Vaccination goes on in France and the health authorities are thoroughly monitoring the different vaccines available. Here is the list of side effects reported in France.
The number of appointments made to get a first dose of Covid-19 vaccine keeps growing. In France, about 37 million first doses have been given, and 30 million people are fully vaccinated. On the global scale, 3.6 billion doses have been injected, and over a billion people are immunized.
After long months of observation and assessment, the health authorities managed to list the vaccine side effects in a precise and compelete fashion.
This July 16, 2021, the Agence nationale de sécurité du médicament - the French National Medicines Safety Agency - has come up with a report listing all side effects of vaccines reported by the French. Pfizer, AstraZeneca, Moderna and Janssen: all vaccines approved in France have been assessed.
In this report, the ANSM explains they have conducted a national inquiry about vaccination in France. The agency bases its analyses on over 59,165,000 injections made as of July 8, 2021 including:
- "Over 45,779,000 injections with COMIRNATY (BioNTech-Pfizer)
- Over 5,566,000 injections with SPIKEVAX (Moderna)
- Over 7,210,000 injections with VAXZEVRIA (AstraZeneca)
- Over 609,000 injections with COVID-19 VACCINE (Janssen)"
Over 61,800 side effect cases have been reported, including all vaccines, since the vaccination campaign started in France. Only 25% of them have been considered severe.
Mild and common side effects have been reported no matter the vaccine given:
- Fatigue
- Injection site pain
- Muscle or joint pain
- Painful limbs
- Swollen lymph nodes
- Skin rash, itching
- Fever
- Headache
- Nausea
- Vomiting
- Dizziness
Pfizer-BioNTech
The Pfizer vaccine study shows likely proportions: 28% of cases have been judged severe. In teens, as in adults, the same effects and signals have been reported.
Among the side effects monitored in Pfizer stand:
- Shingles
- Irregular heartbeat
- Thrombocytopenia / Immunologically-mediated thrombocytopenia / Spontaneous bruises
- Diabetic imbalace in contexts of reactogenicity
- Vaccine failures
- Acute pancreatitis
- Guillain Barré syndrome
- Macrophage activation syndrome
- Reaction to Epstein Barr virus
- Zoster meningoencephalitis
- Idiopathic medullar aplasia
- Acquired hemophilia
- High blood pressure
- Myocarditis (64 cases) and Pericarditis (111 cases)
- Rheumatoid arthritis (22 severe cases since vaccination began, including 15 with arthritis history)
- Glomerular nephropathies, which is a kidney disorder (12 cases since vaccination began, including 8 are relapses)
Most severe cases have been found in people over 50 years of age.
Three severe events have been reported in pregnant or breast-feeding women vaccinated with Pfizer:
- In utero deaths: observed since the beginning of the followup of 3 cases of in-utero death following vaccination with Comirnaty. Relationship with vaccination cannot be made. In utero deaths occur for 1 to 3 pregnancies in 1,000 in the overall population
- Thrombo-embolic events
- Painful uterine contractions
Moderna
Side effects monitored:
- Rheumatoid arthritis (RA): 3 severe cases including one case of positive reintroduction
- Glomerular nephropathies: 3 cases including 2 with positive reintroduction following dose 2 and one case past dose 2. These cases occured in patients between 20 and 80 years old, in a short amount of time (<2 days).
- Mucosal and cutaneous bleeding (menstrual disorder): 15 severe cases. In lack of complementary assessment in cases reported, it cannot be considered to hold vaccine accountable.
- Erythema multiforme: 2 cases of erythema multiforme including one with affirmed diagnosis. There is no severe cutaneous harm that could put the vaccine benefit/risk ratio into question.
- Irregular heartbeat
- Shingles
- Reactogenecity more severe after the 2nd dose
- Chronical pathologies disorder/relapse
- Transient global amnesia
- Hearing disorder (deafness, hearing loss, and tinnitus)
- Faintings, more or less associated with falls
- Delayed reactions: these reactions, although described in vaccine clinical trials, are mostly mild, occuring within 4 to 31 days past vaccination
- Vascular disorder like high blood pressure
- Myocarditis (7 cases) and pericarditis (13 cases)
AstraZeneca
Side effets monitored are:
- Mucosal and cutaneous bleeding (mainly bruising and nose bleed)
- Shingles and herpetic reactivation
- High blood pressure
- Dyspnea and asthma associated with flu-like syndromes
- Acute olyradiculoneuritis (including Guillain Barré syndrome)
- Facial palsy
- Central demyelinating disease
- Erythema nodosum
- Deafness and hear loss
- Ischemic colitis
- Vasculitis
- Myocarditis/pericarditis
- Flu-like syndromes: still mostly reported and the latest data confirmed the results given the previous weeks
- Thrombo-embolic disorder: to even the French followup of thrombo-embolic disorder assessed on the Europea level, it has been decided to focus followup on the following events:
- Cerebral thrombosis
- Splanchnic thrombosis
- Multi-site thrombosis
- Any thrombosis associated with thrombocytopenia
- Isolated disseminated intravascular coagulation (DIC)
Faced with the risk of thrombosis, the ANSM "recommends anyone showing persisting side effects beyond three days like dizziness, headache, sight disorder, nausea/vomiting, shortness of breath, acute chest pain, abdominal pain or limbs or showing cutaneous bruises (petechiae) beyond the injection site should check with their doctor as soon as possible."
Janseen
Side effects monitored are:
- Thrombo-embolic events
- High blood pressure
- Guillain Barre syndrome (4 cases)
- Shingles
- Myocarditis/Pericarditis
- Rare atypical thromboses: observed with 4 to 28 days past vaccination characterized by:
- Vein and/or arterial thrombosis (no matter the localization) associated with fewer platelets (<150G/L)
- Unusual vein and/or arterial thrombosis (localization, clinical context, likely multisite, sometimes successive), especially vein cerebal thrombosis and vein splanchnic thrombosis.
- Capillary leak syndrome: effect reported over the world, no case reported to date in France
In all, no severe side effect related to Covid-19 vaccines has been reported in France, in pregnant or breast-feeding women. This is very good news for young parents who could be worried about the effects of the epidemic in their children or themselves.
