Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Incoherent, Joint swelling, Neurological symptom
Clinical narrative: Fallen ten times; A major neurological event; Joints are swollen; Talks her sentences are jumbled and not coherent; Joints are painful; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fallen ten times) and NEUROLOGICAL SYMPTOM (A major neurological event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included Blood pressure high (High Blood Pressure), Depression, Disability and Obesity. Concomitant products included GABAPENTIN (NEURONTIN) and INFLUENZA VACCINE for an unknown indication.   On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced FALL (Fallen ten times) (seriousness criterion medically significant), NEUROLOGICAL SYMPTOM (A major neurological event) (seriousness criterion medically significant), JOINT SWELLING (Joints are swollen) and INCOHERENT (Talks her sentences are jumbled and not coherent). 14-Jan-2022, the patient experienced ARTHRALGIA (Joints are painful). At the time of the report, FALL (Fallen ten times), NEUROLOGICAL SYMPTOM (A major neurological event), JOINT SWELLING (Joints are swollen), INCOHERENT (Talks her sentences are jumbled and not coherent) and ARTHRALGIA (Joints are painful) outcome was unknown.            Concomitant medications included significant number of medications, including medications to treat high blood pressure, depression and nerve blockers like Neurontin. Treatment information was not provided. The patient had no known drug or food allergies. Medical history included that the patient was disabled, obese and medically fragile.   The patient took booster dose. The patient was evaluated in the emergency room. It was unknown if the patient will be hospitalized at this time as further evaluation is currently ongoing at a local emergency room.  Company comment: This is a spontaneous case concerning a 77-year-old, female patient with medical history of high blood pressure, depression, disability and obesity, who experienced the unexpected serious events of Fall and Neurological symptom, as well as non-serious events of Joint swelling, Incoherent and Arthralgia one day after the third dose of mRNA-1273. The medical history, advanced age, concomitant drugs and flu vaccination remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient with medical history of high blood pressure, depression, disability and obesity, who experienced the unexpected serious events of Fall and Neurological symptom, as well as non-serious events of Joint swelling, Incoherent and Arthralgia one day after the third dose of mRNA-1273. The medical history, advanced age, concomitant drugs and flu vaccination remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.