Age: 38.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Activities of daily living impaired, Condition aggravated, Cough, Impaired work ability, Injection site pain
Clinical narrative: This spontaneous case, initially received on 23-Oct-2016, was reported by a health professional and concerns a 38-year-old female patient. Weight: not provided; Height: not provided. Drug history included Gabapentin which made her itch; tDAP vaccine (Reaction in 2009: Itch, Muscle soreness, Fevers, Aches, ended up a few months later had fallen and was diagnosed with Transverse myelitis). When she had transverse myelitis that was up to her knees as well, and did not lose strength. Antidepressants did not work well with her system, she had these when she had her son. At the time of the event, the patient had contact dermatitis allergy to latex. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received Afluria for influenza vaccination on 06-OCT-2016. Dose regimen: 0.5mL, Route of administration: Intramuscular. Batch number: WT55307. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Oct-2016, the patient's arm was sore where the vaccine was administered. She experienced 99 degree temperature every single day since receiving the vaccine, which progressed to 101. Her legs started to be tingly up to her knees. On the same evening on 06-Oct-2016, she had low grade fever and aches. The fever stayed above 100 for 4 days. On 07-Oct-2016, it seemed to get worse. On 12-Oct-2016, she had a temperature of 101 F and saw her doctor. She was told to take ibuprofen and paracetamol at this visit. She also had cough, throat felt like razor blades and sore throat. Her doctor advised that what she had was viral and was treated with ibuprofen and paracetamol. On 13-Oct-2016, the patient went back to the doctor for strep test, mouthwash with lidocaine and albuterol inhaler. The patient was off work on October 12, 13, 14, 15, 16 and 17. On 21-Oct-2016, the patient went back to the doctor. Her lungs got wheezy and was not coughing up anything. She was given an inhaler, doxycycline and prednisone. She had four doses of doxycycline and 3 doses of prednisone. Reporter's assessment: The reporter felt like all of this was due to the shot because that was when it all started. Follow-up information received 04-Nov-2016: The healthcare professional reported the patient as non-pregnant. Weight: 168 pounds (76.2 kg), height: 5.5 inches (165.1 cm). Medical history includes partial transverse myelitis in 2009 and last period on 26-Oct. Concomitant medication: multivitamin (dose: 1), cyclobenzaprine, fluticasone (2 sprays) and cetirizine. On 06-Oct following vaccination, the patient experienced a reaction to the flu shot (outcome: unknown, stop date: unknown). On 31-Oct following vaccination, the patient saw a neurologist; confirms partial transverse myelitis symptoms have returned (outcome: unknown, associated symptoms: tingling feelings in legs, weak feelings in legs). The patient is to see the neurologist again in 6 weeks. Treatment: No treatment available for transverse myelitis symptoms. MD (medical doctor) follow-up. Reporter comments: The healthcare professional considered the event of partial transverse myelitis symptoms recurred as serious (other important medical event) and classified the events as occupational exposure.  The healthcare professional stated that the neurologist confirms partial transverse myelitis symptoms have returned due to immune response after vaccine. Sender's Comments: Company comments: Listedness: Assessment according to the CCDS for CSL's Inactivated Influenza Virus Vaccine, pyrexia, injection site pain, paraesthesia, oropharyngeal pain are listed.  Viral infection, Transverse myelitis, Cough, throat irritation,, wheezing, impaired work ability, muscle weakness, pain, adverse reaction are unlisted. Assessment according to the Afluria PI, CSL's Transverse myelitis, cough, pyrexia, injection site pain, paraesthesia, oropharyngeal pain are listed.  All other events are unlisted. Causality: Related. Time to onset is the same day of vaccine administration for injection site pain and other systemic events such as pain, fever and paraesthesia. In addition, events of cough, sore throat can also follow influenza vaccination hence causality is considered possibly related. Concomitant medication of "fluticasone" is suggestive of history of asthma. The events of wheezing, cough with onset of ongoing 1-2 weeks later is suggestive of new onset respiratory infection (viral or bacterial) infection complicated with asthma requiring treatment with antibiotics and prednisone. Causality for the event of viral illness is considered unrelated to vaccination. Paraesthesia and limb weakness alone are insufficient to confirm a diagnosis of Transverse myelitis; there is insufficient information such as demonstration of neurological deficit by clinical examination, demonstration of CNS lesion by radiological investigation and or CSF finding, hence causality for the event of transverse myelitis is considered unassessable.