Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Cardiomegaly, Headache, Hepatic enzyme increased, Hepatomegaly
Clinical narrative: Heart attack/MI; Enlarged heart; Enlarged heart, liver, pancreas; Enlarged heart, liver, pancreas; Heart, liver, pancreas and kidney enzymes were elevated; Heart, liver, pancreas and kidney enzymes were elevated; Heart, liver, pancreas and kidney enzymes were elevated; Heart, liver, pancreas and kidney enzymes were elevated; Blood sugar was 347; Fingers and toes started hurting; Anaphylactic reaction; Head began to hurt; This spontaneous case was received on 16-Jul-2021 from Med Communications (reference number: SEQW21-01498), reported by other health professional (nurse) and concerned a 46-year-old, female patient.  The patient's concurrent conditions included egg and thimerosal allergy. The patient was not taking any concomitant medications.  On 09-Nov-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; anatomical location, route of administration and dose: not reported) for influenza prophylaxis. The batch number reported was P100247207 and expiry date was 30-Jun-2021.   On the same day, immediately after receiving Afluria Quadrivalent, patient's head begin to hurt and fingers and toes started hurting. The patient thought she had an anaphylactic reaction. The patient went to the emergency room and it was thought she had a heart attack, but no heart dysfunction was noted. The patient had an enlarged heart, liver, pancreas and kidney enzymes were elevated, her blood sugar was 347 and her heart was enlarged (as reported).   On an unspecified day in Nov-2020, as reported one week later, the patient still had an enlarged heart and the cardiologist thought that the patient had suffered a myocardial infarction (MI). The Cardiologist wanted to prescribe atenolol but the patient declined and stated she had to argue with the medical doctor (MD) that she did not have a MI but an anaphylactic reaction to the vaccine and declined to prescription for atenolol.   On an unspecified day, two months later, no enlarged heart was noted.  On an unspecified day, the patient recovered from the event enlarged heart.  The outcome of the events of anaphylactic reaction, 'myocardial infarction', 'pain in extremity', 'blood sugar abnormal', 'heart enzymes elevated' 'elevated liver enzymes' , 'pancreas enzymes increased', 'renal function test abnormal', 'liver enlargement', 'pancreatic enlargement' and 'headache' was not reported.  The reporter assessed the event of anaphylactic reaction to be related to Afluria Quadrivalent. The reporter stated that she had an anaphylactic reaction the vaccine (as reported). The reporter did not provide causality for any other event.   The events of anaphylactic reaction, enlarged heart, 'myocardial infarction', 'pain in extremity', 'blood sugar abnormal', 'heart enzymes elevated' 'elevated liver enzymes' , 'pancreas enzymes increased', 'renal function test abnormal', 'liver enlargement', 'pancreatic enlargement' and 'headache' were considered to be serious due to medical significance.  Company comment: A 46-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day after vaccination patient's head began to hurt and fingers and toes started hurting. The patient suspected an anaphylactic reaction, however in the emergency room a heart attack was suspected. But no heart dysfunction was noted. As reported the patient had an enlarged heart, liver, pancreas and kidney enzymes were elevated, abnormal blood sugar and her heart was enlarged (as reported). Information regarding the related diagnostic findings have not been provided. Causality for the events headache and pain in extremity could not be ruled out and is assessed as possibly related. With limited information and inconclusive statements, causality for all other events is unassessable.; Reporter's Comments: The reporter stated that she had an anaphylactic reaction the vaccine (as reported).; Sender's Comments: A 46-year-old, female patient was vaccinated with Afluria Quadrivalent. On the same day after vaccination patient's head began to hurt and fingers and toes started hurting. The patient suspected an anaphylactic reaction, however in the emergency room a heart attack was suspected. But no heart dysfunction was noted. As reported the patient had an enlarged heart, liver, pancreas and kidney enzymes were elevated, abnormal blood sugar and her heart was enlarged (as reported). Information regarding the related diagnostic findings have not been provided. Causality for the events headache and pain in extremity could not be ruled out and is assessed as possibly related. With limited information and inconclusive statements, causality for all other events is unassessable.