The participant was diagnosed with dementia in 2015 and a femoral neck fracture on 1 March 2019, and when the fracture was almost repaired in a hospital, the participant moved to the Geriatric Health Services Facility, on 2 April 2019. This facility is staffed by with physicians, nurses, physical therapists, occupational therapists, nutritionists, and care workers.

The Japanese Government (Ministry of Health, Labour and Welfare) decided that healthcare workers and people over 65 years were the first to be vaccinated, and elderly participants were initially included as targeted persons. The participant was 90 years old and died on 25 August 2021, 28 weeks after the first vaccination. The second injection was planned on 25 June was cancelled due to the severe side effects that presented immediately after the first injection. The initial nursing care level was 2 (partial assistance) but was changed to level 5 (bedridden) on July 20, 2021.

The personal vital data and other related information were continuously monitored from April 2019 to August 2021, including the day of the vaccine, June 2, 2021. For example, the night shift care worker checked the digital data every hour, and the “Care Records” were precise and detailed. These records include timetable entries for three meals (e.g., expressed as main dish 6/10, side dish 9/10, where 10/10 = complete meal, 0/10 = no meal), drinks (ml), body temperature, blood pressure, pulse, saturation of percutaneous oxygen (SpO ₂), urination, defecation, and physical and medical examinations. The data summary can be viewed on a computer screen in the facility. It’s important to note that when the individual has a fever, the temperature is measured several times a day, and the last monitored temperature (not the maximum) appears on the PC screen as the default setting.

Contrasting the questionnaire survey among participants ( Suehiro et al., 2021) and the multinational network cohort with electronic health records and health claims data ( Li et al., 2021), the concept of the analysis is also applicable to a single participant. Because data from the million participants with mild to moderate and short-lasting side effects were privately measured and lacked long-term records, the present high-quality data, even for a single participant, are valid for scientific analyses.

Vital records covering 28 months ( Figure 1) revealed a drastic and violent fluctuation, with a significant increase in body temperature, maximum and minimum pressures, and pulse. Additionally, there was a substantial decrease in both the intake of meals and drinks, and weight (eventually leading to no meals and drinks; the patient lost 1/4 of body weight) after the COVID-19 vaccination. This was in contrast to the pre-injection “steady state,” which had persisted for more than two years with sporadic, short-term disorders (detailed in Figure 1).

Vital records limited to the last 6 months (180 days; Figure 2) illustrate the pre-injection horizontal regression line, a significant positive level change for temperature, pressures, and pulse, and a negative level change for meals and drinks, post-injection - regression line. The R ² value and other statistical parameters ( Table 1) suggested that the injection strongly influenced and affected the vital system, inducing a critical phase.

Table 2 presents detailed care records for the period of June 2 ^nd – June 14 ^th, extracted from the full care records ( Osozawa, 2021). During this time, the patient’s temperature increased and remained elevated until death. The patient also experienced hallucinations and a decreased mental state, along with reduced SpO ₂ levels. Another visual hallucination was observed on 17 June. Lingual coating was observed on 18 June. The meal dinner (including breakfast and lunch) was on 2 June, the day of vaccination, after which the patient developed anorexia and did not eat, contrasting with the pre-vaccination period where the patient usually had complete meals and drinks.

Pre-injection disorders are illustrated in Figure 1, and they were short-term, recovered from, and of course, unrelated to the vaccination.

Abrupt and severe disorders that manifested just after the COVID-19 vaccination were evidently causally related to the vaccination ( Figures 1 and 2; Table 1). Death was probably caused by these adverse reactions, particularly due to the absence of meals or drinks for nearly three months.

The fevers observed just after the injection in early June were likely a consequence of an adverse reaction to the vaccine ( Table 2). The subsequent fevers in mid-June and early August were potentially causally related ( Figures 1 and 2; Table 1).

CRP (C-reactive protein) increased from 0.11 mg/dl on 18 February 2021 (pre-injection) to 1.25 on 22 June and 1.12 on 9 July 2021 (post-vaccination; associated fever), and the leukocyte count decreased below the reference values. Thrombocytopenia frequently associated with critical thrombosis ( Ministry of Health, Labour and Welfare; Fueyo-Rodriguez et al., 2021; Waraich and Williams, 2021; Sessa et al., 2021) was not found in the patient, but neutropenia reported by Charan et al. (2021) was probable. An increased CRP over 0.3 (< 0.3: normal level) suggested moderate class inflammation and might have been related to the following reported symptoms: fever flash on June 2; leg pain on June 3; nausea on June 4; visual hallucinations (15 dancing girls are visible; deceased husband is visible) on June 4 and 17; lingual coating on June 18; and tongue swelling on June 21. Fevers exceeding 38°C tended to be associated with SpO ₂ 95 (note that SpO ₂ was minimal at 94 on June 6) and implied lung dysfunction and pneumonia. Polymyalgia rheumatica in early 2020 (see Osozawa, 2021) had a much higher CRP of 7.4 (c.f., Parperis and Constantinou, 2021), which later decreased within the reference values and was unrelated to the present case. These disorders were possibly associated with cytokine release (or storm; Fajgenbaum and June, 2020).

Significant increases in blood pressure and pulse to higher levels can be considered adverse reactions of injection ( Figures 1 and 2; Table 1), presumably caused by inflammation. Inflammation was possibly associated with belching and nausea (and partial chills and fatigue; diarrhea was uncertain due to the dosage of magnesium oxide), which might have affected the appetite, reduced it, and led to anorexia. Note that the participant retained chewing and swallowing abilities, as dentists and physical therapists regularly checked and trained. Thus, the anorexia nervosa triggered by the vaccination reduced the patient’s weight to 3/4 of the pre-vaccination weight.

Another concern was the dosage of the vaccine (0.3 ml/participant in the present case of the COVID-19 Pfizer (Comirnaty) vaccine). The amount is the same for both men and women and Japanese and American individuals. The mean weight of an American woman was 77 kg in 2015-2016 ( CNN), but the patient’s weight was only just over half of 77 kg at 40.5 kg (so the vaccine dosage should have been 0.15 ml). Therefore, I am concerned about the risk of overdosage and its potential to increase adverse reactions, particularly in the Japanese population. The Centers for Disease Control and Prevention recently (November 2021) decided that the dose should be 0.1 ml/US children less than 11 years old.

Written informed consent for publication of the patient’s clinical details was obtained from the patient’s family member. The personal care data are protected by the Personal Information Protection Law, Japan.

Zenodo: Table S2: In Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case study applying detailed personal care records. https://doi.org/10.5281/zenodo.5778025 ( Osozawa, 2021)

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).