Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Suspected COVID-19
Clinical narrative: right away after the 1st dose he felt lightheaded & dizzy; After receiving the 1st dose he had Covid symptoms for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (After receiving the 1st dose he had Covid symptoms for 2 days) and DIZZINESS (right away after the 1st dose he felt lightheaded & dizzy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (SARS CoV-2 test positive. Symptoms began, beginning of December then again on 16 or 17 Dec 2020) in December 2020.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUSPECTED COVID-19 (After receiving the 1st dose he had Covid symptoms for 2 days). On an unknown date, the patient experienced DIZZINESS (right away after the 1st dose he felt lightheaded & dizzy). In February 2021, SUSPECTED COVID-19 (After receiving the 1st dose he had Covid symptoms for 2 days) outcome was unknown. At the time of the report, DIZZINESS (right away after the 1st dose he felt lightheaded & dizzy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported. Case narrative: After receiving the 1st dose on 25Feb2021 he had Covid symptoms for 2 days and had Covid symptoms for 1 day after the 2nd dose.  He says that right away after the 1st & 2nd dose he felt lightheaded & dizzy. No concomitant medication details were reported.  Company comment: This spontaneous case concerns a 69-year-old male patient with no relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID-19 without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred immediately after the first dose of mRNA- 1273 vaccine. The patient reported that after receiving the first dose he had Covid symptoms for 2 days, without further clarification. It is unknown if SARS-CoV-2 test was performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396395 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old male patient with no relevant medical history, who experienced the unexpected non serious event/AESI of Suspected COVID-19 without laboratory confirmation after mRNA- 1273 Moderna vaccine. The event occurred immediately after the first dose of mRNA- 1273 vaccine. The patient reported that after receiving the first dose he had Covid symptoms for 2 days, without further clarification. It is unknown if SARS-CoV-2 test was performed. COVID symptoms were also reported after the second dose. However, since symptoms were not specified and the mRNA-1273 does not contain a virus capable of causing infection, the rechallenge was assessed as not applicable. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.