Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient does not have relevant medical history or concurrent conditions or allergy.  Concomitant products included LEVOTHYROXINE from April 2018 to an unknown date, LISINOPRIL from January 2018 to an unknown date, ACYCLOVIR [ACICLOVIR] from January 2017 to an unknown date, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 01-Mar-2022 to an unknown date and LORATADINE (CLARITINE) from 01-Apr-2022 to an unknown date for an unknown indication.   On 27-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient experienced COVID-19 (COVID-19). 03-May-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2022, SARS-CoV-2 test: positive (Positive) Test took at home.. On 11-May-2022, SARS-CoV-2 test: very light line Very light line, getting lighter. On 12-May-2022, SARS-CoV-2 test: very light line Very light line, getting lighter. On 13-May-2022, Body temperature: 98.3 (High) A bit high for normal of 97.7.. On 13-May-2022, SARS-CoV-2 test: showed a very strong line Showed a very strong line.         Patient had coughed on night of 03-May-2022 and patient took at home COVID test reported positive. On 11 and 12 May, patient COVID tests showed a very light line, getting lighter. On 13-May-2022, the test showed a very strong line just like 04-May-2022. Patient had runny nose a little but that could be pollen. Otherwise patient felt ok. Patient temperature was reported 98.3, which was a bit high for patient, patient normal temperature was mentioned 97.7. Company comment: This spontaneous case concerns a 73-year-old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 32 days after receiving the fourth dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses were given 13 months prior, the interval between the two doses is 28 days, the third dose was given 6 months prior. On May 3, 2022, patient took SARS-CoV-2 test which revealed a positive result, on May 13, 2022 temperature was taken which revealed 98.3. It has been reported that patient had cough on the day of administration of fourth dose of mRNA-1273, took a COVID test which turned out to be positive. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 32 days after receiving the fourth dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses were given 13 months prior, the interval between the two doses is 28 days, the third dose was given 6 months prior. On May 3, 2022, patient took SARS-CoV-2 test which revealed a positive result, on May 13, 2022 temperature was taken which revealed 98.3. It has been reported that patient had cough on the day of administration of fourth dose of mRNA-1273, took a COVID test which turned out to be positive. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.