Age: 32.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age, Spinal X-ray normal
Clinical narrative: This spontaneous case, reported by other non health care professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 719711), concerns a 32-year-old, adult, female patient. The patient's current condition included postural orthostatic tachycardia syndrome (POTS), constipation and hypertension (since an unspecified date). The patient had no allergies. The concomitant medications included FLEXERIL, BYSTOLIC, Senna, Aspirin and melatonin (since an unspecified date). On 13-Oct-2016, the patient (under age of 65 years) was administered with FLUAD (TIV) (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration) for an unknown indication. On 14-Oct-2016, after 1 day of vaccination, the patient experienced tingling in both legs and feet. On 17-Oct-2016, the patient went to PCP (primary care physician) due to tingling. The patient had back X-ray which found negative to rule out back problems. Then the patient had physical therapy. It was reported that the physical therapy did not help the patient. On 30-Oct-2016, the patient's arms also started tingling. On 17-Nov-2016, the patient was consulted by the neurologist who sent her to ER (emergency department) for lumbar puncture and was admitted for 5 days. On an unknown date, the patient was diagnosed with Guillain Barre Syndrome and neuropathy. The patient received IVIG (immunoglobulin) therapy as treatment for the events. At the time of the report, the patient had not recovered from the event (Guillain Barre syndrome). The reporter assessed the case as non-serious because the diagnosis could not be verified. Follow up received from other health professional on 19-Feb-2019: The reporter's information were added in the general tab. The new event 'inappropriate age at vaccine administration' was added in the event tab. The reporter assessed the case as non-serious since the diagnosis could not be verified. The case level outcome was changed from not recovered to unknown. The narrative was amended accordingly. Reporter's Comments: A 32-year-old female patient with postural orthostatic tachycardia syndrome (POTS) syndrome and hypertension experienced Guillain Barre Syndrome (GBS) symptoms, one day after receiving FLUAD TIV (considered as inappropriate age at vaccine administration), and hospitalization for same, more than one month after vaccination. This case meets level 4 of Brighton collaboration case definition for GBS. Considering clinical course of the event and the plausible time to onset after vaccination, the causal role of suspect vaccine cannot be ruled out. Hence, the company assessed the causality as possibly related. Considering the minimal information regarding the clinical examination findings, investigations results supporting diagnosis and ruling out alternate etiologies, the case will be reassessed upon receipt of new information. The event inappropriate age at vaccine administration assessed as not related to suspect vaccine considering the accidental nature of the event (medication error). The company assessed the event as Guillain Barre syndrome (medically significant).