Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gastrointestinal disorder, Inappropriate schedule of product administration, Insomnia, Pruritus
Clinical narrative: Recently got COVID-19/ severe sore throat, bad headache, nasal congestion, cough with colored sputum, rash to chin and chest, hurt to breathe in, muscle ache, cold chills for 8 days, diarrhea for 3 days, severe exhaustion; GI symptoms; could not fall asleep; itchy; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Recently got COVID-19/ severe sore throat, bad headache, nasal congestion, cough with colored sputum, rash to chin and chest, hurt to breathe in, muscle ache, cold chills for 8 days, diarrhea for 3 days, severe exhaustion), GASTROINTESTINAL DISORDER (GI symptoms), INSOMNIA (could not fall asleep), PRURITUS (itchy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030L20A) for COVID-19 immunisation.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 19-Dec-2021, the patient experienced GASTROINTESTINAL DISORDER (GI symptoms), INSOMNIA (could not fall asleep) and PRURITUS (itchy). On 20-Dec-2021, the patient experienced COVID-19 (Recently got COVID-19/ severe sore throat, bad headache, nasal congestion, cough with colored sputum, rash to chin and chest, hurt to breathe in, muscle ache, cold chills for 8 days, diarrhea for 3 days, severe exhaustion). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. At the time of the report, COVID-19 (Recently got COVID-19/ severe sore throat, bad headache, nasal congestion, cough with colored sputum, rash to chin and chest, hurt to breathe in, muscle ache, cold chills for 8 days, diarrhea for 3 days, severe exhaustion), GASTROINTESTINAL DISORDER (GI symptoms), INSOMNIA (could not fall asleep) and PRURITUS (itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications included Vitamin and Birth control.  Company Comment: This is a spontaneous case concerning a 43-year-old, female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (with SARS-CoV-2 test positive). The event occurred approximately 11 months 2 days after the second dose of mRNA-1273 vaccine. Additionally, inappropriate schedule of Vaccine administration (53 days between the first and the second dose) is also noted in this case. Patient is treated with Nyquil, Tylenol and Advil. The outcome of the event is reported as 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 43-year-old, female patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 (with SARS-CoV-2 test positive). The event occurred approximately 11 months 2 days after the second dose of mRNA-1273 vaccine. Additionally, inappropriate schedule of Vaccine administration (53 days between the first and the second dose) is also noted in this case. Patient is treated with Nyquil, Tylenol and Advil. The outcome of the event is reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.