Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
Clinical narrative: now tested positive again; congestion, coughing and feeling run down; congestion, coughing and feeling run down; congestion, coughing and feeling run down; This spontaneous case was reported by a patient and describes the occurrence of COUGH (congestion, coughing and feeling run down), NASAL CONGESTION (congestion, coughing and feeling run down), FEELING ABNORMAL (congestion, coughing and feeling run down) and COVID-19 (now tested positive again) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     Allergy was reported.  Previously administered products included for Product used for unknown indication: Pfizer/BioTech (Dose number 1 in Left arm, Batch /lot No:EM9809) on 17-Feb-2021, Pfizer/BioTech (Dose number 2 in Left arm, Batch /lot No:EN6200) on 11-Mar-2021 and Pfizer/BioTech (Dose number 3 in Left arm) on 27-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer/BioTech, Pfizer/BioTech and Pfizer/BioTech. Concomitant products included TAMSULOSIN, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022, the patient experienced COUGH (congestion, coughing and feeling run down), NASAL CONGESTION (congestion, coughing and feeling run down) and FEELING ABNORMAL (congestion, coughing and feeling run down). On 25-May-2022, the patient experienced COVID-19 (now tested positive again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COUGH (congestion, coughing and feeling run down), NASAL CONGESTION (congestion, coughing and feeling run down), FEELING ABNORMAL (congestion, coughing and feeling run down) and COVID-19 (now tested positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that after taking Paxlovid (which worked great) patient started having symptoms again 5 days after completing the series and after having tested negative for COVID-19.   Patient have now tested positive again and in 3rd day.  The device date was reported 24-May-2022.  Company comment: This spontaneous case concerns a 67-year-old male patient with history of interchange of vaccine products, who experienced the unexpected non-serous AESI of Covid-19, approximately 3 weeks after receiving mRNA-1273 vaccine as 4th dose. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. SARS-CoV-2 test was negative. Five days later, the patient experienced congestion, cough and was feeling weak.  Three days later the patient tested positive for SARS-CoV-2 test. The outcome was reported as not resolved. Approximately five months prior to the Moderna dose, the patient had taken three doses of Pfizer/BioTech Covid-19 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with history of interchange of vaccine products, who experienced the unexpected non-serous AESI of Covid-19, approximately 3 weeks after receiving mRNA-1273 vaccine as 4th dose. The patient was treated with Paxlovid (Nirmatrelvir + Ritonavir) for five days. SARS-CoV-2 test was negative. Five days later, the patient experienced congestion, cough and was feeling weak.  Three days later the patient tested positive for SARS-CoV-2 test. The outcome was reported as not resolved. Approximately five months prior to the Moderna dose, the patient had taken three doses of Pfizer/BioTech Covid-19 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.