Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Cough, Ear pain, Fatigue, Headache
Clinical narrative: Right ear pain; Pain in lower back right teeth; Blood pressure 171/85 mmHg; Fever, unspecified; Vaccination faliure; Flu; This is a spontaneous case initially received from other non-health professional via agency (reference number: SEQ20-00262) on 15-Jan-2020 concerning a 72-year-old, female patient.   The patient's current medical conditions included hearing loss, seasonal allergies, allergies to sulphonamide derivatives, quinolones, sulfa antibiotics and Percocet (oxycodone hydrochloride, paracetamol) and acquired hypothyroidism.   It was reported that patient had a history of autoimmune conditions including hypothyroidism (Hashimoto's) that covered to hyperthyroidism (Grave's). The patient was not diabetic and did not have a heart disease.   The patient's past vaccinations included: chicken pox vaccine in 1949, measles vaccine in 1952, mumps vaccine in unspecified year in 1950's, tetanus booster in 1957, Salk polio vaccine in 1964, TD (tetanus, diphteria) and Sabin oral polio booster on 19-Apr-1965, small pox vaccination on 19-Sep-1968, tetanus booster on 11-Sep-1976, hepatitis B vaccination in 1983, Recombivax HB [hepatitis B vaccine recombinant] in 1989, TD booster  and Engerix-B [hepatitis b vaccine rhbsag (yeast)] on 03-Sep-1998, TD booster on 03-Mar-2000, Pneumovax 23 [pneumococcal vaccine polysacch 23V] on 03-Sep-2003, H1N1 vaccine on 04-Jan-2010, Zostavax [varicella zoster vaccine live (OKA/MERCK)] on 18-Feb-2010, TDAP booster [diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid] on 17-Aug-2011, flu shot on 05-Oct-2011, Fluzone High Dose [influenza vaccine inact split virion 3V] on 30-Sep-2012, Pneumovax pneumococcal vaccine polysacch 23V] on 29-Jun-2013, Fluzone High Dose on 27-Sep-2013, 16-Sep-2014, 06-Sep-2015 and 20-Sep-2016, Prevnar 13 [pneumococcal vaccine conj 13V (crm197)] on 09-Jun-2017, Fluzone High Dose on 19-Sep-2017 and 07-Sep-2018, Shingrix [varicella zoster vaccine rge (cho)], first dose on 12-Mar-2019 and second dose on 08-Jun-2019.   On 17-Sep-2019, the patient was administered Fluad [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number and expiry date: not reported] for influenza prophylaxis.    On 04-Jan-2020, around 3 am, three months and 18 days after vaccination, the patient experienced first flu symptom (throat tickle/mild cough during the night). Cough worsened during the day and into 05-Jan-2020.   On 06-Jan-2020, in the morning, the patient's temperature was 100.2 degrees F (Fahrenheit) by oral thermometer and she made an appointment to be seen at Urgent Care.  Other symptoms followed - paroxysmal coughing, headache, slight chills, fatigue and there were no real body aches.  On the same day, the patient presented to Urgent Care with blood pressure of 171/85 mm/Hg, pulse 88 beats per minute, respiratory rate 12 breaths per minute and temperature 99.2 degrees F.  The patient had flu test performed which was positive for A and negative for B influenza (explicitly coded as Lack of efficacy').   On 06-Jan-2020 the patient was diagnosed with flu and fever, unspecified.   The patient was prescribed Tamiflu (oseltamivir), at a dose of 75 mg, two times every day by oral route for flu and brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide, syrup, at a dose of 5 to 10 millilitre, every six hours as needed, by oral route for cough.   The patient was advised to drink plenty of fluids, to avoid caffeine and to take vitamine C and a daily probiotic. The patient was also advised to take Tylenol (acetaminophen) and/or ibuprofen for fever.   On 13-Jan-2020, the patient's temperature was 99.2 degrees F.   On 14-Jan-2020, the patient started getting right ear pain and pain in her lower back right teeth. She was also stuffed at bed time and took Afrin (oxymethazoline hydrochloride) so she could breathe.   On 16-Jan-2020, the patient's temperature was normal, and the event of fever was resolved.   On the same day, the patient was seeing her primary care physician.   At the time of initial report, the patient was recovering from the event of flu, ear pain, tooth pain and blood pressure high.  The case was assessed as serious for the events of flu and vaccination failure due to the criterion of medical significance.     The reporter considered the event of vaccination failure as related to Fluad.   The reporter did not provide causality assessment for the events of ear pain, tooth pain, flu, fever unspecified and blood pressure high.   This case is linked to 202000174 (same reporter).  Company comment: The patient experienced vaccination failure, influenza, ear pain, toothache, hypertension and pyrexia 3 months and 18 days after vaccination with the suspect product, Fluad (influenza vaccine). Chronology is plausible. The patient had flu test performed in Urgent Care which was positive for A and negative for B influenza. Medical history of hypothyroidism and advanced age (72 years) may have contributed to development of the events. Considering all the above mentioned, causality between suspect product and the events is assessed as related.; Sender's Comments: The patient experienced vaccination failure, influenza, ear pain, toothache, hypertension and pyrexia 3 months and 18 days after vaccination with the suspect product, Fluad (influenza vaccine). Chronology is plausible. The patient had flu test performed in Urgent Care which was positive for A and negative for B influenza. Medical history of hypothyroidism and advanced age (72 years) may have contributed to development of the events. Considering all the above mentioned, causality between suspect product and the events is assessed as related.