Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The 1st time caller was positive for Covid, 24May2022, symptoms were more  flu like, running a low grade fever, achy joints, and bad headache; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The 1st time caller was positive for Covid, 24May2022, symptoms were more  flu like, running a low grade fever, achy joints, and bad headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included AMLODIPINE for Blood pressure, VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and GINKGO BILOBA for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (The 1st time caller was positive for Covid, 24May2022, symptoms were more  flu like, running a low grade fever, achy joints, and bad headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at a dose of 3 tablets twice, 2 antiviral tablets and whatever the other tablet was ,by mouth. At the time of the report, COVID-19 (The 1st time caller was positive for Covid, 24May2022, symptoms were more  flu like, running a low grade fever, achy joints, and bad headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive Positive. On 05-Jun-2022, SARS-CoV-2 test: positive Positive. On an unknown date, SARS-CoV-2 test: negative Negative.         Caller reported that the 1st time caller was positive for Covid, 24May2022, symptoms were more flu like, running a low grade fever, achy joints, and bad headache. The 2nd time caller was positive for Covid, 05-Jun-2022, symptoms felt like a head cold, only worse. Patient could not even describe it, sneezing, coughing, eyes running, felt terrible. Caller was frustrated because she had a sense that she knew she would test positive again and she did test positive again. COVID-19 vaccine: Caller clarified that she received a total of 4 doses, not 5 doses, of the Moderna COVID-19 vaccine.  1st dose- Date- 27-Jan-2021. NDC number, lot number, expiration date- Doesn't know what the number was, 030L20A. Dose and route was unknown.  2nd dose: Date-24-Feb-2021 NDC number, lot number, expiration date- Doesn't know what the number was, 015M20A. Dose and route was unknown  3rd dose- Date- 20Aug2021 NDC number, lot number, expiration date- Doesn't know what the numbers were, 017E21A, and there was a DR14389. Dose and route was unknow. 4th dose- Date-11-Apr-2022 NDC number, lot number, expiration date-Doesn't know what the number was, 005MZIA, must be a 005M21A, handwritten on vaccination card. Dose and route was unknown.   Caller just feels it was critical to really know how many cases were out there as rebound. Caller knows 4 people on Paxlovid in the last month or so, and 3 have had rebound Covid. PSCC Communication- PC filed.  Company Comment: This spontaneous case concerns an 82-year-old female patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 1 month and 13 days after vaccination with a fourth dose of mRNA-1273. The patient experienced flu-like symptoms, low-grade fever, achy joints, and bad headache. She was diagnosed with Covid-19 and started the full course of paxlovid on the same day. She finished the course 5 days after and tested negative on the sixth and ninth day. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 82-year-old female patient with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 1 month and 13 days after vaccination with a fourth dose of mRNA-1273. The patient experienced flu-like symptoms, low-grade fever, achy joints, and bad headache. She was diagnosed with Covid-19 and started the full course of paxlovid on the same day. She finished the course 5 days after and tested negative on the sixth and ninth day. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.