Age: 73.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Pain, Pain in extremity, Polymyalgia rheumatica, Rheumatoid arthritis
Clinical narrative: diagnosed him with PMR; undifferentiated rheumatoid arthritis; severe body pain; rebound pain; severe pain in back; pain ended up in his hands; severe pain in glutes; severe pain in his hips, shoulders, pain ended up in wrist; pain at the injection site; Initial information received on 07-Nov-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked to case 2022SA464402(CLUSTER).  This case involves a 73 years old male patient who was diagnosed him with pmr(polymyalgia rheumatica), undifferentiated rheumatoid arthritis, severe body pain; rebound pain, severe pain in glutes, severe pain in back, pain ended up in his hands, severe pain in his hips, shoulders, pain ended up in wrist and pain at the injection site after receiving vaccines INFLUENZA VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] .  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 25-Sep-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in Left forearm for Immunization.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that within 3 or 4 days he experienced severe body pain(pain)(latency unknown). Caller reporting severe pain in his hips, glutes(myalgia), back(back pain), shoulders(arthralgia), and the pain ended up in his hands(pain in extremity)(latency unknown) and wrist. Caller reporting his pain was more severe in the mornings. Patient reports he took extra strength Tylenol and Naproxen with no relief. He then reports going to his PCP where they did blood work and referred him to a Rheumatologist. His Rheumatologist diagnosed him with PMR (polymyalgia rheumatica) (unknown latency). His treatment included high doses of Prednisone. The high doses of Prednisone did initially resolve his pain, but the Rheumatologist did not want him taking high doses of Prednisone long term. He then decreased his dose of Prednisone to 3-4 mg daily but the patient reports when on low levels he experienced rebound pain. He is currently still on a low dose of Prednisone (since November 2020) and Methotrexate. Caller reports he has been getting a flu shot annually for 30 years and in the past only experienced pain at the injection site(vaccination site pain)(latency unknown). Since the patient has not been able to decrease his dose of Prednisone without pain his Rheumatologist now thinks he has undifferentiated rheumatoid arthritis (rheumatoid arthritis)(latency unknown).   Relevant laboratory test results included: Blood test - On an unknown date : diagnosed him with PMR  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) and INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Arthralgia, Pain, Back pain, Pain in extremity and Myalgia, NAPROXEN (NAPROXEN) for Arthralgia, Pain, Back pain, Pain in extremity and Myalgia, PREDNISONE (PREDNISONE) for Polymyalgia rheumatica and METHOTREXATE (METHOTREXATE) for Polymyalgia rheumatica. Not reported for other events  Outcome: Not recovered for pain, Unknown for other events.  Seriousness criteria: Medically significant for Polymyalgia rheumatica, Rheumatoid arthritis; Sender's Comments: Sanofi company comment dated 16-Nov-2022:  This case involves a 73 years old male patient who was diagnosed him with pmr(polymyalgia rheumatica), undifferentiated rheumatoid arthritis, severe body pain; rebound pain, severe pain in glutes, severe pain in back, pain ended up in his hands, severe pain in his hips, shoulders, pain ended up in wrist and pain at the injection site after receiving vaccines INFLUENZA VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] . The time to onset was not reported with the vaccine. Further information regarding medical history, concurrent condition during vaccination, previous vaccination history, concomitant medication and tolerance, family history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the few reported information, the role of the suspect vaccine cannot be assessed.