Adverse reactions remain rare, occurring in roughly one case per thousand vaccinations.
In the long tradition of medicine's covenant with transparency, Portugal's National Medicines Authority joins 63 other nations this week in inviting citizens and healthcare workers to name what they have experienced after vaccination — not to cast doubt on vaccines, but to deepen the collective understanding of them. The #MedSafetyWeek campaign, now in its sixth year, rests on a quiet but profound premise: that safety is not a fixed property of a medicine, but an ongoing conversation between those who administer it and those who receive it. With over 15,900 suspected adverse reactions documented across 16 million COVID-19 doses in Portugal, regulators are not sounding an alarm — they are tending to the record that makes trust possible.
- Portugal has logged 15,922 suspected adverse reactions to COVID-19 vaccines, including 85 deaths among elderly patients and 5,929 severe cases — numbers that demand honest public accounting.
- The tension is delicate: how to acknowledge real harm without undermining confidence in vaccines that have saved millions of lives globally.
- Infarmed is pushing back against silence by urging healthcare providers to proactively discuss side effects with patients before the needle goes in, so that unusual reactions get reported rather than quietly absorbed.
- The campaign runs through 64 countries and is anchored by the WHO-linked Uppsala Monitoring Centre, signaling that this is not a local concern but a coordinated act of global pharmacovigilance.
- Portugal's RAM Portal remains open for anyone to report a suspected reaction — the infrastructure for transparency exists, and the campaign is simply asking people to use it.
Portugal's medicines regulator, Infarmed, is participating in the sixth annual #MedSafetyWeek campaign through November 7th, joining regulatory agencies across 64 countries in a coordinated push to encourage reporting of suspected vaccine adverse reactions. The campaign, driven largely through social media, targets healthcare workers, patients, caregivers, and family members alike.
Infarmed's position is unambiguous: vaccines are among humanity's most effective defenses against infectious disease. But they are not without risk, and every reported reaction — however minor — helps regulators detect patterns, identify rare effects, and maintain an accurate picture of real-world safety. Reporting is not an act of suspicion; it is an act of care.
The Portuguese data between December 2020 and late September 2021 reflects both the scale of the vaccination effort and the weight of its consequences. Across roughly 16 million doses, 15,922 suspected reactions were recorded. Of those, 5,929 were classified as severe — including 3,612 deemed clinically important, 1,517 causing disability, 557 requiring hospitalization, 158 posing life-threatening risk, and 85 resulting in death, all among elderly patients. Infarmed notes that adverse reactions occur in approximately one per thousand vaccinations, and that roughly 85 percent of severe cases involved temporary effects.
The most frequently reported symptoms included headache, fever, muscle pain, injection-site pain, and fatigue. Pfizer/BioNTech accounted for the largest share of reported reactions, followed by AstraZeneca, Moderna, and Janssen — though Infarmed cautions that these figures cannot be used to compare vaccine safety, given the different populations and conditions under which each was deployed.
This year's campaign places particular emphasis on the moment before vaccination: healthcare providers are encouraged to speak openly with patients about what to expect, so that anything unusual gets noticed and reported. The Uppsala Monitoring Centre, collaborating with the WHO, leads the global effort. In Portugal, reports can be submitted through the RAM Portal on Infarmed's website. The message is not that vaccines carry hidden dangers — it is that documenting what is known, and what is rare, is precisely how public trust is earned and maintained.
Portugal's medicines regulator is joining a coordinated international push this week to get people talking about vaccine side effects. The National Medicines Authority, known as Infarmed, is participating in #MedSafetyWeek through November 7th—the sixth consecutive year it has taken part in the campaign, which this year spans 64 countries and operates primarily through social media.
The goal is straightforward: encourage healthcare workers, patients, caregivers, and family members to report suspected adverse reactions to vaccines, including COVID-19 shots. Infarmed's message is clear that vaccines remain among the most effective tools for preventing infectious disease and have saved millions of lives globally. But like all medicines, they can cause side effects, and every suspected reaction matters. When people report these incidents, regulators can identify patterns, spot new or unusual reactions, and build a fuller picture of how safe a vaccine actually is.
The numbers from Portugal tell a specific story. Between the start of the vaccination campaign on December 27, 2020, and late September 2021, the country recorded 15,922 suspected adverse reactions across roughly 16 million doses administered. Of those, 5,929 were classified as severe—meaning they caused real harm. The breakdown is sobering: 3,612 reactions were deemed clinically important, 1,517 caused disability, 557 led to hospitalization, 158 posed a life-threatening risk, and 85 resulted in death, all among elderly patients. Yet Infarmed emphasizes that adverse reactions remain rare, occurring in roughly one case per thousand vaccinations. About 85 percent of the severe cases involved temporary disability—including time off work—or other clinically significant effects that the person reporting deemed important enough to document.
The most commonly reported side effects were headache (3,826 cases), fever (3,820), muscle pain (3,744), pain at the injection site (3,347), fatigue (1,864), chills (1,618), nausea (1,453), joint pain (1,187), and general body aches (1,067). Dizziness, malaise, limb pain, swollen lymph nodes, weakness, and vomiting rounded out the list. The Pfizer/BioNTech vaccine accounted for 8,434 reported reactions across 10.7 million doses; AstraZeneca had 4,293 reactions from 2.2 million doses; Moderna reported 1,778 from 1.9 million doses; and Janssen had 1,340 from 1.1 million doses. Infarmed cautions that these numbers cannot be used to compare safety profiles between vaccines, since they were deployed in different population groups, at different times, and under different epidemiological circumstances.
This year's campaign places special emphasis on healthcare providers who administer vaccines. They are being encouraged to discuss potential side effects with patients before vaccination, so people know what to watch for and can report anything unusual. The Uppsala Monitoring Centre, which collaborates with the World Health Organization on international drug safety surveillance, is leading the global effort. In Portugal, anyone who suspects a vaccine adverse reaction can report it through the RAM Portal on Infarmed's website. The message is not that vaccines are risk-free—it is that understanding and documenting those risks, however rare, is how regulators keep the public safe.
Notable Quotes
Vaccines are the best way to protect citizens against infectious diseases and have already saved millions of lives, but like all medicines, they can cause adverse reactions that must be reported.— Infarmed (National Medicines Authority)
These data do not permit comparison of safety profiles between vaccines, since they were used in distinct population subgroups and in different time periods and epidemiological contexts.— Infarmed
The Hearth Conversation Another angle on the story
Why does a country need a whole week dedicated to reporting vaccine side effects? Isn't that something people already do?
You'd think so, but reporting is actually voluntary and requires someone to take the step of contacting a regulator. Most people don't know they can do it, or they assume their doctor already reported it. The campaign is about closing that gap—making it visible and easy.
So when Portugal says 85 deaths were reported as adverse reactions, does that mean the vaccines caused those deaths?
That's the crucial distinction. These are suspected adverse reactions—reported cases where someone died after vaccination. It doesn't prove causation. The person could have died from an unrelated illness. That's why the reporting system exists: to collect these signals so regulators can investigate whether there's actually a pattern.
And is there? A pattern?
The data shows 85 deaths among elderly patients across 16 million doses. That's 0.5 percent of the severe reactions reported. Infarmed emphasizes that adverse reactions overall occur in about one per thousand vaccinations. So statistically, they're rare. But rare doesn't mean zero, and that's what the campaign is really about—acknowledging that while also being honest about the numbers.
Why does it matter which vaccine caused which reaction?
Because if one vaccine had significantly more serious side effects, regulators would need to know. But Infarmed explicitly says you can't compare the vaccines using these numbers, because they were given to different age groups at different times. A vaccine given to healthcare workers in January looks different from one given to elderly people in March. The context changes everything.
So what's the actual ask here?
Tell your doctor. Tell the regulator. If you get vaccinated and something feels wrong—even if you're not sure it's related—report it. That's how the system learns. It's not about fear. It's about transparency.