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VAERS Report 2157033

Case Report Section

Détails du rapport Vaer

Âge: 40 ans

Genre: Male

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: ff3319


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2021-08-11
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

painful arm; large lumps of swollen nodes along collar bone on side of injection; hard to move neck; large lumps; unable to lift items; lifting his arm up it felt like a dead arm; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority and product quality group. the reporter is the patient. a 40-year-old adult male received a second dose of intramuscular bnt162b2 (solution for injection; lot ff3319 expiry 31oct2021) as a single dose in the arm on 11aug2021 (at 40-years-old) for covid-19 immunisation. there was no medical history or concomitant medications reported. the patient was not enrolled in a clinical trial and denied any symptoms associated with covid-19. the patient denied being tested for covid since receiving the vaccine. the patient previously received covid-19 immunisation with the first dose of covid-19 vaccine (manufacturer not specified) on an unspecified date. the patient reported after his vaccine when lifting his arm up it felt like a dead arm; he was unable to lift items. the patient also mentioned large lumps of swollen nodes along collar bone on side of injection. hard to move neck. treatment details if any, were not reported. the outcome of the events was not recovered. product quality group provided investigational results on 12feb2022 for bnt162b2: conclusion of previously completed investigation: the complaint for "pfizer biontech covid-19 vaccine" was investigated. the investigation included reviewing the involved batch records, deviation investigation, 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 ff3319. 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. (name withheld) 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. the reported defect could not be confirmed. no root cause or capa were identified as the complaint was not confirmed. ; sender's comments: linked report(s) : gb-pfizer inc-202101367867 same patient/product, different dose/event

Données de laboratoire
na
Liste des symptômes
pain in extremity lymphadenopathy muscular weakness joint range of motion decreased mass limb discomfort
Patient décédé?
Non
Date de décès
N/A
Anomalie congénitale
false
Vaccin administré par :
Other
Vaccin acheté par :
Inconnu
Visite d’un patient à l’urgence?
Non
Patient hospitalisé?
Non
Séjour à l’hôpital
Non
Nombre de jours à l’hôpital
Non spécifié
Invalidité permanente?
Non
Allergies:
na
Maladie actuelle
na