Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Hepatic enzyme increased, Ill-defined disorder, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Liver enzymes elevated; Dehydrated; Sore throat; Vomiting; Orange diarrhea; Within a 4 hour peroid she became ill; Fever got as high as 103F; Sick; Rash; Rigor/chills; Bone pain; This is a non-serious spontaneous case reported by other non-health professional to Med Communications (reference number: SEQ19-04550), initially received on 12-Oct-2019 and follow-up received on 12-Oct-2019 (being processed together), concerning a 20-year-old female patient.  The patient's medical history included thermal urticaria. The patient's concomitant medications included sertraline and vitamin D.  On 10-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza Vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P100120274, expiration date: not reported], for influenza prophylaxis.  On the same day, two hours after vaccination the patient immediately spiked a fever.  On unknown date in Oct-2019, after vaccination, the patient experienced bone pain, rigors and rash.  On 10-Oct-2019, four hours after vaccination, the patient became ill and developed a fever 103 degrees, sore throat, orange diarrhea and vomiting. The patient went to the health center and was told that all symptoms were normal. However, the patient's mother stated that the patient was sick for the next day and half. She was dehydrated so they tried putting her on IV.  On 13-Oct-2019, at night, fever was 102 F.  On an unspecified date, reported as Monday, after vaccination, the patient went back to the clinic and was informed that her liver enzymes were elevated.  On an unspecified date, the outcome of event rash was recovering/resolving and for other events was recovered/resolved. Liver enzymes remained elevated.  The case was assessed as non-serious. The reporter did not provide causality assessment to Afluria Quadrivalent.  Follow up received from physician on 05-Nov-2019: New event of illi-defined disorder was confirmed, onset latency for events ill-defined disorder, fever, sore throat, diarrhea and vomiting was provided, new events of dehydration, sickness and liver enzymes elevated were confirmed, patient's date of birth was confirmed, outcome of all events was recovered except liver enzymes remained elevated but should be checked again at the end of month. It was stated that patient was doing well and able to carry out daily routine. New event of rash was confirmed and outcome was resolving but not completely gone.  Company comment: The patient experienced hepatic enzyme increased, bone pain, dehydration, oropharyngeal pain, rash, chills, vomiting, diarrhoea, ill-defined disorder, pyrexia and malaise after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Concomitant medication sertraline may provide more plausible alternative etiology for the events. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.; Sender's Comments: The patient experienced hepatic enzyme increased, bone pain, dehydration, oropharyngeal pain, rash, chills, vomiting, diarrhoea, ill-defined disorder, pyrexia and malaise after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. Concomitant medication sertraline may provide more plausible alternative etiology for the events. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as unlikely related.