More than 150 million injections of Covid vaccines have been carried out in France according to ANSM, including more than 117 million with Pfizer's Comirnaty vaccine. In total, all vaccines combined, 0.12% of adverse effects are recorded in France, including 25% of serious cases.
New ANSM report on the side effects of Covid vaccines. More than 150 millions d'injections of Covid vaccines have been carried out in France according to the National Medicines Agency information point (ANSM) updated on October 28 of which more than 117 million with Pfizer's Comirnaty vaccine . In total, all vaccines combined, 0.12% adverse effects are recorded in France, including 25% of serious cases. The Medicines Agency does not report any new side effects to watch for in its latest report. What are the Side effects of each vaccine? With l' AstraZeneca ? Pfizer or Modern ? With Janssen (Johnson&Johnson) ? Novavax ? What percentages ? In children and adolescents ? What are the more frequent ? What to do when does it happen? After the 4th dose ?
Like all medicines, vaccines can cause side effects, called 'undesirable'. According to the definition of the Medicines Agency, an adverse effect is an harmful and unwanted reaction occurring in a patient related or likely to be related to a product while it is being used according to the terms of its marketing authorization or during any other use (overdose, misuse, drug abuse, medication error). .
According to the article R. 5121-152 of the Public Health Code, a serious adverse effect is 'an adverse reaction that is lethal, or likely to be life-threatening, or resulting in significant or long-lasting disability or incapacity, or causing or prolonging hospitalization, or manifesting as a congenital abnormality or malformation' .
You can report side effects directly through the national reporting system.
As a reminder, a 'notified case' adverse effect corresponds to a vaccinated person in whom the occurrence of one or more adverse effects after administration of a vaccine has given rise to a pharmacovigilance report . Reported cases are classified according to their seriousness (serious or not serious) and their unexpectedness (expected if the description is in the summary of product characteristics and package leaflet, or unexpected if it is not).
The cases of adverse effects observed following the Covid vaccination in France are monitored by the National Medicines Safety Agency (ANSM). At the time of placing on the market, all the adverse effects linked to a medicine such as a vaccine are not always known. 'especially rare (<1/1000) or delayed effects' explains the ANSM. That is why, when the medicine hits the market and becomes available to a greater number of people, it continues to be constantly monitored and analyzed taking into account the evolution of knowledge and its use in daily life. A weekly then bi-monthly monitoring committee bringing together all the regional pharmacovigilance centers (CRPV) has been set up 'for monitor the safety profile of vaccines in real time from the declarations made by health professionals or by vaccinated persons' reassure authority. More or less frequent side effects are indicated in the notice you vaccine.
→ From December 27, 2020 to October 20, 2022: 121,402 cases since the start of vaccination for more than 117,434,300 injections . 34% among 30-49 year olds, 24% among 50-64 year olds. The majority of adverse effects are expected and not serious, recalls the ANSM. There were no new events reported during the summer of 2022. 'Concerning the cases of death declared, the elements transmitted do not indicate a potential role of the vaccine. These events will continue to be subject to specific monitoring. indicates the ANSM.
→ After the booster dose: No specific signal has been identified, indicates the ANSM, in people who have had a first dose or a second booster dose. 'The profile of reported adverse effects is similar to that reported after the primary vaccination.'
→ Among 5-11 year olds: Since December 20, 2021, 152 cases including 15 serious have been reported for more than 528,400 doses injected. Cases of childhood multisystem inflammatory syndrome (PIMS) are still under surveillance.
→ Among 12-18 year olds: Since June 15, 2021, 3,965 cases including 1,011 serious cases have been reported for more than 10.4 million doses injected. 'No specific signal has been identified in children and young people. Based on the data analyzed, the safety profile of the Comirnaty vaccine in children and young people is comparable to that of adults ' indicates the ANSM.
→ In pregnant and lactating women: No new security signal has been identified as of October 27, 2022. Spontaneous miscarriages account for the majority of adverse effects recorded. 'Current data do not support the conclusion that these events are related to the vaccine , especially since risk factors were associated in several cases and it is a relatively frequent event in the general population (from 12 to 20% of pregnancies according to the studies). Following the 3 cases of fetal cerebral hemorrhage and/or thrombosis occurred in Norway in vaccinated women, a review of cases reported in France was carried out by the CRPV. Nowadays, 2 cases occurred in women in their thirties after vaccination with Comirnaty. ' The chronology of the effects is not compatible with vaccination and there is no other element indicating that these events would be linked to the vaccine. These events therefore do not constitute a safety signal. They will continue to be monitored both at national and European level as part of the specific monitoring of pregnant and breastfeeding women.'
Heart rhythm disorders
Thrombocytopenia / immune thrombocytopenia / spontaneous hematomas
Diabetic imbalance in contexts of reactogenicity
Macrophage activation syndrome
Epstein-Barr virus reactivation
Idiopathic bone marrow depression
Multisystem Inflammatory Syndrome (PIMS)
Parsonage-Turner syndrome (amyotrophic neuralgia)
Cerebral vein thrombosis
Corneal transplant rejection
High blood pressure
Painful uterine contractions
Deaths in the womb
In the communicated announcing the validation of the Moderna vaccine (renamed Spikevax in June 2021) in the European Union on January 6, 2021, the European Medicines Agency (EMA) has reported the side effects seen in the largest clinical trial conducted in phase 3 -before marketing the vaccine- on 30,351 people aged 18 to 94. The most common were pain at the injection site, fatigue , headaches, muscle aches and joints, chills , nausea/vomiting, fever, injection site swelling and redness. The effects are listed in the notice you vaccine.
→ From January 19, 2021 to October 2, 2022 : 31,895 cases since the start of vaccination for more than 23,985,500 injections. 43% among 30-49 year olds and 25% among 50-64 year olds. “A large number of cases concern non-serious local delayed reactions” indicates the ANSM. There is no new signal identified in the summer of 2022 with Moderna's vaccine. “Concerning the cases of death declared, the elements transmitted do not indicate a potential role of the vaccine. These events will continue to be the subject of specific surveillance” says the health agency.
→ After the booster dose: 'No specific signal was identified in people who had a booster dose. The profile of the adverse effects reported is similar to that of the adverse effects reported during the primary vaccination' indicates the ANSM. And no signal specific has been identified after administration of a vaccine regimen with at least two different vaccines .
→ In pregnant and breastfeeding women: No new signal identified as of October 20. The Spontaneous miscarriages account for the majority of adverse event cases recorded in the national pharmacovigilance database. Current data do not allow us to conclude that these events are linked to the vaccine, especially since risk factors were associated in several cases and it is a relatively frequent event in the general population (from 12 to 20 % of pregnancies according to studies). In addition, 3 recent studies (Zauche & al, Kharbanda & al and Magnus & al) did not find a link between spontaneous miscarriages and mRNA vaccines against Covid-19. Thus, the link with the vaccine cannot be established.
More severe reactogenicity after the 2nd dose
Imbalance/recurrence of chronic pathologies
Amnesic stroke (transient amnesia)
Hearing disorders (deafness, hypoacusis)
Loss of consciousness, more or less associated with falls
PIMS (Pedatric Multi-System Inflammatory Syndrome) in 12-18 year olds previously vaccinated with Moderna
Cerebral vein thrombosis
ANCA systemic vasculitis
Autoimmune hemolytic anemia (AIHA)
Delayed reactions (painful, erythematous, pruritic local reactions at the injection site)
High blood pressure type vascular disorders
Deaths in the womb
The Astrazeneca-Oxford vaccine is authorized on January 29, 2021 by the European Medicines Agency and administered in France from February 6 . The vast majority of cases of adverse effects relate to flu-like syndromes, often of high intensity (high fever, body aches, headaches) . L' ANSM advises to favor the use of paracetamol at the lowest dose and for the shortest possible time. Signal on events thromboembolic atypical with the Vaxzevria vaccine has been the subject of conclusions at European level . The summary of product characteristics and instructions have been updated to include 'very rare' side effects such as thrombotic thrombocytopenic syndrome and coagulation disorders. These syndromes require rapid specialized medical care.
→ From February 6, 2021 to October 20, 2022 : 31,094 cases since the start of vaccination for more than 7,861,900 injections. 39% among 50-64 year olds, 25% among 30-49 year olds. The vast majority of these cases concern flu-like syndromes , often from high intensity (high fever, body aches, headache). There were no new signals identified during the summer of 2022.
Mucocutaneous bleeding (mainly bruising and nosebleeds)
Shingles and herpetic reactivation
High blood pressure
Dyspnea and asthma associated with flu-like syndromes
Central demyelinating pathology
Giant cell arteritis
Maladie de Still
Venous and arterial trhomboembolic event
Systemic necrotizing vasculitis
Thrombosis associated with thrombocytopenia
Capillary leak syndrome
Guillain-Barré Syndrome (GBS) / Polyradiculonévrite
The Janssen vaccine or ' Jcovden 'from Johnson&Johnson Laboratories was authorized by the European Medicines Agency on March 11, 2021 and is administered in French pharmacies under the same conditions as the AstraZeneca vaccine (over 55). The phase 3 clinical trial conducted on nearly 44,000 people showed Side effects 'usually mild or moderate and disappeared a few days after vaccination' stated the Agency in its communicated . The most common were pain at the injection site, headache, fatigue, muscle aches and nausea. Reactogenicity was generally lower in intensity and reported less frequently in older adults (≥65 years old) in clinical trials. the CPR of the vaccine lists possible side effects by frequency.
→ From April 24, 2021 to October 20, 2022: 1,700 cases since the start of vaccination for more than 1,089,700 injections. The majority of undesirable effects are not serious, expected and of favorable evolution, in particular effects of reactogenicity (for example discomfort ). There was no new signal identified in the summer of 2022.
High blood pressure
Thrombosis associated with thrombocytopenia
Capillary leak syndrome
Guillain-Barré Syndrome (GBS) / Polyradiculonévrite
Vaccination with Nuvaxovid vaccine from the Novavax laboratory a started in France on March 1, 2022 . In total, more than 33,000 injections have been performed as of October 20, 2022. A total of 80 cases of adverse effects have been analyzed by the reporting CRPVs (Lyon and Grenoble). European authorities have confirmed cases of paresthesia (tingling sensation on the surface of the skin) / hypoesthésie (loss of sensitivity) and anaphylaxis . Among the potential signals under surveillance: pericarditis and chest pain .
According to the analysis published by the ANSM on September 9, 2022, a total of 147 serious cases occurred after the second booster shot realized with the Pfizer vaccine (on 5,098,624 injections). They concern 70 women and 77 men, with an average age of 77.6 years (min 51 years – max 101 years). 'Of all of these 147 cases, no specific characteristic emerges compared to the expected in this population and to cases that could be analyzed after a 1st or 2nd injection, or first reminder of Comirnaty' specifies the ANSM which does not issue a safety signal. As of August 25, 2022, 28 adverse events reported after Moderna's 2nd Spikevax booster including 10 serious out of 306,895 injections.
Menstrual disorders reported after vaccination with an mRNA vaccine are carefully monitored, recalls ANSM in a new analysis of June 23, 2022 . According to the regional pharmacovigilance centers (CRPV), as of April 28, 2022 (latest data): 9,381 reports of cycle disorders reported with the vaccine Comirnaty ( Pfizer ), that is 0.02% of total injections and 1,557 reports of cycle disorders reported with the Spikevax vaccine ( modern ), that is 0.01% of total injections. The effects manifest themselves mainly in two ways : by abnormal bleeding (metrorrhagia, menorrhagia) and by late periods and amenorrhea . These are mostly short-lived and self-limiting events.
At European level, cases of myocarditis have been reported following vaccination with Comirnaty and Spikevax. These manifestations are recognized as a adverse effect of mRNA vaccines by the European Medicines Agency (EMA). Myocarditis is considered an adverse effect can occur very rarely following vaccination with Comirnaty or Spikevax. In France, EPI-PHARE (ANSM-Cnam scientific interest group) conducted a study who confirmed 'the existence of an infrequent risk of myocarditis and pericarditis within 7 days of vaccination against Covid-19 with an mRNA vaccine (Comirnaty and Spikevax) in people aged 12 to 50, particularly among young people aged 12 to 29. This risk is higher with Spikevax vaccine .' This risk appears more marked in young men under 30 after the second dose but is also increased in women under 30 after the second dose. the risk of pericarditis also appears to be greater after the Spikevax vaccine in people under 30 years of age, particularly after the second dose which is thought to cause an excess of cases reaching in the order of 18 per million doses in young men. This study also confirms the favorable clinical course cases of myocarditis and pericarditis following vaccination. To date, the only hypothesis mentioned by the authorities would be the higher concentration of RNA in Spikevax (100 micrograms of RNA versus 30 micrograms in the Pfizer vaccine) . These new data do not currently call into question the benefit/risk ratio of vaccines against Covid-19 for the French health authorities.
After an analysis of reported cases of Guillain-Barré syndrome (GBS) in Europe, the European Medicines Agency considered on July 22, 2021 that there is a possible link with the vaccine Janssen (108 cases worldwide as of June 30, 2021) and Vaxzevria (AstraZeneca). The SmPC of these vaccines now mentions this risk. The EMA considers that the side effect is 'very rare' . No association has been identified between GBS and the COVID-19 vaccines Comirnaty and Spikevax (Moderna). The appearance of evocative symptoms should lead to consult a doctor without waiting. Symptoms to watch out for include:
Pregnant women can get vaccinated against Covid. There are no contraindications. 'The majority of reported adverse effects concern Comirnaty®, which is one of the recommended vaccines (mRNA) for pregnant women and is the most administered vaccine, to date, in France' informs ANSM in a report dated May 31, 2022. According to French pharmacovigilance data validated by ANSM from December 27, 2020 to September 1, 2022:
► Spontaneous miscarriages (FCS) represent the majority of adverse effects recorded . The ANSM recalls that 'This is a relatively common event in the general population' and that' ' a vaccination-related risk cannot be concluded , especially since risk factors were associated in 30% of cases' . ' Several studies have been particularly interested in this risk of FCS and do not find a link with vaccination against COVID-19.
► There is no signal retained to date with vaccination in pregnant women but some side effects such as thromboembolic effects , them dead in the womb them HELLP syndromes and the cases of uterine contractions and metrorrhagia are 'to be monitored' , estimates the French Medicines Agency.
► There is no particular signal on the data in the literature concerning breastfeeding and vaccine against COVID-19 'but the occurrence of mastitis should be monitored' . The effects reported on lactation are quite heterogeneous and in low percentage in a study that is not methodologically robust, argues the ANSM. 'A link with vaccination therefore cannot be established.'
In conclusion, 'data from the literature and from pharmacovigilance monitoring do not, to date, show a risk of vaccination against Covid-19 in pregnant and breastfeeding women'.
For 5-11 year olds: Since December 20, 2021, 148 cases of adverse effects (0.03%) including 15 serious were reported for more than 524,000 injected doses. 'The currently available data does not suggest a specific safety signal to the Comirnaty vaccine in a population of children aged between 5 and 11 years' indicates the ANSM. Cases of childhood multisystem inflammatory syndrome (PIMS) are still under surveillance.
→ Among 12-18 year olds: Since June 15, 2021, 3 605 cas (0.04%) dont 962 serious cases of adverse reactions were reported for more than 10.3 million doses injected. 'No specific signal has been identified in children and young people. Based on the data analyzed, the safety profile of the Comirnaty vaccine in children and young people is comparable to that of adults ' indicates the ANSM.
→ With the Pfizer-BioNTech vaccine : the median time to onset of effects is one day, indicates the ANSM in the July 2021 report.
→ With Moderna's vaccine: the median time to onset of effects is one or two days, indicates the ANSM in the report of July 16. Delayed reactions are well documented in clinical trials with the vaccine. They are mostly non-serious, with painful, erythematous, pruritic local reactions at the injection site, occurring with between 4 and 31 days after vaccination (average time 8 days). Since the start of the follow-up, a few cases of prolonged pain in the vaccinated arm leading to functional impotence that can last a few weeks. The cases of myocarditis and pericarditis mainly occur within 7 days following vaccination (especially after the second dose).
→ With the Janssen vaccine, according to' ANSM ; 49.6% of adverse effects occurred within 24 hours of injection.
Vaccine-related adverse events are monitored by several regional pharmacovigilance centres:
The frequency of the ANSM monitoring committee is now fortnightly . The summary of results and highlights will be published at the end of each committee meeting. The detailed pharmacovigilance reports now cover monthly data and are published alternately according to the type of vaccine (RNA, viral vector).
COVID-19 Vaccine AstraZeneca - Risk of thrombocytopenia and bleeding disorders. VACCINES - DRUG RISKS - 03/29/2021
Update on lot ABV5300 of the AstraZeneca vaccine against COVID-19 13/03/2021. ANSM
ANSM vaccine monitoring file
Summary of Product Characteristics Comirnaty from Pfizer.
Summary of COVID-19 Product Characteristics Vaccine Moderna.
Covid-19 vaccines: why and how to report adverse effects? ANSM. Guide to health professionals. December 24, 2020.
Adverse Reaction Reporting Guide for Patients. December 24, 2020.
What is an adverse effect? Vaccination-Info Service.fr
Reporting of adverse effects. Ministry of Health. February 21, 2018.Source journaldesfemmes.fr