Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Autonomic nervous system imbalance, Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Dizziness
Clinical narrative: Moderna Booster TIA after 4th booster / stroke; Disregulation of Autonomous nervous regulation; God really dizzy and had to go to ER; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Moderna Booster TIA after 4th booster / stroke) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack (because of her fear to get COVID) on 20-May-2022. Concurrent medical conditions included Drug allergy (Pain medication and to many other medications (unspecified).), Hypertension (patient medicated with blood pressure medications.), Food allergy, Penicillin allergy and Allergic reaction to analgesics. Concomitant products included HYDRALAZINE and METOPROLOL SUCCINATE (TOPROL XL) for Blood pressure abnormal, MEPIVACAINE HYDROCHLORIDE (CARBOCAINE) for Increased blood pressure.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Moderna Booster TIA after 4th booster / stroke) (seriousness criterion medically significant), AUTONOMIC NERVOUS SYSTEM IMBALANCE (Disregulation of Autonomous nervous regulation) and DIZZINESS (God really dizzy and had to go to ER). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Moderna Booster TIA after 4th booster / stroke), AUTONOMIC NERVOUS SYSTEM IMBALANCE (Disregulation of Autonomous nervous regulation) and DIZZINESS (God really dizzy and had to go to ER) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure diastolic: 65, 73, 80 and 70. On an unknown date, Blood pressure measurement: 92/66. On an unknown date, Blood pressure systolic: 115, 123, 130, 150 and 160. On an unknown date, Heart rate: 106. On an unknown date, Magnetic resonance imaging: did have a TIA.         Patient was on blood pressure medications.  Patient received 4th booster dose.  Blood pressure runs 115-123 over 65 to 73 Now 130s 150'160, over 80's and 70's. Not dangerously high. Patient went into the emergency room on Thursday (as reported) about 2am and was really dizzy. Cardiologist said no damage and affected her speech. They did MRI and saw that she did have a TIA. Patient's physician said she has dysregulation of autonomous nervous regulation. Had to go off of her medication and it went from that to having a stroke. Then it was out of control. She could not use Lidocaine and Epinephrine and could not use Novocain. She did not provided any reason why she could not use those products. Everything she read said not to use Carbocaine for dental procedures and needs to be monitored, but patient thought that was if they would have to use it for Spinal or something. She did not had that much time and had a doctor's appointment and did not wish to complete report.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (due to medically significant) AESI of transient ischaemic attack (TIA) and received a dose of mRNA-1273.222 (BA.4/BA.5). The patient received previously three doses of mRNA within the appropriate schedule of vaccination. The events onset dates were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that after the 2nd booster dose during the same day of vaccination, the patient started to feel really sick, aches, tiredness, her heart rate went up to 106, feeling so cold she couldn't get warm, joint aches, muscle aches, racing heart beat, chills, aches, headaches. It was reported that the patient went into the emergency room and was really dizzy. The cardiologist said that there was no damage. The patent's speech was affected. A magnetic resonance imaging was performed, and she had a TIA. Patient's physician said she had dysregulation of autonomous nervous regulation, so she had to stop her medication, and this led to a stroke. It was reported that the patient had experienced a similar event in the past and that is why she was taking the beta blocker. However, no further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   This case was linked to MOD-2022-572044 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (due to medically significant) AESI of transient ischaemic attack (TIA) and received a dose of mRNA-1273.222 (BA.4/BA.5). The patient received previously three doses of mRNA within the appropriate schedule of vaccination. The events onset dates were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that after the 2nd booster dose during the same day of vaccination, the patient started to feel really sick, aches, tiredness, her heart rate went up to 106, feeling so cold she couldn't get warm, joint aches, muscle aches, racing heart beat, chills, aches, headaches. It was reported that the patient went into the emergency room and was really dizzy. The cardiologist said that there was no damage. The patent's speech was affected. A magnetic resonance imaging was performed, and she had a TIA. Patient's physician said she had dysregulation of autonomous nervous regulation, so she had to stop her medication, and this led to a stroke. It was reported that the patient had experienced a similar event in the past and that is why she was taking the beta blocker. However, no further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.