Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: separate Antigen tests Both came back positive, started feeling really congested, tired, headache, got really bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (separate Antigen tests Both came back positive, started feeling really congested, tired, headache, got really bad) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. BF214) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma (mild asthma), Sinus disorder NOS (got chronic sinus problems) and Drug allergy. Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) from 01-May-2022 to an unknown date for Prophylaxis.   On 09-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced COVID-19 (separate Antigen tests Both came back positive, started feeling really congested, tired, headache, got really bad). At the time of the report, COVID-19 (separate Antigen tests Both came back positive, started feeling really congested, tired, headache, got really bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.         No treatment details were reported. It was reported that, the patient completed the course of Paxlovid on 07 May 2022 and was tested negative on the same day. Also tested negative on Monday 09 May 2022 after that. The patient started feeling really congested and tired on Tuesday 10 May 2022 and got really bad on Wednesday 11 May 2022. Tested again on Thursday 12-May-2022 and did 2 separate antigen tests and both came back positive. The congestion was worse than last week and at times the patient had a slight headache.  Company Comment:  This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 7 months after receiving a dose of mRNA-1273 as third in the COVID-19 vaccination series (no information disclosed on previous COVID-19 vaccinations). Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and tested negative for COVID-19 on the last day of Paxlovid treatment and two days after. However, on the following day, patient presented with tiredness, slight headache and nasal congestion described as worse than the previous week. Two separate COVID-19 antigen tests done 2 days later became positive.  Outcome of the event COVID-19 was unknown. Patient was reported to have chronic sinus problems which could have contributed to the COVID-19 symptom of nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 7 months after receiving a dose of mRNA-1273 as third in the COVID-19 vaccination series (no information disclosed on previous COVID-19 vaccinations). Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and tested negative for COVID-19 on the last day of Paxlovid treatment and two days after. However, on the following day, patient presented with tiredness, slight headache and nasal congestion described as worse than the previous week. Two separate COVID-19 antigen tests done 2 days later became positive.  Outcome of the event COVID-19 was unknown. Patient was reported to have chronic sinus problems which could have contributed to the COVID-19 symptom of nasal congestion. The benefit-risk relationship of mRNA-1273 is not affected by this report.