Covid-19 vaccines: what are the latest reported side effects?

 

Anaïs Chabalier 15/02/2022, 12:50 – modified24/01/2023, 16:30 Health

Numerous side effects linked to Covid-19 vaccines have been reported by health authorities. What are they? We take stock of the latest adverse effects identified by the ANSM (French National Agency for Medicines and Health Products Safety) and those highlighted in various scientific studies.

79%. That’s the percentage of French people who had completed their vaccination schedule as of February 13, according to  . Four vaccines are available in France: Pfizer/BioNTech, Moderna, AstraZeneca, and Janssen. A fifth has just been authorized and will soon complete the French vaccine arsenal:

The French National Agency for Medicines and Health Products Safety (ANSM), which compiles a list of side effects for the various Covid-19 vaccines, reminds the public that “as with any vaccination, the person who has received the vaccine may experience adverse effects .” In fact  for healthcare professionals, updated on December 23, 2021, it lists the side effects of Covid-19 vaccines, from the most frequent to the rarest.

A total of 136,085,564 doses of the Pfizer, Moderna, AstraZeneca, and Janssen vaccines have been administered, according to the latest COVID-19 vaccine surveillance update covering the period from January 14 to 27, 2022. A total of 137,400 cases of side effects have been recorded since the start of the vaccination campaign. 75% are considered “non-serious” and 25% “serious.”

Potential new side effects reported by patients are also monitored and referenced by health authorities as they occur.

Pfizer vaccine: what are its side effects?

104,822,400 injections have been administered with the Pfizer (Comirnaty) vaccine. A total of 83,708 cases of side effects have been recorded since the start of the vaccination campaign. In its report of February 4, 2022, the ANSM (French National Agency for Medicines and Health Products Safety) indicates that 74% of adverse effects are considered “non-serious” and 26% “serious”.

While the ANSM (French National Agency for Medicines and Health Products Safety) did not identify any new signals or events requiring monitoring during the period of January 14-27, 2022, it reiterated the confirmed signals, namely hypertension, myocarditis, and pericarditis. It also reiterated the potential signals or events already under surveillance, including shingles, cardiac arrhythmias, acute pancreatitis, Epstein-Barr virus reactivation, multisystem inflammatory syndrome, and menstrual disorders. Regarding this last side effect, the Director General of the ANSM stated on December 1, 2021, during her hearing before the Senate, that “the discussions we have had with healthcare professionals are reassuring: the disorders resolve on their own and are most often very short-lived . “

The information sheet provided to healthcare professionals by the ANSM (French National Agency for Medicines and Health Products Safety) summarizing the side effects of the Pfizer vaccine includes:

Very common side effects (≥ 1 in 10):

• a reaction at the injection site (pain, swelling)
• fatigue
• headaches
• myalgia
• chills
• joint pain
• fever
• diarrhea

Common side effects (≥ 1 in 100 to ≤ 1 in 10):

• a reaction at the injection site (redness)
• nausea
• vomiting

Uncommon side effects (≥ 1 in 1,000 to ≤ 1 in 100):

• pain in the extremities
• lymphadenopathy
• insomnia
• a feeling of unease
• itching at the injection site
• hypersensitivity reactions (rash, itching)
• hyperhidrosis
• night sweats
• a decrease in appetite
• lethargy
• asthenia

Rare side effects (≥ 1 in 10,000 to ≤ 1 in 1,000):

• hives
• angioedema

Very rare side effects (≤ 1/10,000):

• myocarditis
• pericarditis

Side effects with an undetermined frequency:

• anaphylaxis
• extensive swelling of the vaccinated limb
• facial swelling

Pfizer vaccine: side effects more frequent in women than in men

A recent Israeli study published on February 3, 2022, in the scientific journal Vaccines, found that women were twice as likely to report side effects following an injection of the Pfizer vaccine. Indeed, according to the scientists, women were 1.89 times more likely to experience side effects after the first dose of the vaccine and 1.82 times more likely after the second injection.

Side effects such as fatigue, muscle pain and headaches are more common in women than in men.

According to the researchers, the proportion of women who reported muscle pain at the injection site was seven times higher than men after the first dose and four times higher after the second injection. The ratio of women who reported headaches was 9.15 times higher after the first dose and 3.28 times higher after the second dose. Chills were also reported and were 5.25 times higher in women after the first dose and 4.26 times higher after the second injection.

Messenger RNA vaccines are not dangerous for people with cancer

Can people with cancer be vaccinated? American scientists are reassuring: mRNA vaccines, namely Pfizer and Moderna, do not pose a danger to cancer patients. A study conducted by the National Comprehensive Cancer Network (NCCN) and published in early February analyzed the side effects reported by more than 1,700 people with cancer between February and May 2021. All had received two injections of the Pfizer vaccine three weeks apart. Among them, 1,183 had a history of cancer, and 17.8% were still undergoing treatment. The results of the study are conclusive: the adverse effects reported by people with cancer are exactly the same as those that have occurred in the rest of the population. Therefore, mRNA vaccines appear to be safe for these patients. According to the study authors, they had never ” been included ” in most of the pilot studies on Covid-19 vaccines , ” despite their vulnerability to infection “.

The Pfizer vaccine is associated with a low but real risk of carditis.

Carditis is an inflammation of the heart most often caused by a viral, bacterial, or parasitic infection. The most common forms are myocarditis and pericarditis.

For the purposes of research published on January 25, 2022 in Annals of Internal Medicine , scientists assessed the risks of carditis associated with the Pfizer vaccine. They followed 160 patients over the age of 12 who were hospitalized for carditis and 1,533 hospitalized patients who did not have carditis.

They found that people who received the Pfizer vaccine were 3.57 times more likely to develop carditis than those who were not vaccinated. ” We observed an increased risk of carditis associated with the use of Pfizer, particularly in young men receiving the second dose ,” the study states.

They emphasize, however, that this risk is low, with the incidence of carditis being 0.57 per 100,000 Pfizer vaccine injections. Nevertheless, the researchers conclude that this risk “should be brought to the attention of vaccinated individuals and physicians and weighed against the benefits of vaccination.”

Comirnaty (Pfizer) and Spikevax ( Moderna) vaccines: cases of myocarditis and pericarditis reported

Rare cases of myocarditis and pericarditis have been reported to the health authority following administration of the Pfizer and Moderna vaccines. According to the agency, these cases “mainly occurred within 14 days of vaccination, more often after the second dose, and in relatively young men . ”

In an opinion published on July 23 , the ANSM (French National Agency for Medicines and Health Products Safety) recommended that healthcare professionals be attentive to “signs and symptoms associated with myocarditis and pericarditis” after the administration of an mRNA vaccine. “Healthcare professionals should advise vaccinated individuals to consult a doctor immediately in case of chest pain, shortness of breath, or palpitations ,” the health authority warned.

Messenger RNA vaccines: they do not increase cardiovascular risk in people under 75 years of age

The Pfizer and Moderna mRNA vaccines do not increase the risk of myocardial infarction, stroke, or pulmonary embolism in people under 75. This is the conclusion of a new study conducted by the Epi-Phare group, a joint initiative of the French National Agency for Medicines and Health Products Safety (ANSM) and the French National Health Insurance Fund (Cnam).

This research, released on January 18, analyzed the risk of cardiovascular events associated with the Pfizer, Moderna, AstraZeneca, and Janssen vaccines in individuals aged 18-74. “This study confirms the safety of mRNA vaccines with regard to the risk of serious cardiovascular events in adults ,” a press release stated. A previous study on the Pfizer vaccine, conducted in individuals over 75, found no evidence of an association between the Pfizer-BioNTech vaccine and the occurrence of serious cardiovascular events within 14 days of vaccination .

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What about the AstraZeneca and Janssen vaccines? A slight increase in cardiovascular risk has been observed. More specifically, this refers to an increased risk of myocardial infarction and pulmonary embolism in adults within two weeks of receiving these vaccines. However, the study authors point out that “COVID-19 itself is strongly associated with a risk of cardiovascular complications . “

What are the reactions associated with the Moderna vaccine?

Since November 2021, the Moderna vaccine (or Spikevax) has been reserved for French citizens over 30 years of age. 22,332,200 Moderna vaccine injections have been administered since its inclusion in the vaccination campaign. As of January 27, 20,550 cases of side effects had been recorded by the ANSM (French National Agency for Medicines and Health Products Safety). 81% of these are considered “non-serious” and 19% “serious”.

During the period from December 31, 2021 to January 13, 2022, the ANSM identified new events to monitor, namely cases of thyroiditis, musculoskeletal disorders, systemic vasculitis with anti-neutrophil cytoplasmic antibodies (ANCA) and cerebral venous thrombosis.

She notes that confirmed adverse events include painful, erythematous, and pruritic local reactions at the injection site, vascular disorders such as hypertension, myocarditis, and pericarditis, as well as erythema multiforme. She also points out that potential adverse events or those already under surveillance include cardiac arrhythmias, shingles, rheumatoid arthritis, hearing problems, and menstrual disorders.

The information sheet provided to healthcare professionals by the ANSM (French National Agency for Medicines and Health Products Safety) summarizing the side effects of the Moderna vaccine includes:

Very common side effects (≥1/10):

• a reaction at the injection site (pain, swelling)
• fatigue
• headaches
• lymphadenopathy
• nausea
• vomiting
• myalgia
• chills
• joint pain
• fever

Common side effects (≥ 1/100 to ≤ 1/10):

• a skin rash
• erythema at the injection site
• hives at the injection site
• a rash at the injection site
• a delayed reaction at the injection site
• diarrhea

Uncommon side effects (≥ 1/1,000 to ≤ 1/100):

• itching at the injection site
• dizziness

Rare side effects (≥ 1/10,000 to ≤ 1/1,000):

• “Three cases of acute peripheral facial paralysis (Bell’s palsy) out of 15,185 people vaccinated in clinical trials were reported in the days following vaccination (22 to 32 days after the 2nd dose),” adds the ANSM .
• facial swelling
• hypoesthesia​

Very rare side effects (≥ 1/10000)

• myocarditis
• pericarditis

Side effects with an undetermined frequency:

• hypersensitivity
• anaphylaxis
• polymorphic erythema

What are the side effects of the AstraZeneca vaccine?

In France, the AstraZeneca vaccine is reserved for people aged 55 and over. 7,851,200 injections have been administered since the start of the vaccination campaign. As of January 27, 28,674 cases of adverse effects related to the vaccine injection had been recorded. 77% of these are considered “not serious” and 23% “serious”.

Since the start of the vaccination campaign, this product has raised numerous concerns. The reason? Reports of thrombosis cases in patients who received this Covid-19 vaccine. Cases of myocarditis and pericarditis had also been reported to the ANSM (French National Agency for Medicines and Health Products Safety) after administration of the AstraZeneca vaccine.

During the period from December 31, 2021, to January 13, 2022, no new signals or events requiring monitoring were identified. However, the ANSM (French National Agency for Medicines and Health Products Safety) reiterates that flu-like syndromes, thrombosis associated with thrombocytopenia,  Guillain-Barré syndrome, and immune thrombocytopenia are confirmed signals. Potential signals or events already under surveillance include shingles and herpes reactivation, dyspnea, vasculitis, deafness and hearing loss, arrhythmias, and pancreatitis.

The information sheet provided to healthcare professionals by the ANSM (French National Agency for Medicines and Health Products Safety) summarizing the side effects of the AstraZeneca vaccine includes:

Very common side effects (≥ 1/10):

• a reaction at the injection site (sensitivity, pain, heat, itching, bruising)
• headaches
• nausea
• myalgia
• joint pain
• fatigue
• a feeling of unease
• a feverish state
• chills

Common side effects (≥ 1/100 to ≤ 1/10):

• a reaction at the injection site (swelling, redness)
• vomiting
• diarrhea
• fever
• thrombocytopenia
• a flu-like illness
• asthenia
• pain in the extremities

Uncommon side effects (≥ 1/1,000 to ≤ 1/100):

• abdominal pain
• hives
• lethargy​
• lymphadenopathy
• a decrease in appetite
• dizziness
• drowsiness
• hyperhidrosis
• an itch
• a skin rash
• muscle spasms

Rare side effects (≥ 1/10,000 to ≤ 1/1,000):

• facial paralysis

Very rare side effects (≤ 1/10,000):

• a thrombotic thrombocytopenic syndrome
• Guillain-Barré syndrome

Side effects with an undetermined frequency:

• anaphylaxis
• hypersensitivity
• capillary leaks
• angioedema
• immune thrombocytopenia
• thrombosis of the veins and cerebrovascular sinuses

AstraZeneca vaccine: what do we know about the cases of thrombosis?

In March 2021,  was temporarily suspended in France following cases of thrombosis that occurred after vaccination. “Severe and very rare cases of thrombosis in association with thrombocytopenia have been reported after the vaccine was marketed. These include venous thromboses such as cerebral venous sinus thrombosis, splanchnic venous thrombosis, as well as arterial thromboses,” explained the ANSM at the time.

The European Medicines Agency (EMA) had ultimately indicated that the benefit-risk balance of the vaccine remained positive. Vaccination therefore resumed in France. In its report of January 7, the ANSM (French National Agency for Medicines and Health Products Safety) indicated that “a total of 29 cases meeting the definition of vaccine-induced immune thrombocytopenia (IVTT)” had been identified.

Janssen vaccine: what are its side effects?

 is the latest addition to the Covid-19 vaccine arsenal: its administration began last April. It can be given to people over 55 and uses the same technology as the AstraZeneca vaccine: it is a viral vector vaccine that uses an adenovirus to trigger an immune response.

Like the AstraZeneca vaccine, its arrival was also marked by a suspension: its use was temporarily stopped in the United States, after cases of thrombosis.

The European Medicines Agency (EMA) had ultimately determined that the benefit-risk balance of the Janssen vaccine remained positive. However, on May 3, 2021, Denmark announced that it was discontinuing its use. In France, vaccination continues, but “the EMA concluded that thromboembolic events associated with thrombocytopenia should be considered very rare adverse effects of the Janssen vaccine .” Four cases of thrombosis associated with thrombocytopenia have been reported in France in patients in their fifties and one in their forties, according to the ANSM (French National Agency for Medicines and Health Products Safety).

As of January 27, 1,079,600 doses of the Janssen vaccine had been administered. A total of 1,345 adverse events had been reported to health authorities. Since the start of the vaccination campaign, 62% of the reported side effects were considered “non-serious” and 38% “serious.”

No new signals or events requiring monitoring were identified by the ANSM between December 31, 2021, and January 13, 2022. Confirmed signals include thrombosis associated with thrombocytopenia, capillary leak syndrome, Guillain-Barré syndrome, immune thrombocytopenia, venous thromboembolism, and transverse myelitis. Potential signals or events already under surveillance include herpes zoster, myocarditis and pericarditis, vaccine failure, Parsonage-Turner syndrome, hypertension, myelitis, and Henoch-  .

The information sheet provided to healthcare professionals by the ANSM (French National Agency for Medicines and Health Products Safety) summarizing the side effects of the Janssen vaccine includes:

Very common side effects (≥1/10):

• pain at the injection site
• headaches, in other words, headaches
• nausea
• Myalgia, in other words, muscle pain
• fatigue

Common side effects (≥ 1/100 to ≤ 1/10):

• a reaction at the injection site (swelling, redness)
• cough
• arthralgia, in other words, joint pain
• fever
• chills

Uncommon side effects (≥ 1/1,000 to ≤ 1/100):

• tremors
• sneezing
• oropharyngeal pain
• a rash, in other words a skin eruption
• hyperhidrosis, in other words, excessive sweating
• muscle weakness
• painful extremities
• back pain
• asthenia, in other words, general weakness
• a feeling of unease
• paresthesia
• dizziness
• diarrhea

Rare reactions (≥ 1/10,000 to ≤ 1/1,000):

• hypersensitivity
• hives
• lymphadenopathy
• hypoesthesia
• tinnitus
• vomiting
• a venous thromboembolism

Very rare side effects (≤ 1/10,000):

• thrombosis in association with thrombocytopenia
• Guillain-Barré syndrome

Side effects with an undetermined frequency:

• anaphylaxis
• capillary leak syndrome
• immune thrombocytopenia

Booster dose: what are the reported side effects?

As of January 27, 2022, more than 22 million booster doses of the Pfizer vaccine had been administered. According to the ANSM (French National Agency for Medicines and Health Products Safety), ” no specific signal has been identified in people who received a booster dose .”

What about the side effects reported after the Moderna booster dose? More than 9.6 million doses of Moderna serum booster had been administered as of January 27, 2022. Similarly, no particular adverse effects have been reported.

Covid-19 vaccines: how to report side effects?

If you experience unexpected side effects after receiving one of the Covid-19 vaccines, it is advisable to consult your doctor and report these adverse effects by contacting your local regional pharmacovigilance center or by submitting