Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had Covid 3 weeks ago; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had Covid 3 weeks ago) and DRUG INEFFECTIVE (Lack of drug effect) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 prophylaxis.  Concurrent medical conditions included Hypertension (Slight hypertension (on Enalapril 2.5mg once a day)), Acid reflux (esophageal) (on Omeprazole 40mg once a day), Parkinson's disease (on Carbidopa- Levodopa), Drug allergy (Propofol), Allergy to animal (Dogs) and Allergy to animal (Cats). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ENALAPRIL for Hypertension, CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA) for Parkinson's disease.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (Had Covid 3 weeks ago) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. In August 2022, COVID-19 (Had Covid 3 weeks ago) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.  Patient reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient administered 1st booster dose and did not had a record of his 1st booster dose details. Patient reported that he had the disease for 5 days. It was reported that the symptoms improved. The patient did not experienced a similar event in the past. Patient had home treatment.  Company comment: This spontaneous case concerns a 78-year-old, male patient with current medical condition of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of second dose of mRNA-1273, patient had a positive SARS-CoV-2 test, the first dose was administered 25 days prior. On an unknown date, the patient was administered with third dose of mRNA-1273. The event Drug ineffective was also noted in this case. The patient was given Paxlovid as treatment at an unspecified dose and frequency. The patient's medical history of Hypertension could be a confounder to the event. The event has resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old, male patient with current medical condition of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 5 months after administration of second dose of mRNA-1273, patient had a positive SARS-CoV-2 test, the first dose was administered 25 days prior. On an unknown date, the patient was administered with third dose of mRNA-1273. The event Drug ineffective was also noted in this case. The patient was given Paxlovid as treatment at an unspecified dose and frequency. The patient's medical history of Hypertension could be a confounder to the event. The event has resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.