Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 after receiving Moderna Vaccine/ Covid symptoms returned and rapid test was strongly positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Initial COVID-19 after receiving Moderna Vaccine/ Covid symptoms returned and rapid test was strongly positive) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Single functional kidney (Single kidney), Penicillin allergy and Allergy to antibiotic (Septra and ceclor). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) from 01-Jan-2003 to an unknown date for an unknown indication.    On 28-Dec-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 after receiving Moderna Vaccine/ Covid symptoms returned and rapid test was strongly positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 after receiving Moderna Vaccine/ Covid symptoms returned and rapid test was strongly positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative every day until Day 16, positive (Positive) Positive (Before starting Paxlovid) and positive (Positive) rapid test was strongly positive (After starting Paxlovid).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on other medications/products within 2 weeks after starting COVID-19 treatment. The patient previously had received COVID-19 Vaccine. Rebound covid - tested negative with a rapid antigen test beginning on Day 5 of Paxlovid. Tested negative every day until Day 16 of Paxlovid. Covid symptoms return and was tested strongly positive.  Company Comment: This spontaneous case concerns a 38 year old female patient with relevant medical history of Asthma, who experienced Non-serious, unexpected, AESI of Covid 19 which occurred 4 months 25 days post vaccination with the dose 4 of mRNA-1273 vaccine. The information regarding the  dose 1,2 3 of the Covid 19 vaccine of this patient was not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency, a non-company drug. The patient reported Rebound covid-19 tested negative with a rapid antigen test beginning on Day 5 of medication, tested negative every day until Day 16. Covid symptoms returned and rapid test was strongly positive. The other treatment information, results of other laboratories/diagnostic procedures were not reported. It is also unknown if any medical consult was done. Outcome of the event was reported as resolving. The concurrent medical illness of Asthma is considered as a confounder for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38 year old female patient with relevant medical history of Asthma, who experienced Non-serious, unexpected, AESI of Covid 19 which occurred 4 months 25 days post vaccination with the dose 4 of mRNA-1273 vaccine. The information regarding the  dose 1,2 3 of the Covid 19 vaccine of this patient was not reported. This patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency, a non-company drug. The patient reported Rebound covid-19 tested negative with a rapid antigen test beginning on Day 5 of medication, tested negative every day until Day 16. Covid symptoms returned and rapid test was strongly positive. The other treatment information, results of other laboratories/diagnostic procedures were not reported. It is also unknown if any medical consult was done. Outcome of the event was reported as resolving. The concurrent medical illness of Asthma is considered as a confounder for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.