Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Hypersensitivity, Pyrexia
Clinical narrative: patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication; Chills; low grade fever; knee hurl no matter if he was sitting or walking/ongoing; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA335342 (Sanofi), US-SA-2024SA345149 (Sanofi), 2024SA345149 (Sanofi).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; hylan g-f 20 (SYNVISC ONE), since 2021) for osteoarthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovering"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "knee hurl no matter if he was sitting or walking/ongoing"; PYREXIA (non-serious) with onset 2021, outcome "recovering", described as "low grade fever"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "recovered", described as "patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for hylan g-f 20 was unknown.  Additional information: Initial information received on 13Nov2024 regarding an unsolicited valid non-serious case received from the patient. This case is linked to US-SA-2024SA345149 (Multiple devices used in same patient (case for left knee)). This case involves an unknown age male patient who was concerned that covid vaccine sensitized his immune system and made him allergic to the medication and his knee hurt no matter if he was sitting or walking/ ongoing pain issues with his knee, after being treated with Covid-19 Vaccine and after the use of medical device HYLAN G-F 20, Sodium Hyaluronate [Synvisc One]. The patient's past medical history, concomitant medications, vaccination(s) and family history were not provided. In 2021, the patient received Synvisc One (HYLAN G-F 20, Sodium Hyaluronate) Injection in the right knee (strength: 48 mg/6ml) once (with unknown dose, route) and in the left knee (strength: 48 mg/6ml) once (with unknown dose, route, frequency) for Osteoarthritis. On an unknown date, the patient received covid-19 vaccine (with unknown formulation , strength, dose, route and frequency) for Immunisation. In 2021 the patient developed a non-serious event "patient is concerned that covid vaccine sensitized his immune system and made him allergic to the medication" (hypersensitivity) (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of Covid-19 Vaccine. In 2021 the patient developed a non-serious event "chills" (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of covid-19 vaccine. In 2021 the patient developed a non-serious event "low grade fever"(pyrexia) (Latency: same day) following the first dose intake (unknown batch number and expiry date) after starting use of HYLAN G-F 20 and sodium and (unknown latency) of Covid-19 Vaccine. In 2021 the patient developed a non-serious event "knee hurt no matter if he was sitting or walking/ongoing pain issues with his knee" (injection site joint pain) (Latency: same day) following the first dose intake (unknown batch number and expiry dale) after starting use of HYLANG-F 20 and sodium and (unknown latency) of covid-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "Consumer of Synvisc One states in 2021, he had Synvisc One installed in both of his knees. Later in the evening, he developed symptoms which were chills and low grade fever which persisted for about a month and both knees hurt no matter if he was sitting or walking. He is concerned that the COVID vaccine sensitized his immune system and made him allergic to the medication. He reports ongoing pain issues with his knees. Caller inquires is it safe to try the product after again after 3 years however is concerned that if he's allergic the symptoms will be more severe. No further information provided by the reporter. He also added that his general practitioner doctor mentioned that there's a plastic material that is used in plastic surgery (not synvisc) that they're seeing that is causing allergic reactions." Action taken with Synvisc one and Covid-19 Vaccine was not applicable. Corrective treatment: not reported for both the events. Outcome: recovered on an unknown date for hypersensitivity and not recovered for injection site pain. A Product Technical Complaint (PTC) was initiated on 13Nov2024 for Synvisc One (lot/batch number: unknown) with Regulatory Authority number: Complaint-051245.  The PTC stated: Based on the complaint from intake team, there is no quality related effect that would attribute to a malfunction a death or serious injury. 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. The product lot number was not provided. A batch record review is not possible. Based on the lack of information, no assessment is possible. It is the requirement 10 review all finished batch records for specification conformance prior lo re lease. Any out of specification result is identified and mitigated through the Nonconforming Material or Product process. Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a CAPA (Corrective and Preventive Actions) is required.  The final investigation was completed on 20Nov2024 with summarized conclusion as No assessment possible. Additional information received on 14Nov2024 from patient: No significant information received. Clinical course updated and text amended accordingly. Additional information was received on 20Nov2024 from quality department: PTC number, details and results were added. Text was amended. Evaluation in light of similar events in the past.  Sanofi assessment: non serious, causal: Yes, Case Listedness: Listed.  BNT162B2 is under agreement with BIONTECH SE.