Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; Constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, return of cold-like symptoms (itchy runny nose) and positive COVID home test.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, return of cold-like symptoms (itchy runny nose) and positive COVID home test.) and DRUG INEFFECTIVE (Lack of efficacy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 007M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included AZITHROMYCIN from 11-May-2022 to 16-May-2022 for an unknown indication.   On 12-Jan-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021 at 1:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced COVID-19 (Constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, return of cold-like symptoms (itchy runny nose) and positive COVID home test.). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, return of cold-like symptoms (itchy runny nose) and positive COVID home test.) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DRUG INEFFECTIVE (Lack of efficacy) to be related. No further causality assessment was provided for COVID-19 (Constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, return of cold-like symptoms (itchy runny nose) and positive COVID home test.).    Pfizer had permission to contact patient about this report.  Patient had constant Bitter taste while taking antiviral medication. Four days after completion of antiviral medication, had return of cold-like symptoms (itchy runny nose) and positive COVID home test.  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Device Date: 23 May 2022  Company comment.  This spontaneous case concerns a 61  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 6 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time).  The report stated that the patient received an unspecified treatment for COVID  19 and Azythromycin for 4 days. Constant Bitter taste was reported while taking antiviral medication. Four days after completion of antiviral medication, the patient mentioned the cold-like symptoms returned and she had a positive COVID  19 home test. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61  year  old female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID  19, approximately 6 months after the third dose of mRNA-1273 vaccine (Drug ineffective was considered since the first two doses were administrated in a correct interval of time).  The report stated that the patient received an unspecified treatment for COVID  19 and Azythromycin for 4 days. Constant Bitter taste was reported while taking antiviral medication. Four days after completion of antiviral medication, the patient mentioned the cold-like symptoms returned and she had a positive COVID  19 home test. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.