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VAERS Report 2156691

Case Report Section

Détails du rapport Vaer

Âge: 65 ans

Genre: Female

Région : Outside US

Patient décédé?
Non
Renseignements sur les vaccins

Nom: COVID19 (COVID19 (PFIZER-BIONTECH))

Type : Coronavirus 2019 vaccine

Fabricant: PFIZER

Lot: fl9994


Date de réception du rapport
2022-03-04
Date à laquelle le formulaire est complèté
Date de vaccination
2022-02-01
Date d’apparition
0
Nombre de jours (date d’apparition – date de vaccination)
0
Description de l’événement indésirable

unwell; thirst; itchy; skin rash; night sweats; sore arm; high temperature; fatigue extreme; breathlessness; appetite lost / loss of appetite; mental exhaustion; pulse rapid/pulse measured on phone towards the end of this period, was increased to 100bpm; thirst decreased; pain injection site; off label use; interchange of vaccine products; this is a spontaneous report received from a contactable reporter (consumer) from the regulatory authority. the reporter is the patient. regulatory number: gb-mhra-webcovid-202202131139504990-is9cn (agency). other case identifier: gb-mhra-adr 26621411 (agency). a 65-year-old female patient received bnt162b2 (comirnaty), administration date 01feb2022 at 12:00 (lot number: fl9994) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "high cholesterol" (unspecified if ongoing); "type ii diabetes" (unspecified if ongoing). the patient's concomitant medications were not reported. past drug history included: ramipril for high blood pressure; metformin for diabetes / type ii diabetes; atorvastatin for high cholesterol. vaccination history included: covid-19 vaccine astrazeneca (dose: 1), administration date: 08jul2021, for covid-19 vaccination; covid-19 vaccine astrazeneca (dose: 2), administration date: 06sep2021, for covid-19 vaccination; fluad, administration date: 08nov2021, for flu vaccination. the following information was reported: off label use (medically significant) with onset 01feb2022, outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant) with onset 01feb2022, outcome "unknown", described as "interchange of vaccine products"; malaise (medically significant), outcome "recovered", described as "unwell"; thirst (medically significant), outcome "recovered", described as "thirst"; vaccination site pain (medically significant) with onset 01feb2022, outcome "recovered" (02feb2022), described as "pain injection site"; pain in extremity (medically significant) with onset 02feb2022 (also reported as 01feb2022), outcome "recovered" (02feb2022 [as reported recovered in 24 hours]), described as "sore arm"; pyrexia (medically significant) with onset 02feb2022 (also reported as 01feb2022), outcome "recovered" (08feb2022 [also reported as 09feb2022]), described as "high temperature"; fatigue (medically significant) with onset 02feb2022, outcome "recovering", described as "fatigue extreme"; dyspnoea (medically significant) with onset 02feb2022, outcome "recovered" (08feb2022), described as "breathlessness"; decreased appetite (medically significant) with onset 02feb2022, outcome "recovered" (08feb2022), described as "appetite lost / loss of appetite"; mental fatigue (medically significant) with onset 02feb2022, outcome "recovering", described as "mental exhaustion"; heart rate increased (medically significant) with onset 02feb2022, outcome "recovered" (09feb2022), described as "pulse rapid/pulse measured on phone towards the end of this period, was increased to 100bpm"; thirst decreased (medically significant) with onset 02feb2022, outcome "recovered" (09feb2022), described as "thirst decreased"; pruritus (medically significant) with onset 04feb2022, outcome "recovered", described as "itchy"; rash (medically significant) with onset 04feb2022, outcome "recovering", described as "skin rash"; night sweats (medically significant) with onset 04feb2022, outcome "recovered" (12feb2022), described as "night sweats". the patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) no temperature; (unspecified date) moderately high temperature; (02feb2022) high; heart rate: (unspecified date) 100 bpm; (unspecified date) 75 bpm; (02feb2022) rapid; sars-cov-2 test: (28jan2022) no - negative covid-19 test; (06feb2022) negative; (07feb2022) negative. therapeutic measures were taken as a result of pruritus, rash. clinical course details: it was mentioned that the patient received the pfizer booster at noon on 01feb2022. sore arm by midnight 01feb2022 (as reported but per context 02feb2022), resolved within 24 hours (02feb2022 but per context 03feb2022). high temperature started midnight 01feb2022 (as reported but also reported as 02feb2022), reduced by 04feb2022 but then returned anew and fluctuated from hour to hour (no temperature to moderately high temperature) till 09feb2022 (also reported as 08feb2022). loss of appetite and thirst throughout. marked fatigue and increased need to sleep most of the time throughout. unable to work except for very short periods. early hours of 04feb2022 whole body skin rash (faint pink bumps, slightly raised), very itchy. resolved within hours through extensive scratching (!but it worked) and pharmacist prescription of antihistamine. night sweats started night of 04feb2022, necessitating change of night clothes and bedding at least once x day, and continued until 12feb2022. pulse measured on phone towards the end of this period, was increased to 100bpm on each measurement until after the reactions resolved at which point it returned to a normal 75bpm. she would rate herself as being seriously unwell during this time. at the end of this incident, it was like a switch had been flicked on again. immediately her appetite and energy returned, she felt mentally sharp again and - although still easily fatigued - functioning again. additional information: patient has not had symptoms associated with covid-19. patient has not tested positive for covid-19 since having the vaccine. patient is not enrolled in clinical trial. no follow-up attempts are possible. no further information is expected

Données de laboratoire
test name: high temperature / no temperature to moderately high temperature; result unstructured data: test result:no temperature; test name: high temperature / no temperature to moderately high temperature; result unstructured data: test result:moderately high temperature; test date: 20220202; test name: high temperature / no temperature to moderately high temperature; result unstructured data: test result:high; test name: pulse measured; result unstructured data: test result:100 bpm; test name: pulse measured; result unstructured data: test result:75 bpm; test date: 20220202; test name: pulse measured; result unstructured data: test result:rapid; test date: 20220128; test name: covid-19 virus test / lateral flow self test / pcr test; result unstructured data: test result:no - negative covid-19 test; test date: 20220206; test name: covid-19 virus test / lateral flow self test / pcr test; test result: negative ; test date: 20220207; test name: covid-19 virus test / lateral flow self test / pcr test; test result: negative
Liste des symptômes
pruritus malaise fatigue rash decreased appetite night sweats pain in extremity dyspnoea pyrexia thirst heart rate increased interchange of vaccine products sars-cov-2 test body temperature vaccination site pain off label use heart rate thirst decreased mental fatigue
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