Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood sodium normal, Burning sensation, Carbon dioxide normal, Computerised tomogram abnormal, Disturbance in attention
Clinical narrative: Allergic to polysorbate 80 which is common component in the Fluad Influenza vaccine and Pfizer Covid vaccines/Possible allergy to vaccine compound; Tightening feeling in cheekbones; Headaches; Ear pressure; Sinus pressure; Immediate BP spike to 180/110 within 15 min of injection of Pfizer vaccine/high blood pressure; Flushed feeling on neck; Some difficulty in comprehension and formulating sentences; Sinus headaches; Episodic tingling/burning sensation of whole body but mainly on both arms and both legs/generalized burning sensation/slight burning sensation through arms and legs; Tinnitus of both ears; Dizziness; Whole body paresthesias/episodic tingling/burning sensation of whole body but mainly on both arms and both legs/distal paresthesias; Myalgias; Fatigue; Head pressure; Weakness and numbness in limbs for two mounts; Decreased concentration; Sleep disturbance; Sinus pain; Body numbness/weakness and numbness in limbs for two mounts/episodic numbness; Small fiber neuropathy; Vertigo; Vertigo; Dizziness; Sinus pressure; Ear pressure; Fatigue; Headaches; This spontaneous case was received on 18-May-2021 from other non-health professional (consumer) via Pfizer with additional documents received on the same day via Med Info (reference number SEQW21-01338) from other non-health professional and concerned a 67-year-old, male patient.  The patient's concurrent conditions included essential hypertension, body mass index high (BMI 25.84), allergy to penicillin (rash), codeine (gastrointestinal upset), iodine contrast (the patient turned grey) and allergy on polysorbate 80. The patient's past medical history included diverticular disease of colon, viral pneumonia, rib fracture, chronic sinusitis. Past surgical history included tonsil and adenoid removal, umbilical hernia repair and repair incisional hernia reducible. The patient's concomitant medications included vitamin B-12 (cyanocobalamin), zinc sulfate, Lipitor (atorvastatin calcium), Benicar (olmesartan medoxomil), Retin-A (tretinoin), vitamin D3 (cholecalciferol), Cinnabar (homeopathic drugs), Ubiquinol CO Q10 (ubiquinol), Vitamin C (ascorbic acid), Cinnamon (cinnamomum verum), all used for an unreported indication. Also, the patient never smoked, and he did not use alcohol.  On 23-Nov-2020, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location, dose, route of administration and anatomical location: not reported) as an influenza prophylaxis. The batch number was not reported.  On 17-Dec-2020, 24 days after receiving Fluad (TIV), the patient became ill with headaches, ear and sinus pressure, dizziness, vertigo and fatigue.  On an unspecified date in Dec-2020, the patient was tested negative twice for covid.  On unspecified date in Dec-2020, the patient recovered from the events of 'headache', 'sensation of pressure in ear', sinus pressure, dizziness, vertigo and fatigue, reported as this condition lasted 7-10 days.  On 21-Jan-2021, at 12:15 the patient was vaccinated with non-company co-suspect, Pfizer Covid vaccine BNT162B2 (dose reported as one, anatomical location: left arm, indication and route of administration: not reported). The batch number reported was EL1284.  On the same day, at 12:30, one month and 29 days after receiving Fluad (TIV) and 15 minutes after receiveing Pfizer Covid vaccine, the patient had immediate blood pressure (BP) spike to 180/110 within 15 min of injection of Pfizer vaccine, headaches, ear pressure, sinus pressure, flushed feeling on neck, tightening feeling in cheek bones .  On the same day, after receiveing Pfizer Covid vaccine and one month and 29 days after receiving Fluad (TIV), the patient also developed continued and moderate sinus headache, dizziness, some difficulty in comprehension and formulating sentences, tinnitus of both ears, and slight burning sensation of whole body but mainly on both arms and both legs which aggravated to moderate that comes and goes lasting for minutes to hours but typically improving when he rests.  On an unspecified date in 2021, unknown amount of time after receiving Fluad (TIV) and co-suspect Pfizer Covid vaccine, the patient had review of systems and was positive for fatigue, sinus pressure, sinus pain, tinnitus, ear pressure, myalgias, generalized burning sensation, headaches, decreased concentration and sleep disturbance. The patient had physical exam which showed BP at 146/83 and pulse at 87, general exam showed no active lesions, no neurocutaneous lesions. Head exam was normocephalic. Mental status was  alert and oriented, appropriately interactive with normal higher cortical functions. Speech was without dysarthria or dysphagia. Cranial nerves were normal II to XII without ptosis or nystagmus. Gait/station/coordination exam showed no truncal or limb ataxia, no gait disorder. Motor exam showed no involuntary movements. Sensory exam showed no change in sensation to pressure (PP), light touch (LT), temperature or vibration. The patient had tenderness on the skull behind the left ear. The patient received corrective treatment however further details were not provided. The patient visited an allergist due to possible allergy to vaccine compound. The patient denied any other medical problems or history of neurological disease. The patient was treated by cardiologist, neurologist and allergist.   On 23-Feb-2021, magnetic resonance imaging (MRI) brain was unremarkable and revealed no evidence of parenchymal haemorrhage, of an intracranial mass or extra-axial fluid collection, normal calibre and morphology of ventricles. Also, the visualized paranasal sinuses and mastoid cells were clear, the orbits and extracranial soft tissues were unremarkable.  On 01-Mar-2021, the patient had allergy testing done during which he had severe anaphylactic reaction that required epinephrine injection and ever since he had rash and itching. Immediate hypersensitivity skin testing to inhalant allergens was positive to mold, tree pollen and weed pollen.  On 03-Mar-2021, the patient presented for follow up, his body numbness improved. The tinnitus was ongoing, but the headaches were better, although he still feels the headache on the back of the head and behind the left ear which is tender to touch. Computerised tomogram (CT) of sinus revealed very mild paranasal sinus disease, no air-fluid levels, there was severe nasal septal deviation to the right, nasal passageways remained patent, the ostiomeatal complexes were patent bilaterally.   On 09-Apr-2021, electromyogram (EMG) revealed that the electrophysiologic study of right upper and lower extremities was normal with no evidence of a polyneuropathy, myopathy or common mononeuropathy, the absent right H-reflex response on its own is of no specific electrodiagnostic significance, but may be a very early findings of a right S1 lumbar radiculopathy. Also, sensory and motor nerve conduction studies of right upper and lower extremities were performed with normal results. As reported, reason for this study was weakness and numbness in limbs lasted for two months. On the same day, metabolic panel revealed protein total at 8.6 g/dL (6.3-8.0), albumin at 5.2 g/dL (3.9-4.9) and glucose at 99 mg/dL (74-99). Also, complete blood count (CBC) with differential and metabolic panel, which included creatinine, sodium, potassium, chloride, carbon dioxide (CO2) and anion gap were within normal reference range.  On 14-Apr-2021, the patient presented for follow up and he still had burning sensation on all four limbs, worse distally which got better for two days when he stopped taking Lipitor (atorvastatin calcium) but restarted again. After normal EMG testing, small fiber neuropathy was suspected with low suspicion. Further serum testing and autonomic testing was required to rule out small fiber neuropathy, however further details were not provided.   On an unspecified date in 2021, the patient had recovered from the events of 'vertigo', ''word finding difficulty' and 'tinnitus'.  At the time of initial reporting on 18-May-2021, the patent had not recovered from the events of sinus headache, 'burning sensation', 'sensation of pressure in ear' and dizziness. The patient was recovering from the events of 'numbness', 'blood pressure high' and 'headache'.  The outcome of the events of small fiber neuropathy, 'allergy to vaccine', 'attention concentration difficulty', 'sleep disturbance', sinus pain, sinus pressure, 'flushed', 'weakness of limbs', 'tingling sensation', 'myalgia', 'muscular tightness', 'head pressure' and fatigue was not reported.  The reporter did not provide causality assessment.  Company comment: A 67-year-old, male patient was vaccinated with Fluad (TIV). 24 days after receiving Fluad (TIV), the patient became ill with headaches, ear and sinus pressure, dizziness, vertigo and fatigue. After 7-10 days, the patient recovered from these events. Based on unsuggestive time relationship, causality for these events is assessed as not related. On 21-Jan-2021 two months after vaccination with suspect product, the patient was vaccinated with non-company co-suspect Pfizer Covid vaccine. On the same day after vaccination with co-suspect vaccine the patient had immediate blood pressure (BP) spike to 180/110 within 15 min of injection of Pfizer vaccine, headaches, ear pressure, sinus pressure, flushed feeling on neck, tightening feeling in cheek bones. On the same day after vaccination with co-suspect vaccine, the patient developed continued and moderate sinus headache, dizziness, some difficulty in comprehension and formulating sentences, tinnitus of both ears, and slight burning sensation of whole body. An unknown amount of time after receiving Fluad (TIV) and co-suspect Pfizer Covid vaccine, the patient had review of systems and was positive for fatigue, sinus pressure, sinus pain, tinnitus, ear pressure, myalgias, generalized burning sensation, headaches, decreased concentration and sleep disturbance. Computerised tomogram (CT) of sinus revealed very mild paranasal sinus disease. Nearly four months after vaccination with suspect product, the patient underwent electromyogram (EMG) due to weakness and numbness in limbs which lasted for two months. After normal EMG testing, small fiber neuropathy was suspected with low suspicion. Advanced age may have contributed to the development of the events. As reported the patient had an allergy on polysorbate 80. Causality for the event allergy to vaccine is assessed as possibly related. Causality for all other events is assessed as unrelated, due to chronological implausibility and significant confounding factor (co-suspect Pfizer Covid vaccine).; Sender's Comments: A 67-year-old, male patient was vaccinated with Fluad (TIV). 24 days after receiving Fluad (TIV), the patient became ill with headaches, ear and sinus pressure, dizziness, vertigo and fatigue. After 7-10 days, the patient recovered from these events. Based on unsuggestive time relationship, causality for these events is assessed as not related. On 21-Jan-2021 two months after vaccination with suspect product, the patient was vaccinated with non-company co-suspect Pfizer Covid vaccine. On the same day after vaccination with co-suspect vaccine the patient had immediate blood pressure (BP) spike to 180/110 within 15 min of injection of Pfizer vaccine, headaches, ear pressure, sinus pressure, flushed feeling on neck, tightening feeling in cheek bones. On the same day after vaccination with co-suspect vaccine, the patient developed continued and moderate sinus headache, dizziness, some difficulty in comprehension and formulating sentences, tinnitus of both ears, and slight burning sensation of whole body. An unknown amount of time after receiving Fluad (TIV) and co-suspect Pfizer Covid vaccine, the patient had review of systems and was positive for fatigue, sinus pressure, sinus pain, tinnitus, ear pressure, myalgias, generalized burning sensation, headaches, decreased concentration and sleep disturbance. Computerised tomogram (CT) of sinus revealed very mild paranasal sinus disease. Nearly four months after vaccination with suspect product, the patient underwent electromyogram (EMG) due to weakness and numbness in limbs which lasted for two months. After normal EMG testing, small fiber neuropathy was suspected with low suspicion. Advanced age may have contributed to the development of the events. As reported the patient had an allergy on polysorbate 80. Causality for the event allergy to vaccine is assessed as possibly related. Causality for all other events is assessed as unrelated, due to chronological implausibility and significant confounding factor (co-suspect Pfizer Covid vaccine).