Age: 1.0
Sex: M
Vaccine: MEN, MMR, PNC13
Symptoms: Malaise, Rhinitis, Vaccination site reaction
Clinical narrative: Enterovirus test positive; Human rhinovirus test positive; Influenza A virus test positive; Febrile convulsion; Feeding disorder; Malaise; Rhinitis/coryza; Vaccination site reaction; Cough; Generalised tonic-clonic seizure; Information has been received from HA (agency # AU-TGA-0000819409) on 05-NOV-2024.  This spontaneous report was received from a physician and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. Previous vaccine reactions: No, not applicable (NA).  On 27-AUG-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, dose, albumin status, lot #, expiration date, route of administration, and indication were not provided); with a dose of meningococcal vaccine a/c/y/w conj (tet tox) (NIMENRIX) (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided); and with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (strength, dose, formulation, lot #, expiry date, route of administration, and indication were not provided); injection site was mentioned as left arm, but it was unspecified which suspect vaccine it corresponded to.  On an unknown date, the patient experienced Enterovirus test positive, the patient experienced Generalised tonic-clonic seizure, the patient experienced Human rhinovirus test positive, the patient experienced Influenza A virus test positive. On an unknown date in August 2024, Human rhinovirus test (Positive, Influenza A virus test (Positive, and Enterovirus test (Positive.   On 27-AUG-2024, the patient experienced cough, feeding disorder, malaise, rhinitis, and vaccination site reaction. It was stated that he had cough/coryza almost immediately following vaccination - had large firm red swelling over injection site after approximetaly (approx.) 24 hours (hrs), left arm which has improved in redness but remained firm. His mother and sibling were also unwell with fever/viral illness (family history). On an unspecified day in August 2024 (not reported, but assessed based on the narrative), he was presented to an emergency department (ED) due to the child being unwell/off food. It was reported that tonic clonic seizure (also reported as generalized tonic-clonic seizure) commenced in the car on the way to the ED (onset date not provided, conflicting information). In ED, he was given intranasal buccal midazolam x2, Intraosseous (IO) levetiracetam (KEPPRA) ("1610" hrs), and phenytoin ("1651" hrs), also given intravenous (IV( ceftriaxone ("1631" hrs), charted for aciclovir but unclear if given (nursing [nsg] signatures crossed out). On 29-AUG-2024, the patient experienced febrile convulsion (Reported reaction: Injection site reaction - minor/common/expected: febrile seizure). On the same day, he recovered from febrile convulsion. Seizure activity lasted total 40 minutes (mins). On an unknown date, rhinovirus, enterovirus and Influenza A virus polymerase chain reaction (PCR) tests were positive (all reported as adverse events; onset and tests dates not provided, but described in narrative as occurring at ED, conflicting information). Thus, on an unspecified date in August 2024 (not reported, but assessed based on the narrative), the patient was admitted to the hospital due to cough, enterovirus test positive, febrile convulsion, feeding disorder, human rhinovirus test positive, Influenza A virus test positive, malaise, rhinitis, and vaccination site reaction (all events except generalized tonic-clonic seizure had management of event reported as "hospital emergency department"). The patient was awaiting an electroencephalogram (EEG) at the hospital and was likely for discharge with seizure management plan and midazolam rescue. Information added from management (Mgt) of Event unstructured: Outcome was known (conflicting information). Further details as provided: seizure of 40min duration, no (nil) further with over 24 hrs of observation, firm lump for approx. 48 hrs total. At the time of the report, the patient was recovering from vaccination site reaction (however, stop date was provided as 29-NOV-2024, conflicting information), and the outcome of cough, enterovirus test positive, feeding disorder, human rhinovirus test positive, Influenza A virus test positive, malaise, rhinitis, and generalized tonic-clonic seizure was unknown. The action taken with the suspect vaccines regarding the events was not reported, but assessed as not applicable.  The Agency considered all of the events to be possibly related to the suspect vaccines.  Upon internal review, generalized tonic-clonic seizure was determined to be medically significant (per ASTL).