Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fear, Feeling abnormal, Impaired work ability, Influenza like illness
Clinical narrative: Heart feeling as out of rhythm; Coughing so much that she felt as though she had ripped a muscle in her chest; Coughing so much that she felt as though she had ripped a muscle in her chest; Respiratory flu-like symptoms; She felt as though she was going to vomit or experience diarrhea; Feel extremely weak, characterizing it as "wavy weirdness''; Feel extremely weak, characterizing it as 'wavy weirdness'/ weakness; Fearing that she was going to pass out/felt as though she was going to pass out while in the car; Stabbing pain in her stomach; She felt as though she was going to vomit or experience diarrhea; This spontaneous case was received on 11-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01582) with additional information received on 13-Aug-2021 (being processed together) via Med Communications (reference number: SEQW21-01582) and concerned an adult, female patient. At the time of initial reporting, the patient was a 62-year-old.  The patient's concurrent conditions included Graves' disease, blood pressure abnormal, history of heart arrythmia and several allergies to other medications. The patient's concomitant medications included unspecified blood pressure medication for blood pressure abnormal. The patient's historical medications included Augmentin (amoxicillin) after which she felt as her skin was on fire and "shot with poison", codeine after which she felt like her blood pressure was increased and "hyped up", unspecified blood pressure medicine from different manufacturer after which she had adverse reaction. If she had not taken any, she kept getting weaker with crazy blood pressure and heart rate spikes and once she got the one from the manufacturer she had been on, the symptoms straightened out within two days and she felt better with the first dose. In addition, the patient reported that she can take amoxicillin only not brand name Augmentin.   On an unspecified date in Nov-2014, the patient was vaccinated with Afluria Trivalent (influenza vaccine; dose, anatomical location, route of administration: not reported) as protection against seasonal influenza. The batch number was not reported. The patient waited the 15-minute period after receiving the injection in case she developed an allergic reaction, which she did not.  On the same day, after receiving Afluria Quadrivalent, the patient went and ran errands and she spent 10 - 15 minutes in one store with no issues. Then she went to store and after about 15 - 20 minutes of shopping, the patient began to feel extremely week, characterizing it as "wavy weirdness". The patient left the store as quick as she could, fearing that she was going to pass out. Patient stated that she felt as though she was going to pass out while in the car and had to distract herself to make sure she remained conscious while she drove home. This weakness lasted about three days and was accompanied by stabbing pain in her stomach, where she felt as though she was going to vomit or experience diarrhea.  On an unspecified date in 2014, about three days from onset, the patient recovered from the event of 'feelings of weakness'.   On an unspecified date, reported as 'after this time period', the patient began to experience respiratory flu-like symptoms including coughing so much that she felt as she had ripped a muscle in her chest. The patient reported that during this time, she also experienced heart feeling as though it was out of rhythm. The patient stated that it took her about three weeks to "pull herself together" and longer to be able to return back to work.  On an unspecified date, about two months from onset, the patient recovered from the events of 'flu-like symptoms', 'coughing' and 'chest discomfort'.    On an unspecified date, the patient recovered from the events of 'arrhythmia cardiac (NOS)' 'pre-syncope', 'weird feeling', 'stomach pain', 'nausea' and 'abdominal discomfort'.  The reporter assessed all events as related to Afluria Trivalent. As reported, the patient received AFLURIA Influenza Vaccine 2014-2015 formulation and had a bad reaction to it. She has been worried ever since to get any other vaccine due to that experience.  The event of 'arrhythmia cardiac (NOS)' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company Comment: An adult female patient developed weakness (characterized as wavy weirdness), presyncope, stomach pain, nausea and abdominal discomfort after vaccination with the suspect product Afluria Trivalent. An unknown amount of time after vaccination the patient developed flu-like symptoms, cough accompanied by chest discomfort and non-specified cardiac arrhythmia. Patients medical history is significant for heart arrythmias and several allergies to other medications. Based on plausible time relationship causality for the events asthenia, weird feeling, presyncope, abdominal discomfort, nausea and stomach pain is assessed as possibly related. Causality for all other events is unassessable due to unclear temporal relationship.; Reporter's Comments: As reported, the patient received AFLURIA Influenza Vaccine 2014-2015 formulation and had a bad reaction to it. She has been worried ever since to get any other vaccine due to that experience.; Sender's Comments: An adult female patient developed weakness (characterized as wavy weirdness), presyncope, stomach pain, nausea and abdominal discomfort after vaccination with the suspect product Afluria Trivalent. An unknown amount of time after vaccination the patient developed flu-like symptoms, cough accompanied by chest discomfort and non-specified cardiac arrhythmia. Patients medical history is significant for heart arrythmias and several allergies to other medications. Based on plausible time relationship causality for the events asthenia, weird feeling, presyncope, abdominal discomfort, nausea and stomach pain is assessed as possibly related. Causality for all other events is unassessable due to unclear temporal relationship.