Détails du rapport Vaer
Âge: 69 ans
Genre: Male
Région : Outside US
- Patient décédé?
- Non
- Renseignements sur les vaccins
-
Nom: COVID19 (COVID19 (MODERNA))
Type : Coronavirus 2019 vaccine
Fabricant: MODERNA
Lot: 045g21a
- Date de réception du rapport
- 2022-02-24
- Date à laquelle le formulaire est complèté
- Date de vaccination
- 2021-12-22
- Date d’apparition
- 1
- Nombre de jours (date d’apparition – date de vaccination)
- 1
- Description de l’événement indésirable
-
on 31 december, i was hospitalized with a severe myocardial infarction/ on 31 december i was hospitalised with a severe heart attack; fast heart rate/rapid heart rate; heartburn; don't feel good/feeling unwell; out of breath/breathless; over the course of the day, less energy, no power/throughout the day less and less energy, no strength; pain in the abdomen, stomach, intestinal areas/pain in the abdominal, stomach, intestinal area; this case was received via regulatory authority (reference number: nl-lrb-00782519) on 16-feb-2022 and was forwarded to moderna on 16-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of myocardial infarction (on 31 december, i was hospitalized with a severe myocardial infarction/ on 31 december i was hospitalised with a severe heart attack) in a 69-year-old male patient who received mrna-1273 (spikevax) (batch no. 045g21a) for covid-19 vaccination. the occurrence of additional non-serious events is detailed below. previously administered products included for product used for unknown indication: biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml (biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml) on 28-apr-2021, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml (biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3ml) on 03-jun-2021. past adverse reactions to the above products included no adverse event with biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3ml. concomitant products included sotalol hydrochloride (sotalol rph) for an unknown indication. on 22-dec-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 23-dec-2021, the patient experienced asthenia (over the course of the day, less energy, no power/throughout the day less and less energy, no strength), abdominal pain (pain in the abdomen, stomach, intestinal areas/pain in the abdominal, stomach, intestinal area), heart rate increased (fast heart rate/rapid heart rate), regurgitation (heartburn), malaise (don't feel good/feeling unwell) and dyspnoea (out of breath/breathless). on 31-dec-2021, the patient experienced myocardial infarction (on 31 december, i was hospitalized with a severe myocardial infarction/ on 31 december i was hospitalised with a severe heart attack) (seriousness criterion hospitalization). on 26-dec-2021, asthenia (over the course of the day, less energy, no power/throughout the day less and less energy, no strength), abdominal pain (pain in the abdomen, stomach, intestinal areas/pain in the abdominal, stomach, intestinal area), heart rate increased (fast heart rate/rapid heart rate), regurgitation (heartburn), malaise (don't feel good/feeling unwell) and dyspnoea (out of breath/breathless) had resolved. at the time of the report, myocardial infarction (on 31 december, i was hospitalized with a severe myocardial infarction/ on 31 december i was hospitalised with a severe heart attack) outcome was unknown. no treatment medication were provided. company comment: this is a regulatory authority report concerning a case of interchange of vaccine products for this 69-year-old male patient, with a medical history of previous vaccination with two doses of covid-19 vaccine comirnaty and concomitant medication with sotalol, who experienced the unexpected serious (seriousness criteria- caused/prolonged hospitalization) event of myocardial infarction (aesi) and unexpected non-serious events of asthenia, abdominal pain, heart rate increased, regurgitation (heartburn), malaise, and dyspnoea. event myocardial infarction occurred 9 days after receiving a dose of mrna-1273 vaccine, dose number unspecified, outcome unknown, while all the other events occurred 1 day after vaccination and resolved with 4 days duration. there is no available information regarding clinical course and treatment medication. the patient's age, medical history of previous vaccination with covid-19 vaccine comirnaty, and concomitant medication with sotalol, which can cause increased heart rate and dyspnoea, remain as confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. most recent follow-up information incorporated above includes: on 16-feb-2022: translation received on 21-feb-2022: no new information was added.; sender's comments: this is a regulatory authority report concerning a case of interchange of vaccine products for this 69-year-old male patient, with a medical history of previous vaccination with two doses of covid-19 vaccine comirnaty and concomitant medication with sotalol, who experienced the unexpected serious (seriousness criteria- caused/prolonged hospitalization) event of myocardial infarction (aesi) and unexpected non-serious events of asthenia, abdominal pain, heart rate increased, regurgitation (heartburn), malaise, and dyspnoea. event myocardial infarction occurred 9 days after receiving a dose of mrna-1273 vaccine, dose number unspecified, outcome unknown, while all the other events occurred 1 day after vaccination and resolved with 4 days duration. there is no available information regarding clinical course and treatment medication. the patient's age, medical history of previous vaccination with covid-19 vaccine comirnaty, and concomitant medication with sotalol, which can cause increased heart rate and dyspnoea, remain as confounders. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report
- Données de laboratoire
-
na
- Liste des symptômes
-
malaise myocardial infarction asthenia abdominal pain dyspnoea heart rate increased regurgitation
- Patient décédé?
- Non
- Date de décès
- N/A
- Anomalie congénitale
- false
- Vaccin administré par :
- Unknown
- Vaccin acheté par :
- Inconnu
- Visite d’un patient à l’urgence?
- Non
- Patient hospitalisé?
- Oui
- Séjour à l’hôpital
- Non
- Nombre de jours à l’hôpital
- Non spécifié
- Invalidité permanente?
- Non
- Allergies:
-
na
- Maladie actuelle
-
na