Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Dizziness, Headache
Clinical narrative: After the second Primary series dose had a worsening headache.; After the second Primary series dose had joint pain.; Dizziness; Caught Covid-19 twice since receiving Moderna Primary Series of vaccine/ caught second case of Covid-19 about 6 weeks ago; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (After the second Primary series dose had a worsening headache.), ARTHRALGIA (After the second Primary series dose had joint pain.), DIZZINESS (Dizziness) and COVID-19 (Caught Covid-19 twice since receiving Moderna Primary Series of vaccine/ caught second case of Covid-19 about 6 weeks ago) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Caught Covid-19 twice since receiving Moderna Primary Series of vaccine/ caught second case of Covid-19 about 6 weeks ago). On an unknown date, the patient experienced HEADACHE (After the second Primary series dose had a worsening headache.), ARTHRALGIA (After the second Primary series dose had joint pain.) and DIZZINESS (Dizziness). At the time of the report, HEADACHE (After the second Primary series dose had a worsening headache.), ARTHRALGIA (After the second Primary series dose had joint pain.), DIZZINESS (Dizziness) and COVID-19 (Caught Covid-19 twice since receiving Moderna Primary Series of vaccine/ caught second case of Covid-19 about 6 weeks ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had caught Covid-19 twice since receiving her Moderna Primary Series of vaccine. The caller had not remember when the patient first caught Covid-19 but caller does knew that it was after patient's first Primary Moderna Covid-19 vaccine. The caller said that patient caught her second case of Covid-19 about 6 weeks ago.  No treatment information was reported.  Company Comment: This spontaneous case concerns an elderly (age not provided), female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and other associated expected, non-serious events. The event COVID-19 occurred approximately 1 year, 3 months after receiving the second dose of the mRNA-1273 vaccine. The start dates of the other events were not provided. It was reported that the patient received two doses of the mRNA-1273 vaccine. The first dose was given on an unspecified date in Jan 2021 and the patient experienced a mild headache. No further details were provided regarding treatment and outcome of the event. After receiving the second dose on an unspecified date in Feb 2021 (given about 4 weeks after the first dose), it was reported that the patient experienced worsening headache, joint pain and dizziness. Treatment information was not provided. It was also reported that the patient experienced COVID-19 twice: first was on an unspecified date after the first dose of the mRNA-1273 vaccine, and second was around Jun 2022 (approximately 1 year, 3 months) after the second dose of the mRNA-1273 vaccine. No further details were provided. The outcomes of the events were unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-610664 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly (age not provided), female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and other associated expected, non-serious events. The event COVID-19 occurred approximately 1 year, 3 months after receiving the second dose of the mRNA-1273 vaccine. The start dates of the other events were not provided. It was reported that the patient received two doses of the mRNA-1273 vaccine. The first dose was given on an unspecified date in Jan 2021 and the patient experienced a mild headache. No further details were provided regarding treatment and outcome of the event. After receiving the second dose on an unspecified date in Feb 2021 (given about 4 weeks after the first dose), it was reported that the patient experienced worsening headache, joint pain and dizziness. Treatment information was not provided. It was also reported that the patient experienced COVID-19 twice: first was on an unspecified date after the first dose of the mRNA-1273 vaccine, and second was around Jun 2022 (approximately 1 year, 3 months) after the second dose of the mRNA-1273 vaccine. No further details were provided. The outcomes of the events were unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.