I have kidney disease and have been told I'm soon in need of a transplant. I have been hassled for 18 months to get this untested injection. I refused.
I was right.
PRAC started an assessment of erythema multiforme (EM;a hypersensitivity (allergic) reaction with characteristic round skin lesions, which may also affect mucous membranes in internal body cavities) to establish whether it is a side effect of Spikevax.The assessment follows a small number of cases reported after vaccination with Spikevax to EudraVigilance (see section 2). Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine.
Further data and analyses have been requested from the marketing authorisation holder to support the ongoing assessment by PRAC.
Glomerulonephritis and nephrotic syndrome
PRAC started an assessment of glomerulonephritis (inflammation of tiny filters in the kidneys) and nephrotic syndrome (kidney disorder causing the kidneys to leak too much protein in the urine) to establish whether they may be side effects of Spikevax. Affected patients may present with bloody or foamy urine, oedema (swelling of the eyelids, feet or abdomen),
or fatigue. The assessment follows a small number of cases reported after vaccination with Spikevax in the medical literature, including cases where patients experienced relapse of pre-existing kidney conditions. Further data and analyses have been requested from the marketing authorisation holder to support the ongoing assessment by PRAC.
PRAC discussed reported cases of menstrual disorders occurring after vaccination against COVID-19.No causal association between COVID-19 vaccines and menstrual disorders has been established so far. Menstrual disorders are very common in the general population and can occur without an underlying medical condition. Causes can range from stress and tiredness to conditions such as fibroids and endometriosis. Women experiencing unexpected vaginal bleeding (e.g. in postmenopausal women) or who are concerned about prolonged or severe menstrual disturbances may want to seek medical advice.The marketing authorisation holders for all COVID-19 vaccines authorised in the EU have been requested to provide further data as part of the MSSRs. PRAC will review all available evidence, including reports of suspected side effects and scientific literature,and will continue monitoring the issue.