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
cellulitis; condition worsened; swelling arm; redness; pain; lower front neck was also painful; headache; injection site painful; injection site was very hard and swollen; injection site very red; injection site very hot; booster: comirnaty; primary immunisation: unknown manufacturer, at least one was non-pfizer vaccine; booster: comirnaty; primary immunisation: unknown manufacturer, at least one was non-pfizer vaccine; this is a spontaneous report from a contactable consumer, the patient. this is a report received from the regulatory agency (ra). regulatory authority report number gb-mhra-webcovid-202202171851053610-vhbtv, safety report unique identifier gb-mhra-adr 26618802. a 78-year-old female patient received bnt162b2 (comirnaty; batch number: fh3220) via an unspecified route of administration on 30oct2021 as dose 3 (booster), single for covid-19 immunisation. medical history included oral lichen planus (i also have it in my mouth, but this is currently needs no treatment), lichen planopilaris (i have lichen plants on my scalp, which i apply a steroid lotion to.)the patient did not have symptoms associated with covid-19 and was not enrolled in clinical trial. concomitant medications included steriods taken for lichen planopilaris. previously, the patient received two doses of covid-19 vaccine (manufacturer unknown) via an unspecified route of administration on unspecified dates for covid-19 immunisation. on 31oct2021, 1 day after vaccination, the patient experienced swelling arm, redness, pain and headache. on same day, the patient experienced injection site painful, injection site was very hard and swollen, injection site very red, injection site very hot and lower front neck was also painful. on 01nov2021, the patient's condition worsened and experienced cellulitis. on 08feb2022, the patient underwent covid-19 virus test and the result was negative. the events swelling arm, redness, pain, cellulitis and headache was reported as serious for being medically significant. clinical course was reported as follows; the patient had the booster on 30oct2021 and when she woke up the next day, the injection site was very hard and swollen, very red and very hot and painful and her lower front neck was also painful. she called emergency 111 on the 01nov2021 for advice, because her symptoms worsened and they did an urgent referral to the minor injuries unit and that she attended later that day. she was told by the doctor on duty, that the injection had caused 'cellulitis' and had prescribed antibiotics. she contacted her general practitioner, to obtain a liquid form of the antibiotic and without seeing her arm, his view was the symptoms were caused by her having lots of antibodies, which he thought was 'good'. the patient had not been tested positive for covid-19 since having the vaccine. the clinical outcome of the events swelling arm and pain was recovered with sequelae on an unknown date. the clinical outcome of the event redness was resolved on 10nov2021, after the duration of 10 days. the clinical outcome of the event headache was resolved on 21nov2021, after the duration of 21 days. the clinical outcome of the event cellulitis was resolving while that of the events injection site painful, injection site was very hard and swollen, injection site very red, injection site very hot, lower front neck was also painful and condition worsened was unknown. no follow-up attempts are needed. no further information is expected
- Données de laboratoire
test date: 20220208; test name: covid-19 virus test; result unstructured data: test result:negative covid-19 test
- Liste des symptômes
headache pain erythema neck pain condition aggravated cellulitis interchange of vaccine products vaccination site warmth vaccination site swelling sars-cov-2 test vaccination site pain peripheral swelling vaccination site erythema off label use
- 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