Wept for entire week (mood swings) [mood swings].Swelling of the legs [swelling of legs].Flushing of face and ankle [flushing].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097720 via patient.This case involves an adult patient who experienced swelling of the legs, flushing of face and ankle and wept for entire week (mood swings), while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection via intra-articular route (unknown dose, frequency, batch number, indication).On an unknown date after receiving the third injection of the series the patient developed swelling of the legs (peripheral swelling), flushing of face and ankle (flushing) and wept for entire week (mood swings) (mood swings).Patient was prescribed cortisone as corrective by the internist.Action taken: not applicable for all event.The patient was treated with cortisone for peripheral swelling, flushing and mood swings.The patient outcome is reported as recovering / resolving for all events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 29-jan-2021.Follow up was received on 08-jan-2021.Global ptc number was added.Additional information was received on 29-jan-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.
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