Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after 4 Moderna covid vaccines; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid after 4 Moderna covid vaccines) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 058F21A and 030L20A) for COVID-19 prophylaxis.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Lung congestion.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid after 4 Moderna covid vaccines). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-Jul-2022 to 25-Jul-2022 for COVID-19, at a dose of bid, 3 tablets in the morning and 3 tablets in the evening. At the time of the report, COVID-19 (Tested positive for Covid after 4 Moderna covid vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No Treatment drug was provided by reporter.  The patient was tested positive for COVID after 4 Moderna COVID vaccines. The events diarrhoea (diarrhea), malaise (felt really sick), palpitations (heart racing), heart rate irregular (pulse up to 220), haemoptysis (spitting blood) and hypertension (Blood pressure high) started after taking Paxlovid. The patient called about Paxlovid.  Her pulmonologist recommended and prescribed Paxlovid, because she had the COVID virus with mild symptoms. She wanted to inform Pfizer, about people who take Paxlovid and Symbicort. The patient took two puffs a day of Symbicort inhaler. She had diarrhea, felt really sick, heart racing, pulse up to 220 spitting up blood. The patient stated that an ambulance was called and when she was in the hospital some of her symptoms subsided.  Her pulmonary doctor said he didn't think Symbicort and Paxlovid were a good combination. The Symbicort was stopped and once her symptoms settled down, she continued her Paxlovid and only missed a day of Paxlovid. She was admitted to the hospital, specifically for her heart racing and spitting up blood. She was reporting as a courtesy, so other people know about taking Paxlovid and Symbicort, as it was a very scary experience. Diarrhea felt really sick and when she was in the hospital, she stopped Symbicort. She started treatment on 20-Jul-2022 in the evening and was only told to finish the full days after her hospitalization. Heart racing, pulse was 220 to sometime in the hospital. Spitting up blood and later the spit looked more pink. Paxlovid was completed on 25-Jul-2022 and restarted Symbicort on 26 Jul 2022. The patient was in hospital from 23 Jul 2022 to 25 Jul 2022. She knew a woman who did get rebound COVID after Paxlovid.  Company Comment: This spontaneous case concerns a 74 year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 81 days after the fourth dose of mRNA-1273 vaccine administration. One day after the diagnosis of COVID-19  the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) 3 tablets in the morning, and 3 tablets in the evening. Patient was also taking Symbicort 2 puffs a day. After starting Paxlovid patient reported diarrhea, felt really sick, heart racing, pulse up to 220 and spitting up blood and had to be hospitalized. Symbicort was stopped. Once Paxlovid regimen was completed, Symbicort was resumed. The ongoing COVID-19 pandemic could be a confounder for 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 74 year-old female patient, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred 81 days after the fourth dose of mRNA-1273 vaccine administration. One day after the diagnosis of COVID-19  the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) 3 tablets in the morning, and 3 tablets in the evening. Patient was also taking Symbicort 2 puffs a day. After starting Paxlovid patient reported diarrhea, felt really sick, heart racing, pulse up to 220 and spitting up blood and had to be hospitalized. Symbicort was stopped. Once Paxlovid regimen was completed, Symbicort was resumed. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.