Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Symptoms never fully disappeared, still had a cough.On 27-May-2022  Patient tested positive again, no change in symptoms; Johnson & Johnson Dose Number: 1 on 08Apr2021; Moderna Dose Number: 2 on 04Nov2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms never fully disappeared, still had a cough.On 27-May-2022  Patient tested positive again, no change in symptoms) and INTERCHANGE OF VACCINE PRODUCTS (Johnson & Johnson Dose Number: 1 on 08Apr2021; Moderna Dose Number: 2 on 04Nov2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson's Janssen COVID-19 Vaccine (Dose Number: 1 Batch/Lot No: 1808982 Location of injection: Arm Right) on 08-Apr-2021; for Drug use for unknown indication: Sulfa (Sulfa drugs). Past adverse reactions to the above products included Allergy with Sulfa; and No adverse event with Johnson & Johnson's Janssen COVID-19 Vaccine. Concurrent medical conditions included Asthma and Depression. Concomitant products included VALACYCLOVIR [VALACICLOVIR] from 06-Oct-2010 to an unknown date, SPIRONOLACTONE from 25-Apr-2022 to an unknown date, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) from 01-Feb-2022 to 18-May-2022 and LEVALBUTEROL [LEVOSALBUTAMOL] from 15-Jan-2021 to an unknown date for an unknown indication.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Johnson & Johnson Dose Number: 1 on 08Apr2021; Moderna Dose Number: 2 on 04Nov2021). In May 2022, the patient experienced COVID-19 (Symptoms never fully disappeared, still had a cough.On 27-May-2022  Patient tested positive again, no change in symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19, at an unspecified dose and frequency and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptoms never fully disappeared, still had a cough.On 27-May-2022  Patient tested positive again, no change in symptoms) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Johnson & Johnson Dose Number: 1 on 08Apr2021; Moderna Dose Number: 2 on 04Nov2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         An unspecified 'Cough suppressant/expectorant with nasal decongestant' was reported as concomitant medication which was started on 17May2022.  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 vaccine.  Device Date was reported as 28May2022.  Company Comment: This is a spontaneous case of interchange of vaccine products for this 33-year-old, female patient with relevant medical history of Asthma and Depression, and past drug history of administration of one dose of the Johnson & Johnson COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving a dose (second dose in COVID-19 vaccination series) of the mRNA-1273 vaccine. On an unspecified date, the patient experienced COVID-19 symptoms which included cough. She initially took an unspecified cough suppressant/expectorant with nasal decongestant. The following day, the patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 18May2022 to 22May2022. It was reported that after the last dose of Paxlovid, the symptoms never fully resolved and the patient still had a cough. One day after the last dose of Paxlovid, the patient also experienced moderate shortness of breath but she tested negative for SARS-CoV-2. It was reported that the symptoms continued all week. Five days after the last dose of Paxlovid, the patient tested positive for SARS-CoV-2. The patient was treated with methylprednisolone (unspecified dosage, frequency and duration). However, the event had not resolved at the time of the report. The medical history of Asthma and Depression, which are known risk factors for COVID-19, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of interchange of vaccine products for this 33-year-old, female patient with relevant medical history of Asthma and Depression, and past drug history of administration of one dose of the Johnson & Johnson COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving a dose (second dose in COVID-19 vaccination series) of the mRNA-1273 vaccine. On an unspecified date, the patient experienced COVID-19 symptoms which included cough. She initially took an unspecified cough suppressant/expectorant with nasal decongestant. The following day, the patient took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 18May2022 to 22May2022. It was reported that after the last dose of Paxlovid, the symptoms never fully resolved and the patient still had a cough. One day after the last dose of Paxlovid, the patient also experienced moderate shortness of breath but she tested negative for SARS-CoV-2. It was reported that the symptoms continued all week. Five days after the last dose of Paxlovid, the patient tested positive for SARS-CoV-2. The patient was treated with methylprednisolone (unspecified dosage, frequency and duration). However, the event had not resolved at the time of the report. The medical history of Asthma and Depression, which are known risk factors for COVID-19, remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.