Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Morning of 19 May 2022, tested positive on a RAT after night of persistent cough and scratchy throat) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 071F21A, 030M20A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Obesity, Blood pressure high (High blood pressure) and Sulfonamide allergy (sulfa drug allergy). Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN DEGLUDEC (TRESIBA), ATORVASTATIN from an unknown date to 19-May-2022 and LISINOPRIL from 02-Feb-2022 to an unknown date for an unknown indication. On 31-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021 at 5:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Morning of 19 May 2022, tested positive on a RAT after night of persistent cough and scratchy throat). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Morning of 19 May 2022, tested positive on a RAT after night of persistent cough and scratchy throat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) On day 17, still testing positive on RAT. Patient had experienced morning of 19-May-2022, tested positive on a RAT after night of persistent cough and scratchy throat. Started Paxlovid that pm (day 0). Immediate improvement on Day 1. Patient was fatigued and had a scratchy throat. Day 2 the same fatigue but otherwise that was fine. It was reported that negative on RAT (this after 3 doses of the Paxlovid). Completed full 5 day course of Paxlovid, daily RATs were negative. On day 12, woke with very sore throat, positive RAT. Symptoms much worse than before cough, sore throat, body aches, very slight fever. On day 17, most symptoms improved (fever, aches, sore throat), some persist (cough). Still testing positive on RAT. Device date was reported as 05-Jun-2022. Pfizer have permission to contact about this report and have permission to contact the patient's healthcare provider. Company comment: This spontaneous case concerns a 57-year-old, female patient with medical history of Obesity, Diabetes, and High blood pressure, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 35 days after administration of fourth dose of mRNA-1273, the third dose of mRNA-1273 was given 6 months prior, the initial two doses of mRNA were given 8 months prior, the interval between the two doses is 25 days. The patient was started on Paxlovid May 19-24, 2022, upon completion after 12 days, patient experienced sore throat, cough, fever and body aches, after 5 days the symptoms improved. Details of concomitant medications, medical history, clinical course and outcome were not provided. The patient's medical history of Obesity, Diabetes and High blood pressure could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 57-year-old, female patient with medical history of Obesity, Diabetes and High blood pressure, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 35 days after administration of fourth dose of mRNA-1273, the third dose of mRNA-1273 was given 6 months prior, the initial two doses of mRNA were given 8 months prior, the interval between the two doses is 25 days. The patient was started on Paxlovid May 19-24, 2022, upon completion after 12 days, patient experienced sore throat, cough, fever and body aches, after 5 days the symptoms improved. Details of concomitant medications, medical history, clinical course and outcome were not provided. The patient's medical history of Obesity, Diabetes and High blood pressure could be confounders to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.