Age: 63.0
Sex: F
Vaccine: FLU4, FLUC3
Symptoms: Haemoglobin urine absent, Hepatic cirrhosis, Hepatic encephalopathy, Hyperlipidaemia, Hypersomnia
Clinical narrative: Abscess of left jaw; Anasarca; Depression; Displaced fracture of right femoral neck/Femoral neck fracture/Left femoral neck fracture; Distal radius fracture, right; Jaw mass; Neck mass; Obstructive sleep apnea; Osteoarthritis; Pancreatic lesion/Stable 1.5 x 1.3 cm cystin the distal body of the pancreas; PVC (premature ventricular contraction); Varicose veins of lower extremities; Mitral valve incompetence; Fatigue; AKI; Worsened anemia; Hepatic encephalopathy; UTI (urinary tract infection); Cirrhosis of liver/Liver cirrhosis secondary to non alcoholic steatohepatitis; HFrEF (heart failure with reduced ejection fraction); Skin tear to posterior aspect of L forearm; Diverticulosis; This spontaneous case was retrieved on 12-Apr-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2604785-1), reported by other healthcare professional, and concerned a 63-year-old, female patient.  The patient's concurrent conditions included liver cirrhosis, hyperlipidemia (HLD), hypothyroidism, anemia, disability and seasonal allergies (runny nose). The patient's historical conditions included hernia and left ovary tumor. The patient's past procedure included transjugular intrahepatic portosystemic shunt (TIPS), bowel blockage repair, repair of umbilical hernia, left ovary tumor removed, cholecystectomy, splenectomy, hip replacement/hip arthroplasty hemi (right), central line insertion, hip hardware removal (right), US Drain, hernia repair umbilical, hip arthroplasty hemi (left). The patient's family history included congestive heart failure, diabetes mellitus (DM), lung cancer. The patient's concomitant medications included benzonatate, bupropion, Calcium carbonate and vitamin d (calcium carbonate, colecalciferol), Clear eyes (naphazoline hydrochloride), diclofenac, diphenhydramine, fexofenadine, furosemide, lactulose, levothyroxine, metoprolol succinate, Mucinex (guaifenesin), ondansetron, pantoprazole, rifaximin, and spironolactone, all used for an unreported indication. The patient's historical drugs included Infed, after which the patient experienced cardiac arrest, nadolol, after which the patient experienced low blood pressure (b/p), prednisone, after which the patient experienced nausea, vomiting and stomach upset. The patient denied alcohol use, electronic cigarette/vaping e-cigarette, substance abuse and tobacco use. The patient was married, with two children.   It was reported that on 18-Mar-2023, the patient was vaccinated with Afluria Quadrivalent (dose: 0.5 ml; route of administration: intramuscular; anatomical location and indication: not reported). The batch number reported was 348372. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On 26-Mar-2023, eight days after receiving Flucelvax Quadrivalent, the patient was at a nursing facility and that morning she woke up and started walking around which was atypical for the patient. Staff reported the patient did not fall or hit her head. The patient was then reported to sleep all throughout the day which was also atypical for her. The staff then reassessed the patient at 16:00 so they could also give the patient her lactulose, however they noticed she was altered mental status (AMS). The staff reported that the patient was usually conversant but was only responding to her name and not question. In the emergency department (ED) the patient's ammonia was elevated at 93, the patient was unable to follow commands or take po medications, therefore a nasogastric (NG) tube was placed for lactulose administration. The patient also had an acute kidney injury (AKI) and worsened anemia. Computerised tomogram (CT) abd pelvis did not demonstrate any acute findings. Additionally, the patient was sedated further with 5 mg Haldol (haloperidol) and 1 mg of Ativan (lorazepam) for the facilitation of the ng tube placement. The patient was well developed, well nourished. Appeared comfortable. The patient's head was normocephalic, atraumatic. No acute pupillary or ocular movement abnormalities. Sclera was non-icteric, and conjunctiva were pink bilaterally. Oropharynx clear and without edema, injection nor exudate. The uvula was midline. There was no appreciable cervical lymphadenopathy. The neck was supple with full range of motion. No respiratory distress. Lungs were clear to auscultation bilaterally with good air exchange. Regular rate and rhythm. No murmur, gallop, or rub. Abdomen was soft, supple, and non-distended. Diffuse abdominal tenderness. There was not any organomegaly, nor were any masses appreciated. The patient was moving all extremities, sensation grossly intact, neuro tremulous. Arousable to verbal stimuli, but not answering questions or following commands. Skin was normal color. Warm and dry. Skin tear to posterior aspect of left (L) forearm, no active bleeding. No swollen or painful joints. No obvious deformities. No lower extremity edema. The patient was not answering questions. The patient experienced hepatic encephalopathy, and ammonia elevated at time of admission. The patient was advised to continue lactulose titrate to achieve two to three bowel movements per day, to continue rifaximin twice daily. The patient experienced urinary tract infection (UTI). The patient was advised to continue Rocephin, follow urine culture, trend procalcitonin. The patient experienced cirrhosis of liver and transjugular intrahepatic portosystemic shunt (TIPS) procedure was performed. Monitor LFTs GI consult as needed. The patient experienced heart failure with reduced ejection fraction (HFrEF), the patient was advised to continue home medications as BP would allow. The patient experienced hyperlipidemia. Could obtain fasting lipid panel continue home medication. The patient experienced hypothyroidism. Obtain TFTs continue home medications. The patient underwent lipase and the result was 13 Units/L, troponin-I high sensitivity was 14 ng/L high, brain natriuretic peptide (BNP) was 273 pg/mL high, ammonia was 93 mCmol/L high, lactate venous was 1.9 mmol/L, pH bld venous was 7.46 High, PCO2 bld venous was 35 mmHg low, PO2 bld venous was 45 mmHg, base excess bld venous was 1 mmol/L, bicarb bld venous calc was 25 mmol/L, oxygen saturation (O2 sat) bld venous calc was 84 %, patient temperature was 37 Deg C, urine studies showed color: yellow, clarity: slightly cloudy, specific gravity: 1.009, pH: 6, protein: negative, glucose: normal, ketones: negative, bilirubin: negative, hgb ur: negative, nitrite: negative, urobilinogen: normal, leukocyte esterase ur: large 500 abnormal, WBC: 51-100 abnormal, red blood cells (RBC): 0-2, bacteria: trace, squamous epithelial: moderate, hyaline casts: 0-2, and nasopharyngeal coronavirus SARS-CoV2 rapid was not detected. The patient underwent XR Chest PAor AP Portable which showed no acute findings in the chest, CT Head without (W/o) intravenous (IV) contrast showed no CT evidence of acute intracranial abnormalities, CT Abd/Pelvis W/O IV contrast showed limited exam due to lack of IV contrast and motion artifact. No acute findings in the abdomen or pelvis. Cirrhosis status post TIPS stent placement. Trace perihepatic free fluid. Diverticulosis. Stable 1.5 x 1.3 cm cystin the distal body of the pancreas. The known pancreatic lesion was not well visualized. This was previously evaluated with MRI on 21-Feb-2023. Left adnexal dermoid with measurements given above.  On 27-Mar-2023, the patient was ordered bupropion, 150 mg, orally, tab, extended rel, daily, ceftriaxone, 1 GM, IVPB, injection, Q24H, for UTI, 100 mL/hr, infuse over 30 minutes, total volume (mL) = 50 furosemide, 40 mg, orally, tablet, daily, heparin, 5,000 units, subcutaneous, injection, Q8H, lactulose, 30 GM = 45 mL, nasogastric tube, syrup, TID, levothyroxine, 50 mCg, orally, tablet, before breakfast, loratadine, 10 mg, orally, tablet, daily, rifaximin, 550 mg, orally, tablet, BID, spironolactone, 100 mg, orally, tablet, daily. The patient experienced abscess of left jaw, anasarca, anemia, arthritis, ascites, bilateral ankle pain, depression, displaced fracture of right femoral neck, distal radius fracture, right, edema of both lower extremities, fatigue, femoral neck fracture, hepatic encephalopathy, HFrEF (heart failure with reduced ejection fraction), iron deficiency anemia, jaw mass, left femoral neck fracture, liver cirrhosis secondary to non-alcoholic steatohepatitis, mitral valve incompetence, neck mass, obstructive sleep apnea, osteoarthritis, pancreatic lesion, premature ventricular contraction (PVC), right hip pain, TIPS (transjugular intrahepatic portosystemic shunt), umbilical hernia repair, UTI (urinary tract infection) and varicose veins of lower extremities. The patient's temperature (T) was 36.4 C (axillary), heart rate (HR) was 90 (monitored), respiratory rate (RR) was 16, blood pressure (BP) was 132/63, SpO2 was 100%, weight (WT) was 87.40 kg, body mass index (BMI) was 27.6 overweight (BMI 25-29.9), oxygen therapy: nasal cannula oxygen flow rate: 2 (L/min), hemodynamics neurologic glasgow coma score was 11. The patient's scheduled medications were bupropion (24 hour extended release), tab, extended rel, 150 mg, orally, daily, ceftriaxone, injection, 1 GM, IVPB, Q24H, for UTI, furosemide, tablet, 40 mg, orally, daily, heparin (heparin 5,000 units/0.5 mL injectable solution), injection, 5,000 units, subcutaneous, Q8H, lactulose (lactulose 10 GM/15 mL oral syrup), syrup, 30 GM, nasogastric tube, TID, levothyroxine, tablet, 50 mCg, orally, before breakfast, loratadine, tablet, 10 mg, orally, daily, rifaximin, tablet, 550 mg, orally, BID, spironolactone, tablet, 100 mg, orally, daily. The patient underwent white blood count (WBC) and the result was 10.7 k/cumm high, red blood count (RBC) was 1.94 million/cumm low, hemoglobin (Hgb) was 7.8 GM/dL Low, hematocrit (Hct) was 23.1 % low, mean cell volume (MCV) was 119 fL high, mean cell haemoglobin (MCH) was 40.2 pg high, mean cell haemoglobin concentration (MCHC) was 33.8 GM/dL, red cell distribution width (RDW) was 20.3 % high, platelet was 222 k/cumm, mean platelet volume (MPV) was 8.1 fL, neutrophils % was 55 %, lymphocytes % was 14 %, monocytes % was 24 %, eosinophils % was 7%, basophils % was 1 %, absolute neutrophil was 5.9 k/cumm, absolute lymphocyte was 1.5 k/cumm, absolute monocyte was 2.5 k/cumm high, absolute eosinophil was 0.7k/cumm high, absolute basophil was 0.1 k/cumm, sodium was 142 mmol/L, potassium was 4.2 mmol/L, chloride was 112 mmol/L high, carbon dioxide was 25 mmol/L, anion gap was 5 mmol/L, blood urea (BUN) was 26 mg/dL high, creatinine was 1.71 mg/dL high, estimated GFR (CKD-EPI, no race) was 33mL/min/1.73m2 low, estimated creatinine renal clearance (CRCL) (CG) was 40 mL/min low, glucose was 80 mg/dL, calcium total was 9.2 mg/dL, phosphorus was 3.5 mg/dL, alkaline phos was 146 Units/L high, alanine aminotransferase (ALT) was 30 Units/L, aspartate aminotransferase (AST) was 51 Units/L high, bilirubin total was 6.1 mg/dL high, total protein was 6.2 GM/dL low, albumin was 1.9 GM/dL low, blood thyroid stimulating hormone (TSH) was 5.02 mcU/mL high and magnesium was 2.2 mg/dL.  The outcome of all events was not reported.  The reporter did not provide causality assessment.    All events were considered as serious due to the seriousness criterion of hospitalization. Additionally, the events of 'acute kidney injury', hepatic encephalopathy, 'liver cirrhosis', heart failure with reduced ejection fraction, hypothyroidism, 'abscess jaw', and 'femoral neck fracture' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  Company comment: A 63-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. Eight days after vaccination the patient the patient developed mental status changes. In the emergency department (ED) the patients ammonia was elevated at 93, the patient was unable to follow commands. The patient had also acute kidney injury and worsening anaemia. Following diagnostic workup hepatic cirrhosis and hepatic encephalopathy have been detected. The patient developed also a urinary tract infection, heart failure with reduced ejection fraction, abscess of jaw, anasarca, depression, femoral neck fracture, distal radius fracture, jaw and neck mass, obstructive sleep apnoea syndrome, osteoarthritis, pancreatic cyst, ventricular extrasystoles, varicose veins of lower extremities, mitral valve incompetence, skin laceration (posterior aspect of left forearm), diverticulosis and fatigue. All information about the events has been supported by relevant diagnostic findings. As reported the patient didnt fell, although numerous fractures are suggestive of traumatic aetiology. Underlying medical history was significant for liver cirrhosis, hyperlipidemia, disability and multiple surgical procedures including abdomen and also hip arthroplasty. The patient's family history included congestive heart failure, diabetes mellitus (DM), lung cancer. Considering the provided information and biological implausibility causality for the events acute kidney injury, urinary tract infection, anaemia, mitral valve incompetence, hepatic cirrhosis and hepatic encephalopathy, heart failure with reduced ejection fraction, abscess of jaw, anasarca, depression, femoral neck fracture, distal radius fracture, jaw and neck mass, obstructive sleep apnoea syndrome, osteoarthritis, pancreatic cyst, ventricular extrasystoles, varicose veins of lower extremities, skin laceration (posterior aspect of left forearm) and diverticulosis. Although chronology for fatigue seems plausible, considering multiple concurrently developed events which provide alternative aetiology causality for the event fatigue is assessed as not related.; Sender's Comments: A 63-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. Eight days after vaccination the patient the patient developed mental status changes. In the emergency department (ED) the patients ammonia was elevated at 93, the patient was unable to follow commands. The patient had also acute kidney injury and worsening anaemia. Following diagnostic workup hepatic cirrhosis and hepatic encephalopathy have been detected. The patient developed also a urinary tract infection, heart failure with reduced ejection fraction, abscess of jaw, anasarca, depression, femoral neck fracture, distal radius fracture, jaw and neck mass, obstructive sleep apnoea syndrome, osteoarthritis, pancreatic cyst, ventricular extrasystoles, varicose veins of lower extremities, mitral valve incompetence, skin laceration (posterior aspect of left forearm), diverticulosis and fatigue. All information about the events has been supported by relevant diagnostic findings. As reported the patient didnt fell, although numerous fractures are suggestive of traumatic aetiology. Underlying medical history was significant for liver cirrhosis, hyperlipidemia, disability and multiple surgical procedures including abdomen and also hip arthroplasty. The patient's family history included congestive heart failure, diabetes mellitus (DM), lung cancer. Considering the provided information and biological implausibility causality for the events acute kidney injury, urinary tract infection, anaemia, mitral valve incompetence, hepatic cirrhosis and hepatic encephalopathy, heart failure with reduced ejection fraction, abscess of jaw, anasarca, depression, femoral neck fracture, distal radius fracture, jaw and neck mass, obstructive sleep apnoea syndrome, osteoarthritis, pancreatic cyst, ventricular extrasystoles, varicose veins of lower extremities, skin laceration (posterior aspect of left forearm) and diverticulosis. Although chronology for fatigue seems plausible, considering multiple concurrently developed events which provide alternative aetiology causality for the event fatigue is assessed as not related.