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VAERS Report 2136762

Case Report Section

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