Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Blood immunoglobulin M decreased, Condition aggravated, Lymphocyte count, Subcutaneous abscess
Clinical narrative: FDA: PRELIMINARY IMMUNOPATHOLOGY INFORMATION CONSIDERATION: POSSIBLE COVID VACCINE CAUSATIVE AGENT FOR COMPLEX IMMUNOPATHY (submitted by retired pediatrician patient) IMMUNOPATHIES: SEVERE IgM DEFICIENCY SEVERE LYPHOCYTIC LEUKOPENIA NON-RESPONSE TO PNEUMOCOCCAL VACCINE LARGE KLEBSIELLA PNEMONIA CUTANEOUS ABSCESS IgM DEFICIENCY In January and February 2021, I received two doses of Pfizer Covid vaccine. In May 2021, during a neurological work-up for peripheral neuropathy, serum studies revealed the IgM level of 30 mg/dL (laboratory normal 60 ? 263), [IgM level in February 1987 was 127 with normal being 60-310]. In September 2021 the IgM level was 26 and I received the third dose of Pfizer Covid vaccine. In early January 2022 IgM level had fallen to 15, rising to 26 later that month. In April 2022, the IgM level was 24. The fourth dose of vaccine was administered in July. IgM levels markedly declined from April to below laboratory detectable levels (less than 12 mg/dL) in October. In January 2023, following an untreated home-identified Covid infection, no response to IgM levels was detected. IgM levels continued to be undetected (less than 12) which was confirmed at the University in March 2023 with a level of 8. In June 2023, IgM level became detectable at 15; however, in September the level was again undetectable. The last IgM obtained in December 2023 was detected at 21. LYMPHOCYTIC LEUKOPENIA The absolute lymphocyte count in November 2021 was 1.09 X 103 (normal 1.2 -3.4 X 103) and persisted in that general range with a count of 0.98 in July 2022. The fourth dose of Pfizer Covid vaccine was administered in July 2022. The following month of August the absolute lymphocyte count dropped by 50% to 0.48, followed in September by further reduction to 0.30 (lowest recorded count). The absolute lymphocyte count has increased to 0.64 in May 2023 and 0.068 in September 2023. The last determination in January 2024 was 0.60. NON-RESPONSE TO PNEUMOCOCCAL VACCINE As part of an immunological work-up by a local immunologist, pneumococcal vaccine was administered in January 2023 with both pre- and post-vaccine antibodies being obtained. No response was detected. An immunologist at University confirmed the lack of response to the vaccine. ABNORMAL BACTERIAL CUTANEOU ABSCESS In July 2023, following a dermatologist punch biopsy on my lateral iliac crest, an abscess developed with two cultures being non-diagnostic and treatment consisted of two anti-gram positive antibiotics. Upon surgical prep, unroofing of the abscess, and swab culture taken at the abscess base, the culture revealed a single organism, heavy growth of Klebsiella pneumoniae which responded to Bactrim and Neomycin topical cream. This incident is the only known expression of my immunodeficiencies. QUESTIONS Should I receive any further Covid vaccines? Pfizer? Should I receive other viral vaccine (H. zoster, RSV)? Influenza vaccine was administered in the fall of 2023 without any apparent clinical complications; however, its effectiveness is unknown. Should I receive any further bacterial vaccines (DPT, pneumococcal) in view of the documented non-response? In the 1960's and 1970's, measles vaccine would not be administered to children around 15 months of age until a negative tuberculosis (Tbc) test {Tine test} was performed with the accepted belief that the response to the measles vaccine would render the Tbc test non-responsive in an individual with previous infection with Tbc. Could my present condition be a similar post viral vaccine expression? I am willing to undergo any further evaluation including receiving all of the above listed vaccines to provide clinical clarification of my condition, fully realizing that restorative treatment is unlikely and may place me at risk of undesirable outcomes. If FDA cannot be involved in further work-up, could the FDA recommend (refer) an inte