Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Chills, Dizziness, Drug ineffective
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I was near to death), PAIN IN EXTREMITY (Arm hurt like a double), ILLNESS (She was sick), OROPHARYNGEAL PAIN (sore throat) and TREMOR (shaking so hard that I stayed under a comforter for 24 hours) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 028A21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced PAIN IN EXTREMITY (Arm hurt like a double). On 12-Jan-2022, the patient experienced ILLNESS (She was sick), OROPHARYNGEAL PAIN (sore throat), TREMOR (shaking so hard that I stayed under a comforter for 24 hours) and CHILLS (violent chills). On 14-Jan-2022, the patient experienced MEMORY IMPAIRMENT (can't remember things too well), DIZZINESS (dizziness), COVID-19 (She took a home test. It was positive) and DRUG INEFFECTIVE (Lack of drug effect). In January 2022, the patient experienced ANXIETY (I was near to death). On 14-Jan-2022, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, ANXIETY (I was near to death), PAIN IN EXTREMITY (Arm hurt like a double), ILLNESS (She was sick), OROPHARYNGEAL PAIN (sore throat), TREMOR (shaking so hard that I stayed under a comforter for 24 hours), MEMORY IMPAIRMENT (can't remember things too well), DIZZINESS (dizziness), CHILLS (violent chills) and COVID-19 (She took a home test. It was positive) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.No concomitant medication was provided.No treatment information mentioned.Patient got the booster on Tuesday 11JAN2022, but says she was exposed to COVID on 10JAN2022. She took the booster and got reactions from that afternoon. Claims it was near to death. She was sick, violent chills, had a sore throat and says she was shaking so hard she had to stay under the covers for 24 hours. She took a home test and it was positive. She also stated she cant remember things too well and was dizzy.Company Comment:This is a spontaneous case concerning a 65-year-old, female patient with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with a SARS-CoV-2 test positive, done at home). The event occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The patient had been exposed to COVID-19 one day before vaccination. COVID-19 remains as a confounder for illness, oropharyngeal pain, chills, tremor and memory impairment. Lack  of efficacy was also noted in the case (since the patient received two previous doses in the correct interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2022: Significant follow up. Reporter added, Patient details received, lab date given, event added and dose batch no received. Sender's Comments: This is a spontaneous case concerning a 65-year-old, female patient with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with a SARS-CoV-2 test positive, done at home). The event occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The patient had been exposed to COVID-19 one day before vaccination. COVID-19 remains as a confounder for illness, oropharyngeal pain, chills, tremor and memory impairment. Lack  of efficacy was also noted in the case (since the patient received two previous doses in the correct interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.