More than 460 reports of menstrual disturbances in women who received a Covid-19 vaccine have been submitted to the State’s medicines regulator.
The Health Products Regulatory Authority (HPRA) said 94 of these related to missing periods and 365 to heavier menstrual bleeding.
“In the vast majority of cases, reports were received directly from a vaccinated woman describing a menstrual disturbance with no associated medical condition,” the regulator said in its latest update on vaccine safety.
Latest investigations by the safety committee of the European Medicines Agency (EMA) suggest there may be "short-lived changes" in menstrual patterns, including absence of menstrual bleeding and heavier-than-usual menstrual bleeding following mRNA vaccination, the HPRA said.
“This further assessment is part of routine ongoing safety monitoring, and the EMA has stated that, at this stage, it is not yet clear whether there is a causal link between the Covid-19 vaccines and reports of changes in menstrual patterns. There is also no evidence to suggest that Covid-19 vaccines affect fertility.”
The EMA has also reviewed studies of 65,000 pregnancies and found the data “reassuring”.
“The review found no sign of increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA Covid-19 vaccination.”
Suspected side-effects
More than 1,000 reports of suspected side-effects following either a third or booster dose of Covid-19 have been received by the authority.
By February 8th, 1,077 reports of suspected side-effects had been received following the administration of 2.7 million third – or booster – doses, according to its latest safety update.
About one in every 2,250 children who has so far received a Covid-19 vaccine has reported a suspected side-effect, the update shows.
A total of 346 reports of suspected side-effects in young people have been made after administration of the Pfizer vaccine. This related to the delivery of 780,000 doses to under-18s up to February 8th.
A total of 54 of the reports related to a child – general vaccination of five to 11 year olds began last month – and the rest related to adolescents aged 12-17.
Overall, the authority says, the reports received are consistent with the types of reports received for adults, with most being mild to moderate in nature. Many had resolved or were resolving at the time of reporting, it said.
Weakness and chest pain
The most commonly reported side-effect among children (325 reports) was “general symptoms and local reactions” such as tiredness, weakness, chest pain and feeling hot. Other significant categories were nervous system issues such dizziness, headache, fainting or feeling faint (237) and gastrointestinal complaints such as nausea, vomiting and abdominal pain (142).
Overall, the HPRA has received a total of 19,468 reports of side-effects, relating to about 10.5 million administered vaccines and boosters – equivalent to one report for every 540 doses.
About 40 per cent of suspected side-effects had resolved or were resolving at the time of reporting.
It has received 120 reports of myocarditis/pericarditis and 10 reports of thrombosis with thrombocytopenia syndrome (TTS)
There have been 14 reports of anaphalaxis following a Pfizer/Moderna vaccine and a "small number" after AstraZeneca/Janssen.
In 106 reports, the person was vaccinated and subsequently died. The median age of this group was 81 years.
“Reports describing a death are carefully reviewed. However, it can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination. This does not mean that the vaccine caused the deaths.”
