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  1. Bhullar AK, Chew ZC, Ong PS, Khor CG, Mohd Amin NH
    Mod Rheumatol Case Rep, 2023 Jan 03;7(1):87-91.
    PMID: 36069645 DOI: 10.1093/mrcr/rxac070
    There are an increasing number of reports of myocarditis associated with mRNA-based COVID-19 vaccination. We describe the case of a female patient with underlying systemic lupus erythematosus, who developed heart failure symptoms following a second dose of the BNT162b2 vaccine. Despite her history of refractory systemic lupus erythematosus, the disease remained stable after she began rituximab treatment. She underwent serial transthoracic echocardiogram and cardiac magnetic resonance imaging for the evaluation of cardiomyopathy. She showed improvement in cardiac function after treatment with glucocorticoids and intravenous immunoglobulin therapy.
    Matched MeSH terms: Vaccination/adverse effects
  2. Tajunisah I, Tan SS, Effendi-Tenang I, Samsudin A, Ling KP, Tan WY, et al.
    Front Cell Infect Microbiol, 2023;13:1243055.
    PMID: 37790912 DOI: 10.3389/fcimb.2023.1243055
    PURPOSE: We report the ocular findings that patients experienced after receiving the coronavirus disease 2019 (COVID-19) vaccination in three different eye centers in Malaysia.

    OBSERVATIONS: A total of four cases were reported. Three patients received the Pfizer-BioNTech vaccine, while the other received the Oxford AstraZeneca type. Ocular symptoms occurred after the first vaccine dose in two patients and after the second vaccine dose in the other two. Three out of four patients required active treatment for their vision complications postvaccination. The first patient had acute-onset retinal pigment epitheliitis within 3 h of vaccination and was treated conservatively. The second patient developed unilateral choroidal neovascularization 3 days after vaccination and required intravitreal antivascular endothelial growth factor injection. The third patient presented with bilateral acute multifocal placoid pigment epitheliopathy a week after vaccination and responded to intravenous methylprednisolone. The fourth patient presented with herpes zoster infection and unilateral anterior nongranulomatous uveitis 2 weeks after vaccination and was treated with oral acyclovir and topical corticosteroids. All patients reported some amount of visual recovery.

    CONCLUSIONS AND IMPORTANCE: Visual symptoms and various ocular adverse events can occur following COVID-19 vaccination, which warrants further investigation and urgent intervention if necessary. We would suggest patients receiving the COVID-19 vaccination be aware of possible ocular complications and report any symptoms, regardless of severity.

    Matched MeSH terms: Vaccination/adverse effects
  3. Almas T, Rehman S, Mansour E, Khedro T, Alansari A, Malik J, et al.
    Biomed Pharmacother, 2022 May;149:112843.
    PMID: 35325848 DOI: 10.1016/j.biopha.2022.112843
    The coronavirus disease 2019 (COVID-19) has overwhelming healthcare systems globally. To date, a myriad of therapeutic regimens has been employed in an attempt to curb the ramifications of a severe COVID-19 infection. Amidst the ongoing pandemic, the advent and efficacious uptake of COVID-19 vaccination has significantly reduced disease-related hospitalizations and mortality. Nevertheless, many side-effects are being reported after COVID-19 vaccinations and myocarditis is the most commonly reported sequelae post vaccination. Majority of these diseases are associated with COVID-19 mRNA vaccines. Various studies have established a temporal relationship between these complications, yet the causality and the underlying pathogenesis remain hypothetical. In this review, we aim to critically appraise the available literature regarding the cardiovascular side effects of the various mRNA vaccines and the associated pathophysiology.
    Matched MeSH terms: Vaccination/adverse effects
  4. Ong MJY, Khoo CS, Lee YX, Poongkuntran V, Tang CK, Choong YJ, et al.
    Epilepsia Open, 2023 Mar;8(1):60-76.
    PMID: 36214033 DOI: 10.1002/epi4.12658
    OBJECTIVE: Epilepsy is a non-communicable disease costing a massive burden globally. It is known that there is increased prevalence of morbidity and mortality following COVID-19 infection among people with epilepsy (PWE). However, there is limited information about the adverse events following COVID-19 immunization among PWE. Hence, this study aimed to assess the safety and adverse events following immunization (AEFI) of various COVID-19 vaccines among PWE from our centre, focusing on neurological AEFI.

    METHODS: This cross-sectional study recruited 120 adult PWE from the Neurology Clinic of the Universiti Kebangsaan Malaysia Medical Centre (UKMMC). Consent-taking was conducted via synchronous or asynchronous approaches, followed by a phone call interview session. The interview collected socio-demographic information, epilepsy-related variables, and vaccination-related variables. Univariate analysis and multiple logistic regression analysis were done to confirm factors associated with the AEFI of COVID-19 vaccination.

    RESULTS: Among all types of COVID-19 vaccines, most of the PWE received the Cominarty® COVID-19 vaccination (52.5%). Overall, local AEFI was the quickest to develop, with an average onset within a day. PWE with normal body mass index (BMI) had a higher risk of developing both local and systemic AEFI compared to those underweight and obese PWE (OR: 15.09, 95% CI 1.70-134.28, P = 0.02).

    SIGNIFICANCE: COVID-19 vaccines are safe for PWE. AEFI among PWE are similar to those of the general population following COVID-19 vaccination. Therefore, clinicians should encourage PWE to take COVID-19 vaccines.

    Matched MeSH terms: Vaccination/adverse effects
  5. Ab Rahman N, Lim MT, Lee FY, Wo WK, Yeoh HS, Peariasamy KM, et al.
    Sci Rep, 2023 Nov 22;13(1):20471.
    PMID: 37993548 DOI: 10.1038/s41598-023-47486-x
    This study assessed the association between COVID-19 vaccines, SARS-CoV-2 infection and the risk of thrombocytopenia and venous thromboembolism (VTE). This self-controlled case series study used hospital records between 1st February 2021 and 28th February 2022 linked to the national immunisation registry and COVID-19 surveillance data in Malaysia. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) of events in the risk period (day 1-21 post-exposure) relative to control period with the corresponding 95% confidence interval (CI) adjusted for calendar period. We found no significant increased risk of thrombocytopenia in 1-21 days following BNT162b2, CoronaVac and ChAdOx1 vaccines while the risk was increased following SARS-CoV-2 infection (IRR 15.52, 95% CI 13.38-18.00). Similarly, vaccination with BNT162b2, CoronaVac, or ChAdOx1 was not associated with an increased risk of VTE during the 1-21 days risk period. SARS-CoV-2 infection was associated with increased risk of VTE (IRR 39.84, 95% CI 27.45-32.44). Our findings showed low event rates of thrombocytopenia and VTE following booster vaccination with comparable safety profiles between those who received homologous and heterologous booster combinations. Our findings showed the risk of thrombocytopenia and VTE was not increased after COVID-19 vaccination while the risks were substantially higher after SARS-CoV-2 infection.
    Matched MeSH terms: Vaccination/adverse effects
  6. Bermawi B, Donastin A, Sari NDK, Kurniasari DW, Adriansyah AA, Ferdiansyah MA, et al.
    Med J Malaysia, 2024 Mar;79(2):124-127.
    PMID: 38553914
    INTRODUCTION: Vaccination is an effective way to overcome the spread of Coronavirus Disease 19 (COVID-19). However, it can give rise to adverse event following immunisation (AEFI). AEFI is an important aspect that is assessed in vaccine safety standards. It is assumed that different vaccine platforms can give rise to different degrees of AEFI severity, but so far there have been no studies that discuss the differences in the degree of AEFI on each type of COVID- 19 vaccine platform.

    AIM: Evaluate the differences in the degree of AEFI on each type of COVID-19 vaccine platform.

    MATERIALS AND METHODS: The research used a quantitative analytical observational design with a cross sectional approach. Data collection from participants was carried out by filling out questionnaires. The collected data was tabulated and statistical analysis was carried out.

    RESULTS: A total of 217 respondents who received three doses of vaccine participated in the study. Of the 651 vaccine doses studied, the results showed that there were significant differences in the degree of AEFI between the three types of vaccine platforms. The degree of AEFI was significantly different (p < 0.05) between each type of vaccine platform, with the degree of AEFI starting from the lowest, namely inactivated vaccine, then viral vector vaccine and the highest was nucleic acid vaccine.

    CONCLUSION: The degree of AEFI differs significantly between each COVID-19 vaccine platform. The degree of AEFI, from the mildest to the most severe, was inactivated vaccine, viral vector vaccine and nucleic acid vaccine. No serious AEFI was reported.

    Matched MeSH terms: Vaccination/adverse effects
  7. Doskaliuk B, Ravichandran N, Sen P, Day J, Joshi M, Nune A, et al.
    Rheumatol Int, 2023 Sep;43(9):1651-1664.
    PMID: 37351634 DOI: 10.1007/s00296-023-05345-y
    Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p 
    Matched MeSH terms: Vaccination/adverse effects
  8. R N, Sen P, Griger Z, Day J, Joshi M, Nune A, et al.
    Rheumatology (Oxford), 2024 Jan 04;63(1):127-139.
    PMID: 37084267 DOI: 10.1093/rheumatology/kead180
    OBJECTIVES: Disease flares in the post-coronavirus disease 2019 (COVID-19) vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs).

    METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models.

    RESULTS: Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P 

    Matched MeSH terms: Vaccination/adverse effects
  9. Andreoli L, Lini D, Schreiber K, Parodis I, Sen P, Ravichandran N, et al.
    Rheumatology (Oxford), 2024 May 02;63(5):1341-1351.
    PMID: 37505460 DOI: 10.1093/rheumatology/kead382
    OBJECTIVES: We investigated coronavirus disease 2019 (COVID-19) vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.

    METHODS: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares and AID-related treatment modifications were analysed upon diagnosis of AID vs healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine.

    RESULTS: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, P = 0.01; minor AE 40% vs 25.9%, P = 0.03; major AE 17.5% vs 4.6%, P 

    Matched MeSH terms: Vaccination/adverse effects
  10. Venugopal V, Ng DC
    BMJ Case Rep, 2024 Sep 10;17(9).
    PMID: 39256178 DOI: 10.1136/bcr-2024-261058
    The BCG vaccine is considered a safe and efficacious vaccine in the prevention of severe forms of tuberculosis. BCG osteomyelitis is a rare complication of the BCG vaccine that occurs in vaccinated young children. We report a case of BCG osteomyelitis in a male toddler, presenting with painful left wrist swelling without preceding fever or systemic symptoms. Radiographic evidence of osteomyelitis in the left wrist was observed. Initial treatment with conventional antibiotics for acute haematogenous osteomyelitis showed no improvement. The diagnosis of Mycobacterium bovis BCG osteomyelitis was confirmed via tissue samples for histopathological examination and mycobacterial cultures. The patient responded well to treatment with oral antituberculous therapy. This case highlights the importance of considering BCG osteomyelitis in the differential diagnosis of unexplained joint swelling in BCG-vaccinated young children.
    Matched MeSH terms: Vaccination/adverse effects
  11. Al-Herz W, Husain EH, Adeli M, Al Farsi T, Al-Hammadi S, Al Kuwaiti AA, et al.
    Pediatr Infect Dis J, 2022 11 01;41(11):933-937.
    PMID: 36102730 DOI: 10.1097/INF.0000000000003678
    AIMS: To present the details of Bacillus Calmette-Guérin (BCG)-vaccine associated complications (VACs) in combined immunodeficiencies (CID) patients.

    METHODS: Five centers participated in this retrospective study and completed a data form, which included general patients' information, clinical and laboratory data.

    RESULTS: Among 236 CID patients, 127 were BCG vaccinated. 41.9% of patients with family history of CID and 17.1% who were diagnosed by screening were BCG vaccinated. Twenty-three patients (18.1%) developed BCG-VACs. The median age of VACs was 6 months and the median time from vaccination to complications was 6 months. The highest rate of BCG-VACs was recorded in patients receiving the Russian BCG strain compared to the Tokyo and Danish strains. Univariate analysis of T-lymphocyte subsets showed increased odds of BCG complications in patients with CD3+, CD4+, and CD8+ counts of ≤250 cells/µL. Only CD8 + count ≤250 cells/µL had increased such odds on multivariate analysis. VACs were disseminated in 13 and localized in 10 patients. Localized complication occurred earlier after vaccination (median: 4 months) compared with disseminated ones (median: 7 months). There were no significant associations between sex, administered vaccine strain, serum immunoglobulins levels, lymphocyte subsets counts, and the chance of having either localized or disseminated BCG-related complications.

    COCLUSIONS: Although contraindicated, many patients with CID continue to be vaccinated with BCG. Low CD8 + count is a risk factor for BCG-related complications and localized complications occurred earlier than disseminated ones. Considerations should be undertaken by health care authorities especially in countries with high incidence of CID to implement newborn screening, delay the time of BCG vaccine administration beyond 6 months of age and to use the relatively safer strains like the Danish and Tokyo ones.

    Matched MeSH terms: Vaccination/adverse effects
  12. Im Teoh JH, Mustafa N, Wahab N
    J ASEAN Fed Endocr Soc, 2023;38(1):125-130.
    PMID: 37252417 DOI: 10.15605/jafes.038.01.19
    Autoimmunity associated with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has been well-described as the mechanism of development of thyroid dysfunction following Coronavirus Disease 19 (COVID-19) infection and SARS-CoV-2 vaccination. However, the occurrence of thyroid eye disease (TED) after SARS-CoV-2 vaccination is scarcely described. The postulated mechanisms include immune reactivation, molecular mimicry and the autoimmune/inflammatory syndrome induced by adjuvants (ASIA). We report a case of new-onset TED after receiving the SARS-CoV-2 vaccine.
    Matched MeSH terms: Vaccination/adverse effects
  13. Chan PWK, Goh AYT
    Med J Malaysia, 2000 Dec;55(4):527-8.
    PMID: 11221171
    Matched MeSH terms: Vaccination/adverse effects*
  14. Hamidon BB, Raymond AA
    Med J Malaysia, 2003 Dec;58(5):780-2.
    PMID: 15190671
    Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the central nervous system (CNS) that is known to occur spontaneously in association with specific and non-specific viral illnesses and after vaccination against various pathogens. Although it is often a self-limited monophasic illness, the fatality rate is estimated to be as high as 20%, and many patients suffer residual neurologic impairment 1. The diagnosis is mainly based on clinical and radiological findings. The clinical presentation varies from merely, an asymptomatic condition to loss of consciousness, seizures, ataxia, optic neuropathy, cranial nerve palsies, and motor dysfunction. MRI of the brain is the single most important diagnostic radiological investigation and can facilitate early diagnosis and prompt treatment. This case report describes a patient with ADEM presenting with only seizures after vaccination with anti-tetanus toxin.
    Matched MeSH terms: Vaccination/adverse effects
  15. Rahmat H, Leelavathi M, Wan Ismail WF
    Med J Malaysia, 2022 Nov;77(6):637-642.
    PMID: 36448378
    INTRODUCTION: The new COVID-19 vaccine was met with worldwide overwhelming uncertainties pertaining to its safety profile, effectiveness, and potential adverse reactions when it was first introduced. This led to vaccine refusal and delay in vaccine uptake in many countries including Malaysia. The objective of this study was to determine the Adverse Events Following Immunization (AEFI) to the COVID-19 vaccine.

    MATERIALS AND METHODS: A retrospective cross-sectional study was conducted among healthcare workers who received the COVID-19 vaccine during the first phase of immunisation from eight public primary clinics in Johor Bahru district. Data were collected between May and September 2021 using a self-administered questionnaire.

    RESULTS: A total of 240 healthcare workers participated and all of them received the Pfizer Messenger RNA vaccine. Our study found that a large majority of vaccine recipients (87.5%, n=210) experienced AEFI to COVID-19 vaccine for either the first, second, or both doses. More than 80% of them experienced more than one type of AEFI. The most common AEFI reported during the first and second dose was localised symptom such as pain at injection site (60-68%), pain on the injected arm (52-61%), and swelling at injection site (32-33%). Common systemic symptoms were fever (22- 57%), myalgia (20-45%), and dizziness (24-26%). Although a large majority experienced AEFI, these reactions were mostly of mild to moderate severity (47.3-73.6%). The mean duration of AEFI onset was within 30 minutes to about 1 day (0.33-22.5 hours) of injection and lasted between 30 minutes and 2.5 days. There was no association between demographic characteristic of participants and severity of AEFI to COVID-19 vaccine. Mean duration of fever was significantly (p=0.005) longer after the second dose (34.2 hours) of vaccine compared to first (20.6 hours) CONCLUSION: This study shows that a large majority of COVID-19 vaccine recipients experienced AEFI; however, these reactions were mostly of mild to moderate severity and lasted between 30 minutes and 2.5 days. A large majority experienced more than one type of AEFI. The most common AEFI was localised reactions consisting of pain and swelling at the injection site and pain on the injected arm. The most common systemic reactions were fever, myalgia, and dizziness. Duration of fever was significantly longer after the second dose.

    Matched MeSH terms: Vaccination/adverse effects
  16. Shahrudin MS, Mohamed-Yassin MS, Nik Mohd Nasir NM
    Am J Case Rep, 2023 Jan 18;24:e938667.
    PMID: 36650730 DOI: 10.12659/AJCR.938667
    BACKGROUND Herpes zoster is a condition in which there is reactivation of varicella zoster virus (VZV), which is usually seen in the elderly and those with immunocompromised states. Recently, however, there have been many reports of herpes zoster after administration of COVID-19 vaccines, although initial trials showed that these vaccines have good safety and immunogenicity profiles. At the time of writing, about 5 billion people worldwide had received their full course of COVID-19 vaccination. This case report describes an elderly man who developed herpes zoster after receiving a booster dose of the Pfizer-BioNTech (BNT162b2) vaccine, with no adverse effects after the first and second dose. CASE REPORT An 82-year-old man with underlying type 2 diabetes mellitus, hypertension, dyslipidemia, and cerebrovascular disease presented with left-sided chest and upper back pain. The pain was intermittent, burning in nature, and disturbed his sleep. A week prior to his presentation, he received a COVID-19 vaccine (BNT162b2) booster dose. Examination revealed multiple vesicles along his anterior and posterior T3 dermatome. He was diagnosed with herpes zoster and treated with a course of oral acyclovir. Upon review 7 days later, he had recovered well, with resolution of his vesicles and pain. CONCLUSIONS COVID-19 vaccination remains an important measure to prevent transmission of infection and to reduce the mortality and morbidity caused by it. However, healthcare practitioners should be aware of the possible association between COVID-19 vaccination and herpes zoster. Appropriate explanation and safety advice on the possible adverse events following COVID-19 vaccination, including herpes zoster infection, should be given to patients. This will facilitate early recognition and treatment of this condition.
    Matched MeSH terms: Vaccination/adverse effects
  17. Hss AS, Koh MT, Tan KK, Chan LG, Zhou L, Bouckenooghe A, et al.
    Vaccine, 2013 Dec 2;31(49):5814-21.
    PMID: 24135573 DOI: 10.1016/j.vaccine.2013.10.013
    Dengue disease is a major public health problem across the Asia-Pacific region for which there is no licensed vaccine or treatment. We evaluated the safety and immunogenicity of Phase III lots of a candidate vaccine (CYD-TDV) in children in Malaysia.
    Matched MeSH terms: Vaccination/adverse effects
  18. Balasundram R
    Med J Malaya, 1972 Dec;27(2):89-94.
    PMID: 4145716
    Matched MeSH terms: Vaccination/adverse effects*
  19. Fong EP, Bay BH
    Med Hypotheses, 2002 Apr;58(4):264-9.
    PMID: 12027517
    The aetiology of the keloid scar has not been completely elucidated. Numerous hypotheses have been proposed in the past to explain the unusual characteristics of the keloid scar. While we do know that there is excessive and ongoing collagen-deposition, the exact triggering stimulus is a subject of conjecture. We present some of our photographic records of keloids and electron microscopic findings of keloid edges and reiterate the sebum hypothesis. We also attempt to explain the features of keloids in the light of the present knowledge of immunology and cell biology.
    Matched MeSH terms: Vaccination/adverse effects
  20. Santhanes D, Wong CP, Yap YY, San SP, Chaiyakunapruk N, Khan TM
    Hum Vaccin Immunother, 2018 Jan 02;14(1):124-133.
    PMID: 28933635 DOI: 10.1080/21645515.2017.1381811
    A scoping review was performed to identify factors that may lead to human papillomavirus (HPV) vaccine hesitancy among women in low- and middle-income countries in South East Asian Region (SEAR) and Western Pacific Region (WPR). A systematic search of English and non-English articles using Pubmed, EMBASE, PsycINFO, Cochrane, MEDLINE, and CINAHL plus was conducted. Only 63 studies conducted in SEAR and WPR were included from inception until December 2016. Results of these studies have shown that poor awareness and knowledge of practices on cervical cancer prevention was evident in both SEAR and WPR. Concerns on safety and efficacy of the vaccine, and costs in getting vaccinated were significant barriers. Most women stated that they needed more information, and strongly welcomed a physician's recommendation in both geographical regions. Women also felt they have a low risk of acquiring HPV infection and cervical cancer. Most women in SEAR and WPR were unable to decide on whether to accept HPV vaccination.
    Matched MeSH terms: Vaccination/adverse effects
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