Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urticaria
Clinical narrative: But still had faint positive line with Covid test By then it was 8-9 days after first symptom; broke out in hives; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (But still had faint positive line with Covid test By then it was 8-9 days after first symptom) and URTICARIA (broke out in hives) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028h21a, 032b21a and 047a21a) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety depression (currently on Zoloft and propranolol). Concomitant products included PROPRANOLOL for Anxiety and Depression, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression and Anxiety, VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], VITAMIN A NOS and MELATONIN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (broke out in hives). On 16-May-2022, the patient experienced COVID-19 (But still had faint positive line with Covid test By then it was 8-9 days after first symptom). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; LORATADINE (CLARITINE) ongoing since an unknown date for Hives, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, COVID-19 (But still had faint positive line with Covid test By then it was 8-9 days after first symptom) and URTICARIA (broke out in hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) positive. On 16-May-2022, SARS-CoV-2 test: positive (Positive) positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment  Patient started paxlovid 1 day after positive test, 3 days after first symptom and felt better with each dose, mostly symptom free at end of 5 day course, But patient still had faint positive line with COVID test. By then it was 8-9 days after first symptom. Two days later, COVID symptoms restarted extremely stuffy, possible sinus infx, fatigue although not as severe as previous body aches and fatigue. Restarted isolation. Patient unable to wean off meds without urticaria restarting. Patient did not experienced worsening hives during COVID.  Device Date : 04Jun2022  Company comment: This spontaneous case concerns a 31-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, 4months 19days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. She took a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. On day 8-9 of starting the regimen, the patient tested weakly positive for SARS-CoV-2 test. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Approximately nine months prior to the third dose, the patient has received the two primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, 4months 19days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. She took a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. On day 8-9 of starting the regimen, the patient tested weakly positive for SARS-CoV-2 test. The outcome was reported as not resolved. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Approximately nine months prior to the third dose, the patient has received the two primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.