Sex: F
Vaccine: PPV, TDAP
Symptoms: Burning sensation, Disability, Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: frozen shoulder; a partial tear of her right rotator cuff; not able to raise her arm above her head/ she was unable to move her hand and arm; right shoulder pain/ pain at the injection site/ her right arm was burning and throbbing; swelling; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-APR-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot# N005597 (expiry date not provided but upon internal validation established as 19-OCT-2018) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) lot# C5446AA, both administered in right shoulder (dose, route of administration were not provided) for prophylaxis at medical clinic. On or about 04-APR-2018, less than 48 hours after receiving her vaccinations, the patient returned to medical clinic with right shoulder pain. She stated that she had pain at the injection site where the vaccinations were administered. The patient's shoulder pain was so substantial that she was unable to move her hand and arm. Her physician's plan of care for the patient included taking ibuprofen and icing her arm for the next 48 hours and she advised the patient to stay home for 24 to 48 hours and not go to work. On or about, 09-APR-2018, the patient again returned to her physician because her right shoulder pain had not diminished. The patient stated that the pain in her right shoulder was constant and that she was able to obtain some relief from ibuprofen, but that the pain was still an 8 on a scale of 1-10 and that her right arm was burning and throbbing. Physician advised the patient to avoid lifting with the affected arm and to put ice or a cold pack on the sore joint for 10 to 20 minutes at a time every 1 to 2 hours for the next 3 days or until the swelling went down. Further, the physician ordered a magnetic resonance imaging (MRI) of the patient's right shoulder, which was completed on 18-APR-2019 (conflicting information). On or about, 19-APR-2018, the patient again visited her physician to follow-up on her right shoulder pain. She had then regained some range of motion in her shoulder but was still not able to raise her arm above her head. During this visit, physician extended patient's disability until 19-JUN-2018. On or about, 31-MAY-2018, the patient established care with physician for an evaluation of her MRI as well as a diagnosis of her shoulder pain. Physician informed the patient that she had a partial tear of her right rotator cuff and what he referred to as "frozen shoulder." Prior to 03-APR-2018, the patient was not suffering from any shoulder pain or injury on the date that she received the vaccinations. The patient continued to suffer residual effects and complications from the shoulder injury she received as a result of the vaccinations. She was unable to work from 04-APR-2018, until 28-FEB-2019, due to the residual effects and complications from the shoulder injury she received as a result of the vaccinations. As set forth fully above, the patient sustained personal injuries as a result of the vaccines. As a direct and proximate result, the patient suffered personal injuries and damages, including, but not limited to, past and future medical expenses, past and future loss of earnings, and pain and suffering. The outcome of the events was unknown. The reporter considered the events to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).  The events were considered to be disabling by the reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N005597; deviceage and unit: 0 ; malfunction: Unknown; 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