Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (rapid COVID test (home test) came back positive/went to Pharmacy on 19Jan2022 and took a PCR test, came back positive), FEELING ABNORMAL (couple days went by, felt like crap), FEELING COLD (feeling cold), PAIN (little bit of aches) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Jan-2022 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced FEELING COLD (feeling cold), PAIN (little bit of aches), CHILLS (chills) and PYREXIA (fever). In January 2022, the patient experienced FEELING ABNORMAL (couple days went by, felt like crap). On 18-Jan-2022, the patient experienced COVID-19 (rapid COVID test (home test) came back positive/went to Pharmacy on 19Jan2022 and took a PCR test, came back positive). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (rapid COVID test (home test) came back positive/went to Pharmacy on 19Jan2022 and took a PCR test, came back positive), FEELING ABNORMAL (couple days went by, felt like crap), FEELING COLD (feeling cold), PAIN (little bit of aches), CHILLS (chills) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. On 19-Jan-2022, SARS-CoV-2 test: positive (Positive) got results on the 20th. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. The reporter reported that, the second shot was scheduled for 10-Feb-2022. Company Comment: This spontaneous case concerns a 48 year old female with no medical history reported, who experienced non-serious, unexpected, AESI event of Covid 19 which occurred 7 days post vaccination with the 1st dose of mRNA-1273 vaccine ( Moderna Covid-19 Vaccine). This was accompanied by other non-serious, unexpected events of feeling cold, pain and expected events of chills and pyrexia which occurred one day after the vaccination with the 1st dose . On an unknown day in Jan 2022 this patient experienced non-serious, unexpected event of feeling abnormal. This patient took paracetamol and Guaifenesin. The re-challenge for this case is not applicable since the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: No new information was received. Sender's Comments: This spontaneous case concerns a 48 year old female with no medical history reported, who experienced non-serious, unexpected, AESI event of Covid-19 which occurred 7 days post vaccination with the 1st dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). This was accompanied by other non-serious, unexpected events of feeling cold, pain and expected events of chills and pyrexia which occurred one day after the vaccination with the 1st dose . On an unknown day in Jan 2022 this patient experienced non-serious, unexpected event of feeling abnormal. This patient took paracetamol and Guaifenesin. The re-challenge for this case is not applicable since the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid-19 Vaccine) is not affected by this report.