Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Product administered at inappropriate site, Swelling
Clinical narrative: swelling, pain, achiness in both hands, the right being worse; Arthritis in both hands; hands are now crooked; swelling, pain, achiness in both hands, the right being worse; mistakenly injected at the top of her arm, on shoulder; could not move her fingers; rotator cuff was irritated as well.; injection was painful; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 82 years old female patient who experienced injection was painful (injection site pain), swelling, pain, achiness in both hands, the right being worse (peripheral swelling), arthritis in both hands (arthritis), hands are now crooked (hand deformity), swelling, pain, achiness in both hands, the right being worse (pain in extremity), mistakenly injected at the top of her arm, on shoulder (product administered at inappropriate site), could not move her fingers (musculoskeletal stiffness) and rotator cuff was irritated as well (unevaluable event) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination and family history were not provided.   In September (complete date not reported), the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via an unknown route in the top of arm, on shoulder for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection was painful (injection site pain), swelling, pain, achiness in both hands, the right being worse (peripheral swelling), arthritis in both hands (arthritis), hands are now crooked (hand deformity), swelling, pain, achiness in both hands, the right being worse (pain in extremity), could not move her fingers (musculoskeletal stiffness) and rotator cuff was irritated as well (unevaluable event) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   It was actual medication error due to product administered at inappropriate site. It was reported that the injection was painful and mistakenly injected at the top of her arm, on shoulder.   Other relevant tests were not reported.  Final diagnosis were peripheral swelling, arthritis, hand deformity and pain in extremity, injection site pain, musculoskeletal stiffness, unevaluable event and  product administered at inappropriate site.  The patient was treated with PREDNISONE (PREDNISONE) and the patient soaked her arms in epsom salt for increased mobility and for arthritis going to physical therapy.  At the time of report, the patient outcome was unknown for all events.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.