Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Headache, SARS-CoV-2 test
Clinical narrative: Her face & infusion arm turned red; Felt hot; She saw stars; Her head was just popping; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her face & infusion arm turned red), FEELING HOT (Felt hot), FEELING ABNORMAL (She saw stars) and HEADACHE (Her head was just popping) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ERYTHEMA (Her face & infusion arm turned red), FEELING HOT (Felt hot), FEELING ABNORMAL (She saw stars) and HEADACHE (Her head was just popping). At the time of the report, ERYTHEMA (Her face & infusion arm turned red), FEELING HOT (Felt hot), FEELING ABNORMAL (She saw stars) and HEADACHE (Her head was just popping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative for Covid-19.   No concomitant medications were reported.  No treatment information was provided.  Regeneron IV is a co-suspect but it is not able to code.  It was reported that the patient received a partial dose of the Regeneron IV monoclonal antibodies infusion on Saturday. She only got the infusion for 1 to 2 minutes because as soon as it started she saw stars, felt hot, her face & infusion arm turned red, & her head was just popping.  Company comment- This case concerns a 63 year old female with no reported medical history , who experienced Non-serious , unexpected event of erythema , feeling hot , feeling abnormal and expected event of headache which occurred 7 months and  22 days after vaccination with the 2nd  dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . These events were  reported after infusion with monoclonal antibodies ( Regeneron IV infusion ) which the patient took  ( as advised ) ,  when her husband became Covid 19 positive. The re-challenge for this case is not applicable since the outcome of the events  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 63 year old female with no reported medical history , who experienced Non-serious , unexpected event of erythema , feeling hot , feeling abnormal and expected event of headache which occurred 7 months and  22 days after vaccination with the 2nd  dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . These events were  reported after infusion with monoclonal antibodies ( Regeneron IV infusion ) which the patient took  ( as advised ) ,  when her husband became Covid 19 positive. The re-challenge for this case is not applicable since the outcome of the events  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.