Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | 602MF013 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8506KA | IM |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 5YB5G | IM |
Acute kidney injury; sepsis; abscess limb; This serious case was reported by a consumer via other manufacturer and described the occurrence of acute kidney injury 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 tobacco user. Concurrent medical conditions included asthma, hypertension, drug hypersensitivity, bipolar disorder, sinusitis bacterial and fungal skin infection. Concomitant products included fluticasone propionate, fluticasone propionate;salmeterol xinafoate (Advair), salbutamol (Albuterol), azelastine, buprenorphine, mirtazapine (Mirtazepine Teva), olanzapine, oxybutynin, propranolol and venlafaxine. 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, the patient experienced acute kidney injury (Verbatim: Acute kidney injury) (serious criteria hospitalization, GSK medically significant, life threatening and other: Serious as per reporter), sepsis (Verbatim: sepsis) (serious criteria hospitalization, GSK medically significant, life threatening and other: Serious as per reporter) and abscess limb (Verbatim: abscess limb) (serious criteria hospitalization, life threatening and other: Serious as per reporter). The outcome of the acute kidney injury, sepsis and abscess limb were resolved. It was unknown if the reporter considered the acute kidney injury, sepsis and abscess limb to be related to Boostrix. The company considered the acute kidney injury, sepsis and abscess limb to be unrelated to Boostrix. Additional Information: GSK Receipt Date: 21-FEB-2025 The patient's past medical treatments, vaccinations and family history were not provided. At the time of the event, the patient had ongoing bacterial rhinosinusitis and fungal skin infection, Concomitant medications included Fluticasone propionate, Salmeterol xinafoate (Advair), Salbutamol (Albuterol), Azelastine, Buprenorphine, Mirtazapine (Mirtazepine Teva), Olanzapine, Oxybutynin, Propranolol and Venlafaxine. On 29-OCT-2024, the patient received a dose 1 of suspect Boostrix not produced by Sanofi Pasteur in unknown administration site (strength and expiration date: not provided) for drug used for unknown indication and received a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection in unknown administration site (dose, strength and expiration date not provided) for drug used for unknown indication and received a dose of suspect Novavax covid-19 vaccine injection not produced by Sanofi Pasteur in unknown administration site (dose, strength and expiration date: not provided) for drug used for unknown indication. On 06-Nov-2024, 8 days after receiving Boostrix, Influenza USP trival A-B subvirion no preservative vaccine (Fluzone) and Novavax Covid-19 vaccine, the patient developed abscess limb, acute kidney injury and sepsis (latency-8 days). These events were assessed as medically significant and life-threatening, and the patient was hospitalized for these events. It was not reported if the patient received a corrective treatment for the events. It was unknown if the reporter considered the acute kidney injury, sepsis and abscess limb to be related to Fluzone and Novavax Covid-19 vaccine.; Sender's Comments: Acute kidney injury, Sepsis and Abscess limb are unlisted events which are considered unrelated to GSK vaccine Boostrix.
Asthma; Bipolar disorder; Drug hypersensitivity; Fungal skin infection; Hypertension; Sinusitis bacterial
Medical History/Concurrent Conditions: Tobacco user
FLUTICASONE PROPIONATE; ADVAIR; ALBUTEROL; AZELASTINE; BUPRENORPHINE; MIRTAZEPINE TEVA; OLANZAPINE; OXYBUTYNIN; PROPRANOLOL; VENLAFAXINE