Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Death, Myocarditis, Product label issue
Clinical narrative: some of them have died/57 death; Myocarditis; they never put an insert in the package/Moderna is not checking if the medication is being given to the vessels and they should put it in their package -do not give in the vein/do not insert the medication in the vessel/; do not insert the medication in the vesse/right now people are getting the medication in the vessel as accidents; Based on the current case data, this case has been classified as invalid. This invalid case case was reported by a nurse and describes the occurrence of DEATH (some of them have died/57 death) and MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (some of them have died/57 death) (seriousness criteria death and medically significant), MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PRODUCT LABEL ISSUE (they never put an insert in the package/Moderna is not checking if the medication is being given to the vessels and they should put it in their package -do not give in the vein/do not insert the medication in the vessel/) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (do not insert the medication in the vesse/right now people are getting the medication in the vessel as accidents). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDITIS (Myocarditis), PRODUCT LABEL ISSUE (they never put an insert in the package/Moderna is not checking if the medication is being given to the vessels and they should put it in their package -do not give in the vein/do not insert the medication in the vessel/) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (do not insert the medication in the vesse/right now people are getting the medication in the vessel as accidents) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case is considered as invalid as the multiple patient is reported and Moderna vaccine also not specified.  No concomitant medication information provided No treatment medication information provided. QC Comment: No further investigation is required as lableing for MODERNA COVID-19 VACCINE (or Spikevax for BLA product) can be found at https://modernacovid19global.com/ as directed by the QR code on our vial labels & cartons. Fact Sheets can be located on the Moderna website and there is guidance within these documents as to how the vaccine should be administered.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Non-significant follow-up received on 29-APR-2022, no new information was updated. On 29-Apr-2022: Non-significant follow-up received on 29-APR-2022, no new information was updated. On 29-Apr-2022: Non-significant follow-up received on 29-APR-2022, no new information was updated. On 29-Apr-2022: Non- significant follow up received on 29-Apr-2022, QE numbers provided as: QE-017682 & QE-017684 was updated. On 27-Jun-2023: PQC investigation report received updated QC comment; Reported Cause(s) of Death: unknown cause of death