Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Tested positive for COVID; Body ached and arm was sore; Body ached and arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), MYALGIA (Body ached and arm was sore) and VACCINATION SITE PAIN (Body ached and arm was sore) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004F21A, 030M20A and 041L20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient was taking other medications or products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Allergy (Drug name was not reported). Concomitant products included METFORMIN, PRAVASTATIN and LOSARTAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. In April 2022, the patient experienced MYALGIA (Body ached and arm was sore) and VACCINATION SITE PAIN (Body ached and arm was sore). On 19-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID). On 04-May-2022, COVID-19 (Tested positive for COVID) had resolved. At the time of the report, MYALGIA (Body ached and arm was sore) and VACCINATION SITE PAIN (Body ached and arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, SARS-CoV-2 test: (Positive) Tested positive for COVID at home with no symptoms. On 25-Apr-2022, SARS-CoV-2 test: (Negative) Tested negative for COVID. On 30-Apr-2022, SARS-CoV-2 test: (Positive) Tested positive. On 04-May-2022, SARS-CoV-2 test: (Negative) Tested negative again.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  On 18-Apr-2022, patient had second booster COVID shot.  Since taking second booster, patient's body ached and arm was sore.  On 20-Apr-2022, physician tested patient again and prescribed the 5 day course of Paxlovid.  On 25-Apr-2022, patient tested negative for COVID, but still stayed isolated.   On 30-Apr-2022, patient woke up with a scratchy throat and a runny nose and was tested positive. Physician thought that patient's test on 25-Apr was likely a false negative.  Symptoms persisted until 03-May-2022 and tested negative again on 04-May-2022.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-635562 (Patient Link).