Age: 7.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza, Microscopy, No reaction on previous exposure to drug, Oliguria, Parvovirus infection
Clinical narrative: Sepsis; Acute kidney injury; Hepatitis acute; Pyrexia; Vomiting; Hypervolaemia; Parvovirus infection; Information has been received from Regulatory Agency (agency # AU-TGA-0000774651).  This spontaneous information was received from other health care professional concerning a 7-year-old male patient.  Patient's concomitant therapies were not provided. The patient's medical history included: otitis media, croup, impetigo. The patient had no previous vaccine reactions (also reported as not applicable). No regular medications immunised as per childhood schedule with no previous issues. On 16-APR-2023, the patient initially presented to hospital with fever and vomiting. He was assessed in emergency department (ED) there and discharged home. On 17-APR-2023, he subsequently presented to hospital with fever and vomiting and was assessed in ED and discharged home. A respiratory viral PCR collected during that presentation was positive for Influenza B.  On 18-APR-2023, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (dose, lot #, expiry date, route of administration and vaccination site were not provided); and with influenza vaccine inact split 4v (FLUQUADRI) (dose, lot #, expiry date, route of administration and vaccination site were not provided), both administered for prophylaxis. The reporter reported that they were unsure of the exact timing of immunization.  On 18-APR-2023, the patient experienced pyrexia and vomiting. On 18-APR-2023, he represented to hospital with fever and vomiting and was admitted for observation and intravenous (IV) fluid hydration. Bloods collected on admission showed that he had an acute kidney injury with creatinine of 104. Hospital admission and development of acute kidney injury requiring peritoneal dialysis at hospital was reported. On 21-APR-2023, the patient experienced acute kidney injury, hepatitis acute, hypervolaemia and parvovirus infection. On 21-APR-2023, he continued to have ongoing fevers and bloods were repeated which showed rapidly progressing renal failure (creatinine at 440, urea at 24, bicarbonate at 18) leading to fluid overload and oliguria and required urgent transfer to hospital for specialty assessment. He was also found to have an acute hepatitis with alanine transaminase (ALT) at 3560 and aspartate aminotransferase (AST) at 2000, and an infective hepatitis screen showed acute parvovirus infection. On 22-APR-2023, he arrived at hospital and was admitted under the nephrology team due to his acute renal failure. On an unspecified date, the patient experienced sepsis (the reported reaction was sepsis). On 24-APR-2023, the patient commenced peritoneal dialysis for raised urea (41.6) and fluid overload in the context of acute oliguria renal failure (creatinine 800). He required acute peritoneal dialysis from 24-APR-2023 to 28-APR-2023. He had microscopic haematuria (>100 RBC on microscopy) and proteinuria (albumin/creatinine ratio 92). He was treated with high dose methylprednisolone for 3 days followed by 2 days of oral prednisolone at 1mg/kg. On 24-APR-2023, he underwent renal biopsy, which demonstrated acute tubular injury with no glomerular abnormalities on light microscopy or electron microscopy. He had a transiently low C3/C4 which normalized 7 days post admission to hospital. The final specialty consensus diagnosis was acute kidney injury secondary to tubular injury in the context of multiple concurrent infections (Influenza B, parvovirus, giardia intestinalis) and preceding dehydration. The symptoms of these infections started prior to vaccination and signs of acute kidney injury were also present at the time of vaccination. At the time of this report, the patient was recovering from hypervolaemia. At the time of this report, the patient had not recovered from sepsis. At the time of this report, the outcome of acute kidney injury, hepatitis acute, parvovirus infection, pyrexia and vomiting was unknown. It was also reported that the patient has ongoing but improving acute kidney injury which was expected to resolve in the medium term (weeks to months). He would be discharged from hospital with ongoing follow up to monitor his kidney function long term.  The causal relationship between the suspect vaccines and the aforementioned adverse events was reported as possible.  Upon internal review the events of acute kidney injury, hepatitis acute and sepsis were considered to be medical significant. The event of hypervolaemia was considered to be medically significant due to peritoneal dialysis which is on the supplemental list.  No follow-up should be scheduled for this report as no further information could be obtained from the local regulatory authority. Additional information was not expected.