Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Irritability, Laboratory test normal, Memory impairment, Muscular weakness
Clinical narrative: feeling bad; confused; rash all over the body; anxiety/extreme anxiety; She says that her mom´s memory is off; exhausted/her mother felt physically exhausted.; arm was a limp; very irritable; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling bad), CONFUSIONAL STATE (confused), RASH (rash all over the body) and ANXIETY (anxiety/extreme anxiety) in a 99-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Allergic reaction to antibiotics (amoxicillin), Sulfonamide allergy (Sulfa), Egg allergy and Allergy to antibiotic (Z-pack antibiotic).  On 12-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced FEELING ABNORMAL (feeling bad) (seriousness criterion hospitalization), CONFUSIONAL STATE (confused) (seriousness criterion hospitalization), RASH (rash all over the body) (seriousness criterion hospitalization), ANXIETY (anxiety/extreme anxiety) (seriousness criterion hospitalization), AMNESIA (She says that her mom´s memory is off), FATIGUE (exhausted/her mother felt physically exhausted.) and MUSCULAR WEAKNESS (arm was a limp). In October 2023, the patient experienced IRRITABILITY (very irritable). The patient was hospitalized from 13-Oct-2023 to 14-Oct-2023 due to ANXIETY, CONFUSIONAL STATE, FEELING ABNORMAL and RASH. At the time of the report, FEELING ABNORMAL (feeling bad), CONFUSIONAL STATE (confused), RASH (rash all over the body), ANXIETY (anxiety/extreme anxiety), AMNESIA (She says that her mom´s memory is off), IRRITABILITY (very irritable), FATIGUE (exhausted/her mother felt physically exhausted.) and MUSCULAR WEAKNESS (arm was a limp) had not resolved.   Concomitant medication was not reported.  It was reported that on the same night of vaccination the patient started feeling bad. On 13-Oct-2023, around 11:15-11:30 AM the patient went to hospital and checked for stroke, because her arm was a limp. However it was negative. On 14-Oct-2023 the patient went back home. Her affected arm was not the one where she received the injection, but the other arm. The patient went to her assisted living center but was not doing that well. The patient had terrible rash all over her body and terrible anxiety. It was reported that the patient's memory was off and was confused. They gave her a cream for the rash. The patient was very irritable. At the hospital they were told that all of these were because of the Moderna Covid vaccine as if the vaccine didn´t agree with her mother.   Company comment: This is a Spontaneous case reported by a patient family member, concerning a 99-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization) events of Feeling abnormal, Confusional state, Rash and Anxiety, which occurred the same day after an unspecified dose of SPIKEVAX 2023-2024. First and second dose of mRNA-1273 vaccine were administered with an interval of 42 days; hence, Inappropriate schedule of vaccine administered was noted. As reported, the night of vaccination patient started feeling bad. The next day, she went to hospital, where she was checked for a stroke, because her arm was a limp. It came back negative, so she was sent back home after 1 day. Her affected arm was not the one where she received the injection. Patient has a terrible rash all over her body and terrible anxiety. Her memory is off, she is confused. She also seems very irritable. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. Patient´s elderly age could be a confounding factor for the case. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live follow-up received