Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records

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Methods: Applying long-term personal vital care data for 28 months for an elderly patient, I investigated and evidenced adverse reactions after the first dose of the COVID-19 Pfizer vaccination. Results: The precise, detailed, and continuous data statistically clarified the long-term fevers associated with no meals or drinks. Interrupted time series analysis showed significant and fluctuating increases of body temperatures, pressures, and pulses, although solely long-term plots showed an abrupt and timely increase in these vital data after the vaccine. Conclusions: Anorexia was fatal, and newly reported in the present care records since the patient received the first dose of the COVID-19 vaccine." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/11-4/v2", "name": "Case Report: Anorexia as a new type of adverse reaction caused by..." } } ] } Home Browse Case Report: Anorexia as a new type of adverse reaction caused by... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Osozawa S. Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.12688/f1000research.75277.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Case Report Revised Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] Soichi Osozawa https://orcid.org/0000-0001-5554-1320 Soichi Osozawa https://orcid.org/0000-0001-5554-1320 PUBLISHED 04 Jan 2024 Author details Author details Tohoku University, Sendai, Aob, 9808578, Japan Soichi Osozawa Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Emerging Diseases and Outbreaks gateway. Abstract Background: In Japan, more than 1,000 participants died shortly after receiving the coronavirus disease 2019 (COVID-19) vaccine, but the causal relation between the injection and death remains uncertain. Methods: Applying long-term personal vital care data for 28 months for an elderly patient, I investigated and evidenced adverse reactions after the first dose of the COVID-19 Pfizer vaccination. Results: The precise, detailed, and continuous data statistically clarified the long-term fevers associated with no meals or drinks. Interrupted time series analysis showed significant and fluctuating increases of body temperatures, pressures, and pulses, although solely long-term plots showed an abrupt and timely increase in these vital data after the vaccine. Conclusions: Anorexia was fatal, and newly reported in the present care records since the patient received the first dose of the COVID-19 vaccine. READ ALL READ LESS Keywords case report, COVID-19 vaccine, adverse reactions, before-after study, statistic interrupted time analyses, fever, anorexia Corresponding Author(s) Soichi Osozawa ( [email protected] ) Close Corresponding author: Soichi Osozawa Competing interests: No competing interests were disclosed. Grant information: This case report was supported by funding from the Japan Society for the Promotion of Science, “Extrusion Wedge of the Sambagawa High P-T Metamorphic Rocks,” in the form of a grant awarded to the author (20540441). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2024 Osozawa S. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Osozawa S. Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.12688/f1000research.75277.2 ) First published: 04 Jan 2022, 11 :4 ( https://doi.org/10.12688/f1000research.75277.1 ) Latest published: 04 Jan 2024, 11 :4 ( https://doi.org/10.12688/f1000research.75277.2 ) Revised Amendments from Version 1 The conclusion, incorporating medically appropriate terms, was revised by me without involving a medical co-authorship, which was deemed impossible. Medically suitable terminology was applied, particularly in the Abstract, alternating with unsuitable terms. The end of the Introduction was revised, replacing it with medically appropriate terms. Half of the Patient Information was modified using medically appropriate terms. The second sentence of the Methods section was adjusted with more suitable terminology. The timeline was extensively modified, incorporating more appropriate terms. "Tongue coat" was replaced with "lingual coating." Unsuitable English, including terminology, was revised in the Discussion. References need to be provided for "cytokine storm," including the newly cited source: Fajgenbaum DC, June CH: Cytokine Storm. N Engl J Med 2020; 383: 2255-73. doi: 10.1056/NEJMra2026131. The statement "This case report was supported by funding from the Japan Society for the Promotion of Science" appears peculiar as the funding does not seem to be for medical research, but it is retained for technical reasoning. The conclusion, incorporating medically appropriate terms, was revised by me without involving a medical co-authorship, which was deemed impossible. Medically suitable terminology was applied, particularly in the Abstract, alternating with unsuitable terms. The end of the Introduction was revised, replacing it with medically appropriate terms. Half of the Patient Information was modified using medically appropriate terms. The second sentence of the Methods section was adjusted with more suitable terminology. The timeline was extensively modified, incorporating more appropriate terms. "Tongue coat" was replaced with "lingual coating." Unsuitable English, including terminology, was revised in the Discussion. References need to be provided for "cytokine storm," including the newly cited source: Fajgenbaum DC, June CH: Cytokine Storm. N Engl J Med 2020; 383: 2255-73. doi: 10.1056/NEJMra2026131. The statement "This case report was supported by funding from the Japan Society for the Promotion of Science" appears peculiar as the funding does not seem to be for medical research, but it is retained for technical reasoning. To read any peer review reports and author responses for this article, follow the "read" links in the Open Peer Review table. READ REVIEWER RESPONSES Introduction According to the descriptions by the World Health Organization (2021): “Like any vaccine, coronavirus disease 2019 (COVID-19) vaccines can cause mild to moderate, short-term side effects, such as a low-grade fever or pain or redness at the injection site, fatigue, headache, chills, diarrhea, and allergic reaction. Most reactions to vaccines are mild and go away within a few days on their own. More serious or long-lasting side effects to vaccines are possible but extremely rare. Vaccines are continually monitored for as long as they are in use to detect rare adverse events and implement approaches to limit their occurrence.” To date, except for anaphylactoid reactions, blood clots, myocarditis ( Nassar et al ., 2021 ) or pericarditis ( Ashaari et al. , 2021 ), and Guillain-Barré syndrome ( McKean and Chircop, 2021 ; Kanabar and Wilkinson, 2021 ), adverse reactions to the COVID-19 vaccines are mild or moderate, occur shortly after vaccination and are not associated with more serious or lasting illness ( Medicines & Healthcare products Regulatory Agency UK , 2021). Similarly, the reactions peaked within one day, although in rare cases lasted a week ( Menni et al. , 2021 ). The likelihood of accepting the vaccine were lower when the probability of serious adverse reactions such as paralysis was 1/100,000 in contrast to 1/million or 1/100 million ( Kaplan and Milstein, 2021 ). The present research, which incorporates elements of “implementation research” (an integrated concept that links research and practice to accelerate the development and delivery of public health approaches; Theobald et al. , 2018 ) is connected to evidence-based intervention. It does not fall under the strict definition of a clinical study associated with a clinical double-blind study and is presented as a case report. I applied the statistical concept of interrupted time series analysis to an elderly participant who received the first dose of the COVID-19 Pfizer vaccine on June 2, 2021. While this analysis is typically applied to populations, the concept remains the same even for a single participant. In Japan, over 1,000 participants died shortly after receiving COVID-19 vaccine injections until September 2021, but the causal relationship between the injection and death remains uncertain ( Ministry of Health, Labour and Welfare , Japan). Herein, I report previously unreported serious side effects, including unexpected adverse reactions, based on thoroughly monitored reliable long-term care records. Case report Patient information 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. Methods This research used a method of statistical analysis that involves tracking a long-term period before and after a point of intervention, in order to assess the intervention’s effects. According to Ferron and Rendina‐Gobioff (2005) and others, “the time series refers to the data over the period, while the interruption is the intervention, which is a controlled external influence or set of influences. The effects of the intervention are evaluated by changes in the level and slope of the time series and the statistical significance of the intervention parameters”. For this case report, the intervention is the COVID-19 Pfizer (Comirnaty) vaccination, given on 2 June 2021. I created a figure illustrating vital data tracking over a long-term period (28 months) using the Care Records for the patient (1,500-page hard copies in Japanese; Figure 1 ; created using Excel 2008 for Mac). Additionally, I generated a figure depicting vital data tracking over a short-term period (6 months) from the summary records (28-page hard copy in Japanese) produced by the care records for the patient ( Figure 2 ; created using Excel 2021) for the application of interrupted time series analyses. Table 1 provides a summary of the statistical analyses. Figure 1. Continuously monitored body temperature (°C), maximum and minimum pressures (mmHg), pulse (beat per minute), meals (a meal expressed as main dish such as 6/10 and side dish 9/10; e.g., 10/10 = complete meal, 0/10 = no meal), drinks (ml), and weight (kg) since admission in April 2019 to the patient’s death in August 2021. The COVID-19 vaccine was injected on 2 June 2021 (intervention), but the second injection planned on 25 June was cancelled. 5 pre-injection disorders are also shown. Figure 2. Interrupted time-series analysis for monitored body temperature (°C), maximum and minimum pressures (mmHg), pulse (beat per minute), meals (maximum/day: 60 = 20 x 3 meals), and drinks (ml) for 180 days (6 months) interrupted by 92 nd day when the patient received the COVID-19 vaccine. The last one-week plots were omitted by body temperature disturbance. The regression line with the equation, coefficient of determination (R 2 ), and level change by the interruption are shown. Table 1. Statistical data for monitored body temperature (°C), maximum and minimum pressures (mmHg), pulse (beat per minute), meals (maximum/day: 60 = 20 x 3 meals), and drinks (ml) for 180 days (6 months) interrupted by 92nd day of COVID-19 vaccine injection. The last one week of data were omitted by body temperature disturbance. Temperature Systolic pressure Diastolic pressure Pulse Meals Drinks Pre injection Post injection Pre injection Post injection Pre injection Post injection Pre injection Post injection Pre injection Post injection Pre injection Post injection Approximate line Y = 0.0198X + 363.82 Y = −01184X + 386.05 Y = 0.0631X + 126.48 Y = −0.461X + 202.14 Y = 0.0067X + 70.176 Y = −0.1926X + 105.84 Y = 0.0234X + 70.028 Y = −0.0924X + 93.87 Y = −0.0568X + 43.378 Y = −0.00613X + 9.1024 Y = −1106X + 711.49 Y = −2.9479X + 499.76 R 2 0.05456 0.3092 0.0229 0.13881 0.00076 0.08187 0.01625 0.07037 0.04908 0.015306 0.00059 0.47893 R 0.2336 0.5561 0.1513 0.3726 0.02757 0.2861 0.2336 0.5561 0.2215 0.1237 0.02429 0.692 Intersept 365.6416 375.15 132.276 159.728 70.7924 88.1208 365.6416 375.15 38.1524 3.3064 701.3148 228.452 Level change 9.5084 27.452 17.3284 9.5084 34.846 472.8628 Mean 364.7391304 370.3506494 129.3870968 141.5128205 70.48387097 80.51282051 71.11956522 81.78205128 40.80434783 0.571428571 707.0108696 110.3246753 Variance 5.293836598 22.3885851 126.7398317 786.1232101 43.29593268 232.6946387 24.58994267 60.7960373 48.31294792 2.537593985 15269.26362 9186.406357 Degree of freedom 106 98 101 126 126 102 166 T −9.508283138 −3.584842235 −5.400334604 −10.4218197 53.85510717 35.32764719 P(T ≤ t) one cided 3.58883E-16 0.000263903 2.21535E-07 5.0612E-19 4.90704E-77 1.98408E-79 T-statistic value one cided 1.659356034 1.660551217 1.66008063 1.657036982 1.659929976 1.654084713 P(T ≤ t) two cided 7.17767E-16 0.000527805 4.43071E-07 1.01224E-18 9.81407E-77 3.96815E-79 T-statistic value two cided 1.982597262 1.984467455 1.983731003 1.978970602 1.983495259 1.974357764 Standard error 0.23741822 0.540398724 1.167387635 3.174665761 0.682310533 1.727212957 0.51710209 0.872923671 0.71799775 0.360827835 12.75840106 10.92938891 Median 365 369 128 145.5 70 81 71 82 42 0 715 100 mode 366 370 118 134 69 79 69 85 41 0 750 0 Standard deviation 2.289578397 4.80316892 11.25787865 28.03788883 6.579964489 15.2543318 4.986751967 7.758715299 6.924119548 3.186745151 123.0375641 96.52574931 Kurtosis −0.158797152 4.18250794 −0.496755519 −0.502688586 1.435971906 −0.274371303 0.558465175 −0.142253583 2.078199143 43.9182879 1.797232424 2.607666508 Skewness −0.244577106 1.782714479 0.270761688 −0.479761826 −0.070640615 −0.430961688 0.637685506 0.097637692 −1.251988422 6.172032188 −0.34146775 1.184237268 Confidence interval (95%) 0.471533078 1.075851215 2.318532607 6.32156715 1.355127613 3.439320392 1.027009386 1.737857532 1.426005507 0.718500012 25.33928576 21.76319372 For body temperature for example, an interrupted time-series analysis approach was utilized. A linear regression model was fitted to describe the magnitude of change in temperatures in transitioning from one phase to another and the trend of temperatures at any specific time segment. Parameters of interest included: baseline error trend; immediate change in daily temperatures from the last observation in the pre-implementation phase to the first observation in the implementation phase; change in the slope of temperature trend from pre-implementation to implementation; immediate change in daily temperatures from the last observation in the implementation phase to the first observation in the post-implementation phase; temperature trend in the post-implementation phase; and estimated reduction in daily temperatures into the implementation phase ( Elsaid et al. , 2013 ). Timeline 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. Table 2. Representative patient’s care records from June 2 – June 14, after Osozawa (2021) . Date Time Temperature, °C Notes SpO 2 2 nd June 07:50 36.0 Received vaccine at 09:30 2 nd June 13:40 37.7 2 nd June 13:48 37.6 2 nd June 15:14 38.0 2 nd June 19:41 37.1 3 rd June 06:19 37.1 3 rd June 11:18 37.2 3 rd June 14:40 38.0 95 3 rd June 19:42 37.8 4 th June 07:00 37.4 Visual hallucination of 15 dancing girls 4 th June 15:00 38.6 Noted decreased mental status 95 4 th June 16:40 38.8 4 th June 19:13 37.0 5 th June 05:56 36.8 95 5 th June 08:42 36.9 95 5 th June 14:50 37.1 95 5 th June 19:08 37.0 95 6 th June 08:32 36.9 Temperature continued around 37.0 94 14 th June 12:36 38.8 Maximum temperature before death Discussion Factor of disorder: adverse reaction of the COVID-19 vaccination 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. Recommendations 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. Conclusion The long-term vital records provided excellent data on adverse reactions, including abnormally prolonged fevers, high blood pressures, pulses, and severe anorexia, ultimately leading to death. Informed consent 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. Data availability Underlying data 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). References Ashaari S, Sohaib HA, Bolger K: A case report: symptomatic pericarditis post-COVID-19 vaccination. Eur. Heart J. - Case Rep. 2021; 5 (10): 1–5. PubMed Abstract | Publisher Full Text Charan J, et al. : Tocilizumab in COVID-19: a study of adverse drug events reported in the WHO database. Expert Opin. Drug Saf. 2021; 20 : 1125–1136. PubMed Abstract | Publisher Full Text Elsaid K, Truong T, Monckeberg M, et al. : Impact of electronic chemotherapy order forms on prescribing errors at an urban medical center: results from an interrupted time-series analysis. Int. J. Qual. Health Care. 2013; 25 : 656–663. PubMed Abstract | Publisher Full Text Fajgenbaum DC, June CH:Cytokine Storm. N. Engl. J. Med. 2020; 383 : 2255–2273. PubMed Abstract | Publisher Full Text | Free Full Text Ferron J, Rendina-Gobioff G: Interrupted Time Series Design, Encyclopedia of Statistics in Behavioral Science. Am. Cancer Soc. 2005; Publisher Full Text Fueyo-Rodriguez O, Valente-Acosta B, Jimenez-Soto R, et al. : Secondary immune thrombocytopenia supposedly attributable to COVID-19 vaccination. BMJ Case Rep. 2021; 14 : e242220. PubMed Abstract | Publisher Full Text Kanabar G, Wilkinson P: Guillain-Barré syndrome presenting with facial diplegia following COVID-19 vaccination in two patients. BMJ Case Rep. 2021; 14 : e244527. PubMed Abstract | Publisher Full Text Kaplan RM, Milstein A: Influence of a COVID-19 vaccine’s effectiveness and safety profile on vaccination acceptance. PNAS. 2021; 118 (10): e2021726118. PubMed Abstract | Publisher Full Text Li X, Ostropolets A, Makadia R, et al. : Characterizing the background incidence rates of adverse events of special interest for covid-19 vaccines in eight countries: a multinational network cohort study. BMJ. 2021; 373 . Publisher Full Text Menni C, Klaser K, May A, et al. : Vaccine side effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect. Dis. 2021; 21 : 939–949. PubMed Abstract | Publisher Full Text McKean N, Chircop C: Guillain-Barré syndrome after COVID-19 vaccination. BMJ Case Rep. 2021; 14 : e244125. PubMed Abstract | Publisher Full Text Nassar M, et al. : COVID-19 vaccine-induced myocarditis: Case report with literature review. Diabetes Metab. Syndr. Clin. Res. Rev. 2021; 15 : 102205. PubMed Abstract | Publisher Full Text Osozawa S: 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 [Data set]. Zenodo. 2021. Publisher Full Text Parperis K, Constantinou M: Remitting seronegative symmetrical synovitis with pitting oedema following BNT162b2 mRNA COVID-19 vaccination. BMJ Case Rep. 2021; 14 : e244479. PubMed Abstract | Publisher Full Text Sessa M, Kragholm K, Hviid A, et al. : Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines. Expert Opin. Drug Saf. 2021; 20 : 1451–1453. PubMed Abstract | Publisher Full Text Suehiro M, et al. : Adverse events following COVID-19 virus vaccination in young Japanese population: The first cross-sectional study conducted by a questionnaire survey after the first injection. medRxiv preprint. 2021. Publisher Full Text Theobald S, Neal BN, Gyapong M, et al. : Implementation research: new imperatives and opportunities in global health. Lancet. 2018; 392 : 2214–2228. Publisher Full Text Waraich A, Williams G: Haematuria, a widespread petechial rash, and headaches following the Oxford AstraZeneca ChAdOx1 nCoV-19 Vaccination. BMJ Case Rep. 2021; 14 : e245440. PubMed Abstract | Publisher Full Text Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 04 Jan 2022 ADD YOUR COMMENT Comment Author details Author details Tohoku University, Sendai, Aob, 9808578, Japan Soichi Osozawa Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation Competing interests No competing interests were disclosed. Grant information This case report was supported by funding from the Japan Society for the Promotion of Science, “Extrusion Wedge of the Sambagawa High P-T Metamorphic Rocks,” in the form of a grant awarded to the author (20540441). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (2) version 2 Revised Published: 04 Jan 2024, 11:4 https://doi.org/10.12688/f1000research.75277.2 version 1 Published: 04 Jan 2022, 11:4 https://doi.org/10.12688/f1000research.75277.1 Copyright © 2024 Osozawa S. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Osozawa S. Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.12688/f1000research.75277.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 04 Jan 2022 Views 0 Cite How to cite this report: Chakrabarti SS. Reviewer Report For: Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.5256/f1000research.79125.r226957 ) The direct URL for this report is: https://f1000research.com/articles/11-4/v1#referee-response-226957 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 18 Dec 2023 Sankha Shubhra Chakrabarti , Banaras Hindu University, Varanasi, Uttar Pradesh, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.79125.r226957 I read with interest the case report of COVID-19 vaccination resulting in a downwards progression of a previously healthy elderly ultimately culminating in death. There are some concerns which need to be addressed. 1. The author probably does ... Continue reading READ ALL I read with interest the case report of COVID-19 vaccination resulting in a downwards progression of a previously healthy elderly ultimately culminating in death. There are some concerns which need to be addressed. 1. The author probably does not belong to the field of medical research and is not probably a clinical doctor either. Hence, the description of the case lacks some details. And some parts of it seem apparently lacking in medical details. I was deeply interested by the case because we have had similar experiences in our patients. I strongly suggest getting in touch with a medical co-author who would review the article and make it more acceptable. Just one example. "long-term vital records of this patient offered excellent data for adverse reactions to the COVID-19 Pfizer vaccine, including abnormally long-lasting fevers, high blood pressure, high pulse, and severe anorexia, ultimately leading to the patient’s death" This is not a justified statement. A single case report does not provide meaningful data. Further, long lasting fevers etc. are lay terms. More medically appropriate terms need to be used. Involving a medical co-author will also be meaningful as the author mentions "The author had an existing relationship with the patient prior to the study." 2. "This case report was supported by funding from the Japan Society for the Promotion of Science," This is peculiar as the funding apparently is not for medical research. The author should modify the statement to acknowledge general funding support etc. but not keep it like this. 3. Terminologies such as "tongue coat" visible etc. are not medically sound. The writing needs to be refined. 4. References need to be provided for cytokine storm. The report is valuable but needs to be almost completely rewritten along with a medical co-author. Is the background of the case’s history and progression described in sufficient detail? Partly Are enough details provided of any physical examination and diagnostic tests, treatment given and outcomes? Partly Is sufficient discussion included of the importance of the findings and their relevance to future understanding of disease processes, diagnosis or treatment? No Is the case presented with sufficient detail to be useful for other practitioners? No Competing Interests: No competing interests were disclosed. Reviewer Expertise: Geriatric Pharmacovigilance, Geriatric Neuropsychiatry I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Chakrabarti SS. Reviewer Report For: Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.5256/f1000research.79125.r226957 ) The direct URL for this report is: https://f1000research.com/articles/11-4/v1#referee-response-226957 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 04 Jan 2022 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 2 (revision) 04 Jan 24 Version 1 04 Jan 22 read Sankha Shubhra Chakrabarti , Banaras Hindu University, Varanasi, India Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Chakrabarti S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 18 Dec 2023 | for Version 1 Sankha Shubhra Chakrabarti , Banaras Hindu University, Varanasi, Uttar Pradesh, India 0 Views copyright © 2023 Chakrabarti S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I read with interest the case report of COVID-19 vaccination resulting in a downwards progression of a previously healthy elderly ultimately culminating in death. There are some concerns which need to be addressed. 1. The author probably does not belong to the field of medical research and is not probably a clinical doctor either. Hence, the description of the case lacks some details. And some parts of it seem apparently lacking in medical details. I was deeply interested by the case because we have had similar experiences in our patients. I strongly suggest getting in touch with a medical co-author who would review the article and make it more acceptable. Just one example. "long-term vital records of this patient offered excellent data for adverse reactions to the COVID-19 Pfizer vaccine, including abnormally long-lasting fevers, high blood pressure, high pulse, and severe anorexia, ultimately leading to the patient’s death" This is not a justified statement. A single case report does not provide meaningful data. Further, long lasting fevers etc. are lay terms. More medically appropriate terms need to be used. Involving a medical co-author will also be meaningful as the author mentions "The author had an existing relationship with the patient prior to the study." 2. "This case report was supported by funding from the Japan Society for the Promotion of Science," This is peculiar as the funding apparently is not for medical research. The author should modify the statement to acknowledge general funding support etc. but not keep it like this. 3. Terminologies such as "tongue coat" visible etc. are not medically sound. The writing needs to be refined. 4. References need to be provided for cytokine storm. The report is valuable but needs to be almost completely rewritten along with a medical co-author. Is the background of the case’s history and progression described in sufficient detail? Partly Are enough details provided of any physical examination and diagnostic tests, treatment given and outcomes? Partly Is sufficient discussion included of the importance of the findings and their relevance to future understanding of disease processes, diagnosis or treatment? No Is the case presented with sufficient detail to be useful for other practitioners? No Competing Interests No competing interests were disclosed. Reviewer Expertise Geriatric Pharmacovigilance, Geriatric Neuropsychiatry I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Chakrabarti SS. Peer Review Report For: Case Report: Anorexia as a new type of adverse reaction caused by the COVID-19 vaccination: a case report applying detailed personal care records [version 2; peer review: 1 approved with reservations] . F1000Research 2024, 11 :4 ( https://doi.org/10.5256/f1000research.79125.r226957) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/11-4/v1#referee-response-226957 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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