Summary

VAERS is a blessing. It’s a public vaccine pharmacovigilance system with millions of adverse event reports. The CDC is instructed to maintain the database and inform the public about any safety signals they should find in it. Alas, they widely ignore this responsibility.

I am here to help change that, so I took a look into the LAB_DATA field of VAERS entries in adverse event for both the HPV vaccines and all other vaccines.

There were 9 entries about women aged 12-25 which had the LAB_DATA field populated with the results of follicle-stimulating hormone levels tests.

Of these 9 entries 8 had menopausal FSH levels and 1 had a level of 0.8 IU/l.

The average FSH level in female HPV vaccinees aged 12-25 was 72.4 ±23.3 IU/l (95% CI: 49.2 – 95.7 IU/l) which is physiological only in post-menopausal women.

In comparison the average FSH level in females aged 15-34 who received another vaccine was 13.7 ±8.1 IU/l (95% CI: 5.6 – 21.8 IU/l).

EDIT: All patients who had elevated FSH levels took GARDASIL or GARDASIL9. The only patient with physiological FSH levels took CERVARIX.

Introduction

I stumbled over a publication from 2017 which states: “Approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived. […] If 100% of females in this study had received the HPV vaccine, data suggest the number of women having ever conceived would have fallen by 2 million [in the USA].”

This stimulated me to browse VAERS for all reports which LAB_DATA field contain FSH level test results.

Methods

I searched all VAERS reports for entries which LAB_DATA field matched the following Regular Expression:

/(^FSH\W)|(\WFSH\W)|(\WFSH$)/

It would have made sense to look for LH, estradiol and AMH levels as well, but time is a precious resource and there are lots of other peculiarities in the VAERS database that I would like to write about, so FSH will have to do for today.

I have plotted all the lab results to a scatter chart against patient age for both vaccinees receiving a HPV vaccine and vaccinees receiving another vaccine.

Results

These are the results for female HPV vaccinees aged 12-25:

53.9, 4.5, 96.5, 108, 0.7, 118.8, 162.2, 111.7,, 3.5, 81, 0.8, 72, 55, 150, 9, 73.4, 101.5, 101.5

average: 72.4 IU/l

95% CI: 49.2 – 95.7 IU/l

These are the results for female non-HPV vaccinees aged 15-34:

6.6, 4.8, 5.6, 7.8, 5.9, 36.7, 6.9, 79.4, 61.87, 4.09, 6.8, 11.7, 6.8, 5, 6.68, 6.1, 4.29, 4.29, 6.3, 9.8, 6.6, 7.2

average: 13.7 IU/l

95% CI: 5.6 - 21.8 IU/l

.

Notes

I’d like you to look at these MedDRA terms on my safety signal website pervaers.com:

• All pregnancy-related outcomes

• Infertility female

• Cervical displasia

• Abortion spontaneous

• Foetal disorder

• Foetal death

• Exposure during pregnancy

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