Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Agitation, Amnesia, Confusional state, Dizziness, Echocardiogram
Clinical narrative: Agitated; She didn't remember calling him; Room was in circles and didn't know where she was; She weight 123 and now weighs 115 lbs; Unable to eat; Room was in circles and didn't know where she was/Dizzy; Throwing up; Didn't feel well; She was sick for three weeks; This spontaneous case was received on 02-Dec-2021 from other non-health care professional (consumer) via Agency (reference number: SEQW21-05795) and concerned an 85-year-old, female patient.  The patient's medical history and concomitant were not reported. The patient's historical vaccine included Johnson and Johnson vaccine and fainted with that one. It was also reported that she did not have a good reaction to medicines, last year or the year before she had to have someone to drive her home.  On an unspecified date in Nov-2021, reported as beginning of November, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.  On the same date, at 2 p.m. after receiving influenza virus vaccine polyvalent, the patient had no problem coming home, but after that she did not feel well. After dinner she also did not feel well and went to bed early.   On an unspecified date in Nov-2021, at 1 a.m. after receiving influenza virus vaccine polyvalent, room was in circles and the patient did not know where she was. She called nephew and he showed up and she asked why he was there. She did not remember calling him.  On an unspecified date in Nov-2021, into three weeks later after receiving influenza virus vaccine polyvalent, the patient was dizzy and throwing up. She weighed 123 and now weighed 115 lbs. She went to physician's office for echocardiogram and other tests with no results provided. The patient was agitated and stated she was sick for three weeks and was unable to eat.  On an unspecified date in Nov-2021, the patient recovered from the event of 'illness'.  The outcome of other events was not reported.  The reporter assessed the events to be related to influenza virus vaccine polyvalent. Reported as she would like to know if anyone else has called in about this side effect.  Company comment: An 85-year-old, female patient was vaccinated with the suspect product influenza virus vaccine polyvalent. On the same day after vaccination the patient felt unwell. As reported patient was ill for three weeks experiencing agitation, amnesia, confusion, decreased weight due to vomiting and eating difficulties as well as dizziness. Information regarding the underlying medical history and concomitant medications has not been provided. Patient went to physician's office for echocardiogram and other tests with no results provided. Causality for the events agitation, amnesia, confusion, feeding disorder and decreased weight is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.; Reporter's Comments: Side affect; Sender's Comments: An 85-year-old, female patient was vaccinated with the suspect product influenza virus vaccine polyvalent. On the same day after vaccination the patient felt unwell. As reported patient was ill for three weeks experiencing agitation, amnesia, confusion, decreased weight due to vomiting and eating difficulties as well as dizziness. Information regarding the underlying medical history and concomitant medications has not been provided. Patient went to physician's office for echocardiogram and other tests with no results provided. Causality for the events agitation, amnesia, confusion, feeding disorder and decreased weight is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.