Sex: M
Vaccine: PNC13
Symptoms: Nodule, Pain in extremity, Peripheral swelling, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Polymyalgia rheumatica; He had Prevnar 13 several years ago; pea sized nodule; Moderate amount of swelling and pain at injection site; Moderate amount of swelling and pain at injection site; This is a spontaneous report from a contactable physician. A 72-year-old male patient received second dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 19Dec2019 at single dose on the right arm for Routine Geriatric Vaccination. Medical history included diabetes mellitus, testosterone low, high cardiac risk. Concomitant medication included metformin, empagliflozin (JARDIANCE), rosuvastatin calcium (CRESTOR), testosterone and prednisone. The patient previously took PREVNAR 13 and pneumococcal vaccine. The patient stated that he reacted within the first day, and that slowly got better after about 10 days. It had a pea sized nodule. About 24-48 hours later (after vaccination), patient started having pain and swelling in his right arm. It looked like he had a banana or two, taped to his arm; so it was a moderate amount of swelling and pain at the injection site. This reaction lasted about 10 days and gradually got better after a couple days. Then 2 to 3 weeks after the injection, he hard really bad myalgia in his hips and shoulders that he has never had before, so he saw his private doctor, and doctor diagnosed patient with Polymyalgia rheumatica. He is being treated with big doses of steroids. When he went to see his private doctor, he could hardly walk, he could hardly move and gave him some Solu-Medrol and Decadron and told the patient that he should be better by the next day. The next day he went from hardly being able to walk, to helping his neighbor move a 150-pound hot water heater out of the house, it was amazing! The patient stated that it was almost completely gone but he is monkeying around with the steroids to try and get them as low as he can. The patient stated that he suddenly has had all kinds of medical issues in the last 3 months his weight was 215 and he has gone down to 170 (he lost 45 pounds and he is not sure what is going on). He is set up to get CAT scans because his doctors are worried about maybe him having cancer. His current weight, he is struggling to keep at 175. He was 6'3 but now he is about 6'2. He started losing weight and height, prior to receiving the Prevnar 13 vaccine. He had Prevnar 13 several years ago and thinks that maybe he shouldn't have had the Prevnar 13 done, that maybe he reacted because he had a previous pneumococcal vaccine. He had no reaction to the Prevnar 13. Patient was on the Crestor when he got the Prevnar 13 injection. His doctor did a CPK test just to see if there was any muscle breakdown, and caller just states that his CPK was normal (Feb2020). He has a high calcium score. The patient had a Sed Rate drawn about a week ago. The result was 30 but the units are unknown. The outcome of polymyalgia rheumatica was recovering, moderate amount of swelling and pain and pea sized nodule was recovered on an unspecified date and other event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The diagnosed Polymyalgia rheumatica represents an intercurrent medical condition unrelated to the vaccine use. 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.