Age: 33.0
Sex: F
Vaccine: PNC13
Symptoms: Brain scan abnormal, C-reactive protein increased, Condition aggravated, Demyelination, Eye pain
Clinical narrative: This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2018066027), license party for ENBREL. Initial Receipt Date = 14/MAY/2018. This serious spontaneous report (USASP2018066027) was reported to Amgen on 14/MAY/2018 by a consumer and involves a 33 year old female patient who had one brain change/neuro change/neurological problems, facial droop mimicking Bell's palsy, eye pressure, and left sided tingling and numbness while receiving ENBREL. No historical medical condition was reported. The patient's historical drugs included unspecified topicals and unspecified light treatments. The patient's current medical condition included severe plaque psoriasis and psoriatic arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began ENBREL on an unknown date. On 27/JUL/2017, the patient took her fourth ENBREL shot and on 01/AUG/2017, the patient had left sided tingling and numbness, with eye pressure. Also, the patient had a facial droop mimicking Bell's palsy. The patient notified her physician and went to an appointment on 07/AUG/2017. The patient was sent to the ER (emergency room) and admitted to the hospital on 08/AUG/2017 because they thought she was having a stroke. On an unknown date in AUG/2017, the patient was tested for MS (Multiple Sclerosis) and she only had one brain change. The patient was hospitalized for five days and discharged on 13/AUG/2017. Subsequently, on an unknown date in AUG/2017, the patient stopped taking ENBREL and was placed on prednisone for a month. The patient stated she had neurological problems. Also, the patient stated that she was under the care of a neurologist and they felt like her neuro change was caused by ENBREL. The patient stated that her symptoms were intermittent, but not a week went by that she did not have some sort of symptom. Additionally, the patient stated this week she was going to get more ocular testing done to check for MS (Multiple Sclerosis) again and if that would come back abnormal she would have to go for a heavier MRI (magnetic resonance imaging) test. No treatment information was received. The outcome of the events facial paralysis, ocular discomfort, neurological symptom, hypoaesthesia, and paraesthesia was reported as unknown. Action taken with ENBREL was withdrawn on an unknown date in AUG/2017 for the events paraesthesia, hypoaesthesia, ocular discomfort, facial paralysis, and neurological symptom. The consumer reported that her physician considered that the event neurological symptom was possibly related to ENBREL. The causal relationship between the events paraesthesia, hypoaesthesia, ocular discomfort, facial paralysis and ENBREL was not provided by the consumer. Follow up has been requested. Amgen Comments: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. Follow-up (23May2018): This is a follow-up spontaneous report from a contactable physician based on information received by Pfizer from Amgen, manufacturer control number US-AMGEN-USASP2018066027, license party for ENBREL. ADDITIONAL INFORMATION RECEIVED ON 23/MAY/2018: This follow up information reported by the physician and involves a patient who experienced facial droop mimicking Bell's palsy 1 brain change/neuro change/neurological problems/eye pressure/pain EOM without visual changes/left sided tingling and numbness, small area of gliosis/demyelination/abnormal brain MRI/ left sided tingling and numbness/l arm paresthesia/facial paresthesia/left arm or leg paresthesias/weakness LUE/arm numbness, pain or pressure behind the eye/ persistent eye pain, worsening headache/headaches dull, worse with over-exertion/stress/concentrating, facial swelling, C5-C6- likely moderate left neuroforaminal stenosis (series 5, image 21), throat tightness, joint swelling, tremors hands esp during times of stress/tremors at rest notable in fingers, tremors hands esp during times of stress, glucose 108 (H) [PT: blood glucose abnormal], Cl 110 (H) [PT: blood chloride increased], vt D 18 (l) [PT: vitamin D decreased], prot 73 (high) [PT: protein total increased], elevated album [PT: blood albumin increased], CRP: 5.5 [PT: c-reactive protein increased], small area of gliosis/demyelination [PT: gliosis], small papules on lower abdomen [PT: papule], painful muscles [PT: myalgia], sweats [PT: hyperhidrosis], rash [PT: rash], joint swelling [PT: joint swelling], psoriasis is reappearing shins/LE, elbows, torso/psoriatic patches Bi ant tibial surface, patch Bi elbow extensors, finger change color in cold, finger change color in cold while receiving ENBREL. The previously reported events of neurological symptom. Ocular discomfort was subsumed to facial paralysis. The previously reported events of paraesthesia and hypoaesthesia was subsumed to demyelination. The patient's historical medical conditions included 0.50 pack cigarettes per day and quit on 17/SEP/2014, abnormal pap smear of cervix, pelvic pain in female, post-traumatic stress disorder on 27Jan2017, shingles in May2017, and urinary tract infection on 03Sep2015. Patient's current condition included alcohol use 1.2 oz/week (two glasses of wine per week), birth control, and anxiety. The patient's surgical history included colposcopy, gynecologic cryosurgery, "intrauterine device insertion" and vaginal delivery. The patient's family history included colon cancer, hypertension, chronic obstructive pulmonary disease (COPD), bipolar disorder, alcohol abuse, drug abuse, anxiety disorder, diabetes, heart disease, cancer, leukemia, breast cancer, and depression. The patient's concomitant medications included XANAX, Vitamin D3, PARAGARD T380A, and LEXAPRO. The patient's co-suspect medication included prednisone and PREVNAR. The patient began ENBREL on an unknown date in JUL/2017. On 31/JUL/2017, the patient was seen by the physician and PREVNAR was administered. Immediately after 24 hours on 01/AUG/2017, the patient's neurologic symptoms started as she experienced facial swelling, throat tightness, pain or pressure behind her eye with pain "EOM," without visual changes. On 03/AUG/2017, the patient was evaluated by her primary care physician with left eye injection or pain, left facial numbness, left arm paresthesia and she was diagnosed with Bell's palsy, Lyme IgM and IgG were negative. Subsequently, prednisone prescription was given or antiviral. The patient was started on prednisone 50 mg per day with decreasing dose to 30 mg. On 08/AUG/2017, the patient was hospitalized for worsening headache and persistent eye pain (CLARIFICATION PENDING). Additionally, laboratory tests were performed which revealed protein was 73 (high) (unit not provided) and albumin was elevated. Also, the patient underwent magnetic resonance imaging (MRI) of the brain which revealed that four mm T2 or flair high signal intensity in the left frontal periventricular white matter. This finding was non specific and might represent a small area of gliosis or demyelination. Moreover, the patient underwent magnetic resonance imaging (MRI) of the cervical spine C5-C6 which revealed left uncovertebral joint hypertrophy, likely moderate left neuroforaminal stenosis and possible mass effect on the exiting left C6 nerve root. The patient received SOLUMEDROL for three days and was placed on tapering schedule as per her neurologist. On 09/AUG/2017, patient's vitamin D was 18 (unit not provided) low. On 12/AUG/2017, the patient was discharged from the hospital. On 14/AUG/2017, the patient was evaluated with increased headache or left upper extremity (LLE) or left lower extremity (LLE) sensory changes, increased prednisone back to one mg per kg. On an unknown date in AUG/2017, the patient was unable to tolerate prednisone. The patient self tapered off the prednisone for over past two weeks. The patient did not tolerate as she had weight gain, insomnia, heat flashes or temperature dysregulation. The patient did not note significant change in symptoms off prednisone. The patient had notable facial paresthesia localized to left jaw line. The patient had improved or resolved left arm or leg paresthesias. The patient also had weakness in left upper extremities (LUE). The patient had tremors in hands especially during times of stress. The patient had dull headaches and worse with over-exertion or stress or concentrating. The patient's psoriasis was reappearing on shins of left extremities, elbows and torso. The patient saw her neurologist and felt symptoms concerning for demyelination was related to ENBREL. The patient was referred to demyelinating specialist. Also, ENBREL therapy was discontinued due to psoriatic arthritis. On 01/SEP/2017, the patient underwent laboratory test which revealed that her glucose was 108 (unit not specified) high, chloride was 110 (unit not specified) high, and C-reactive protein was 5.5 (unit not specified). On 04/SEP/2017, the patient answered history of present illness and review of systems that mentioned patient had sweats, finger change color in cold, had joint pain, joint swelling and painful muscles. On an unknown date, the patient physical examination revealed tremors at rest notable in fingers, upper extremities (UE) or lower extremities (LE) bilateral proximal and distal strength intact, sensation was grossly intact, on her skin, rash was noted, psoriatic patches bilateral anterior tibial surface, patch bilateral elbow extensors and small papules on lower abdomen. Treatment for the events demyelination and gliosis included SOLUMEDROL. Treatment of the events facial paralysis, throat tightness, swelling face included prednisone. The outcome of the events demyelination and eye pain were reported as not recovered/ not resolved. The outcome of the events facial paralysis, headache, swelling face, cervical spinal stenosis, throat tightness, arthralgia, tremor, stress, blood glucose abnormal, blood chloride increased, vitamin D decreased, protein total increased, blood albumin increased, C-reactive protein increased, gliosis, papule, myalgia, hyperhidrosis, rash, joint swelling, skin discolouration, sensitivity to weather change, psoriasis, paresthesia, hypoesthesia, and muscular weakness were reported as unknown. Action taken with ENBREL was reported as unknown for the events eye pain, swelling face, throat tightness, headache, tremor, stress, psoriasis, protein total increased, blood albumin increased, gliosis, demyelination, papule, rash, cervical spinal stenosis and facial paralysis. Action taken with ENBREL was withdrawn on an unknown date in AUG/2017 for the event arthralgia. The physician reported that the events demyelination, facial paralysis were possibly related to ENBREL. The causal relationship between the events eye pain, swelling face, throat tightness, headache, tremor, stress, psoriasis, blood glucose abnormal, arthralgia, blood chloride increased, vitamin D decreased, protein total increased, blood albumin increased, gliosis, papule, myalgia, hyperhidrosis, c-reactive protein increased, rash, cervical spinal stenosis, joint swelling, skin discolouration, sensitivity to weather change and ENBREL was not provided by the physician. Amgen Company comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. The batch/lot number for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up. Sender's Comments: A contributory role of PREVENAR 13 and ENBREL might be completely excluded towards the occurrence of facial swelling, throat tightness, pain or pressure behind eye considering the close temporal relationship. All other events are considered unrelated to the use of suspect drugs: Hypoaesthesia, paraesthesia and weakness in left upper extremities are compatible with Demyelination/ facial paralysis; cervical spinal stenosis, psoriasis, skin discolouration and sensitivity to weather change, blood glucose abnormal, blood chloride increased, vitamin D decreased, protein total increased, blood albumin increased, C-reactive protein increased are associated with the patient's underlying medical conditions.  Small papules on lower abdomen, painful muscles, tremor, stress, sweats, rash and joint swelling representing intercurrent medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.