Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pruritus, SARS-CoV-2 test
Clinical narrative: extreme itching without hives or rash; Paxlovod "rebound" with negative post-treatment test converting to positive (day four post-treatment) with recurrence of symptoms three days following completion of medication course; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (extreme itching without hives or rash) and COVID-19 (Paxlovod "rebound" with negative post-treatment test converting to positive (day four post-treatment) with recurrence of symptoms three days following completion of medication course) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had no known allergy.  Concurrent medical conditions included Asthma and Hypertension. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and CETIRIZINE for an unknown indication.   On 15-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022, the patient experienced PRURITUS (extreme itching without hives or rash) and COVID-19 (Paxlovod "rebound" with negative post-treatment test converting to positive (day four post-treatment) with recurrence of symptoms three days following completion of medication course). At the time of the report, PRURITUS (extreme itching without hives or rash) and COVID-19 (Paxlovod "rebound" with negative post-treatment test converting to positive (day four post-treatment) with recurrence of symptoms three days following completion of medication course) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Comedication also included Monteleukast. Device Date : 24May2022  Company Comment: This is a spontaneous case concerning  a  62-year-old, male patient with concurrent medical conditions of Asthma and Hypertension, who experienced the unexpected non-serious events of Pruritus, Covid-19. The events occurred 61 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient was tested for SARS-CoV-2 test, initial results was negative then tested positive.  Patient was treated with nirmatrelvir, ritonavir tablets at an unspecified dose. The events were reported as resolving. The concurrent medical conditions of Asthma and Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  62-year-old, male patient with concurrent medical conditions of Asthma and Hypertension, who experienced the unexpected non-serious events of Pruritus, Covid-19. The events occurred 61 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient was tested for SARS-CoV-2 test, initial results was negative then tested positive.  Patient was treated with nirmatrelvir, ritonavir tablets at an unspecified dose. The events were reported as resolving. The concurrent medical conditions of Asthma and Hypertension remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.