Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Electroencephalogram, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment/ Suspected COVID-19 infection; Interchange of vaccine products; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ Suspected COVID-19 infection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    The patient's past medical history included Headache. Concurrent medical conditions included Hypothyroidism, Lichen sclerosis atrophicus, Allergy to antibiotic (Clindamycin), Allergy to antibiotic (Cephalosporins), Allergy to antibiotic (Ampicillin) and Food allergy (raw-onions). Concomitant products included PREDNISONE, ALBUTEROL [SALBUTAMOL], BENZONATATE (TESSALON), LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL for an unknown indication.   On 30-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). In April 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ Suspected COVID-19 infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 04-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ Suspected COVID-19 infection) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive (Prior Paxlovid treatment). On 08-May-2022, Electroencephalogram: abnormal (abnormal) abnormal. On 08-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 30-Apr-2022 patient received Paxlovid for the treatment of COVID-19. The patient completed the course of  5 days treatment and discontinued on 04-May-2022. After 5 days, on 08-May-2022, patient's symptoms of sore throat, sinus pain and nasal congestion returned (It was not clearly reported when the patient had experienced the symptoms previously). The patient did not receive any treatment.  Patient was not hospitalized.  The causality of the event COVID-19 with co-suspect JANSSEN COVID-19 vaccine was reported as possible.  Company Comment: This is a Spontaneous case concerning a 66-year-old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) ADR of COVID-19. The event occurred approximately 6 months and a half after the second dose of COVID-19 vaccination schedule. First dose administered Janssen vaccine, and second dose mRNA-1273 vaccine; hence, Interchange of vaccine products is noted. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, patient´s symptoms of sore throat, sinus pain and nasal congestion returned. SARs-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 66-year-old female patient, with no relevant medical history, who experienced the unexpected, serious (medically significant) ADR of COVID-19. The event occurred approximately 6 months and a half after the second dose of COVID-19 vaccination schedule. First dose administered Janssen vaccine, and second dose mRNA-1273 vaccine; hence, Interchange of vaccine products is noted. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, patient´s symptoms of sore throat, sinus pain and nasal congestion returned. SARs-CoV-2 test was performed, with positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.