Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive that evening and on Day 8 tested positive again/ It was a suspected rebound infection; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive that evening and on Day 8 tested positive again/ It was a suspected rebound infection) and DRUG INEFFECTIVE (Lack of drug effect) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O71F, 038A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Hypercholesterolemia. Concomitant products included PRAVASTATIN from an unknown date to 02-May-2022, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT PF), BRIMONIDINE TARTRATE, NETARSUDIL MESILATE (RHOPRESSA), NAPROXEN, MELATONIN, DOCUSATE SODIUM, SAMBUCUS NIGRA (SAMBUCUS [SAMBUCUS NIGRA]), VITAMIN C [ASCORBIC ACID], CALCIUM, COLECALCIFEROL (CALCIUM WITH D3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 2:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive that evening and on Day 8 tested positive again/ It was a suspected rebound infection) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 07-May-2022 for COVID-19 immunization, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive that evening and on Day 8 tested positive again/ It was a suspected rebound infection) was resolving and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking other medications within 2 weeks of starting COVID-19 treatment and patient previously received a COVID-19 vaccination.  Reportedly, Patient completed 5 days of Paxlovid and 2 days and 5 days after finishing Paxlovid Patient tested negative on Rapid antigen tests and on 7 days after completion, Patient experienced respiratory symptoms (increased coughing/nasal congestion). Patient tested positive that evening and on Day 8 tested positive again. It was a suspected rebound infection.  Device Date was reported as 16-May-2022.  Company Comment:  This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 6 months after receiving third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also included as an event.  Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and had tested negative using rapid antigen test on the second and fifth day after finishing Paxlovid treatment. Two days later, patient experienced increased coughing and nasal congestion for which two COVID-19 antigen tests done one day apart came out positive.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days, which falls within the recommended vaccine dosing schedule. The second dose of mRNA-1273 vaccine was given 7 months and 7 days prior to current vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 6 months after receiving third dose of mRNA-1273 vaccine.  Additionally, Drug ineffective was also included as an event.  Patient had completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and had tested negative using rapid antigen test on the second and fifth day after finishing Paxlovid treatment. Two days later, patient experienced increased coughing and nasal congestion for which two COVID-19 antigen tests done one day apart came out positive.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at an interval of 29 days, which falls within the recommended vaccine dosing schedule. The second dose of mRNA-1273 vaccine was given 7 months and 7 days prior to current vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.