Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Feeling abnormal, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Tested positive on a home Covid-19 test/ Chills/ Sore throat; Little whoozy right after his second dose; Light headed right after his second dose; More than 11 months between primary series of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive on a home Covid-19 test/ Chills/ Sore throat), FEELING ABNORMAL (Little whoozy right after his second dose), DIZZINESS (Light headed right after his second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 11 months between primary series of the Moderna Covid-19 vaccine) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 017B22A and 059E21A) for COVID-19 prophylaxis.     Concomitant products included DULOXETINE and GABAPENTIN for an unknown indication.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2022, the patient experienced FEELING ABNORMAL (Little whoozy right after his second dose), DIZZINESS (Light headed right after his second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 11 months between primary series of the Moderna Covid-19 vaccine). On 19-Jul-2022, the patient experienced COVID-19 (Tested positive on a home Covid-19 test/ Chills/ Sore throat). At the time of the report, COVID-19 (Tested positive on a home Covid-19 test/ Chills/ Sore throat), FEELING ABNORMAL (Little whoozy right after his second dose), DIZZINESS (Light headed right after his second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 11 months between primary series of the Moderna Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2022, SARS-CoV-2 test: (Positive) Tested positive on a home Covid-19 test.         No medical history and Treatment medication was reported. On 16-Jul-2022, the patient had a sore throat with chills.  Company Comment: This spontaneous case concerns a 72-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest COVID-19 which occurred six days after receiving the second dose of mRNA-1273. Inappropriate schedule of vaccine administered was noted in the case as the second dose was administered more than 11 months after the first dose. Patient developed sore throat and chills three days after vaccination. Home COVID-19 virus test done three days after symptoms onset showed positive result. The clinical course and treatment details were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-610103 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest COVID-19 which occurred six days after receiving the second dose of mRNA-1273. Inappropriate schedule of vaccine administered was noted in the case as the second dose was administered more than 11 months after the first dose. Patient developed sore throat and chills three days after vaccination. Home COVID-19 virus test done three days after symptoms onset showed positive result. The clinical course and treatment details were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.