Age: 73.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Prothrombin time prolonged, Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal, Vaccination complication
Clinical narrative: This spontaneous case, was initially received by pharmacist on 27-Nov-2017, concerning a 73-year-old, elderly, male patient. The patient's current conditions included glaucoma, colitis and deep vein thrombosis (DVT) (since unspecified dates). Concomitant medications included warfarin, balsalazide and timolol for an unknown indication. On 20-Oct-2017, the patient was administered FLUAD (TIV) (dose: 0.5 ml, anatomical location: right arm, batch number: 179403, expiry date: 30-Jun-2018 and route of administration: not reported). On the same day, the patient was administered with PREVENAR (anatomical location: right arm, dose, route of administration, batch number and expiry date: not reported). On the same day, after vaccination, the patient was unable to move his arms due to severe pain. On 29-Oct-2017, the patient went to clinic and underwent magnetic resonance imaging (MRI) and the result was not reported. Reporter informed that, on an unspecified date, an orthopaedist advised the patient to drink lots of fluids as he suspected the patient had a vaccination reaction. On 06-Nov-2017, patient's X-ray (result not reported) was done. This physician ordered 6 days of physical therapy and prescribed TENDINYL. Subsequently, the orthopaedist referred him to a rheumatologist. On an unspecified date, he consulted rheumatologist and mentioned he had excruciating pain for 26 days. The rheumatologist prescribed MEDROL PAK which helped initially. The patient was treated with the same which helped but when the medication was withdrawn the pain started. Reportedly, the physician investigated if the pain was related to SIRVA syndrome (shoulder injury related to vaccine administration) or polymyalgia rheumatica. The patient was also prescribed 20 mg of prednisone (10 mg in the morning, 10 mg in the evening) and felt he had immediate relief. It was reported that, the patient was wearing off the prednisone. On 14-Nov-2017, the following lab investigations performed - comprehensive metabolic panel: glucose 99, blood urea nitrogen 21, creatinine 0.79, eGFR (estimated glomerular filtration rate) 88, eGFR (estimated glomerular filtration rate) 103, sodium 141, potassium 5.3, chloride 105, carbon dioxide 30, calcium 9.0, total protein 6.8, albumin 3.8, globulin 3.0, albumin/globulin ratio: 1.3, bilirubin total 0.7, alkaline phosphatase 64, aspartate aminotransferase (AST) 12, alanine aminotransferase (ALT) 8L, INR (international normalized ratio) 1.3H, prothrombin time 13.1, sedimentation rate by modified Westergren 75H, complete blood count: white blood cell-9.9, red blood cell 12.5L, hemoglobulin: 12.5L, haematocrit: 37.9L, mean corpuscular volume (MCV) 91.5, mean corpuscular hemoglobulin (MCH) 30.2, mean corpuscular hemoglobin concentration (MCHC) 33.0, red blood cell distribution width (RDW) 11.8, platelet count 274, mean platelet volume (MPV) 9.9, absolute neutrophils 7405, absolute lymphocytes 1297, absolute monocytes 802, absolute eosinophils 327, absolute basophils 69, neutrophils 74.8%, lymphocytes 13.1%, monocytes 8.1%, eosinophils 3.3%, basophils 0.1%, C-reactive protein 84.8. On 07-Dec-2017, 1 month 18 days after vaccination, the patient was diagnosed with polymyalgia rheumatica (PMR) and on an unspecified date the patient underwent magnetic resonance imaging (MRI) (result not reported). Because of the success of prednisone and physical therapy, the prednisone dose was reduced to 5 mg per day. As per the patient, pain persisted, and he was very sad as no one showed any concern about this matter (the doctors and the public pharmacy where he got the medication). At the time of this report, the patient had not recovered from the events. Follow-up information received with IRD 24-Jan-2018: Reporter type was updated to pharmacist from other non-health professional. Additional events-Polymyalgia rheumatica (PMR) was added as diagnosis and excruciating pain was added as symptom. The event mobility decreased was updated as symptom of polymyalgia rheumatica. TENDINYL was added as a treatment medication and the indication of prednisone was updated to polymyalgia rheumatica. Narrative was amended with the relevant information. Follow up report received from the consumer on 07-Feb-2018: The start date (07-Dec-2017) of the event polymyalgia rheumatica was added. The narrative was amended accordingly.