Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Depression, Feeling abnormal, Illness, Immunisation reaction
Clinical narrative: Sick; Depressed; Flare up/felt horrible after COVID-19 vaccines; Covid vaccine triggered symptoms; Flare up/felt horrible after COVID-19 vaccines; Second dose was administered on 28-JUN-2021 and booster was administered on 01-SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DEPRESSION (Depressed), FEELING ABNORMAL (Flare up/felt horrible after COVID-19 vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was administered on 28-JUN-2021 and booster was administered on 01-SEP-2021) and IMMUNISATION REACTION (Covid vaccine triggered symptoms) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was administered on 28-JUN-2021 and booster was administered on 01-SEP-2021). On an unknown date, the patient experienced ILLNESS (Sick), DEPRESSION (Depressed), FEELING ABNORMAL (Flare up/felt horrible after COVID-19 vaccines), IMMUNISATION REACTION (Covid vaccine triggered symptoms) and CONDITION AGGRAVATED (Flare up/felt horrible after COVID-19 vaccines). At the time of the report, ILLNESS (Sick) and DEPRESSION (Depressed) had not resolved, FEELING ABNORMAL (Flare up/felt horrible after COVID-19 vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was administered on 28-JUN-2021 and booster was administered on 01-SEP-2021) outcome was unknown and IMMUNISATION REACTION (Covid vaccine triggered symptoms) and CONDITION AGGRAVATED (Flare up/felt horrible after COVID-19 vaccines) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that the primary reporter did not have the lot number information, because the packaging was discarded.  The reporters causality for the events of COVID VACCINE TRIGGERED SYMPTOMS AND FLARE UPS/FELT HORRIBLE AFTER THE COVID 19 VACCINES unknown onset and COVID VACCINE TRIGGERED SYMPTOMS AND FLARE UPS/FELT HORRIBLE AFTER THE COVID 19 VACCINES unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporters causality for the events of COVID VACCINE TRIGGERED SYMPTOMS AND FLARE UPS/FELT HORRIBLE AFTER THE COVID 19 VACCINES unknown onset, SICK and DEPRESSED was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.