Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID with slight cough so she had a rebound or relapse of COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID with slight cough so she had a rebound or relapse of COVID) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O84J21A, 028L20A, O13A21A and O49C21A) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder NOS (Doctor thought she had slight heart problem so instead of standard Paxlovid dose of 3 pills twice daily, doctor prescribed her Paxlovid as 2 pills twice daily which she took 28Apr2022 through 02May2022), Chemotherapy (She had chemo last year from Feb2021 to Jul2021.) from February 2021 to July 2021 and Radiotherapy (Radiation in Oct2021 for this condition.) in October 2021. Concurrent medical conditions included Follicular lymphoma (Follicular lymphoma cancer Currently in remission.) since January 2021 and Allergy (Patient thinks that some of the slight cough is allergies too but not all of it.). Concomitant products included LOVASTATIN for Blood cholesterol abnormal, LOSARTAN for Blood pressure abnormal, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Follicular lymphoma.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for COVID with slight cough so she had a rebound or relapse of COVID). The patient was treated with CILGAVIMAB, TIXAGEVIMAB (EVUSHELD) ongoing from 03-May-2022 for Booster, at a dose of UNK, Unknown other than 2 injections and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Apr-2022 to 02-May-2022 for COVID-19, at a dose of UNK, 2 pills twice daily: nirmatrelvir and ritonavir, strength, Blue and white pills. At the time of the report, COVID-19 (Positive for COVID with slight cough so she had a rebound or relapse of COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 02-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 04-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         The patient's doctor thought she had a slight heart problem so instead of the standard Paxlovid dose of 3 pills twice daily, physician prescribed her Paxlovid as 2 pills twice daily which she took from 28 Apr 2022 through 02 May 2022. The patient thought she recovered completely, she thought that some of the slight cough was allergies too, but not all of it. Product complaint was filled with description as the patient took Paxlovid for indication COVID. Paxlovid therapy completed on 02-May-2022. She took COVID test on 09-May-2022 which was positive for COVID so she had a rebound or relapse of COVID, on 20-May-2022 was the first date since 09-May-2022 that she tested negative for COVID on COVID test. Patient reported that product complained was not for suspect product. On 03-May-2022 patient taken 2 injections of Evusheld as booster for compromised people.  Company Comment: This is a spontaneous case concerning an 85-year-old female patient with medical history of Follicular lymphoma in remission (post chemotherapy and radiation therapy), who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 3 months after receiving the fourth dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative after completing the treatment. The patient was also given Tixagevimab and Cilgamivab injections as booster for compromised patient 1 day after completing the treatment of Nirmatrelvir/Ritonavir. 11 days after the initial positive test, the patient tested positive with slight cough and the test became negative after 5 days. Medical history of Follicular lymphoma in remission (post chemotherapy and radiation therapy) remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 85-year-old female patient with medical history of Follicular lymphoma in remission (post chemotherapy and radiation therapy), who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 3 months after receiving the fourth dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days and tested negative after completing the treatment. The patient was also given Tixagevimab and Cilgamivab injections as booster for compromised patient 1 day after completing the treatment of Nirmatrelvir/Ritonavir. 11 days after the initial positive test, the patient tested positive with slight cough and the test became negative after 5 days. Medical history of Follicular lymphoma in remission (post chemotherapy and radiation therapy) remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.