Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic immune activation, Thyroid function test, White blood cell count
Clinical narrative: T cell dysfunction; She then had a severe immune overactivation following the first dose of the Pfizer-BioNTech COVID-19 vaccine/ This was accompanied by development of marked total body tender lymphadenopathy; aggravating her Long COVID symptoms; aggravating her Long COVID symptoms; This is a literature report.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "symptomatic acute COVID-19 infection", start date: 23Nov2020 (not ongoing), notes: recovered at home over 2 weeks; "Long COVID" (ongoing); "suddenly passing out" (unspecified if ongoing); "sleeping for hours after eating" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: SYSTEMIC IMMUNE ACTIVATION (medically significant) with onset 23Apr2021, outcome "recovering", described as "She then had a severe immune overactivation following the first dose of the Pfizer-BioNTech COVID-19 vaccine/ This was accompanied by development of marked total body tender lymphadenopathy"; POST-ACUTE COVID-19 SYNDROME (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 23Apr2021, outcome "recovering" and all described as "aggravating her Long COVID symptoms"; IMMUNE SYSTEM DISORDER (medically significant), outcome "recovering", described as "T cell dysfunction". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (unspecified date) subsequently decreased, notes: while on inhalation therapy; (29Jun2022) Elevated, notes: from acute COVID-19 infection; Alanine aminotransferase (normal high range 40): (unspecified date) 0 IU/l, notes: Center; (unspecified date) 75 IU/l, notes: Vertex; Antibody test: (unspecified date) high; Aspartate aminotransferase (normal high range 35): (unspecified date) 0 IU/l, notes: Center; (unspecified date) 40 IU/l, notes: Vertex; Blood albumin (normal high range 5.5): (unspecified date) 0 g/dl, notes: Center; (unspecified date) 6.0 g/dl, notes: Vertex; Blood alkaline phosphatase: (unspecified date) subsequently decreased, notes: while on inhalation therapy; (29Jun2022) Elevated, notes: from acute COVID-19 infection; Blood alkaline phosphatase (normal high range 147): (unspecified date) 0 IU/l, notes: Center; (unspecified date) 260 IU/l, notes: Vertex; Blood creatinine (normal high range 1.3): (unspecified date) 0 mg/dl, notes: Center; (unspecified date) 2.0 mg/dl, notes: Vertex; Blood immunoglobulin M: (unspecified date) positive, notes: IgM positive for EBV VCA and CMV; Blood urea (normal high range 25): (unspecified date) 0 mg/dl, notes: Center; (unspecified date) 30 mg/dl, notes: Vertex; CD8 lymphocytes: (05May2021) extremely dysfunctional, notes: producing essentially no IFN? or TNFa upon stimulation; (22Feb2022) improvement in CD8 T cell dysfunction; Cell marker: (unspecified date) went from levels below detection pre-treatment to, notes: 15+/- 6% post-treatment; (unspecified date) sustained increase; Full blood count: (unspecified date) remains normal, notes: following 15 months of continuous nebulized treatment; severity scores (0-10): (03Mar2021) 8/10, notes: for overall symptom severity and for the individual symptoms of dysnomia, low grade fever, cough, and sore throat; (03Mar2021) 10/10, notes: for difficulty concentrating, chills, lymph nodes, gastrointestinal symptoms, muscle and joint pain; (03Mar2021) between 3 and 5, notes: headaches, PEM, postural hypotension and sleep difficulty symptom severity scores; (23Apr2021) increased from her Long COVID baseline of 8-10., notes: for overall symptom severity; (23Apr2021) 6-8, notes: headaches, PEM, postural hypotension and sleep difficulty severity scores increased; (23Apr2021) her joint pain declining from 10 to 3; (23Apr2021) muscle tightness decreased from 10 to 3; (23Apr2021) brain fog decreased (from 9 to 2); (23Apr2021) headaches (from intermittent daily to, notes: infrequent and mild/manageable); (26May2021) decreased from 10-5, notes: joint and muscle pain severity (Day 21 on treatment); (26May2021) decreased from 10 to 5, notes: muscle tightness severity (Day 21 on treatment); (26May2021) decreased from 9 to 4, notes: brain fog severity (Day 21 on treatment); (26May2021) headaches decreased from intermittent daily to, notes: infrequent and mild/manageable (Day 21 on treatment); (04Jul2021) fatigue decreasing from 8 to 2; Liver function test: (unspecified date) slightly elevated by the acute COVID infection; (unspecified date) remains normal, notes: following 15 months of continuous nebulized treatment; Platelet count (normal high range 450.0): (unspecified date) 0 x10 3/mm3, notes: Center; (unspecified date) 500.0 x10 3/mm3, notes: Vertex; Red blood cell count (normal high range 5.40): (unspecified date) 0 10*6/uL, notes: Center; (unspecified date) 7.50 10*6/uL, notes: Vertex; Renal function test: (unspecified date) normal, notes: following 15 months of continuous nebulized treatment; Serology test: (unspecified date) showed that following the first COVID vaccine,, notes: patient did develop good neutralizing antibody responses to SARS-CoV-2; (unspecified date) 1428, notes: For VZV: Varicella-zoster virus, IgG; (unspecified date) Less than 90, notes: HSV2 (herpes simplex virus) IgG; (unspecified date) Less than 90, notes: HSV1 (herpes simplex virus) IgG; (unspecified date) greater than 750, notes: EBV (Epstein Barr virus) IgG VCA; (unspecified date) 63.3, notes: EBV (Epstein Barr virus) IgM VCA; (unspecified date) greater than 600, notes: EBV (Epstein Barr virus) EBNA (EBV nuclear antigen) IgG; (unspecified date) greater than 150, notes: EBV (Epstein Barr virus) EA IgG; (unspecified date) Less than 1:20, notes: HHV6 (Human herpesvirus 6) IgM; (unspecified date) 1:160, notes: HHV6 (Human herpesvirus 6) IgG; (unspecified date) 31.2, notes: CMV (Cytomegalovirus) IgM; (unspecified date) greater than 10, notes: CMV (Cytomegalovirus) IgG; (unspecified date) HHV6 and VZV IgG titers were also elevated; (Jan2022) tested for reactivation of her herpesviruses; Thyroid function test: (unspecified date) remains normal, notes: following 15 months of continuous nebulized treatment; White blood cell count (normal high range 10.5): (unspecified date) 0 x10 3/mm3, notes: Center; (unspecified date) 15.0 x10 3/mm3, notes: Vertex. Therapeutic measures were taken as a result of systemic immune activation, post-acute covid-19 syndrome, condition aggravated.  Clinical course: This case involves a 61- year-old female who was healthy until she suffered symptomatic acute COVID-19 infection on November 23, 2020, with severe fatigue, chills, cough, headache, laryngitis, loss of smell and extreme muscle and joint pain. She recovered at home over 2 weeks, but within 4 weeks after acute COVID she developed symptoms of Long COVID with ongoing severe fatigue, brain fog, post exertional malaise, headache, laryngitis, feeling freezing cold, and extreme muscle and joint pain, increased bruising and difficulty walking and suddenly passing out and sleeping for hours after eating, like the clinical phenomena described for ME patient 1. She was a fully self-employed professional who was unable to work and support herself after the acute COVID-19 infection. In 3/3/21 her severity scores for overall symptom severity and for the individual symptoms of dysnomia, low grade fever, cough, and sore throat were 8/ 10; her severity scores for difficulty concentrating, chills, lymph nodes, gastrointestinal symptoms, muscle and joint pain were 10/10; and her headaches, PEM, postural hypotension and sleep difficulty symptom severity scores were between 3 and 5. She then had a severe immune overactivation following the first dose of the Pfizer-BioNTech COVID-19 vaccine on April 23, 2021, further aggravating her Long COVID symptoms. This was accompanied by development of marked total body tender lymphadenopathy, very similar to ME patient 1. It is thought that immune overactivation like that described above can lead to T-cell dysfunction as discussed earlier. Her overall symptom severity score increased from her Long COVID baseline of 810. Her headaches, PEM, postural hypotension and sleep difficulty severity scores increased to 68. At this time, 12 days after receiving the SARS-CoV-2 vaccine, her CD8 T-cells were extremely dysfunctional producing essentially no IFN? or TNFa upon stimulation. Twelve days (5/5/21) after the vaccine she started the nebulized therapy. Within 1½ hours of the first dose, she had a dramatic decrease in many of her severe symptoms including brain fog, headache, wobbly walk and her laryngitis. Most of her other symptoms gradually improved over the next few weeks, including passing out after eating, and the severe cold feeling. On May 26, 2021 (Day 21 on treatment) the patient reported that her joint and muscle pain severity had decreased from 10 to 5; muscle tightness had decreased from 10 to 5; brain fog decreased from 9 to 4, and headaches decreased from intermittent daily to infrequent and mild/manageable. She was able to resume some work, such as client meetings within two weeks of starting the nebulized treatment.  No follow-up attempts are possible.; Sender's Comments: Based on the available information and implied temporal association, a causal relationship between the reported events Systemic immune activation, Post-acute COVID-19 syndrome, Condition aggravated, Immune system disorder and suspect product BNT162b2 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-PV202400022994 Same article/ drug and different patient/event;