Age: 74.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: We were exposed so probably have it (rebound) too / My wife also became positive/having recurrent symptoms; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (We were exposed so probably have it (rebound) too / My wife also became positive/having recurrent symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 015M20A and 039K20-2A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Lipids increased (Mild elevated lipids). Concomitant products included ATORVASTATIN, CALCIUM CARBONATE (OS-CAL), FISH OIL and RALOXIFENE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (We were exposed so probably have it (rebound) too / My wife also became positive/having recurrent symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from May 2022 to May 2022 for COVID-19 treatment, at a dose of UNK, bid, 3 caps, not really tablets, were oblong and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (We were exposed so probably have it (rebound) too / My wife also became positive/having recurrent symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Body temperature: 101 low grade fever like 101. In May 2022, SARS-CoV-2 test: positive (Positive) tested again initially and her PCR was positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The first Booster was Moderna on November 9th, 21 or November 4th, the second Booster was Moderna on 13-Apr-22. The patient had Flu Vaccine (Unspecified Flu Vaccine), the high dose since they were both above 65 years. It was reported that the caller's wife had a minimal cold. The patient does not want to retest, said that they were exposed so she probably had it (rebound) too. The caller and the patient received Paxlovid because both were in their 70's and both. Both had positive tests and both had symptomatic mild to moderate Paxlovid to prevent hospitalization and death. The patient has some recurrent mild symptoms. The patient took Paxlovid as the patient was having recurrent symptoms. The patient tested again initially and PCR was positive. At that time patient was having a low grade fever like 101, cough, aches, body aches and headache. It was asked if the caller believed that there was a causal relationship between Paxlovid and the symptoms that wife had and caller said that, yes the patient started getting it as well.  Company Comment: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19. She was tested positive with PCR after the treatment and had low grade fever, Cough, headache, and body aches and was treated with paracetamol for fever. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19. She was tested positive with PCR after the treatment and had low grade fever, Cough, headache, and body aches and was treated with paracetamol for fever. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.