Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: huge red thing on her arm; PCR  COVID-19 test, which resulted positive (headache, upper-airway cough syndrome (nasal drip), oropharyngeal pain); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (huge red thing on her arm) and COVID-19 (PCR  COVID-19 test, which resulted positive (headache, upper-airway cough syndrome (nasal drip), oropharyngeal pain)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced COVID-19 (PCR  COVID-19 test, which resulted positive (headache, upper-airway cough syndrome (nasal drip), oropharyngeal pain)). On an unknown date, the patient experienced ERYTHEMA (huge red thing on her arm). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (huge red thing on her arm) and COVID-19 (PCR  COVID-19 test, which resulted positive (headache, upper-airway cough syndrome (nasal drip), oropharyngeal pain)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative and negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient had been taking an allergy medication prior to the treatment medications.  Company comment.  This spontaneous case concerns a 63  year  old, female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID - 19. The events occurred approximately 14 months after the administration of the second dose of mRNA-1273 vaccine, which was administrated in an appropriate schedules (Lack of efficacy was considered). The patient also received a third dose of mRNA  1273 approximately 9 months after her second dose. The report stated that the patient experienced sore throat, nasal drip, headache and one day later she took a PCR COVID-19 test which resulted positive. She took Paxlovid and Tylenol for her symptoms No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-580241, MOD-2022-580246 (Patient Link).; Sender's Comments: This spontaneous case concerns a 63  year  old, female patient with no relevant medical history, who experienced the unexpected, non  serious AESI of COVID - 19. The events occurred approximately 14 months after the administration of the second dose of mRNA-1273 vaccine, which was administrated in an appropriate schedules (Lack of efficacy was considered). The patient also received a third dose of mRNA  1273 approximately 9 months after her second dose. The report stated that the patient experienced sore throat, nasal drip, headache and one day later she took a PCR COVID-19 test which resulted positive. She took Paxlovid and Tylenol for her symptoms No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.