Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Started feeling ill on 5/31 and tested positive on 01/Jun/22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Started feeling ill on 5/31 and tested positive on 01/Jun/22) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K2IA, 018FZIA, O2F?AZIA and 024MZOA) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood pressure high, Blood cholesterol abnormal and Drug allergy (Allergy to unspecified drug). Concomitant products included ROSUVASTATIN, LEVOTHYROXINE, LOSARTAN, AMLODIPINE and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced COVID-19 (Started feeling ill on 5/31 and tested positive on 01/Jun/22). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Started feeling ill on 5/31 and tested positive on 01/Jun/22) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         Device Date : 02Jun2022   Company Comment: This spontaneous case concerns a 60-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred 1 month 16 days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was tested positive on 20-May-2022 she started with paxlovid from 20 th to 25 May 2022 and tested negative on next three consecutive days. She started feeling ill on 31 st May and tested positive on the next day. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred 1 month 16 days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was tested positive on 20-May-2022 she started with paxlovid from 20 th to 25 May 2022 and tested negative on next three consecutive days. She started feeling ill on 31 st May and tested positive on the next day. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.