Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound infection. Day 14 test turned positive again after being negative on day six. Symptoms recurred with cough malaise headache sore throat. Test turn positive again; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) and COVID-19 (Rebound infection. Day 14 test turned positive again after being negative on day six. Symptoms recurred with cough malaise headache sore throat. Test turn positive again) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D [VITAMIN D NOS] and OMEGA-3 FATTY ACIDS for an unknown indication.    On 21-Dec-2021 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced COVID-19 (COVID-19). On 02-May-2022 at 5:00 AM, the patient experienced COVID-19 (Rebound infection. Day 14 test turned positive again after being negative on day six. Symptoms recurred with cough malaise headache sore throat. Test turn positive again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-Apr-2022 to 24-Apr-2022 for COVID-19, at an unspecified dose and frequency. In April 2022, COVID-19 (COVID-19) had resolved. At the time of the report, COVID-19 (Rebound infection. Day 14 test turned positive again after being negative on day six. Symptoms recurred with cough malaise headache sore throat. Test turn positive again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Day 6  test Negative. On 02-May-2022, SARS-CoV-2 test: positive (Positive) Day 14 test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medical history reported as Allergy. The symptoms which reoccurred were reported as cough, malaise, headache and sore throat. Company comment-This spontaneous case concerns a 53-year old, female patient with no medical history reported, who experienced the non-serious AESI of COVID-19 and COVID-19(reported as Rebound infection) after receiving third dose of mRNA-1273 vaccine. The event COVID-19 occurred on unknown date and COVID-19(reported as Rebound infection) occurred approximately 4 months 11 days after vaccine. Patient reported Covid-19 on an unknown date and was treated with PAXLOVID for 6 days. SARS-CoV-2 test done on day 6 was negative. Symptoms recurred with cough, malaise headache sore throat and a positive SARS-CoV-2 test on Day 14. No further details on clinical course, other lab test results and treatment received were reported. Outcome of the event COVID-19 was resolved and COVID-19(reported as Rebound infection) is not resolved. The current pandemic situation of COVID 19 may remain as confounder.  Benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 53-year old, female patient with no medical history reported, who experienced the non-serious AESI of COVID-19 and COVID-19(reported as Rebound infection) after receiving third dose of mRNA-1273 vaccine. The event COVID-19 occurred on unknown date and COVID-19(reported as Rebound infection) occurred approximately 4 months 11 days after vaccine. Patient reported Covid-19 on an unknown date and was treated with PAXLOVID for 6 days. SARS-CoV-2 test done on day 6 was negative. Symptoms recurred with cough, malaise headache sore throat and a positive SARS-CoV-2 test on Day 14. No further details on clinical course, other lab test results and treatment received were reported. Outcome of the event COVID-19 was resolved and COVID-19(reported as Rebound infection) is not resolved. The current pandemic situation of COVID 19 may remain as confounder.  Benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.