Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Interchange of Vaccine Products; metal taste; runny nose; sore throat; low grade temp; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), DYSGEUSIA (metal taste), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (low grade temp) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028X21A and 046H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EJ168S Location of injection: Arm Left) on 28-Dec-2020 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EJ1686 Location of injection: Arm Left) on 29-Jan-2022. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concomitant products included ROSUVASTATIN and ESCITALOPRAM for an unknown indication.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (COVID-19). On 25-May-2022, the patient experienced DYSGEUSIA (metal taste), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (low grade temp). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), DYSGEUSIA (metal taste), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PYREXIA (low grade temp) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine Products) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: tested positive on day four via home antigen test (Positive) Tested positive on day four via home antigen test. On 25-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Healthy female internal medicine physician. Rebound Covid. She had a significant exposure driving her daughter home from the train on 13-May-2022. Tested positive on day four via home antigen test. She began Paxlovid and took this for 5 days. No side effects except metal taste (similar to Lunesta). She had very little in the way of Covid symptoms initially, just a low grade temp once.  Then today (5/25/22) developed runny nose and sore throat. Patient did a nasal PCR panel and the Covid was positive. Should the Paxlovid be a longer initial course.  Company Comment: This is a spontaneous case concerning a 61-year-old female patient and a case of Interchange of Vaccine Products with previous COVID-19 vaccination history using 2 doses of non-company product Pfizer / BioNTech, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient had a significant exposure from her daughter and tested positive 4 days later and started 5 days treatment with Paxlovid. Patient only complained of metal taste during the duration of the treatment. However, 5 days post treatment, patient had an episode of runny nose and sore throat and tested positive once again, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old female patient and a case of Interchange of Vaccine Products with previous COVID-19 vaccination history using 2 doses of non-company product Pfizer / BioNTech, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient had a significant exposure from her daughter and tested positive 4 days later and started 5 days treatment with Paxlovid. Patient only complained of metal taste during the duration of the treatment. However, 5 days post treatment, patient had an episode of runny nose and sore throat and tested positive once again, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.