Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Electrocardiogram ambulatory, Fatigue, Headache, Loss of consciousness
Clinical narrative: woke up at 5AM on 4Feb2022 and passed out in her bathroom.; her first primary series was J&J vaccine; slept for the next 24 hours; woke up with a headache for 2-3 days afterwards.; Extreme fatigue for 2-3 days afterwards; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (woke up at 5AM on 4Feb2022 and passed out in her bathroom.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 (had it in Nov2020), was reported.) in November 2020. Previously administered products included for Product used for unknown indication: J&J vaccine (First primary series was J&J vaccine was reported.) and J&J vaccine (First primary series was J&J vaccine was reported.). Past adverse reactions to the above products included No adverse event with J&J vaccine and J&J vaccine.    On 03-Feb-2022 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (her first primary series was J&J vaccine). On 04-Feb-2022 at 5:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (woke up at 5AM on 4Feb2022 and passed out in her bathroom.) (seriousness criterion medically significant). In February 2022, the patient experienced SOMNOLENCE (slept for the next 24 hours), HEADACHE (woke up with a headache for 2-3 days afterwards.) and FATIGUE (Extreme fatigue for 2-3 days afterwards). At the time of the report, LOSS OF CONSCIOUSNESS (woke up at 5AM on 4Feb2022 and passed out in her bathroom.), SOMNOLENCE (slept for the next 24 hours), HEADACHE (woke up with a headache for 2-3 days afterwards.) and FATIGUE (Extreme fatigue for 2-3 days afterwards) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (her first primary series was J&J vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 antibody test: negative (Negative) Took a COVID-19 test and it came out negative.         No concomitant medication was reported.  No treatment medication was reported.  Patient weight was reported as 150 without units.  Company Comment: This is a spontaneous case of interchange of vaccine products for this 71-year-old, female patient with past drug history of administration of two doses of the Johnson&Johnson COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of loss of consciousness and other associated unexpected and expected, non-serious events. The event loss of consciousness occurred 15 hours after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start dates of the other events were not provided. Fifteen hours after vaccination, the patient woke up and passed out in the bathroom. She then slept for the next 24 hours. She woke up on an unspecified date with headache and extreme fatigue for 2 to 3 days. The patient stated that the side effects felt similar to when she had COVID-19 in Nov2020. However, she took a COVID-19 test and the result was negative. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This is a spontaneous case of interchange of vaccine products for this 71-year-old, female patient with past drug history of administration of two doses of the Johnson&Johnson COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of loss of consciousness and other associated unexpected and expected, non-serious events. The event loss of consciousness occurred 15 hours after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start dates of the other events were not provided. Fifteen hours after vaccination, the patient woke up and passed out in the bathroom. She then slept for the next 24 hours. She woke up on an unspecified date with headache and extreme fatigue for 2 to 3 days. The patient stated that the side effects felt similar to when she had COVID-19 in Nov2020. However, she took a COVID-19 test and the result was negative. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.