Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, SARS-CoV-2 test, Underweight, Vaccination site pain
Clinical narrative: Patient was being slightly underweight; The arm was sore for 2 days after most recent vaccine in March 2024; arthritis; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (arthritis), UNDERWEIGHT (Patient was being slightly underweight) and VACCINATION SITE PAIN (The arm was sore for 2 days after most recent vaccine in March 2024) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Knee pain (bone on bone contact in the knee which caused pain Since 2.5 years prior to the vaccine). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (2 doses) in 2021, Spikevax on 26-Apr-2023 and Spikevax on 21-Oct-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Spikevax and Spikevax.    On 22-Mar-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. In March 2024, the patient experienced ARTHRITIS (arthritis) and VACCINATION SITE PAIN (The arm was sore for 2 days after most recent vaccine in March 2024). On an unknown date, the patient experienced UNDERWEIGHT (Patient was being slightly underweight). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DICLOFENAC DIETHYLAMINE (VOLTAREN [DICLOFENAC DIETHYLAMINE]) for Pain, at an unspecified dose and frequency and ALENDRONATE SODIUM (ALENDRONATE) for Bone density abnormal, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (arthritis) had not resolved, UNDERWEIGHT (Patient was being slightly underweight) outcome was unknown and VACCINATION SITE PAIN (The arm was sore for 2 days after most recent vaccine in March 2024) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the sore arm was completely resolved.  It was stated that there were no side effects following any of the previous Moderna Covid vaccines. It was stated because there were no side effects with the first 4 vaccines, reporter questioned whether the vaccines were placebos. However, reporter stated a PCP Covid test resulted negative since then.  The pain in the knee/wrist/joints/muscles has increased, prompting reporter to schedule knee replacement surgery in Nov 2024. Surgery was scheduled after the last vaccine. Reporter stated it was now "harder to get up off the floor" and "joints were not as agile and were less movable. Reporter stated pain in the wrists after doing yoga poses like downward dog.  Company Comment: This is a Spontaneous case concerning an 86-year-old female patient with medical history of knee pain, who experienced the non-serious AESI of Arthritis which occurred on the same month after a dose of SPIKEVAX 2023-2024 received as the fifth dose of COVID-19 Vaccination schedule. It was reported that the pain in the knee/wrist/joints/muscles had increased, and a knee replacement surgery was scheduled. No further clinical information or diagnostic tests results were disclosed for analysis. The medical history of knee pain remains a strong confounder; patient's advanced age also remains confounding. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2024: Live non-significant follow-up received; reference ID added.