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Reports of menstrual disorders in Vaccine Adverse Event Reporting System (VAERS)

Figure1 (Flow diagram of case inclusion in this study) depicts the report selection procedure, including the reasons for exclusion. By November 12, 2021, 1,742,590 cases of adverse events were recorded in the VAERS database, and 60.94% of them were female. The category including menstrual disorders events 14,331 reports (1.36%), of which 13,118 (90.90%) were exposed to COVID19 vaccine and 13,13 (9.10%) were exposed to another vaccine. There were 1,047,452 (98.64%) other adverse events, 587,325 (56.07%) were exposed to COVID-19 vaccine and 460,130 (43.93%) were exposed to other vaccines.

Flow diagram of case inclusion in this study

Table 1 outlines the fundamental features of the 14,431 instances of menstrual disorders that have been documented. Reports of menstrual disorders are not mutually exclusive of each other, and multiple conditions may be encompassed in one adverse reaction report. The most prevalent event in both groups was Menstruation irregular, with 4626 cases (35.26%) reported in the COVID-19 vaccine group and 372 cases (28.33%) in the non-COVID-19 vaccine group. The COVID-19 vaccine group reported 2698 cases (20.57%) of Menstruation delayed,2088 cases (15.92%) of Intermenstrual bleeding, and Menorrhagia was reported only 28 cases (0.21%). The non-COVID-19 vaccine group reported 251 cases of Metrorrhagia (19.12%), 301 cases of Amenorrhoea (22.90%) and only 6 cases of Intermenstrual bleeding (0.46%).

The median age at the time of reporting was 35years in both groups, with a mean age of 36years in the COVID-19 vaccine group, which was greater than 16years in the non-COVID-19 vaccine group. A high proportion of the reported age was undetermined in both groups. Nearly half (48.82%) of the reported menstrual irregularities in the non-COVID-19 vaccine group were reported in the younger age group (<20years). Whereas in the COVID-19 vaccine group, a higher proportion (42.55%) was reported in the prime age group (3049years). After Fisher's exact test, there was a discrepancy between the two age groups (P value<0.001).

The interval from vaccine exposure to reported onset was reported in 11,681 cases (80.94%), with a median of 3.0days. There were 10,877 cases (82.92%) in the COVID-19 vaccine group with an adverse reaction reporting interval<100days. The non-COVID-19 vaccination group had an average reporting gap of 8days. After Fisher's exact test, there was a difference in the reporting interval between the two groups (P value<0.001). The following 20 non-COVID-19 vaccinations have been linked to recorded cases of menstrual disorders: Influenza virus vaccine(38 reports), Hepatitis B virus vaccine(51reports), Tetanus and diphtheria toxoids vaccine(9 reports), Pneumococcal vaccine (3 reports), Varivax-varicella virus live(14reports), Tetanus toxoid (1report), Human papillomavirus(1073 reports), Hepatitis A (12 reports), Anthrax vaccine (20 reports), Measles(1report), Measles, mumps and rubella virus vaccine(15 reports), Lyme disease vaccine(4reports), Rabies virus vaccine(2reports), Smallpox vaccine(2reports), Meningococcal conjugate vaccine(3 reports), Hepatitis A+hepatitis B vaccine(4 reports), Ebola Zaire vaccine(1 report), Meningococcal group b vaccine(1 report), Varicella-zoster vaccine(1 report), Unknow(57 reports).

The reported species of serious adverse events were mainly related to Death, Life-threatening, Emergency room visits, Hospitalized, Prolonged hospitalization, and Disability. There were no reports of deaths in the COVID-19 vaccine group, and a total of 1079 serious adverse events were reported (8.22%). 901 serious adverse events (68.62%) were documented in the non- COVID-19 vaccine group, three fatalities were reported which were the result of exposure to Human papillomavirus vaccine (2 reports) and Hepatitis B virus vaccine (1 report). More than one-third of the reports in both groups mentioned a prescription or nonprescription drugs that the vaccine recipient was taking at the time of vaccination and 1175 cases (8.20%) were suffering from a disease, while 6481 cases (45.22%) had been diagnosed with a disease prior to vaccination.

Table 2 describes the characteristics of the 13,118 menstrual disorders reported as a consequence of exposure to the COVID-19 vaccine. 9613 cases (73.28%) were reported in relation to Pfizer-Biontech, 2748 cases (20.95%) for Moderna and 742 cases (5.66%) for Janssen. The reported rates of other menstrual events differed between groups (p<0.001), except Intermenstrual bleeding, Hypomenorrhoea, Menorrhagia. Comparison between groups revealed that the distribution of reports of menstrual disorders by age group was heterogeneous (p<0.001). Except for the type of vaccine that could not be characterized, the remaining three groups reported significantly higher proportions in the 3039 age group than in other age groups, respectively accounting for 19.53%, 38.54%, and 31.67% of the total. The dose distribution by injected vaccine was likewise heterogeneous (P<0.001), with Dose 1 being reported at a significantly higher rate than Dose 2 and Dose 3. Only 1596 cases (16.60%) of vaccine recipients recovered from the adverse event when the adverse reaction information was reported, and 66.33% did unrecoverable at the time of reporting.

Analyses of the stated odds ratio for the COVID-19 vaccination incidents are shown in Tables 3, 4, 5, 6. The distribution of adverse events according to type (Menstrual disorder vs. other adverse reactions) and vaccination status (COVID-19 vaccines vs. other vaccines) is reported in Table 3. ROR estimated to be 7.83 (95% CI: 7.398.28), implies that COVID-19 vaccine may be a risk sign for the occurrence of events related to menstrual disorders. To further validate the correlation, three sensitivity analysis of the ROR were also performed. Firstly, aggregated by region of adverse reaction reporting (US vs. non-US) and vaccination status, ROR was 0.78(95% CI: 0.700.88), suggested that the reports of menstrual disorders after vaccination with the COVID-19 vaccine are unrelated to the regional distribution. Secondly grouped by age and type of report, compared the reported rates of adverse events associated with menstrual disorders in the 3049 age group with those in other age groups, ROR was 5.78(95% CI: 4.866.88). Finally, excluding reports of unknown age, ROR was 12.46(95% CI: 10.4114.92). Suggests that age may be a risk indicator for the event of menstrual disorders after vaccination with the COVID-19 vaccine.

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COVID-19 vaccine and menstrual conditions in female: data analysis of the Vaccine Adverse Event Reporting System (VAERS) - BMC Women's Health - BioMed...