Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: positive for COVID-19, so likely a BA.4 or BA.5 Omicron variant; Vaccination failure; positive for COVID-19; This is a literature report for the following literature source(s):   A 43-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 04Jan2021 (not ongoing); "Anemia" (unspecified if ongoing); "Physical Fatigue (Lack of energy)" (unspecified if ongoing), notes: Score 1 some impact on daily life; "Low Muscle Tone" (unspecified if ongoing), notes: Score 2 some impact on daily life; "Brain Fog/Difficulty Concentrating" (unspecified if ongoing), notes: Score 2 some impact on daily life; "Cognitive fatigue (easily tired with cognitive tasks)" (unspecified if ongoing), notes: score 1 some impact on daily life; "Difficulty with Memory" (unspecified if ongoing), notes: score 2 some impact on daily life; "Headache" (unspecified if ongoing), notes: score 2 some impact on daily life; "Emotional Lability" (unspecified if ongoing), notes: score 1 some impact on daily life; "Vivid Dreams/Nightmares (Ongoing)" (ongoing), notes: score 1 some impact on daily life; "Difficulty with Sleep/Unrestful Sleep" (unspecified if ongoing), notes: score 2 some impact on daily life; "Rashes" (unspecified if ongoing), notes: score 1 some impact on daily life; "Heat Intolerance (Unable to tolerate warmer temperatures)" (unspecified if ongoing), notes: score 2 some impact on daily life; "Pale Skin" (unspecified if ongoing), notes: score 1 some impact on daily life; "speaking difficulties" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Sep2021, outcome "recovered" (Sep2021); COVID-19 (medically significant) with onset Sep2021, outcome "recovered" (Sep2021), described as "positive for COVID-19"; DISEASE RECURRENCE (medically significant) with onset 2022, outcome "recovered", described as "positive for COVID-19, so likely a BA.4 or BA.5 Omicron variant". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5 foot and 5 inches; severity scores: (unspecified date) 8-10; physical activity: (unspecified date) Normal; SARS-CoV-2 test: (04Jan2021) Positive; (Sep2021) Positive; (2022) Positive, notes: BA.4 or BA.5 Omicron variant; Weight: (unspecified date) 132 lbs. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient (average height/weight, in good health except "mild chronic anemia") developed COVID-19 on 01Apr2021. Relevant pre-COVID-19 symptomatology was unremarkable. After acute COVID-19 resolved, she progressively developed severe fatigue, extremely poor exercise intolerance, severe muscle and joint aches, dyspnea, palpitations (no chest discomfort), significant "dizziness" (both postural and resting), and profound difficulty concentrating and remembering ("clouded thinking") with severity scores 8-10. She had significant headaches, various sensory symptoms, vivid dreams, and some alterations in taste and smell. Unlike Patient, she never experienced noticeable fever during long COVID-19. Following Pfizer BioNTech vaccinations, two months after long COVID onset (29Mar2021 to 28Apr2021), there was no symptom diminishment except possible mild relief of some "speaking difficulties", headache, and dizziness. In September2021, testing positive for COVID-19 after an exposure, her medical team recommended infusion of casirivimab/imdevimab MCA cocktail (13Sep2021) to prevent her condition worsening. Consistent with Patient, all long COVID symptoms disappeared entirely within five days of receiving MCA. Again, low muscle tone acquired during long COVID, significantly improved after resuming normal physical activity. She remains in remission to date (October2023), over 2 years later, even though, during Summer2022, this patient developed mild upper respiratory illness, testing positive for COVID-19, so likely a BA.4 or BA.5 Omicron variant. She received no treatment (oral or infusion), had a short-lived illness, and returned to normal status without redeveloping any long COVID symptomatology.  No follow-up attempts are possible.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and  the reported events Vaccination failure , Vaccination failure , Vaccination failure cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202400022630 Same article/ drug/event and different patient;