Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 032M20A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Jan-2021 to an unknown date, MONTELUKAST SODIUM (SINGULAIR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine. Patient had sore throat and mild aches.  The indication for Paxlovid was reported as Treatment of COVID-19.  Company Comment:This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced non-serious , AESI of Covid 19 which occurred on an unknown date  post vaccination with the third dose of mRNA-1273 vaccine. The dose 1 and dose 2 of the Covid 19 vaccine of this patient were also  mRNA-1273 vaccine given last 28-02-2021 and 2-03-2021 . The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 at an unspecified dose and frequency. However  after completing the Paxlovid treatment on Tuesday evening on 24 May, he felt good,  tested negative on Thursday 26 May.  But Saturday 28 May  when he  woke up he had a  sore throat and some mild aches and  tested again at 12 noon using the rapid test and turned out to be  positive. The other details surrounding the events like other treatment medications , results of other  laboratories/diagnostic  procedures were not reported. There was no report if any medical consult was done. The outcome of the event was reported as not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old male patient with no relevant medical history reported , who experienced non-serious , AESI of Covid 19 which occurred on an unknown date  post vaccination with the third dose of mRNA-1273 vaccine. The dose 1 and dose 2 of the Covid 19 vaccine of this patient were also  mRNA-1273 vaccine given last 28-02-2021 and 2-03-2021 . The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 at an unspecified dose and frequency. However  after completing the Paxlovid treatment on Tuesday evening on 24 May, he felt good,  tested negative on Thursday 26 May.  But Saturday 28 May  when he  woke up he had a  sore throat and some mild aches and  tested again at 12 noon using the rapid test and turned out to be  positive. The other details surrounding the events like other treatment medications , results of other  laboratories/diagnostic  procedures were not reported. There was no report if any medical consult was done. The outcome of the event was reported as not resolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.