Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Infectious mononucleosis, Influenza, Influenza A virus test positive, Influenza B virus test positive, Infusion site haemorrhage
Clinical narrative: This is a serious spontaneous case, initially received from consumer on 06-Mar-2018, concerning a 57-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medication or recent immunizations. It was reported that, the patient was healthy prior to flu shot. On 24-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (unknown if it was the right or left arm), batch number: XT59706 and expiry date: 02-Jun-2018). On the same day, within 30 minutes of vaccination, the patient had sharp pain in the back of head (reported that, as something hit her back of head), felt unwell, neck stiffness, she could not move her head left to right, knees, hips began to burn, sting and received ADVIL LIQUID-GEL capsule (200 mg). It was reported that, after receiving ADVIL (1/every 6 hours), headache resolved (on 25-Oct-2017). Within 2 weeks of vaccination, the patient also experienced burning, stinging and heaviness in feet and legs, which made her difficult to walk. She experienced dizziness, intense pain in feet, legs, chest and experienced cough producing sputum. On an unspecified date in 2017, she went to her first treating doctor and her CBC (complete blood count) was done and sputum was tested which found to be positive for flu. Examinations (unspecified) determined wheezing, bacterial infection in lungs and was prescribed with Z-PAK (500 mg, 2 1st day, 1 next 4 days), FLOVENT (220/2 puffs twice/day), benzonatate (100mg, prn, 1 pill every 4-6 hours as needed) (for cough), RESPICLICK puffer. On an unspecified date in 2017 (reported as 6 days later), after receiving last dose of Z-PAK, the patient returned to doctor as she did not feel better (cough worsened, and chest pain was unbearable). Chest X ray was done which showed clear chest and lungs. The patient had swelling of liver and spleen, which pushed against ribs. The patient had pneumonia with symptoms green sputum, productive coughing along with chest pain and was prescribed with AUGMENTIN (875 mg, twice a day for 10 days). It was started that, no changes were observed, and her symptoms had worsened. On an unspecified date in 2017, she went to her 2nd treating doctor and pulmonary function test and CT-A (computed tomography angiography) scan with contrast were done to determine pain in lungs, lungs burning when breathing, coughing, swelling of hands and knees. It was reported that, doctor thought it might be PE (pulmonary embolism). She stated that, after scanning, her IV (intravenous) site began to bleed (blood squirting out underneath gauze/tape), which heated her up and she was advised to not to use her left arm. Bleeding stopped, and another pad of gauze and tape was added to IV site. It was confirmed that, patient had no PE and she stated that she was a bleeder now (no bleeding issue before). The patient stopped to receive all medications (AUGMENTIN, Benzonatate, FLOVENT and RESPICLICK) as per the doctor. Other blood investigations were done which showed the presence of several viruses- EPV (Epstein Barre, Virus), Mono (mononucleosis), cytomegalovirus, high white blood cells count and other blood panels (unspecified). The patient was advised to go to nearest hospital. On an unspecified date in 2017, the patient had rheumatoid arthritis and fibromyalgia with symptoms (stinging in feet, legs, hand, fingers and joints swelling). On 02-Jan-2018, the patient returned to her office with coughing. On 26-Jan-2018, the patient felt sick again. On 29-Jan-2018, after 3 months 4 days of vaccination, swab test was done which confirmed A and B type flu infection (lasted in 10 days). The patient was prescribed with TAMIFLU and after 2 days of receiving TAMIFLU, she had severe stomach pain and lungs became severely congested, and stopped TAMIFLU. It was reported that, within 24 hours of stopping of TAMIFLU, she was able to cough up phlegm, breathe easier and stomach pain subsided. As of 28-Feb-2018, the patient's lungs were sensitive (still coughing up mucus) and felt tired all the time. It was reported, she started yoga and walks every day, but could not run longer as it hurt her lungs. She started chiropractic visits for spinal (neuro) adjustments for back pain and Vitamin C (2000 mg, tid (3 times a day), vitamin B complex (500 mg, od, 1/day), Vitamin B12 (liquid- 1000 mcg, od, 1 dropperful/day), Vitamin D3 (liquid - 5000 mcg, od, 1 dropperful/day), Calcium (1000 mg, od, 1/day, turmeric with pepper (650mg, bid, 2/day), Ginger Root (100 mg, od, 1/day) to rebuild her immune system. The patient had recovered from the events influenza (reported as lasted in 10 days) with symptoms headache, event infusion site haemorrhage, stomach pain and not yet recovered from the event rheumatoid arthritis with symptoms musculoskeletal stiffness, mobility decreased, burning sensation, pain, limb discomfort, gait disturbance, pain in extremity, back pain, joint swelling, peripheral swelling; event fibromyalgia, event pneumonia with symptoms chest pain, productive cough, wheezing, pulmonary congestion, dizziness, pulmonary pain, cough, sputum discoloured, condition aggravated; events lung infection, Epstein-Barr virus infection, infectious mononucleosis, cytomegalovirus infection, feeling hot, increased white blood cell count, haemorrhagic disorder, symptoms malaise and fatigue. The reporter considered the causality of the events as related to the suspect vaccine.