Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bursitis, Depression, Dyspnoea, Osteoarthritis
Clinical narrative: Osteoarthritis knee; Covid vaccines caused a flare up of her arthritis, also she had joint pain, hands hurt..she could barely walk; Shoulder bursitis; Depressed state; Increased shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis knee) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    The patient's past medical history included Knee surgery NOS. Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. In April 2021, the patient experienced DYSPNOEA (Increased shortness of breath). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis knee) (seriousness criterion medically significant), ARTHRITIS (Covid vaccines caused a flare up of her arthritis, also she had joint pain, hands hurt..she could barely walk), BURSITIS (Shoulder bursitis) and DEPRESSION (Depressed state). In 2021, DYSPNOEA (Increased shortness of breath) had resolved. At the time of the report, OSTEOARTHRITIS (Osteoarthritis knee), BURSITIS (Shoulder bursitis) and DEPRESSION (Depressed state) had not resolved and ARTHRITIS (Covid vaccines caused a flare up of her arthritis, also she had joint pain, hands hurt.she could barely walk) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: (Negative) Not Covid.         No concomitant medications were reported.  Patient took booster dose.  The patient took Humira shortly afterwards she was out of breath for four days and it got progressively worse during the four days. On 02-Apr-2021, she could not walk 10 feet without being out of breath. She had an episode in Apr-2021 where she had shortness of breath that got progressively worse and it started the day after her injection. She had osteoarthritis in both knees and she took steroid injections in it. She had knee surgery for osteoarthritis. She had Covid test and it was not Covid. She was 95 percent better after four days. It was  unknown if patient was enrolled in a COVID-19 Vaccine Trial. Her first two Covid vaccines caused a flare up of her arthritis, also she had joint pain, hands hurt and her physician said it was due to the Covid vaccine. The booster dose did not have the same reaction. She could barely walk. Her physician said she might have to stop taking Humira in 2021. Her father was not well and she was depressed, sad and crying all day. Her husband had Covid and she was quarantined. In the past only thing that had helped this issue was a steroid injection. She had bursitis in her left shoulder and it started acting up pretty bad on 14-May-2021.  The reporter did not provide any causality assessment for the event of osteoarthritis with Humira. The reporter assessed the event of increased shortness of breath to be reasonably possible to Humira. The reporter assessed that the events of walking difficulty, shoulder bursitis, depressed state, arthritis flare up and hand pain had no reasonable possibility with Humira.  The reporter assessed the event of arthritis to be probably related to Moderna vaccine. The reporter did not provide any causality assessment for the rest of the events with Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Compan   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up contains event details, suspect product details, treatment information and updated narrative.  Company Comment: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Ankylosing spondylitis, who experienced the unexpected, serious  (medically significant) event of Osteoarthritis (Osteoarthritis knee), and non-serious adverse event of special interest Arthrosis  that occurred on unknown dates in the context of receiving a dose of mRNA-1273 vaccine. Patient experienced osteoarthritis in both knees for which steroid injections were taken and knee surgery was performed. Patient presented with joint pains, hand pain and difficulty walking. Arthritis flares  were observed in the first 2 doses of mRNA-1273 vaccine administration but not in the booster dose.  Patient received 3 doses of mRNA-1273 vaccine all given on unknown dates and intervals. The relevant medical history of Ankylosing spondylitis could be considered a confounder, and elderly age as a predisposing risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Ankylosing spondylitis, who experienced the unexpected, serious  (medically significant) event of Osteoarthritis (Osteoarthritis knee), and non-serious adverse event of special interest Arthrosis  that occurred on unknown dates in the context of receiving a dose of mRNA-1273 vaccine. Patient experienced osteoarthritis in both knees for which steroid injections were taken and knee surgery was performed. Patient presented with joint pains, hand pain and difficulty walking. Arthritis flares  were observed in the first 2 doses of mRNA-1273 vaccine administration but not in the booster dose.  Patient received 3 doses of mRNA-1273 vaccine all given on unknown dates and intervals. The relevant medical history of Ankylosing spondylitis could be considered a confounder, and elderly age as a predisposing risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.