Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Magnetic resonance imaging abnormal, Orthopaedic examination abnormal, Pain, Pain in extremity
Clinical narrative: continues with pain with range of motion; cardiac catherization; near full thickness supraspinatus tear and tendinopathy; The patient received "one steroid inejction" on an unspecified date, that was not effective; pain immediately after injection in her right arm/ still complaining of right arm pain; hurt to raise her arm/ acceptable range of motion; local reaction; it felt like pins and needles; This spontaneous report was received from a registered nurse referring to a 65 years old female patient. The patient's historical condition included small cerebral aneurysm in 2015. The patient's current conditions included kidney stones and osteoarthritis. The patient was allergic to penicillin. The patient's concomitant medication was unknown.  On 14-NOV-2018, the patient was vaccinated a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R011632, expiration date was unknown, but upon internal validation established as 02-FEB-2020; dose and frequency were not reported) via intramuscular route in the right arm for prophylaxis (indication also reported as preventive).    On the same date, the patient had pain immediately after injection in her right arm, it felt like pins and needles, and hurt to raise her arm. The patient saw her health care professional (HCP) on 06-DEC-2018. The HCP considered it a local reaction and prescribed ibuprofen. The patient returned on 17-DEC-2018 still complaining of right arm pain, that was tender to palpation over the tricep, with no brusing, swelling or erythema. The HCP ordered a creatine kinase level that was normal and prescribed cyclobenzaprine hydrochloride (FLEXERIL). The patient had no improvement and had right arm x-ray on 31-DEC-2018, that showed no fracture. The patient had an orthopedic evaluation and magnetic resonance imaging (MRI) on 13-MAR-2019, that showed a near full thickness supraspinatus tear, and tendinopathy. The patient received one steroid injection on an unspecified date, that was not effective (drug ineffective). A cardiac catherization was performed to this patient in May 2019. The patient had an out-patient arthoscopy on 19-AUG-2019, and 20 outpatient physicial therapy sessions. At the time of report, the patient had acceptable range of motion, but continues with pain with range of motion. The patient had sought medical attention.   The nurse stated that the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe was discarded after injection on 14-NOV-2018 and was not available for retrieval.  Outcome of hurt to raise her arm was recovering. Outcome of right arm pain and pain with range of motion was not recovered. Outcome of other events was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  The events were considered to be medically significant by the reporter (it was reported as "intervention to prevent serious criteria: yes"). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R011632; expirationdate: 02-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent