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Adverse events following immunisation of COVID-19 vaccine among health care workers in the first phase of vaccination

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: Dizziness/chemically induced
A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial

Dunson TR, McLaurin VL, Israngkura B, Leelapattana B, Mukherjee R, Perez-Palacios G, et al.

Contraception, 1993 Aug;48(2):109-19.
PMID: 8403908 DOI: 10.1016/0010-7824(93)90002-O

A comparative multicenter clinical trial of two low-dose combined oral contraceptives (OCs) was conducted in Malaysia, Egypt, Thailand, and Mexico. Efficacy, safety and acceptability were investigated in women taking either a norgestrel-based (NG) OC or a norethindrone acetate-based (NA) OC. This paper includes analysis of 892 women, all of whom were at least 42 days but within 26 weeks postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had significantly (p < .05) fewer menstrual-related complaints. Discontinuations due to menstrual problems were significantly more common among NA users (primarily amenorrhea). Discontinuations in the NG group were primarily for other personal reasons, e.g. unable to return to the clinic. There was also a significant difference between the two groups for the 11-month gross cumulative life table discontinuation rates due to menstrual problems (p < .01); the NA group had the higher rate.

Matched MeSH terms: Dizziness/chemically induced
Fulltext Preliminary experience with moclobemide for the treatment of depressive disorders in Malaysia

Indran SK

Singapore Med J, 1995 Apr;36(2):189-90.
PMID: 7676265

The objective of this study was to describe preliminary experience with moclobemide in the treatment of depressive disorders in the University outpatient clinic in Malaysia. Twenty patients who satisfied DSM III R criteria for depressive disorders and scored more than 16 on the Hamilton Rating Depression Score at the initial interview were recruited into this open study. The primary diagnosis of 4 patients was later ascertained to be panic disorder(2), schizophrenia(1) and social phobia(1). Patients rated themselves as improved by first follow up (7-14 days), and rated their depression as very mild to mild by the third follow up visit (ie at a mean of 46 days). Side effects were minimal and compliance good.

Study site: outpatient psychiatric clinic at the General Hospital, Kuala
Lumpur.

Matched MeSH terms: Dizziness/chemically induced
The effect of melatonin on delirium in hospitalised patients: A systematic review and meta-analyses with trial sequential analysis

Ng KT, Teoh WY, Khor AJ

J Clin Anesth, 2020 Feb;59:74-81.
PMID: 31279283 DOI: 10.1016/j.jclinane.2019.06.027

OBJECTIVES: Melatonin is an endogenous hormone, which regulates circadian rhythms and promotes sleep. In recent years, several randomised controlled trials examining the prophylactic use of melatonin to prevent delirium were published with conflicting findings. The primary aim of this review was to determine the effect of melatonin on the incidence of delirium in hospitalised patients.
DATA SOURCES: MEDLINE, EMBASE and CENTRAL were systematically searched from their inception until December 2018.
REVIEW METHODS: All randomised clinical trials were included.
RESULTS: Sixteen trials (1634 patients) were included in this meta-analysis. Incidence of delirium was not significantly lower in patients who received melatonin, with an odd ratio, OR (95%Cl) of 0.55 (0.24-1.26); ρ = 0.16, certainty of evidence = low, trial sequential analysis = inconclusive. However, patients who randomised to melatonin had a significantly shorter length of stay in intensive care units, with a mean difference, MD (95%CI) of -1.84 days (-2.46, -1.21); ρ 

Matched MeSH terms: Dizziness/chemically induced