Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Injection site bruising, Injection site discolouration, Lethargy, Pain, Pyrexia
Clinical narrative: low grade fever of 99.1; body aches; lethargic; slept all day; some bruising at the injection site on her left thigh; there was discoloration at the site; Initial information received on 16-Nov-2023 regarding an unsolicited valid non-serious case received from a patient via specialty pharmacy.  Country:   This case involves 58 years old female patient (108.8 kg) who reported that there was discoloration at the site, low grade fever of 99.1, body aches, lethargic, slept all day and some bruising at the injection site on her left thigh after receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT] via dupilumab singledose prefilled pen.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On 12-Jul-2022, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection at a dose of 300 mg QOW subcutaneous (strength: 300 mg/2ml, batch number, expiry date: unknown) for nasal polyp unspecified via dupilumab singledose prefilled pen.  In 2023 the patient developed a non-serious event "there was discoloration at the site" (injection site discolouration) (unknown latency) following the first dose intake of DUPILUMAB.  In 2023 the patient developed a non-serious event "some bruising at the injection site on her left thigh" (injection site bruising) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of DUPILUMAB.  On 10-Nov-2023, the patient received unknown dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On 11-Nov-2023, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  Information regarding batch number and expiry date has been requested.  On 11-NOV-2023 the patient developed a non-serious event "low grade fever of 99.1" (pyrexia) 1 year 4 months following the first dose intake of DUPILUMAB and on same day following the administration of INFLUENZA VACCINE and (latency :1 day) COVID-19 VACCINE.  On 11-NOV-2023 the patient developed a non-serious event "body aches" (pain) 1 year 4 months following the first dose intake of DUPILUMAB and on same day following the administration of INFLUENZA VACCINE and (latency :1 day) COVID-19 VACCINE.  On 11-NOV-2023 the patient developed a non-serious event "lethargic" (lethargy) 1 year 4 months following the first dose intake of DUPILUMAB and on same day following the administration of INFLUENZA VACCINE and (latency :1 day) COVID-19 VACCINE.  On 11-NOV-2023 the patient developed a non-serious event "slept all day" (somnolence) 1 year 4 months following the first dose intake of DUPILUMAB and on same day following the administration of INFLUENZA VACCINE and (latency :1 day) COVID-19 VACCINE.  It was reported "Patient reported that she had some bruising at the injection site on her left thigh from the injection administered on 10/31/2023 she stated that there was discoloration at the site but it was not bad stating she gives herself the injection in her thighs alternating between left and right thigh she started bruising only on the left thigh and wanted to know if she should inject in the abdomen. Patient stated that she received her covid and flu vaccines last friday and on saturday 11/11/2023, she had a low grade fever of 99.1, body aches, was lethargic and slept all day, she stated that she woke up on sunday and was feeling energetic and back to normal. It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available."  Action taken with DUPILUMAB (DUPIXENT) was unknown for all events. Action taken with INFLUENZA VACCINE  and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable for all events.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for injection site discolouration, injection site bruising, was Recovered on 12-Nov-2023 for other events.