Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Anticoagulant therapy, Atrial fibrillation, Condition aggravated, Dry eye, Feeling cold
Clinical narrative: Permanent atrial fibrillation; Accelerated heart rate/ pulse into high spikes of 170+/peak 181 heart rate; Numbness in upper arm; Upper arm tissue felt bruised; Nasal passages felt slightly inflamed where it was easy to have nasal drip from excessive body heat in normal 70 degree house; My body lacking thermo-regulation; Eyes felt like a pin was being jabbed but eyes were likely experiencing super-dryness; Inflamed blood vessels especially on left eye; Eyes felt like a pin was being jabbed; Heavy sweater from being overly cold (my body lacking thermo-regulation); My brain felts like it was attacked from tingling sensations and blood surges; This spontaneous case was received on 25-Nov-2022 reported by other non-healthcare professional (consumer) (reference number: SEQW22-06068) with additional information received on 28-Nov-2022 (reference number: SEQW22-06082) (being processed together) and concerned 64-year-old, male patient.   The patient's concurrent condition included cardiomyopathy, atrial fibrillation, paroxysmal atrial fibrillation and penicillin allergy. The patient's body mass index (BMI) was at 26.8. The patient's concomitant medications included diltiazem HCL and Eliquis (apixaban). The patient's historical vaccine included Afluria Quadrivalent (influenza vaccine inact split 4v) in 2021 (discrepantly reported as 06-Au-2021 and November 2021) after which the patient did not experience these symptoms, as reported.   On 03-Nov-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: 0.5ml, route of administration: intramuscular (IM), anatomical location: left deltoid) for prevention on influenza disease. The batch number reported was AS3617B and expiry date 30-Jun-2023.  On the same day, within one hour after receiving Afluria Quadrivalent, the patient's upper arm tissue felt bruised. Within two hours the patient reported that her brain felt like it was being attacked from tingling sensations and blood surges (as reported the patient subsequently understood it was likely accelerated heart rate). Within three hours the patient's nasal passages felt slightly inflamed where it was very easy to have nasal drip from excessive body heat in normal 70 degree house. Then the patient required heavy sweater from being overly cold. As reported, his body was lacking thermo-regulation. Within four hours the patient's eyes felt like a pin was being jabbed but his eyes were likely experiencing super dryness. The patient had observed inflamed blood vessels especially on left eye which forced him to seek sleep around 9:30 PM and the patient would usually stay up until midnight.   On 04-Nov-2022, the patient recovered from all events except of continued numbness in upper arm.   On the same day, the patient visited physician's office. Vital signs showed blood pressure at 120/80, pulse at 171 and oxygen saturation (O2SatR) at 98. The patient had high pulse spikes of over 170 and accelerated heart rate with heart rate peak at 181. The patient had been able to relax since 2:30 PM when his pulse returned back to his normal rate of 80 to 90 (unless drug taken which lowers it into upper 70s). The patient was diagnosed with permanent atrial fibrillation. Treatment with Eliquis was discontinued and the rhythm of diltiazem dose was increased from 30 mg two times daily to 60 mg three times daily for a few days to moderate the impact of the flu shot. The doctor ordered echocardiogram transthoracic with doppler and color flow to check for heart damage.  At the time of initial reporting, the patient had not recovered from the event of permanent atrial fibrillation.   The outcome for the events 'heart rate increased' and 'numbness of upper arm' was not reported.   The reporter assessed all events to be related to Afluria Quadrivalent. The patient stated that flu shot caused his symptoms. The patient had severe reaction. As reported, the patient recommended that patients with a history of atrial fibrillation to not receive Seqirus influenza vaccine Afluria Quadrivalent.   The event of permanent atrial fibrillation was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 64-year-old, male patient was vaccinated with Afluria Quadrivalent. Within hours after vaccination, the patient's upper arm tissue felt bruised and patient reported paraesthesia, numbness of upper arm, increased heart rate, nasal inflammation and feeling of coldness. Reportedly, patient had temperature regulation disorder. The patient developed eyes discomfort, eyes dryness and eyes inflammation, also. Next day, the patient was diagnosed with atrial fibrillation. The patient's concurrent condition included cardiomyopathy, atrial fibrillation, paroxysmal atrial fibrillation and penicillin allergy. Information regarding relevant diagnostic findings was not reported. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events, with the currently available information and plausible temporal relationship.; Reporter's Comments: The patient stated that flu shot caused his symptoms. The patient had severe reaction. As reported, the patient recommended that patients with a history of atrial fibrillation to not receive Seqirus influenza vaccine Afluria Quadrivalent.; Sender's Comments: A 64-year-old, male patient was vaccinated with Afluria Quadrivalent. Within hours after vaccination, the patient's upper arm tissue felt bruised and patient reported paraesthesia, numbness of upper arm, increased heart rate, nasal inflammation and feeling of coldness. Reportedly, patient had temperature regulation disorder. The patient developed eyes discomfort, eyes dryness and eyes inflammation, also. Next day, the patient was diagnosed with atrial fibrillation. The patient's concurrent condition included cardiomyopathy, atrial fibrillation, paroxysmal atrial fibrillation and penicillin allergy. Information regarding relevant diagnostic findings was not reported. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for all events, with the currently available information and plausible temporal relationship.