Report #2896309

Overview

Sex

Female

Age

Age unknown

State

NY

Recovered

Recovered

Vaccinated

—

Onset

Jun 1, 2021

Days to onset

—

Hospital days

—

Symptoms (7)

Symptom narrative

developed COVID-19 infection despite vaccination; developed COVID-19 infection despite vaccination; flare-up of joint pain; flare-up of joint pain; This is a literature report for the following literature source(s). A 67-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic Lyme disease", start date: 2010 (unspecified if ongoing); "post-treatment Lyme disease syndrome", start date: 2010 (unspecified if ongoing); "joint pain with inflammation", start date: 2010 (unspecified if ongoing); "mild cognitive impairment" (unspecified if ongoing); "several embedded tick bites", start date: 2010 (unspecified if ongoing), notes: several embedded tick bites; "chronic fatigue" (unspecified if ongoing), notes: She complained of a several year history; "migratory joint pain in her knees" (unspecified if ongoing), notes: migratory joint pain in her knees; "occasionally in the hips" (unspecified if ongoing), notes: occasionally in the hips, pelvis, shoulders and heels,; "intermittent night sweats" (unspecified if ongoing), notes: intermittent night sweats; "intermittent neuropathic symptoms in her toes" (unspecified if ongoing); "joint pain with inflammation" (unspecified if ongoing); "peripheral inflammation" (unspecified if ongoing); "Knee pain" (unspecified if ongoing); "status post motor vehicle accident" (unspecified if ongoing); "Heberden's nodules consistent" (unspecified if ongoing); "H. Pylori infection", start date: 2010 (unspecified if ongoing); "joint inflammation", start date: 2010 (unspecified if ongoing); "intestinal hyperpermeability/leaky gut", start date: 2010 (unspecified if ongoing); "multiple food allergies", start date: 2010 (unspecified if ongoing); "Borrelia burgdorferi" (unspecified if ongoing); "Erythema migrans rash" (unspecified if ongoing); "Babesia microti" (unspecified if ongoing); "Ehrlichia chaffeensis" (unspecified if ongoing); "Coxiella burnetii" (unspecified if ongoing); "Bartonella henselae" (unspecified if ongoing); "Bartonella quintana" (unspecified if ongoing); "Metabolic syndrome" (unspecified if ongoing); "reactive hypoglycemia" (unspecified if ongoing); "Hypercortisolemia" (unspecified if ongoing); "Peripheral Neuropathy" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "stress" (unspecified if ongoing); "overactive adrenal cortex" (unspecified if ongoing); "antibiotics" (unspecified if ongoing); "herbal support protocol" (unspecified if ongoing); "Lyme flare-up", start date: Apr2019 (unspecified if ongoing); "injury" (unspecified if ongoing); "possible Bakers cyst" (unspecified if ongoing); "flushing" (unspecified if ongoing), notes: menopausal symptoms; "viral infection", start date: Apr2019 (unspecified if ongoing); "osteopenia" (unspecified if ongoing), notes: especially in the lumbar-sacral spine; "decreased dexterity in her hands" (unspecified if ongoing). The patient's family history included: "type 2 diabetes" (unspecified if ongoing), notes: There was a family history of type 2 diabetes (father, brother); "low carbohydrate elimination diet" (unspecified if ongoing); "probiotics" (unspecified if ongoing); "mild Herxheimer reaction" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: (mother). The patient's concomitant medications were not reported. Past drug history included: Doxycycline for Lyme; Hydroxychloroquine for Babesia exposure; Atovaquone/proguanil for Babesia; Nystatin; Sublingual b12 supplementation for low B12 levels, notes: 1000 mcg/d for her borderline low B12; Cefdinir, notes: 300 mg PO BID for one month; Rifampin for gastrointestinal support, notes: 300 mg BID; Hydroxychloroquine for Lyme; Hydroxychloroquine for Ehrlichia; Doxycycline for Babesia; Doxycycline for Ehrlichia; Atovaquone/proguanil for Ehrlichia; Atovaquone/proguanil for lyme; Bovine immunoglobulins for gastrointestinal support; Chemet for elevated heavy metals; Ethylenediaminetetraacetic for elevated heavy metals; Raloxifene for osteopenia, notes: (Evista) 60 mg once a day. The following information was reported: ARTHRALGIA (medically significant), CONDITION AGGRAVATED (medically significant) all with onset Jun2021, outcome "recovered" and all described as "flare-up of joint pain"; COVID-19 (medically significant) with onset Dec2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "developed COVID-19 infection despite vaccination". The patient underwent the following laboratory tests and procedures: Bartonella test: increased to 1:256+ during that time, notes: (normal range less than 1:64); SARS-CoV-2 test: positive; X-ray: revealed moderate osteoarthritic changes at the, notes: proximal interphalangeal joints and metacarpophalangeal joints with mild soft tissue swelling. Clinical Course: A 67-year-old female with a past medical history significant for several embedded tick bites first presented to the medical office in 2010. She had documented exposure to Lyme disease with positive CDC IgM and IgG western blot results, positive Bb C6 peptide, positive Lyme ELISA IgM/IgG antibodies, as well as evidence of exposure to Babesia microti and Ehrlichia chaffeensis. She had complained of several years of chronic fatigue, migratory joint pain involving the knees, hips, pelvis, shoulders, and heels, intermittent night sweats, and transient tingling sensations in her toes. Additional past medical history had included exposure to H. pylori, borderline low vitamin B12 levels, elevated heavy metal levels, positive rheumatoid factor with negative CCP suggestive of joint inflammation without active rheumatoid arthritis, intestinal hyperpermeability, and multiple food allergies. Elevated cortisol levels had also suggested stress-related adrenal hyperactivity. She had been prescribed hydroxychloroquine, doxycycline, atovaquone/proguanil, and nystatin with dietary modifications, probiotics, bovine immunoglobulins, vitamin B12 supplementation, and stress-reduction measures. During treatment, she had experienced a mild Herxheimer reaction characterized by transient worsening of cognitive difficulties, headaches, sweats, and shortness of breath, although her knee pain gradually improved. One month later, most major symptoms had resolved except early awakening, and she had been transitioned to cefdinir and nystatin. Following completion of two months of antibiotic therapy, her symptoms had remained in remission, and antibiotics were discontinued in favor of herbal support. Heavy metal chelation therapy had been initiated for three months, resulting in improvement of lead and mercury levels over time. Residual intermittent tingling and knee discomfort gradually resolved, although she later experienced an itchy chest rash suggestive of possible Lyme re-exposure with associated sore throat, swollen glands, headaches, ear pain, and right shoulder pain. Repeat testing showed low positive Bartonella henselae and Coxiella burnetii antibodies, and she had been treated with hydroxychloroquine, doxycycline, rifampin, and supportive gastrointestinal measures, with complete symptom resolution within one week and negative repeat Q-fever titers. Between 2014 and 2017, Lyme symptoms had remained in remission with gradual decline in serologic titers, though rheumatoid factor remained mildly elevated. In 2018, she developed bilateral knee swelling, thumb pain, tremor, and menopausal flushing, though testing remained otherwise unremarkable and rheumatoid factor normalized. In 2019, she experienced a Lyme flare following a viral infection with limb heaviness and migratory pain, though symptoms improved with herbal therapy. Imaging later revealed osteopenia and reduced knee cartilage, and treatment included raloxifene, vitamin D, calcium supplementation, and rehabilitative therapies. In 2020, she remained clinically stable, Lyme and Q-fever titers turned negative, and COVID-19 preventive supplementation was discussed otherwise, she stated that she was in good health and felt she was functioning at 100% of normal.In Jun2021, the patient received the Pfizer COVID vaccine and experienced a brief flare-up of joint pain that resolved promptly. Her primary complaints included a swollen knuckle, stiffness of the fingers, and worsening knee pain with decreased range of motion. X-rays of the hands revealed moderate osteoarthritic changes at the proximal interphalangeal and metacarpophalangeal joints with mild soft tissue swelling. ByDec2021, she experienced her first case of COVID-19, during which her functioning was impaired, and she reported generalized aches, pains, myalgias, migratory joint and muscle pain suggestive of reactivation of underlying Lyme disease and/or Bartonella, along with an elevated Bartonella quintana titer of 1:256+. She also developed a cough but denied shortness of breath. At that time, she had already received her second Pfizer COVID vaccination and remained on nutritional supplementation, including curcumin, broccoli-seed extract, and beta glucan for immune support. Doxycycline 100 mg twice daily with nystatin 500,000 units two tablets twice daily and triple probiotics twice daily were prescribed for two weeks to prevent overlapping bacterial superinfection. At follow-up in Jul2022, she reported feeling completely back to normal except for mild depression related to social isolation during the pandemic. She had fully recovered from COVID-19 without sequelae or ongoing Lyme flare-ups. Physical examination revealed osteoarthritic changes with Heberden nodules. A stricter low-carbohydrate diet was recommended for mildly elevated HbA1c of 5.8%, and repeat DEXA demonstrated worsening osteoporosis with a T-score of -2.6 and elevated urine N-telopeptide, consistent with increased bone turnover. Calcitonin-salmon nasal spray was initiated as she declined bisphosphonate therapy. At her annual follow-up in Jul2023, she denied significant active Lyme symptoms and attributed persistent knee pain and stiffness to cartilage loss, although she remained physically active. Tick-borne titers showed stable low-positive Bartonella henselae antibodies and decreasing Bartonella quintana titers. Rheumatoid factor remained within normal limits, VEGF was below normal, and HbA1c normalized to 5.3%. A positive Cologuard test prompted colonoscopy, which was negative. In March 2025, she returned with ongoing arthritic symptoms of the hands and knees and a mild left-hand tremor. Repeat Lyme IgM immunoblot remained CDC positive, with positive 23 kDa, 31 kDa, and 41 kDa Borrelia-specific bands. Rheumatoid factor was elevated at 20 IU/mL with negative CCP, confirming ongoing peripheral joint inflammation. Due to concern for possible neuroinflammation and family history of Alzheimer's disease, additional laboratory evaluation was performed, including CBC, CMP, thyroid function tests, vitamin D, CRP, ANA, VEGF, serum heavy metals, Bartonella and Q-fever titers, G6PD, APOE status, and plasma neurodegenerative biomarkers. Results were within normal limits except for elevated plasma p-tau 217 at 0.33 pg/mL, while APOE status was 3/3 and other Alzheimer's markers were within normal range. As she was considered an appropriate candidate, she consented to undergo a 9-week dapsone combination therapy protocol with methylene blue, tetracycline, rifampin, azithromycin, nutraceutical support, and high-dose folate supplementation. Potential adverse effects including temporary anemia, Herxheimer reactions, rash, and transient methemoglobinemia were discussed, and weekly CBC, CMP, and methemoglobin monitoring was initiated from week three. She completed the protocol in September 2025, including a four-day high-dose dapsone pulse followed by one month of mitochondrial regeneration support. She tolerated treatment well, experiencing only a temporary Herxheimer reaction with increased fatigue and headaches, which resolved following completion of therapy. In 2021, she experienced a brief post-vaccination joint pain flare that resolved promptly but later developed COVID-19 with generalized aches, migratory musculoskeletal pain, and elevated Bartonella quintana titers, for which doxycycline and nystatin were prescribed. By mid-2022, she had fully recovered except for mild depression and worsening osteoporosis, for which calcitonin-salmon nasal spray was initiated. In 2023, she denied significant active Lyme symptoms, with ongoing knee stiffness attributed to degenerative changes, and a positive Cologuard test was followed by a negative colonoscopy. In Mar2025, she returned with arthritic symptoms of the hands and knees and mild left-hand tremor. Repeat Lyme immunoblot remained CDC positive, rheumatoid factor was elevated, and inflammatory markers suggested ongoing peripheral joint inflammation. Due to concern for possible neuroinflammation, extensive laboratory evaluation was performed, revealing elevated plasma p-tau 217 with otherwise normal studies, making her a suitable candidate for dapsone combination therapy. After informed consent, she completed a 9-week dapsone combination protocol with methylene blue, rifampin, azithromycin, tetracycline, and nutraceutical support, followed by a one-month mitochondrial regeneration protocol. She tolerated treatment well, experiencing only a temporary Herxheimer reaction with increased fatigue and headaches, which resolved after completion of therapy.; Sender's Comments: Based on the available information the serious events ARTHRALGIA, CONDITION AGGRAVATED are most likely related to the multiple underlying medical conditions, hence unrelated to the suspect drug BNT162b2. Drug efficacy varies from person to person and is affected by many factors. The association between the events COVID-19, DRUG INEFFECTIVE with the suspect product cannot be fully 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.

Medical history

Medical History/Concurrent Conditions: Adrenal cortex activity increased; Antibiotic therapy; Babesia; Baker's cyst; Bartonella hensalae infection; Borrelia burgdorferi infection; Breast cancer ((mother)); Chronic fatigue (She complained of a several year history); Condition aggravated; Coxiella burnetii infection; Ehrlichia chaffeensis; Erythema migrans; Flushing (menopausal symptoms); Food allergy; Heberden's nodes; Helicobacter pylori infection; Herbal supplement; Hypercortisolemia; Inflammation; Injury; Jarisch-Herxheimer reaction; Joint inflammation; Joint pain (migratory joint pain in her knees); Joint pain; Knee pain; Leaky gut; Low carbohydrate diet; Lyme disease; Metabolic syndrome; Mild cognitive impairment; Motor vehicle accident; Neuropathic pain; Night sweats (intermittent night sweats); Osteopenia (especially in the lumbar-sacral spine); Osteoporosis; Pain in hip (occasionally in the hips, pelvis, shoulders and heels,); Peripheral neuropathy; Post treatment Lyme disease syndrome; Probiotic therapy; Reactive hypoglycemia; Reduced dexterity; Rochalimaea quintana infection; Stress; Tick bite (several embedded tick bites); Type 2 diabetes mellitus (There was a family history of type 2 diabetes (father, brother)); Viral infection

Lab data

Test Name: Bartonella quintana titer; Result Unstructured Data: Test Result:increased to 1:256+ during that time; Comments: (normal range less than 1:64); Test Name: SARS-CoV-2; Test Result: Positive ; Test Name: X-rays of the hands; Result Unstructured Data: Test Result:revealed moderate osteoarthritic changes at the; Comments: proximal interphalangeal joints and metacarpophalangeal joints with mild soft tissue swelling