Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19/ With blockage in my head, like when I have problems with my sinuses/ My voice is a little bit blocked/ Upper chest problems/ Felt very tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19/ With blockage in my head, like when I have problems with my sinuses/ My voice is a little bit blocked/ Upper chest problems/ Felt very tired) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57164B) for COVID-19 prophylaxis.     The patient's past medical history included Sinus disorder (blockage in my head, like when I have problems with my sinuses).    On 25-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced COVID-19 (Tested positive for Covid-19/ With blockage in my head, like when I have problems with my sinuses/ My voice is a little bit blocked/ Upper chest problems/ Felt very tired) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Tested positive for Covid-19/ With blockage in my head, like when I have problems with my sinuses/ My voice is a little bit blocked/ Upper chest problems/ Felt very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. On 25-Feb-2021, the patient received first dose of Moderna COVID-19 vaccine with batch number 011A21A. On 25-MAR-2021, the patient received second dose of Moderna COVID-19 vaccine with batch number 007B21A. On 18-NOV-2021, the patient received first booster dose of Moderna COVID-19 vaccine with batch number 066R2187. On 27-MAR-2022, the patient received second booster dose of Moderna COVID-19 vaccine with batch number 03I821A.  The patient tested positive for Covid-19.The patient felt very tired and with blockage in head, like when had problems with sinuses, upper chest problems and voice was a little bit blocked.  The patient symptoms were really mild.  No treatment information was reported.  COMPANY COMMENT:This spontaneous case concerns a 70-year-old female patient, with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) event of COVID-19 which occurred respectively 4 days after mRNA-1273.222 dose administration, which was the patient's 5th dose of COVID-19 vaccination schedule. Patient was previously vaccinated with 2 initial doses (28 days apart) and 2 booster doses of mRNA-1273 with last booster dose approximately 6 months prior to 5th dose of revaccination. Clinical course included symptoms of sinuses blockage, voice blockage, chest discomfort, tiredness which occurred the same day the SARS-CoV2 test positive. It might be of importance to note that symptoms were described as mild. There is limited information on treatment and hospitalization details in the case. All events outcome was reported as not resolved at the time of the report. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2021-064154 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history reported, who experienced the unexpected, serious (hospitalization) event of COVID-19 which occurred respectively 4 days after mRNA-1273.222 dose administration, which was the patient's 5th dose of COVID-19 vaccination schedule. Patient was previously vaccinated with 2 initial doses (28 days apart) and 2 booster doses of mRNA-1273 with last booster dose approximately 6 months prior to 5th dose of revaccination. Clinical course included symptoms of sinuses blockage, voice blockage, chest discomfort, tiredness which occurred the same day the SARS-CoV2 test positive. It might be of importance to note that symptoms were described as mild. There is limited information on treatment and hospitalization details in the case. All events outcome was reported as not resolved at the time of the report. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.