A Pharmacovigilance Study of Covishield in a Tertiary Care Teaching Hospital in Tamil Nadu

Goldlin, T J Ainsy; Kalyanaraman, Shantaraman; Ravichandran, Mirunalini; Ramya, J Ezhil

doi:10.4103/jpp.jpp_63_21

Cited by 10 publications

(16 citation statements)

References 9 publications

(9 reference statements)

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“…Eleven (11) of those studies use a cross-sectional study design. [8][9][10][11][12][13][14][15][16][17][18] The other three (3) studies are cohort studies. [19][20][21] The characteristics of the studies found can be explored in Table 3.…”

Section: Resultsmentioning

confidence: 99%

“…[18] In addition, the increased menstrual disturbance after the Covid-19 vaccination was also associated with anxiety or stress because the Covid-19 vaccine was still newly discovered. [13] Another hypothesis is the ability of mRNA-based vaccines that were assessed to induce novel immune responses that could affect the hypothalamicpituitary-ovarian axis. [19] Menstrual changes that occurred post-Covid-19 vaccination have negatively affected the quality of life of more than 50% of women.…”

Section: Resultsmentioning

confidence: 99%

“…[19][20][21] The characteristics of the studies found can be explored in Table 3. [9][10][11][12][13][14][15][16][17][18][19][20][21] These menstrual changes appear variably in different populations. Three studies mentioned that menstrual disorders are one of the rarer post-vaccination side effects in Africa (0.5%), India (0.16%) and Spain (1st dose: 0.7%, 2nd dose: 0.25%).…”

Section: Resultsmentioning

confidence: 99%

“…Three studies mentioned that menstrual disorders are one of the rarer post-vaccination side effects in Africa (0.5%), India (0.16%) and Spain (1st dose: 0.7%, 2nd dose: 0.25%). [10,13,14] In contrast, menstrual disorders are the second most common side effect (4,8%) in female doctors and dentists in Jordan and Saudi Arabia. [12] But, it is consistent that the majority of menstrual changes happen mostly after the rst dose (46.7%) in comparison to the second dose (32.4%) or after both doses (20.9%).…”

Section: Resultsmentioning

confidence: 99%

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Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

Muskitta

Siagian

Rumondang

2023

Preprint

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Covid-19 vaccination has proven to be an effective measure to reduce morbidity and mortality. However, some reports have linked Covid-19 vaccination with alterations in menstruation. Considering that menstruation is an important health component for people who menstruate, this information may cause hesitancy to get vaccinated. There are limited systematic reviews regarding the impact of Covid-19 vaccination on changes in menstrual patterns. Therefore, it is necessary to review the available literature on this topic. A systematic review was done in accordance with the PRISMA statement. The literature search was done by hand and on four databases: PubMed, EMBASE, ProQuest, and CENTRAL. All found articles were screened based on predetermined criteria. Articles that meet the requirements were critically appraised and analyzed. Fourteen (14) articles consisting of 11 cross-sectional studies and 3 cohorts were found. The outcomes mentioned in the studies include changes in menstrual cycle range, durations, estimated blood quantities, and menstruation symptoms. There are changes in the menstrual pattern after the administration of the Covid-19 vaccination, in the form of irregular menstruation, menorrhagia, worsening of menstruation symptoms, and intermenstrual bleeding. However, these changes only occur temporarily. Therefore, the administration of the Covid-19 vaccination is beneficial for people who menstruate.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

Muskitta

Siagian

Rumondang

2023

Preprint

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“…3 Pharmaceutical companies worldwide have developed various vaccines and India plays an important role in COVID-19 vaccination as it is one of the biggest pharmaceutical manufacturers and second most populated country in the world. 4 COVISHIELD is a recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein vaccine manufactured by serum institute of India. 4 In individuals 18 years of age and older use of COVISHIELD was approved for prevention of COVID-19 disease.…”

Section: Introductionmentioning

confidence: 99%

Assessment of adverse events following first dose of COVISHIELD in healthcare workers of a tertiary care hospital in western Uttar Pradesh: A prospective observational study

et al. 2022

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Background: COVID‑19 pandemic is a great health challenge around the world. Immunization appears best preventive strategy where monitoring the safety of COVID-19 vaccines is immensely important as limited safety data available on them. Aims and Objectives: This study was conducted to perform safety surveillance and causality assessment of adverse events following immunization (AEFI) with COVID-19 vaccine. Materials and Methods: This prospective observational study was conducted on healthcare workers who received their first dose of COVISHIELD during first phase of COVID-19 vaccination in January–February 2021 at F.H. Medical College and Hospital, Tundla, Firozabad. Approval for the study was taken from institutional ethical committee. The details of AEFIs were collected and duly noted in standard AEFI case reporting form of Ministry Of Health And Family Welfare, Immunization Division, Govt. of India and reported to District Immunization Officer. Causality assessment was done in accordance with protocol of the World Health Organization. Results: Out of 419 vaccinees, 210 had developed AEFIs, and 527 AEFIs were reported considering the fact that one recipient could have experienced multiple AEFIs. Majority AEFIs were related to general disorders and administration site conditions (67.35%), where fever (28.46%), chills (16.69%),and pain at injection site (15.75%) were more common, followed by musculoskeletal and connective tissue disorders (19.55%) where myalgia (18.03%) was more commonly reported. Out of 527 AEFIs reported, majority (524, 99.43%) showed consistent causal association to immunization and 3 (0.57%) AEFIs showed inconsistent association. AEFIs classified as consistent causal association (524) mostly were vaccine product related reactions (520, 99.23%) and rest (4, 0.76%) were immunization anxiety related reactions. Severity assessment of AEFIs was done using Modified Hartwig and Siegel Severity Scale, out of total 527 AEFIs reported 60.9% were of mild severity and rest 39.1% were categorized as moderate severity. Conclusion: As adverse events post-vaccination with COVISHIELD were mild to moderate in severity and lasted for a short duration, the inconvenience caused by these AEFIs outweigh the protection offered by the vaccination against COVID-19.

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Azd-1222

2022

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A Pharmacovigilance Study of Covishield in a Tertiary Care Teaching Hospital in Tamil Nadu

Cited by 10 publications

References 9 publications

Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

Effect of Covid-19 Vaccination on Menstrual Pattern Changes : a Systematic Review

Assessment of adverse events following first dose of COVISHIELD in healthcare workers of a tertiary care hospital in western Uttar Pradesh: A prospective observational study

Azd-1222

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