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
positive molecular swab in symptomatic vaccinated; positive molecular swab in symptomatic vaccinated; rhinorrhea; congestion nasal; cough; this is a spontaneous report received from a contactable reporter(s) (other hcp) from the regulatory authority and product quality . regulatory number: it-minisal02-842788. a 40 year-old male patient received bnt162b2 (comirnaty), intramuscular, administered in arm left, administration date 08dec2021 (lot number: 1f1016a, expiration date: 30apr2022) as dose 3 (booster), 0.3ml single, intramuscular, administered in arm left, administration date 05feb2021 (lot number: el0725, expiration date: 31mar2021) as dose 2, 0.3ml single and intramuscular, administered in arm left, administration date 15jan2021 (lot number: ej6797, expiration date: 30apr2021) as dose 1, 0.3ml single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. the following information was reported: vaccination failure (medically significant) with onset 08feb2022, outcome "unknown", covid-19 (medically significant) with onset 08feb2022, outcome "recovering" and all described. positive molecular swab in symptomatic vaccinated"; rhinorrhoea (non-serious) with onset 08feb2022, outcome "recovering", described as "rhinorrhea"; nasal congestion (non-serious) with onset 08feb2022, outcome "recovering", described as "congestion nasal"; cough (non-serious) with onset 08feb2022, outcome "recovering", described as "cough". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10feb2022) positive. final conclusion for lot number 1f1016a: due to the fact, that no complaint sample was available and received at sanofi a full investigation cannot be performed. the investigation can only be performed based on the coa, the deviation system and a documentation check of the affected batch. with respect to the reason od complaint "product use attributes / lack of effect" a check of the deviation system of the semi-finished and finished drug product batch 1f1016/1f1016a was performed and showed no hint regarding the reason of complaint "product use attributes / lack of effect" during the manufacturing process. the coa (certificate of analysis) of the batch release was checked and met the specification in all tests points. furthermore, the documentation of the semi-finished and finished drug product batch 1f1016/1f1016a were checked and showed no indication of problems during the manufacturing process. all measurements associated with the complaint defect necessary to assure the quality of the product were performed before release, the product quality was assured. final conclusion: based on these results the reason of complaint "product ude attributes / lack of effect" was not related to the manufacturing process, but must have other reasons. the conclusion code "no fault detectable" was chosen. the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. the final scope was determined to be the associated lot(s) of the reported lot el0725 and lot ej6797. a complaint sample was not returned. no related quality issues were identified during the investigation. there is no impact on product quality, regulatory, validation and stability. regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. the ntm process determined that no regulatory notification was required for lot el0725. whereas the ntm process determined that regulatory notification was required for lot ej6797. the reported defect could not be confirmed. no root cause or capa were identified as the complaint was not confirmed. follow-up attempts are completed. no further information is expected
- Données de laboratoire
test date: 20220210; test name: covid-19 pcr test; test result: positive
- Liste des symptômes
nasal congestion rhinorrhoea cough covid-19 sars-cov-2 test vaccination failure
- 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