Détails du rapport Vaer
Région : Outside US
- Patient décédé?
- Renseignements sur les vaccins
Nom: COVID19 (COVID19 (PFIZER-BIONTECH))
Type : Coronavirus 2019 vaccine
- Date de réception du rapport
- Date à laquelle le formulaire est complèté
- Date de vaccination
- Date d’apparition
- Nombre de jours (date d’apparition – date de vaccination)
- Description de l’événement indésirable
asymptomatic covid-19 post-vaccination infected by sars-cov-2 despite receiving the proper bnt162b2 administration protocol; asymptomatic covid-19 post-vaccination infected by sars-cov-2 despite receiving the proper bnt162b2 administration protocol; this is a non-interventional study report. real-world data are needed to guide health-policy-makers, especially now that the implementation of a third-dose administration protocol is being discussed. thanks to a longitudinal study,funded by the ministry of health, authors investigated the antibody response, over a 6-month period, in 1110 health-care professionals (hcps) injected with both doses of the bnt162b2 vaccine (january- february2021) at the redacted hospital. health-care professionals previously infected by sars-cov-2 were identified by testing their sera, a few minutes before the first vaccination dose(t0), for the presence of antibodies against the viral nucleocapsid-protein(n) (anti-sars-cov-2 electrochemiluminescence immunoassay (eclia)).they were further tested after21 (t1) (immediately before the second vaccination dose), 42 (t2) and 180 (t3) days for the presence of antibodies against the receptor-binding domain (rbd) of the viral spike (s) protein (anti-sars-cov-2-s eclia). as part of a follow-up programme, hcps were also sporadically subjected to rt-pcr amplification tests of nasopharyngeal swabs as well as to serological tests at time-points different from those of the longitudinal study. in conclusion, 6 months after the vaccination of 1110 hcps, 12 of them were infected despite receiving the proper bnt162b2 administration protocol (except for one, who was infected between the two doses). however, because some of the hcps did not undergo anti-n serological testing, the number of infections might be underestimated. post-vaccination infections, distributed throughout the whole observation period, were often associated with the presence of unvaccinated sars-cov-2-infected households. importantly, no in hospital (or related public areas) secondary cases were observed among colleagues (more than 95% of the hospital employees were vaccinated). their study showed that, in the observed cohort of hcps, no severe clinical manifestations of coronavirus disease 2019 occurred. authors might speculate that the latter is the consequence of the efficacy of the bnt162b2 vaccine, but infection and symptomatology were not related to a low anti-rbd antibody response. in the light of these data, authors think that implementation/modification of current vaccine protocols should focus on further studies evaluating clinical outcomes in individuals who are infected after vaccination, their anti-rbd antibody titre and, importantly, the possible key role of memory immunity in the protection from severe coronavirus disease 2019. a 57 year-old female patient received bnt162b2 (bnt162b2), administration date 2021 (batch/lot number: unknown) as dose 2, single and administration date 2021 (batch/lot number: unknown) as dose 1, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. in 2021, the patient experienced asymptomatic covid-19 post-vaccination infected by sars-cov-2 despite receiving the proper bnt162b2 administration protocol. covid-19 was asymptomatic and the hcp found out about the infection only through the serological test at t3. the patient is a hcp with position of administrative. there was no close contacts a sars-cov-2 positive unvaccinated household. the patient underwent the following laboratory tests and procedures: anti-rbd: (2021) less than 0.4 bau/ml (t1); (2021) 2047 bau/ml (t2); (2021) more than 2500 bau/ml (t3); polymerase chain reaction (pcr) cycles: (2021) not applicable for rdrp gene; (2021) not applicable for e gene; rt-pcr test (2021) positive, notes: type of variant: na. the outcome of the event was unknown. the investigator considered there was a reasonable possibility that the event "asymptomatic covid-19 post-vaccination infected by sars-cov-2 despite receiving the proper bnt162b2 administration protocol" was related to bnt162b2. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; sender's comments: the vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine bnt162b2 to vaccination failure cannot be ruled out.,linked report(s) : it-pfizer inc-202200293862 same article, suspect product, similar events, different patients
- Données de laboratoire
test date: 2021; test name: anti-rbd; result unstructured data: test result:less than 0.4; comments: bau/ml (t1); test date: 2021; test name: anti-rbd; result unstructured data: test result:2047; comments: bau/ml (t2); test date: 2021; test name: anti-rbd; result unstructured data: test result:more than 2500; comments: bau/ml (t3); test date: 2021; test name: pcr cycles; result unstructured data: test result:not applicable; comments: rdrp gene; test date: 2021; test name: pcr cycles; result unstructured data: test result:not applicable; comments: e gene; test date: 2021; test name: rt-pcr test; test result: positive ; comments: type of variant: na
- Liste des symptômes
polymerase chain reaction antibody test vaccination failure asymptomatic covid-19
- Patient décédé?
- Date de décès
- Anomalie congénitale
- Vaccin administré par :
- Vaccin acheté par :
- Visite d’un patient à l’urgence?
- Patient hospitalisé?
- Séjour à l’hôpital
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Maladie actuelle