Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiovascular examination, Cardiovascular function test normal, Ear, nose and throat examination normal, Limb discomfort, Movement disorder
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 55-year-old female patient received, on 15Mar2016, PREVNAR 13 (NDC 00005-1971-05) via an unspecified route of administration, in the right arm, at 0.5 ml single dose. Relevant medical history included fibromyalgia, arthritis, thyroid disorder, muscle disorder, deterioration in her back (back discomfort), endocrine disease, hypothyroidism, post-traumatic stress disorder (PTSD), fusion of vertebra (fusion at T 11 and T 12), fusion lumbar spine, anxiety, borderline personality, major depression, tobacco user, alcohol use, loss of intervertebral disc space height at C4-C5, mild central stenosis, mild facet arthrosis, uncovertebral joint degenerative, spondylotic changes (with loss of intervertebral disc space), degenerative retrolisthesis, and cervix cauterized in the past. Past drug event included drug allergy due to amitriptyline, amoxicillin, and penicillamine. Concomitant medication included hydrocodone 750 mg, thrice daily from 15May2015 (ongoing); levothyroxine 150 ug, from an unspecified date, in 2002 (ongoing) for thyroid disorder; oral NORCO; oral NORFLEX (Tablet) 100 mg, twice daily; oral EFFEXOR 50 mg, daily; oral SYNTHROID 125 ug, daily; oral XANAX 1 mg, thrice daily; oral GRALISE 1800 mg, daily; oral loratadine 10 mg, daily; oral MUCINEX 600 mg, daily; oral aspirin 81 mg, daily; oral ZITHROMAX Z-PAK 2 tablets on day 1 followed by 1 tablet daily on days 2-5; and oral PHENERGAN WITH CODEINE four time a day. The patient experienced discomfort in her arm on 15Mar2016, discomfort in her upper extremities ("discomfort was just not in her right arm, it was in her upper extremities") on 18Mar2016, stiffness on an unspecified date, movement disorder ("she could not lay on her arm on her right side, she could not get her arm above her head without extreme pain and she cannot move her right arm without having pain") on 18Mar2016, excruciating pain on an unspecified date, in Mar2016, discomfort in her neck and back on unknown date and neck and shoulder muscle spasms on unknown date. The patient was hospitalized from 23Mar2016 due to upper extremities discomfort. At admission: patient was cooperative and uncomfortable, alert, oriented to person, place and time, skin warm, skin normal in color, mucous membranes pink, mucous membranes moist. Patient was well groomed, and complained of upper extremities pain. Pain: to bilateral shoulders, to bilateral upper arms, onset of pain 1 week prior to arrival, on a scale 0-10 patient rates pain as 10. Relevant examinations (Mar2016) included: Head exam included finding of head atraumatic, normocephalic. Eye exam included finding of eyelids normal to inspection, Pupils equally round and reactive to light, Extraocular muscles intact. ENT exam normal. Neck: minimal neck tenderness. Respiratory: respiratory and chest exam normal. Cardiovascular: cardiovascular exam included finding of heart rate regular rate and rhythm, Heart sound normal. Abdominal exam included finding of abdomen nontender, bowel sound normal. Upper extremity: mild pain on ROM of both arms. Lower extremity: Lower extremity exam included finding of inspection normal, range of motion normal. Neuro exam normal. Skin exam normal. Psychiatric exam normal. Conclusion: spondylotic changes with loss of intervertebral disc space height, marginal osteophyte formation and mild degenerative retrolisthesis of C5-C6. Mild associated central stenosis at this level and moderate bilateral foraminal narrowing, right greater than left. No findings of fracture or traumatic listhesis. The remainder of the cervical spine of normal appearance. The patient received TORADOL for pain, FLEXERIL from 13Apr2016 (ongoing) as muscle relaxant therapy; intramuscular NORFLEX (injection) 60 mg, from 23Mar2016; intramuscular morphine sulfate 4 mg, from 23Mar2016; and another drug for stiffness (she doesn't know the name of the second medication she received). The patient did not recover from the events on an unspecified date. Discharge: Patient discharge to home, ambulating with assistance. Follow-up (29May2016) This follow-up report is being submitted to amend previously reported information: Verbatim: "Discomfort in my neck and back" split and coded as two separated adverse events. Follow-up (22Jul2016): New information reported from the contactable consumer includes: medical history, concomitant medications, patient's clinical course and case seriousness changed from non-serious to serious (hospitalization required).