Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: COVID symptoms again after being symptom free; Interchange of vaccine products; Re vaccination with a different Covid 19 Vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID symptoms again after being symptom free), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Re vaccination with a different Covid 19 Vaccine ) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Asthma, Drug allergy and Birth control. Concomitant products included ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) for Birth control. In March 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. In November 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Re vaccination with a different Covid 19 Vaccine ). In 2022, the patient experienced COVID-19 (COVID symptoms again after being symptom free). At the time of the report, COVID-19 (COVID symptoms again after being symptom free) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Re vaccination with a different Covid 19 Vaccine ) outcome was unknown. It was reported that on an unspecified date in 2022, experienced COVID symptoms again after being symptom free(dose number in series 2). Patient was symptom free on the 30-Jun-2022 (same day as finishing the pills). On 03-Jul-2022 symptoms relapsed and were worse than before. The action taken with J and J and Moderna was not applicable  and action taken with paxlovid was treatment discontinued. Causality for event Covid-19  Janssen has reported as possible. No treatment medications were reported. Company Comment: This spontaneous case concerns a 39 year old female patient  initially vaccinated with one dose  of Co-suspect, non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination ,  with reported  Co-suspect drug NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced Non-serious , unexpected, of Covid 19 which occurred on an unknown date in 2022 post vaccination with the 2nd dose of mRNA-1273 vaccine . This patient received  a non-company co-suspect drug of Paxlovid  ( dose , frequency and duration not reported)  for Covid 19 treatment however after treatment it was reported there were recurrence of symptoms worse than before. Other details surrounding the events were not reported like results of laboratories/diagnostic procedures and no information provided if any medical consult was done. Outcome of the event is not resolved. The ongoing  Covid 19 pandemic is considered as a confounder for the event.  Event of Interchange of vaccine products and Covid 19 Immunization (Re vaccination with a different Covid 19 Vaccine )  also occurred. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2022: Removed tracking only classification, added Moderna as suspect and Janssen as co-suspect.; Sender's Comments: This spontaneous case concerns a 39 year old female patient  initially vaccinated with one dose  of Co-suspect, non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination ,  with reported  Co-suspect drug NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced Non-serious , unexpected, of Covid 19 which occurred on an unknown date in 2022 post vaccination with the 2nd dose of mRNA-1273 vaccine . This patient received  a non-company co-suspect drug of Paxlovid  ( dose , frequency and duration not reported)  for Covid 19 treatment however after treatment it was reported there were recurrence of symptoms worse than before. Other details surrounding the events were not reported like results of laboratories/diagnostic procedures and no information provided if any medical consult was done. Outcome of the event is not resolved. The ongoing  Covid 19 pandemic is considered as a confounder for the event.  Event of Interchange of vaccine products and Covid 19 Immunization (Re vaccination with a different Covid 19 Vaccine )  also occurred. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.