Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID/Rebound of COVID symptoms after tested negative/Sore throat/Runny nose/Congestion/Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID/Rebound of COVID symptoms after tested negative/Sore throat/Runny nose/Congestion/Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Recent). Concurrent medical conditions included Hypertension, Hypercholesteraemia and Drug allergy (Drug unspecified). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) from 01-Apr-2022 to an unknown date, OXYCODONE from 01-Apr-2022 to 17-May-2022, IBUPROFEN from 01-Apr-2022 to 18-May-2022 and ATORVASTATIN from 01-Apr-2022 to 02-May-2022 for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive COVID/Rebound of COVID symptoms after tested negative/Sore throat/Runny nose/Congestion/Headaches). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 07-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 11-May-2022, COVID-19 (Positive COVID/Rebound of COVID symptoms after tested negative/Sore throat/Runny nose/Congestion/Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 11-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         Patient initials were redacted. Concomitant medications information included the patient had lisinopril HCTZ (proprietary medicinal product name), oxycodone (proprietary medicinal product name), ibuprofen (proprietary medicinal product name) and atorvastatin (proprietary medicinal product name). Patient started Paxlovid treatment on day 2 of testing positive. On day 10, patient tested negative for Covid-19. On day 14, Covid symptoms rebounded, sore throat, runny nose, congestion and headaches. On day 15, 16 and 17, patient tested positive for Covid-19. company comment This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with concurrent medical conditions included hypertension and hypercholesterolemia, who experienced the unexpected, non-serious AESI of covid 19 Infection about 5 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 07 months prior to the 3 dose. On 02-May-2022, SARS-CoV-2 test was positive. Patient was treated with PAXLOVID from for 5 days from day 2 of testing positive, from 03-May-2022 to 07-May-2022, for COVID-19 Infection. On 11-May-2022, SARS-CoV-2 test was negative on day 10 and the event had resolved. It was reported that on day 14, Covid symptoms rebounded, with sore throat, runny nose, congestion and headaches. On day 15, 16 and 17, patient tested again positive for Covid-19. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case reported by a consumer, concerns a patient of unknown age and gender, with concurrent medical conditions included hypertension and hypercholesterolemia, who experienced the unexpected, non-serious AESI of covid 19 Infection about 5 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 07 months prior to the 3 dose. On 02-May-2022, SARS-CoV-2 test was positive. Patient was treated with PAXLOVID from for 5 days from day 2 of testing positive, from 03-May-2022 to 07-May-2022, for COVID-19 Infection. On 11-May-2022, SARS-CoV-2 test was negative on day 10 and the event had resolved. It was reported that on day 14, Covid symptoms rebounded, with sore throat, runny nose, congestion and headaches. On day 15, 16 and 17, patient tested again positive for Covid-19. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement