation over left thigh but her predominant symptom was weak. She has had extensive evaluation for this complaint including neurologic consultation, vestibular rehabilitation, physiatry, rheumatology, and had serologic testing for autoimmune diseases, skin and muscle biopsy. She had the first of two EMGs in April 2022 - this showed evidence of a myopathic process; her second EMG in June 2022 also showed evidence of a myopathic process but no poly or mononeuropathy. She was treated with intravenous immune globulin (IVlG) from May - September 2022 but she did not improve. She had a muscle biopsy done in August 2022 which showed moderately severe myofiber atrophy, but no evidence of myositis. She had a recent rheumatologic consultation who did not feel the cause for her weakness was autoimmune. She had a consultation with local oncologic physiatrist who recommended physical therapy. On 17-FEB-2023, esophagogastroduodenoscopy (EGD) showed small hiatal hernia and colonoscopy showed divertic small polyp. As of this time, her complaint of "walking on a trampoline" persisted. She was in the midst of physical therapy at a local outpatient rehabilitation center. The outcome of pneumonitis was reported as recovered/resolved. The outcome of the rest events was not provided.   The reporter considered pneumonitis and ataxic gait to be related to pembrolizumab (KEYTRUDA). The causality between the rest events and pembrolizumab (KEYTRUDA) was not provided. The causality between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.     The event pneumonitis was considered to be medically significant by the physician.   The physician considered ataxic gait to be serious for the following reason: medically significant and permanent or significant disability/incapacity.  Upon internal review, malignant neoplasm progression and hypothyroidism were determined to be medically significant.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that is now valid, therefore it is being sent to distribution.