Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Liver function test, Magnetic resonance imaging, Platelet count, Polymerase chain reaction, Red blood cell count
Clinical narrative: This fourth recent severe episode began following the first dose of the Pfizer-BioNTech COVID-19 vaccine; This is a literature report for the following literature source(s).  A 69-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "ME/CFS", start date: Apr1974 (unspecified if ongoing); "ME/CFS", start date: Apr1974 (unspecified if ongoing), notes: diagnosed 47 years previously, with 3 severe episodes of ME/CFS during her lifetime after viral infections (April 1974, March 1984, April 1996; "exacerbations" (unspecified if ongoing); "ME/CFS", start date: Mar1984 (unspecified if ongoing); "ME/CFS", start date: Apr1996 (unspecified if ongoing); "ME/CFS", start date: Mar1984 (unspecified if ongoing); "ME/CFS", start date: Apr1996 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetanus, administration date: 2009, for exacerbations; Influenza, administration date: 2014, for exacerbations. The following information was reported: CHRONIC FATIGUE SYNDROME (medically significant) with onset 24Apr2021, outcome "recovering", described as "This fourth recent severe episode began following the first dose of the Pfizer-BioNTech COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 40): 75 ug/L, notes: Vertex; 0 ug/L, notes: Center; Aspartate aminotransferase (normal high range 35): 40 ug/L; 0 ug/L, notes: Center; Blood albumin (normal high range 5.5): 6 g/dl, notes: Vertex; 0 g/dl, notes: Center; Blood alkaline phosphatase (normal high range 147): 260 ug/L, notes: Vertex; 0 ug/L, notes: Center; Blood creatinine (normal high range 1.3): 2 mg/dl, notes: Vertex; 0 mg/dl, notes: Center; Blood urea (normal high range 25): 30 mg/dl, notes: Vertex; 0 mg/dl, notes: Center; Full blood count: remained normal, notes: following 15 months of continuous treatment with the nebulized agent described here; Immunology test: SARS-CoV-2 spike protein but had no evidence of ne; she had no SARS-CoV-2, notes: capsid antibodies by ELISA; severity score: 10/10; 10/10, notes: scored PEM, lymph nodes, sleep problems, headaches difficulty concentrating and dysnomia (difficulty retrieving words) at 10/10 in severity; Liver function test: remained normal, notes: following 15 months of continuous treatment with the nebulized agent described here; Magnetic resonance imaging: studies showed multiple neuro-inflammatory lesions, notes: bilaterally in the subcortical regions of her brain; Platelet count (normal high range 450): 500 x10 3/mm3, notes: Vertex; 0 x10 3/mm3, notes: Center; Polymerase chain reaction: Negative; Red blood cell count (normal high range 5.40): 7.50 10*6/uL, notes: Vertex; 0 10*6/uL, notes: Center; Renal function test: remained normal, notes: following 15 months of continuous treatment with the nebulized agent described here; Serology test: showed that following the first COVID vaccine, notes: ME/CFS patient ME patient 1 did develop antibodies by ELISA to the SARS-CoV-2 spike protein but had no evidence of neutralizing antibody; 598, notes: For VZV IgG AB; 4.85, notes: HSV1 IgG; 726, notes: EBV IgG VCA; More than 36, notes: EBV IgM VCA; Less than 600, notes: EBV EBNA IgG; Not detected, notes: HHV6 IgG; Not detected, notes: CMV IgG; Not detected, notes: HSV2 IgG; Thyroid function test: remained normal, notes: following 15 months of continuous treatment with the nebulized agent described here; White blood cell count (normal high range 10.5): 15 /mm3, notes: Vertex; 0 /mm3, notes: Center. Therapeutic measures were taken as a result of chronic fatigue syndrome.  Clinical course: Reported as, ME/CFS patient improves on a nebulized antioxidant/ anti-pathogen agent after relapsing into fourth severe episode of ME/CFS. At presentation, ME/CFS patient, ME patient 1, was a 69-year-old female with ME/CFS diagnosed 47 years previously, with 3 severe episodes of ME/CFS during her lifetime after viral infections (April 1974, March 1984, April 1996). This fourth recent severe episode began following the first dose of the Pfizer-BioNTech COVID-19 vaccine on April 24, 2021. ME patient 1 previously had significant exacerbations often for 2-4 months of her ME/CFS symptoms following vaccines such as tetanus (2009) and influenza (2014), after which she decided not to take any more vaccines. However, she decided because of the severity of acute COVID-19 disease and as a requirement of her employment to take the first dose of vaccine, with devastating consequences. She has no other major medical problems. ME patient 1 was highly functional working full time as a professional by following a very strict protocol of supplements and pacing. Her self-reported overall severity score for her ME/CFS symptoms prior to vaccination was 2 (Fig. 3A). Similar to our data in ME/CFS patients, her immunological profile showed CD8 T-cell dysfunction as seen in the representative FACS plot (Fig. S1B) and in the mean of 3 different time points taken over 3 years with only 2.3 ± 0.7% (n = 3) of her CD8 T-cells producing IFN? and 0.01 ± 0.01% (n = 3) producing TNFa upon PMA stimulation compared to 34 ± 10.9% and 25.5 ± 2.8%, respectively, the mean observed of three different time points over 2 years in a healthy individual (HC 1) (Fig. 4, Fig. S1A representative FACS plot). This >90% reduction in cytokine production illustrates the profound dysfunction of her CD8 T-cells. Within 48 h after the SARS-CoV-2 vaccine her left arm was extremely sore and swollen (where she received the vaccine), with biceps muscle fasciculations, and left axillary adenopathy. Within one week she had massive total body extremely tender lymphadenopathy (10+), muscle and joint pain, increased bruising and bilateral conjunctivitis, a splitting headache worsened by positioning her head downwards, extreme fatigue and PEM, sleeping most of the time, and narcolepsy following eating. She progressively worsened such that by day 10 post vaccine (5/ 4/21) she felt like she was in a cytokine storm, barely able to speak because of brain fog and word retrieval problems, wobbly with a wide-based gait, as she was not certain of her footing and her head began bobbing much like a patient with Parkinson's Disease. At this time, the patient self-reported an overall severity score of 10/10. She also scored PEM, lymph nodes, sleep problems, headaches, difficulty concentrating and dysnomia (difficulty retrieving words) at 10/10 in severity. Instead of calling an ambulance she start a nebulized antioxidant/anti-pathogen agent. Within 1½ hours of her first nebulizer treatment most of her very severe symptoms decreased (headache, brain fog, difficulty walking, head bobbing and passing out after eating), and she felt some increase in energy. This improvement was such that she did not need hospitalization and she was able to function well enough that she could just care for herself while living alone.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug and event chronic fatigue syndrome cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400044359 Same article/ drug and different patient/event;