Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Disturbance in attention, Fatigue
Clinical narrative: got very sick; she had a very bad reaction, the side effects of this drug are terrible; missed 3 days at work; This morning woke up better; achy all over; could not concentrate; could barely stay awake; fever chill; almost crashed driving; nauseated; Fever(max 102.9°F); so exhausted; hallucinating; weakness; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (hallucinating) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), ASTHENIA (weakness), SOMNOLENCE (could barely stay awake), IMPAIRED DRIVING ABILITY (almost crashed driving), NAUSEA (nauseated), PYREXIA (Fever(max 102.9°F)) and FATIGUE (so exhausted). 20-Sep-2021, the patient experienced PAIN (achy all over), DISTURBANCE IN ATTENTION (could not concentrate) and CHILLS (fever chill). On 21-Sep-2021, the patient experienced POOR QUALITY SLEEP (This morning woke up better). On an unknown date, the patient experienced ILLNESS (got very sick), VACCINATION COMPLICATION (she had a very bad reaction, the side effects of this drug are terrible) and IMPAIRED WORK ABILITY (missed 3 days at work). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 20-Sep-2021, DISTURBANCE IN ATTENTION (could not concentrate), SOMNOLENCE (could barely stay awake) and IMPAIRED DRIVING ABILITY (almost crashed driving) had resolved. On 21-Sep-2021, PYREXIA (Fever(max 102.9°F)) had resolved. At the time of the report, HALLUCINATION (hallucinating), ASTHENIA (weakness), ILLNESS (got very sick), VACCINATION COMPLICATION (she had a very bad reaction, the side effects of this drug are terrible), POOR QUALITY SLEEP (This morning woke up better), PAIN (achy all over), IMPAIRED WORK ABILITY (missed 3 days at work), CHILLS (fever chill), NAUSEA (nauseated) and FATIGUE (so exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Body temperature: 102.9 (High) 102.9F by noon and 101-102 (High) around 101-102F. On 21-Sep-2021, Body temperature: 97 (normal) 97 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HALLUCINATION (hallucinating), ASTHENIA (weakness), ILLNESS (got very sick), VACCINATION COMPLICATION (she had a very bad reaction, the side effects of this drug are terrible), POOR QUALITY SLEEP (This morning woke up better), PAIN (achy all over), DISTURBANCE IN ATTENTION (could not concentrate), IMPAIRED WORK ABILITY (missed 3 days at work), SOMNOLENCE (could barely stay awake), CHILLS (fever chill), IMPAIRED DRIVING ABILITY (almost crashed driving), NAUSEA (nauseated), PYREXIA (Fever(max 102.9°F)) and FATIGUE (so exhausted) to be possibly related.    Concomitant product was not provided by the reporter Treatment product  was not provided by the reporter  Nurse called in to report the side effects after her first and second doses. She states that she took the product and got very sick, she had a very bad reaction, the side effects of this drug are terrible, she had to miss 3 days at work. After the second shot everything was way out of control. With the fever at 102.9F, she was so exhausted, hallucinating, nauseated, weak, achy all over and the fever chills. She had a one hour drive from work to home, she almost crashed driving, could barely stay awake, could not concentrate. This morning (as reported) woke up better.  Company Comment: This case concerns a 58 years old female whose medical history was not provided, who experienced the serious unlisted event Hallucination and other non serious events, reported spontaneously via phone call. The patient denies further contact, so further information is not expected. The event occurred 35 days after the first dose of a proper product schedule of administration (28 days between doses). The rechallenge is positive for fever and pain, as per these events were reported after the first dose, and recurred after the second dose. For Hallucinations, the rechallenge is not applicable as no further doses will be available. As per this is a spontaneously reported case, the causality as reported is assumed as possibly related. The events outcome at the time of the report is unknown. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report.   This case was linked to MOD-2021-326936 (Patient Link).; Sender's Comments: This case concerns a 58 years old female whose medical history was not provided, who experienced the serious unlisted event Hallucination and other non serious events, reported spontaneously via phone call. The patient denies further contact, so further information is not expected.  The event occurred 35 days after the first dose of a proper product schedule of administration (28 days between doses).  The rechallenge is positive for fever and pain, as per these events were reported after the first dose, and recurred after the second dose. For Hallucinations, the rechallenge is not applicable as no further doses will be available. As per this is a spontaneously reported case, the causality as reported is assumed as possibly related. The events outcome at the time of the report is unknown. The benefit-risk relationship of Moderna nMRNA-1273 is not affected by this report.