Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chronic fatigue syndrome, Feeling abnormal, Fibromyalgia, Gliosis, Headache
Clinical narrative: Abnormal kidney function; Hashimoto Disease; Migraine; Infections; Inflammatory reactions; C7 radiculopathy; Nerve damage; Tricep damage; Benign nodule in left eye and on thyroid; Begin nodule in left eye and on thyroid; Fibromyalgia; This vaccine had ruined his nursing career/he is applying for disability; Reactivated virus in central nervous system; Post ischemic gliosis; Felt bad that night; This spontaneous case was received on 19-Feb-2021 from other health professional (nurse) via Agency (reference number: SEQW21-00609) and concerned a 49-year-old male patient.  The patient's relevant medical history and patient's concomitant medications were not reported.  On 11-Oct-2018, the patient was vaccinated with Afluria (TIV) (influenza vaccine, dose, route of administration, indication and anatomical location: not reported). The batch number reported was YT38207B, expiry date: 30-Jun-2019.   On the same day, that night after receiving Afluria (TIV), the patient felt bad.  On 12-Oct-2018, the patient recovered from event of feeling bad.   On an unspecified day in Oct-2018, reported as the following week, the patient woke up with terrible headache. He went to Urgent Care and was sent to the emergency room. The patient was diagnosed with migraine.    On an unspecified day in Oct-2018, the patient started having infections, inflammatory reactions, abnormal kidney function, Hashimoto Disease, cervical (C)7 radiculopathy, nerve damage, triceps damage, multiple T2 hypersensitivity related to MRI, the benign of nodule in left eye and on thyroid, fibromyalgia, chronic fatigue syndrome, short term memory issues and increased CSF protein.  On 26-Oct-2018, the patient was hospitalised, but no further details were provided.   On 27-Oct-2018, the patient was discharged from hospital.   On an unspecified day in Jan-2020, reported as last January, the patient was diagnosed with post ischemic gliosis on the brain. The patient saw multiple physicians.   On an unspecified date, reported as now, the patient had reactivated virus in central nervous system.   On an unspecified date, the vaccine ruined the patient's nursing career and he was applying for disability and looking into compensation fund.  At the time of initial reporting on 19-Feb-2021, the patient did not recover from the events.  The reporter assessed all events as related. He stated that Vaccine Adverse Event Reporting System (VAERS) reported 18 reactions from this lot number and he would like to know if we have performed any quality check (QC). He stated we have immunity from prosecution, and he was sure we do not perform the QC. The vaccine had ruined his nursing career and he was applying for disability and looking into Program for funds. The patient read online that there were bad adverse reactions to squalene.  The events of migraine, 'infection', 'inflammatory reaction', 'cervical radiculopathy', nerve damage, 'muscle damage', 'benign thyroid nodule', 'nodule' and 'fibromyalgia' were assessed as serious due to the criterion of hospitalization. The events of 'function kidney abnormal' and 'Hashimoto's disease' were assessed as serious due to the criterion of hospitalization and medical significance. The event of 'impaired work ability' was assessed as serious due to criterion of disability.  Company Comment: A 49-year-old male patient developed renal impairment, autoimmune thyroiditis, migraine, infection, inflammation, cervical radiculopathy, nerve injury, muscle injury, benign neoplasm of thyroid gland and nodule (both reported as benign nodule in left eye and on thyroid), fibromyalgia, impaired work ability, viral infection (reported as reactivated virus in central nervous system), gliosis (reported as post ischemic gliosis) and feeling abnormal after vaccination with the suspect product, Afluria (TIV). Chronology for the event viral infection is unassessable. Chronology for the event gliosis seems unsuggestive. All other events developed within a month, chronology is therefore assessed as plausible. Information regarding the underlying medical history and concomitant medications have not been provided. More clarification regarding the performed MRI and other related findings is needed. Due to lack of information, causality for the event viral infection is unassessable. Since information regarding the aetiology and pathohistology of benign neoplasm of thyroid gland and nodule was not reported, causality is unassessable. Causality for the events gliosis and impaired work ability is assessed as not related, due to biological implausibility. Causality for all other events cannot be totally excluded and is assessed as possibly related.; Reporter's Comments: He stated that Vaccine Adverse Event Reporting System (VAERS) reported 18 reactions from this lot number and he would like to know if we have performed any quality check (QC). He stated we have immunity from prosecution, and he was sure we do not perform the QC. The vaccine had ruined his nursing career and he was applying for disability and looking into Program for funds. The patient read online that there were bad adverse reactions to squalene.; Sender's Comments: A 49-year-old male patient developed renal impairment, autoimmune thyroiditis, migraine, infection, inflammation, cervical radiculopathy, nerve injury, muscle injury, benign neoplasm of thyroid gland and nodule (both reported as benign nodule in left eye and on thyroid), fibromyalgia, impaired work ability, viral infection (reported as reactivated virus in central nervous system), gliosis (reported as post ischemic gliosis) and feeling abnormal after vaccination with the suspect product, Afluria (TIV). Chronology for the event viral infection is unassessable. Chronology for the event gliosis seems unsuggestive. All other events developed within a month, chronology is therefore assessed as plausible. Information regarding the underlying medical history and concomitant medications have not been provided. More clarification regarding the performed MRI and other related findings is needed. Due to lack of information, causality for the event viral infection is unassessable. Since information regarding the aetiology and pathohistology of benign neoplasm of thyroid gland and nodule was not reported, causality is unassessable. Causality for the events gliosis and impaired work ability is assessed as not related, due to biological implausibility. Causality for all other events cannot be totally excluded and is assessed as possibly related.