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Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes
Write-up: This is a spontaneous case, reported by a physician to Regulatory Authority (regulatory reference number: IT-MINISAL02-513213) and initially retrieved on 27-Nov-2018, concerning an 87-year-old, elderly male patient of body weight 72 kg and height 171 cm. On 16-Nov-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml (frequency reported as 1DF), route of administration: intramuscular, batch number: 251225C1A, expiry date: 30-Jun-2019 and anatomical location: not reported]. On 18-Nov-2018, 2 days after vaccination, the patient was diagnosed with Guillain Barre syndrome (GBS). On 23-Nov-2018, electromyogram was performed but the results were not reported. On an unspecified date, lab tests (unspecified) were performed, and the results were not reported. On 30-Nov-2018, the patient died and the cause of death was unknown. It was unknown whether autopsy was performed. The patient had not recovered from the event GBS, at the time of death. The reporter assessed this case as serious (life threatening) and the causality as related to suspect vaccine. Follow-up reported by a physician and retrieved from Regulatory Authority (regulatory reference number: IT-MINISAL02-513213) on 10-Dec-2018: The date of vaccination (16-Nov-2018), batch number (251225C1A) and expiry date (30-Jun-2018) were added. It was reported that patient underwent unspecified lab tests. The patient died on 30-Nov-2018. Added new event ''death''. The narrative was amended accordingly. Case Comment: A 87-year-old male patient was diagnosed with Guillain Barre syndrome (GBS), 2 days after receipt of FLUAD (TIV). The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. It was reported that patient died, 14 days post vaccination. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event GBS as possibly related to suspect vaccine. Due to lack of information regarding, cause of death, diagnoses/symptoms leading to death, medical history of the patient at the time of vaccination, the causality of event death is unassessable. Progressive age of the patient with the event GBS (outcome not recovered) is considered as a risk factor for the event death. The company assessed the event (Guillain Barre syndrome) as serious (medically significant).
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