Sex: U
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Pyrexia, Renal disorder, Vasculitis
Clinical narrative: some kidney damages.; leukocytoclastic vasculitis; wake up very sweaty; everything ached/First initially for the first day in two days that was still really terrible and painful; very sore arm; a little chilled /I was getting chilled; woke up a little flushed; little lower felt a little tired; didn't have any energy/Not feeling all that greater happy energy; low grade fever/feverish/temperature was little high; it is not really high but it would be under 100 degrees Fahrenheit, may be 99 to a 100 something; diagnosed vasculitis flare up; Initial information received on 28-May-2024 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced low grade fever/feverish/temperature was little high; it is not really high but it would be under 100 degrees fahrenheit, may be 99 to a 100 something, little lower felt a little tired, woke up a little flushed, diagnosed vasculitis flare up, leukocytoclastic vasculitis, everything ached/first initially for the first day in two days that was still really terrible and painful, very sore arm, a little chilled /i was getting chilled, didn't have any energy/not feeling all that greater happy energy, wake up very sweaty and some kidney damages. while receiving vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included Giant cell arteritis on 11-SEP-2021. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Cutaneous vasculitis on 17-OCT-2023.  Concomitant medications included LEVOTHYROXINE (LEVOTHYROXINE) for Thyroiditis; PRAVASTATIN (PRAVASTATIN) for Blood cholesterol increased; and AMLODIPINE (AMLODIPINE) for Blood pressure increased.  On 09-Jun-2022, the patient received a  dose of suspect COVID-19 VACCINE (formulation, strength, expiry date unknown)  not produced by Sanofi Pasteur lot number not reported via unknown route in the arm nos for Prophylactic vaccination On 27-Sep-2023, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, expiry date unknown) lot UT8057DA via intramuscular route in unknown administration site for Annual flu vaccination  On an unknown date the patient had low grade fever/feverish/temperature was little high; it is not really high but it would be under 100 degrees fahrenheit, may be 99 to a 100 something (pyrexia), little lower felt a little tired (fatigue), woke up a little flushed (flushing), serious leukocytoclastic vasculitis (cutaneous vasculitis),everything ached/first initially for the first day in two days that was still really terrible and painful (pain), very sore arm (pain in extremity), a little chilled /i was getting chilled (chills) (unknown latency), didn't have any energy/not feeling all that greater happy energy (asthenia), wake up very sweaty (hyperhidrosis) and some kidney damages. (renal disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and (unknown latency) following the administration of COVID-19 VACCINE.  On 18-OCT-2023 the patient developed a non-serious diagnosed vasculitis flare up (vasculitis) 22 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and 1 year 4 months 9 days following the administration of COVID-19 VACCINE.  Relevant laboratory test results included: Biopsy - On 18-Oct-2023:  [Positive for leukocytoclastic vasculitis Comments - Confirms vasculitis] Biopsy kidney - On 26-Oct-2023:  [positive for kidney issues, systemic autoimmune involvment] Full blood count - On 18-Oct-2023:  [CBC was grossly abnormal]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness Criteria: Medically significant for event cutaneous vasculitis and hospitalization for event Renal disorder; Sender's Comments: Sanofi Company Comment dated 04-Jun-2024: This case involves an unknown age and unknown gender patient who experienced low grade fever/feverish/temperature was little high; it is not really high but it would be under 100 degrees fahrenheit, may be 99 to a 100 something, little lower felt a little tired, woke up a little flushed, diagnosed vasculitis flare up, leukocytoclastic vasculitis, everything ached/first initially for the first day in two days that was still really terrible and painful, very sore arm, a little chilled /i was getting chilled, didn't have any energy/not feeling all that greater happy energy, wake up very sweaty and some kidney damages. while receiving vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Further information on allergy history, family history, past or concomitant medication, laboratory investigation, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the limited reported information, the role of the individual suspect vaccine cannot be assessed.