Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Ventricular extrasystoles, Vomiting
Clinical narrative: Elevated heart rate almost 120 beats per minute/Tachycardia; Frequent skipped beats about every 7th beat/PVCs; Shaking; She threw up once/Vomiting one time; Chills/teeth chattering; Fever 100; Nausea; Slight headache; Soreness in muscle where injection was given; This is a spontaneous case , reported by other non-health professional (consumer) to agency (reference number: SEQ19-07039), initially received on 26-Nov-2019, concerning a 51- year-old, female patient.  The patient past medical history included breast cancer and topical sensitivity (rash) as adverse reaction to neomycin, while the patient's current medical history included allergy to penicillin and sulfa.   The patient's concomitant medications included levothyroxine for an unknown indication.  On 21-Nov-2019, at 5.30 pm, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100142911, expiry date: 30-Jun-2020] for influenza prophylaxis.  On the same day, at 10 pm, 4 hours and 30 minutes after vaccination, the patient experienced soreness in muscle where vaccine was administered and slight headache.   At midnight, 6 hours and 30 minutes after vaccination, the patient woke up with additional symptoms of chills, teeth chattering, shaking, fever of 100 (units were not specified), nausea, elevated heart rate at almost 120 beats per minute with frequent skipped beats about every 7th beat. The patient vomited once. Headache and fever were treated with Advil (ibuprofen), while the corrective treatment for other events was not provided.  The next day, on 22-Nov-2019, the patient was seen by her physician for elevated heart rate and skipped beats. Electrocardiogram was performed and the results showed tachycardia and premature ventricular contractions (PVCs). It was reported that elevated heart rate and skipped beats lasted about 24 hours.   On 23-Nov-2019, within of 48 hours of first symptoms, the outcome of other events was also resolved.  The reporter assessed the case as non-serious.  The reporter assessed the events of tachycardia and PVCs as related to Afluria Quadrivalent, but did not provide the causality assessment for the other events.  Company Comment: The patient experienced tachycardia, ventricular extrasystoles, tremor, vaccination site pain, vomiting, headache, chills, pyrexia and nausea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of breast cancer and concomitant medication levothyroxine may have contributed to development of the events. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Reporter's Comments: The physician advised that elevated heart rate and skipped beats might have been the patient's reaction to the vaccine.; Sender's Comments: The patient experienced tachycardia, ventricular extrasystoles, tremor, vaccination site pain, vomiting, headache, chills, pyrexia and nausea on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of breast cancer and concomitant medication levothyroxine may have contributed to development of the events. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.