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
off label use; interchange of vaccine products; i have an odd taste sensation for the left side of my tongue too./taste disorder; bell's palsy; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory agency (ra). the reporter is the patient. regulatory number: gb-mhra-webcovid-202202101126109180-bxfro (ra). other case identifier(s): gb-mhra-adr 26586443 (ra). a 61 year-old male patient received bnt162b2 (comirnaty), administration date 03jan2022 (lot number: fl9994) as dose 3 (booster), single for covid-19 immunisation. relevant medical history included: "blood donor" (ongoing), notes: regular blood donor; "penicillin allergy" (ongoing). concomitant medication(s) included: influenza virus taken for influenza immunisation, administration date nov2021. past drug history included: covid-19 vaccine astrazeneca, start date: 10mar2021, stop date: 10mar2021, for covid-19 vaccination, notes: dose 1, batch pv46671; covid-19 vaccine astrazeneca, start date: 01jun2021, stop date: 01jun2021, for covid-19 vaccination, notes: second dose, batch pv46689. patient has not had symptoms associated with covid-19, not had a covid-19 test. the following information was reported: off label use (medically significant), outcome "unknown", described as "off label use"; interchange of vaccine products (medically significant), outcome "unknown", described as "interchange of vaccine products"; bell's palsy (medically significant) with onset 09feb2022, outcome "not recovered", described as "bell's palsy"; taste disorder (medically significant), outcome "not recovered", described as "i have an odd taste sensation for the left side of my tongue too./taste disorder". the events "off label use", "interchange of vaccine products", "bell's palsy" and "i have an odd taste sensation for the left side of my tongue too./taste disorder" were evaluated at the physician office visit and emergency room visit. therapeutic measures were taken as a result of off label use, interchange of vaccine products, bell's palsy, taste disorder. it was reported that bell's palsy was diagnosed on 09feb2022 at accident and emergency (a&e). patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). the left side of his face has lost some muscle power, so he had a sloping smile, his eyebrows didn't raise to the same level and his left eye didn't fully wink. he has an odd taste sensation for the left side of his tongue too. it was stated that the bell's palsy was sudden, on the 09feb2022, so no gradual build-up of symptoms to his knowledge. so that was 38 days (as reported) after the third dose of covid vaccine. his left side of his lips has feeling, but it's like having the dentist anaesthetic injection & when drinking he has to be careful not to let drink slip out of his mouth. left side of his tongue has been affected, as previously stated earlier. no rashes to his knowledge to date. he went to hospital on the 09feb2022, a+e department at about 19:30 and was attended to there, where his condition was diagnosed as bell's palsy. it wasn't a stroke as checked, which was his initial concern. he has been prescribed by the a+e doctor prednisolone 5mg tablets (12 a day for at least a week), aciclovir 400mg tablets (5 times a day for at least a week) and omeprazole 20mg gastro-resistant capsules (1 a day, for at least a week) plus an eyewash to keep his eye hydrated. he was seeing his general practitioner (gp) on monday 14feb2022, who might add to the prescription when the current one runs out. his symptoms were ongoing, as treatment has just begun. no reactions to any vaccines in the past. he had the flu jab in nov2021. no history of any long or short-term medical conditions. stated that he ran a 9-mile exercise on monday (07feb2022), no issues, always tried to be as fit as he could be. no history of nervous system problems. never been diagnosed with covid-19, as far as he was aware. no follow-up attempts are possible. no further information is expected
- Données de laboratoire
- Liste des symptômes
interchange of vaccine products off label use taste disorder bell's palsy
- 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
blood donor (regular blood donor); penicillin allergy