Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
auto immune problem maybe PMR/indicated a possible autoimmune problem, potentially Polymyalgia Rheumatica (PMR); unspecified autoimmune disease; his wife has been putting on his socks for the past 5 weeks; can barely get out of bed; joint pain makes it nearly impossible to get out of bed during the night or early morning; Prednisone is enabling him to get out of bed; he cannot function without Prednisone; couldn't touch his toes; joint pain in the hip/The pain has since spread to the hips, shoulders, wrists, and neck/Soreness/severe aches or pains in the morning that lessen by afternoon; This spontaneous case was reported by an other health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (auto immune problem maybe PMR/indicated a possible autoimmune problem, potentially Polymyalgia Rheumatica (PMR)) and AUTOIMMUNE DISORDER (unspecified autoimmune disease) in a 73-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis and non-company product included Influenza vaccine for an unknown indication. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS. Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Pre-diabetic. On 17-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 20-Oct-2025, the patient experienced POLYMYALGIA RHEUMATICA (auto immune problem maybe PMR/indicated a possible autoimmune problem, potentially Polymyalgia Rheumatica (PMR)) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (unspecified autoimmune disease) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (his wife has been putting on his socks for the past 5 weeks; can barely get out of bed), MOBILITY DECREASED (joint pain makes it nearly impossible to get out of bed during the night or early morning; Prednisone is enabling him to get out of bed; he cannot function without Prednisone; couldn't touch his toes) and ARTHRALGIA (joint pain in the hip/The pain has since spread to the hips, shoulders, wrists, and neck/Soreness/severe aches or pains in the morning that lessen by afternoon). The patient was treated with Prednisone in November 2025 at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (auto immune problem maybe PMR/indicated a possible autoimmune problem, potentially Polymyalgia Rheumatica (PMR)), AUTOIMMUNE DISORDER (unspecified autoimmune disease), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (his wife has been putting on his socks for the past 5 weeks; can barely get out of bed), MOBILITY DECREASED (joint pain makes it nearly impossible to get out of bed during the night or early morning; Prednisone is enabling him to get out of bed; he cannot function without Prednisone; couldn't touch his toes) and ARTHRALGIA (joint pain in the hip/The pain has since spread to the hips, shoulders, wrists, and neck/Soreness/severe aches or pains in the morning that lessen by afternoon) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: had 3 "blood things" taken; one ruled out Lyme disease and (Negative) blood tests for rheumatoid arthritis, which came back negative. On an unknown date, Red blood cell sedimentation rate: 60 normal range: less than 20. On an unknown date, Viral test: (Negative) Tick panel tests were conducted, all returning negative results. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that patient experienced joint pain in the hip shortly after receiving a COVID-19 booster shot. The pain had since spread to the hips, shoulders, wrists, and neck. The patient visited urgent care where blood work indicated a possible autoimmune problem, potentially Polymyalgia Rheumatica (PMR). The individual has been prescribed Prednisone, which alleviates the pain but has not received a definitive long-term diagnosis. It was reported that the pain made it nearly impossible for patient to get out of bed during the night or early morning. It was mentioned that his wife has been putting on his socks for the past 5 weeks. Patient was informed that he could see a rheumatologist in June, but this does not work for him as he can barely get out of bed. Patient had received all his shots from Moderna since their initial circulation. The symptoms patient was currently experiencing are the first of their kind in his life. It was reported that patient thought just like it started out with one joint being painful and then it was like all my joints over the next couple of weeks got worse and worse. It was reported that the prednisone was the only way patient can function in the morning. It was reported that by noontime, patient's symptoms were improved, but he cannot function before then without prednisone. The patient expressed relief from pain even after taking the first two Prednisone pills. Patient was able to touch his toes, which he couldn't do before, and his shoulders, elbows, and wrists, which were all severely sore, are were manageable. Patient reported that it was not just one joint on the right, but both arms, hips, neck, and shoulders. It was reported that patient got the flu shot, and was having reaction, or it was something else that caused it. After it was mentioned PMR, patient found he had all the symptoms severe aches or pains in the morning that lessen by afternoon. Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2025: Live follow up received contains significant information. Additional reporter was added, medical history was added, lab tests were added, suspect product start date was updated, new event was added, narrative was updated and reference numbers were added.; Reporter's Comments: Company comment: Patients elderly age is a confounder. The benefit-risk relationship of product is not affected by this report.
Pre-diabetic
Test Name: Blood test; Result Unstructured Data: had 3 "blood things" taken; one ruled out Lyme disease; Test Name: Blood tests for rheumatoid arthritis; Test Result: Negative ; Test Name: SED rate by modified Westergren; Result Unstructured Data: 60 normal range: less than 20; Test Name: Tick panel tests; Test Result: Negative