Détails du rapport Vaer
Âge: 30 ans
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
swollen lymph nodes; headache nos; this is a solicited report from a contactable consumer received from the regulatory authority (ra). the regulatory authority report number is gb-mhra-ycvm-202108032359556880-uvq18. safety report unique identifier gb-mhra-adr 25750442. a 30-year-old male patient received second dose of bnt162b2 (pfizer-biontech covid-19 mrna vaccine, formulation: solution for injection, batch/lot number: unknown), via an unspecified route of administration on 01aug2021 (at the age of 30-years-old) as dose 2, single for covid-19 immunisation. the patient medical history and concomitant medications were not reported. patient was not enrolled in clinical trial. the patient previously received first dose of covid-19 vaccine (manufacturer unknown) for covid-19 immunization. patient had not symptoms associated with covid-19. the patient experienced swollen lymph on 03aug2021, headache nos on 01aug2021. no medical conditions, treatment was received for the headache as paracetamol taken day before swollen lymph nodes. the patient underwent lab tests and procedures which included sars-cov-2 test: negative (no - negative covid-19 test) on an unknown date. the outcome of event headache was reported as recovered on 02aug2021 and lymphadenopathy was not recovered. the reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. since no determination has been received, the case is managed based the company causality assessment. no follow-up attempts are possible, information about lot/batch number cannot be obtained. no further information is expected. follow-up (21feb2022): this is a solicited follow-up report received from a contactable consumer via regulatory authority (ra). updated information: study description captured, biological product (vaccine) captured, indication of suspect product captured. no follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; sender's comments: based on the information in the case report, a possible causal relationship between reported events lymphadenopathy, headache and suspect drug bnt162b2 cannot be completely excluded. the impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate
- Données de laboratoire
test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test
- Liste des symptômes
headache lymphadenopathy sars-cov-2 test
- 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