Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Abscess limb, Acute kidney injury, Sepsis
Clinical narrative: Sepsis; Abscess limb; Acute kidney injury; This serious case was reported by a consumer via other manufacturer and described the occurrence of sepsis in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G) for prophylaxis.   Co-suspect products included Influenza vaccine (Fluzone) (batch number UT8506KA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 602MF013) for prophylaxis.   The patient's past medical history included asthma, smoker, hypertension and bipolar disorder. Concurrent medical conditions included sinusitis bacterial, fungal dermatitis and drug allergy (BUPROPRION drug allergy). Concomitant products included fluticasone propionate;salmeterol xinafoate (Advair), salbutamol (Albuterol), azelastine, buprenorphine, mirtazapine (Mirtazepine Teva), oxybutynin, propranolol, venlafaxine and olanzapine.   On 29-OCT-2024, the patient received the 1st dose of Boostrix (intramuscular), Fluzone (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 06-NOV-2024, 8 days after receiving Boostrix and Fluzone, the patient experienced sepsis (Verbatim: Sepsis) (serious criteria hospitalization, GSK medically significant, life threatening and other: serious as per reporter), abscess limb (Verbatim: Abscess limb) (serious criteria hospitalization, life threatening and other: serious as per reporter) and acute kidney injury (Verbatim: Acute kidney injury) (serious criteria hospitalization, GSK medically significant, life threatening and other: serious as per reporter). The outcome of the sepsis, abscess limb and acute kidney injury were resolved.   It was unknown if the reporter considered the sepsis, abscess limb and acute kidney injury to be related to Boostrix.     The company considered the sepsis, abscess limb and acute kidney injury to be unrelated to Boostrix.   Additional Information: GSK Receipt Date: 13-JAN-2025 Patient was received by Novavax on 06-Jan-2025. A 60 year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (LOT: 602MF013) on 29-Oct-2024. The following secondary suspect medications were reported: FLUZONE [INFLUENZA VACCINE](influenza vaccine) and BOOSTRIX(tetanus vaccine toxoid). The following medical history was reported: ASTHMA, SMOKER, HTN, BIOPOLAR D/O, BUPROPRION, BACTERIAL RHINOSINUSITIS and YEAST DERMATITIS. The following concomitant medications were reported: ADVAIR(fluticasone propionate), ALBUTEROL [SALBUTAMOL](salbutamol), AZELASTINE(azelastine), BUPRENORPHINE(buprenorphine), MIRTAZAPINE(mirtazapine), OLANZAPINE(olanzapine), OXYBUTYNIN(oxybutynin), PROPRANOLOL(propranolol) and VENLAFAXINE(venlafaxine). On 06-Nov-2024, on 9 day after vaccination the patient experienced ABSCESS LIMB(Abscess limb)(Serious: Life Threatening and Caused/Prolonged Hospitalization), ACUTE KIDNEY INJURY(Acute kidney injury)(Serious: Life Threatening, Caused/Prolonged Hospitalization and Other Medically Important Condition), SEPSIS(Sepsis)(Serious: Life Threatening, Caused/Prolonged Hospitalization and Other Medically Important Condition). At the time of reporting, the event outcome of Abscess limb was Recovered/Resolved, Acute kidney injury was Recovered/Resolved and Sepsis was Recovered/Resolved.; Sender's Comments: Sepsis, Abscess limb and Acute kidney injury are unlisted events which are considered unrelated to GSK vaccine Boostrix.