Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: feet and legs started swelling up; face swelling; eyelid swelling; fatigue; fever; a little headache; feeling like car is driving while not doing anything; feeling hot; hallucinating; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Chronic kidney disease stage 4 (stage 4 kidney disease).    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING HOT (feeling hot), FEELING ABNORMAL (feeling like car is driving while not doing anything), HEADACHE (a little headache) and PYREXIA (fever). On 28-May-2021, the patient experienced PERIPHERAL SWELLING (feet and legs started swelling up), SWELLING FACE (face swelling), SWELLING OF EYELID (eyelid swelling) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinating), PERIPHERAL SWELLING (feet and legs started swelling up), FEELING HOT (feeling hot), SWELLING FACE (face swelling), FEELING ABNORMAL (feeling like car is driving while not doing anything), SWELLING OF EYELID (eyelid swelling), HEADACHE (a little headache), FATIGUE (fatigue) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Blood pressure measurement: 191/90 mmHg (High) 191/90. On 27-May-2021, Heart rate: high (High) rapid heart rate. On 28-May-2021, Blood pressure measurement: 187/87 mmHg (High) 187/87.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's symptoms started about 45-mins after getting the first dose. These symptoms were a little headache, feeling like car was driving while not doing anything, wondering why the next car was moving,  felt like hallucinating, rapid heart rate, getting fever and hot. It was cold, but felt hot.Needed to call a friend to help stay alert while driving home from the vaccination facility. A blood pressure (BP) of 191/90 on 27-May-2021 and BP was still high at 187/87 on 28-May-2021. On the morning of 28-May-2021, feet and legs started swelling up and the patient could not see the TV because of face and eyelid swelling, and fatigue. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.