Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Fall, Gait disturbance, Immunisation reaction, Impaired self-care, Inflammatory marker increased
Clinical narrative: Night sweats; headaches; significant weight loss; Nervous about getting vaccines; Joint Pain; Knee replacement; Muscle Pain; adverse event to this vaccine really changed his ambulatory ability; Fallen twice; PMR(Polymyalgia rheumatica); Didn't feel well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 30Sep2019 as dose number unknown , single (Lot number: AG8356) at the age of 67 years, in arm for immunisation. The patient's relevant medical history included: "Peripheral neuropathy" (unspecified if ongoing), notes: Peripheral neuropathy He was diagnosed probably before then maybe a few years before 2016.; "Atrial fibrillation" (unspecified if ongoing), notes: Atrial fibrillation He was diagnosed around 2016, 2015. It is a chronic condition. Concomitant medication(s) included: FLECAINIDE taken for atrial fibrillation; ELIQUIS taken for anticoagulant therapy. The following information was reported: MALAISE (non-serious) with onset 2019, outcome "unknown", described as "Didn't feel well"; FALL (non-serious) with onset 2019, outcome "unknown", described as "Fallen twice"; MYALGIA (non-serious) with onset 2019, outcome "unknown", described as "Muscle Pain"; POLYMYALGIA RHEUMATICA (medically significant) with onset 2019, outcome "unknown", described as "PMR(Polymyalgia rheumatica)"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2019, outcome "unknown", described as "adverse event to this vaccine really changed his ambulatory ability"; KNEE ARTHROPLASTY (non-serious) with onset Jul2020, outcome "unknown", described as "Knee replacement"; NIGHT SWEATS (non-serious), outcome "unknown"; CLUSTER HEADACHE (non-serious), outcome "unknown", described as "headaches"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "significant weight loss"; NERVOUSNESS (non-serious), outcome "unknown", described as "Nervous about getting vaccines"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint Pain". The events "fallen twice" and "muscle pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown Results, notes: His doctor tested him through a blood test and his inflammation markers were elevated; Computerised tomogram: Unknown Results; X-ray: Unknown Results. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical course: Caller stated that he was just making a report and they transferred him but all he heard was music so he hung up and called back directly. Caller stated he called in regards to Pneumococcal Conjugant 13 Valiant Vaccine. He asked if that was also known as Prevnar 13. Caller is a male that stated he received the Prevnar 13 vaccine 30Sep2019 Lot AG8356. He stated that after the vaccine he developed PMR(Polymyalgia rheumatica). He called to see if there are any reports of this associated with Prevnar 13. He received it back in Sep2019 and two days after he received it he didn't feel well. His doctor tested him through a blood test and his inflammation markers were elevated. This got progressively worse and two years later he has to take prednisone to treat his inflammation markers. He was diagnosed with polymyalgia rheumatica causing him joint pain and muscle pain when he was tested with blood tests. He asked has there been an established link with Pfizer as in, an adverse event with the vaccine and polymyalgia rheumatica. He does not have the NDC, it was not included in his medical records he received through his patient portal. His physician may have that information. He confirmed that he does not have the NDC or EXPIRY. Suspect Product Dose: He doesn't think that information was provided in the patient portal.  Dose Change: He hasn't had the vaccine since that time. There was a note in his chart that there is a potential allergic reaction to an ingredient in that vaccination. A few weeks ago his HCP talked to him about getting another vaccination that he thinks is Pfizer vaccine. His doctor said there is a similarity to that vaccine and the pneumonia vaccine. He clarified the other vaccine to a tetanus vaccine. There could be an additional reaction that he wouldn't want. There might be a common ingredient to both that might cause another spike in his polymyalgia rheumatica. He clarified that it might be a mistake saying an allergic reaction. His rheumatoid arthritis doctor said that every vaccine causes stimulation in the immune system and that may have caused him to develop polymyalgia rheumatica. Other vaccine name: He didn't receive the other vaccine. His HCP wanted him to get it because his record didn't indicate if he got it recently after his HCP checked his health record. There could be an ingredient between the tetanus and the pneumonia vaccine that could be a problem. He declined to take it because he didn't want to take the risk he doesn't think his doctor did either. Suspect Product - Indication: Prevention. He works in healthcare as a consultant. He works in hospitals occasionally and they usually want all vaccinations up to date. He thought he would get the Pneumococcal Conjugant 13 Valiant Vaccine so that all his vaccines were current. Reporter Type: He provided as an Other Health Professional. He clarified that he was in marketing, strategic planning, and business development. He would be in the category of administration and not a clinician in any way. Patient age: He would have been in 2009, 67 years old. He clarified that in 2019 when the adverse event happened he would have been 67 years old. Adverse Event - Diagnosed with polymyalgia rheumatica: He does not have any record of it. Polymyalgia rheumatica is a diagnosis by exclusion. They had to rule out many other things to come to that conclusion of polymyalgia rheumatica. He went through a lot of different tests, CT scans, x-rays, blood tests to rule out cancer, rheumatoid arthritis, autoimmune disorders before they came to a point where they diagnosed him and came to polymyalgia rheumatica. He had other symptoms that were noticed and he reported to his provider as night sweats, headaches, and significant rapid weight loss. There was a lengthy period before they finalized the diagnosis of polymyalgia rheumatica. In addition to prednisone, he has still been on prednisone 2 and a half year later. The doses varied with time. When his polymyalgia rheumatica got really bad, he was also prescribed oxycodone to help with the pain. Prednisone: He has the most recent prescription bottle because he has been consuming quite a few pills ongoing. NDC/LOT/EXPIRY: He doesn't think that it is indicated on the label. He clarified that it is in a pharmacy bottle. He does not have the NDC/LOT/EXPIRY for the prednisone. He does not have the NDC/LOT/EXPIRY for his previous prednisone prescriptions. Adverse Event - Diagnosed with polymyalgia rheumatica - Outcome: He stated that the initial onset of his polymyalgia rheumatica was the most severe stage of it. He had a smaller reoccurrence of polymyalgia rheumatica where he had night sweats and higher inflammation markers in February or March of this year. He clarified to Feb2022 or Mar2022. He had elevated inflammation markers. He clarified that maybe reoccurrence might not be the right word, maybe a spike where they went up even higher and created night sweats when he was sleeping, greater joint or muscle pain. His HCP doubled the prednisone. If a person researches polymyalgia rheumatica, another condition associated with it is giants' cell arteritis an inflammation of the temple area of a person's head which can lead to stroke or blindness. He was scanned a couple of times with ultrasounds of his temples to make sure he didn't have any inflammation in those vessels. He sees an ophthalmologist on a regular bases to check for giants cell arteritis, to see if there is any indication that he is developing it. Adverse Event - Diagnosed with polymyalgia rheumatica - Outcome: he stated that it did worsen in 2022 but as with prednisone his doubled inflammation markers have come down but they are still elevated. There are physical symptoms attached to that. He saw his rheumatoid arthritis HCP this week for a follow up appointment. About a week or two ago, before the appointment his inflammation markers were checked. Right after the initial onset of the condition he was going to a gym every day and was very active. As his symptoms got worse and worse he could barely get off the couch, wasn't going to the gym every day. He fell twice at home because he was so weak, on separate dates in the evening as he was getting ready for bed and when he got up to go for more pain medication and to go to the bathroom. He fell about 2am. When he saw his doctor this week, his HCP suggested he go to physical therapy. In the initial onset he went to physical therapy twice. He went for 6 weeks one time then 5 weeks until his Medicare benefits were used up. His doctor stated that it might be a good idea to do physical therapy again. This has really changed his lifestyle, significantly impacted his income. He was going to continue to do healthcare consulting but he hasn't been able to do that. Concomitant Medications: He doesn't think they would be relevant because he has been on them for a very long time. He has atrial fibrillation and he takes flecainide and Eliquis as a blood thinner. Both twice a day but he doesn't know the dose off the top of his head. Testing: When this agent queried about additional testing the caller provided that the side effects of prednisone causes heart arrhythmias. Due to prednisone and polymyalgia rheumatica he has had more frequent episodes of atrial fibrillation. There are other significant side effects to taking prednisone as well that have to be monitored. He clarified that he doesn't have the side effects, but he has been tested for them, like one of them is osteoporosis, he got a scan for that and his bone density was normal. His HCP wants him to get off prednisone as soon as possible but he is unable to do that. His rheumatoid arthritis doctor suggested that he go on another medication for his polymyalgia rheumatica where he injects himself with an EpiPen. As an additional treatment in the past year or more ago his HCP tried to add methotrexate for the polymyalgia rheumatica as well. He does not have the NDC/LOT/EXPIRY or treatment dates. He stated that the pharmacy or doctor would know. Did the AEs require a visit to the Emergency Room/Physicians Office: When he was first diagnosed, two days after he was just starting to feel the symptoms. As a timeline, he got the vaccine on 30Sep2019, the second time he fell in his home was 16Nov2019 and the following day he went to the emergency room due to the muscle pain and the fall. He asked the HCP to check his inflammation markers and to check what was ordered for lab tests and he asked to have it added to his test. The two markers were the highest they had ever been before and then since. He really thought the HCP would admit him to the hospital and they did not. As a single person it was difficult for him. It was difficult to manage his household, cook meals, personal hygiene. If he had to go to the hospital for a CT scan to check for cancer he needed a wheelchair in the waiting room in the hospital to go back to imaging. He used wheelchairs at his Primary Care Provider to be wheeled back to the office or x-ray or ultrasound. He had a very severe reaction. His adverse event to this vaccine really changed his ambulatory ability. He has gone to his primary care provider many times for this and to other specialists like ortho, Rheumatology, vascular surgery, physical therapy for ultrasounds, x-rays of joints so see if he has disease like RA or other injury. Had a chest x-ray to see if he had pneumonia for night sweats. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Shoulder, upper arm. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): No previous, he is not sure. He does not recall getting it before. Did any AE(s) require a visit to Emergency Room: Yes; Physician Office: Yes. If Yes, which AE(s): Not provided. If the patient was hospitalized, how many days was the hospital stay: Not applicable. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): He may have gotten a flu vaccine depending on the year. He gets a flu shot every year at his pharmacy. He does not remember that year what the timing was. He does not recall anything within a week or two. It varies year to year with his flu vaccine, he may have gotten it in August or October. He is nervous about getting vaccines these days. AE(s) following prior vaccinations: None. He got the Pfizer Covid vaccine and the Pfizer booster vaccine and had no problems, he also got shingles vaccine and flu vaccine and had no problems. Patient's Medical history including illness at time of vaccination: None. Pertinent Details: Include surgical procedures and dates: Not before. He stated that in Jul2020 he had a knee replaced but that was a year out from being vaccinated. Family Medical History Relevant to AE(s): None. Relevant Tests: Unknown. He does not have access, he would have access to that information looking at the patient portal. Most were done with one provider health system there in Athens with the exception of the vascular ultrasounds done in the vascular surgeons office for the giants cell. He clarified he does not have this information. It was done in the Piedmont Health System, all done in one system. He went to the one hospital that is employed by [Name withheld] Health as well. X-rays, Ultrasounds, Bone Density, CT scan were all at the Piedmont Hospital. It is easy for him and for Pfizer to follow-up. He asked with the LOT number for the Pneumococcal Conjugant 13 Valiant Vaccine is this agent able to search to see if that adverse event is related to the LOT number. He asked what are the next steps that Pfizer will take. He would also like to file a vaccine injury claim with the national injury vaccine compensation. He declined the information for Pfizer Legal and stated it is not a lawsuit he would file. There is a program. It bypasses a lawsuit. They review his claim and if it is found legit they will provide compensation.  No follow-up attempts possible. No further information expected.