Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Cardiac monitoring, Device dislocation, Dizziness, Electrocardiogram abnormal
Clinical narrative: she experienced some blurred vision; vasovagal syncope; dizziness; HTN; sweating profusely; aching; hot; Headache; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (HTN), VISION BLURRED (she experienced some blurred vision) and SYNCOPE (vasovagal syncope) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032264) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (single dose, lot number 071F21A) on 08-Nov-2021, Moderna COVID-19 vaccine (single dose, lot number 065K21A) on 21-Apr-2022 and Moderna COVID-19 Bivalent (lot number 055F22B) on 10-Oct-2022; for Product used for unknown indication: pneumonia shot (pneumonia shot) on 08-Sep-2023 and Flu shot (Flu shot) on 08-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna COVID-19 Bivalent, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and pneumonia shot.   On 10-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 13-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SYNCOPE (vasovagal syncope) (seriousness criteria hospitalization and medically significant). On 15-Oct-2023, the patient experienced VISION BLURRED (she experienced some blurred vision) (seriousness criterion hospitalization). In October 2023, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization), HYPERTENSION (HTN) (seriousness criterion hospitalization), HYPERHIDROSIS (sweating profusely), PAIN (aching), FEELING HOT (hot) and HEADACHE (Headache). The patient was hospitalized from sometime in October 2023 to sometime in October 2023 due to DIZZINESS, HYPERTENSION, SYNCOPE and VISION BLURRED. At the time of the report, DIZZINESS (dizziness), HYPERTENSION (HTN), VISION BLURRED (she experienced some blurred vision), SYNCOPE (vasovagal syncope), HYPERHIDROSIS (sweating profusely), PAIN (aching), FEELING HOT (hot) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Blood glucose: 101.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient took the Moderna shot on Tuesday afternoon 10-oct-2023 over that week she was sweating profusely, perspiration was dropping off her. Patient did not remember taking medications before calling her doctor on Friday but may have taken 650 mL Tylenol. Usually had some symptoms like this before, but not as bad. Reported that they did a few tests including putting her on a heart monitor. They kept her there until Sunday afternoon while on a heart monitor. Nurse checked her legs, as she was concerned for blood clots. Also had checked her elbows. Kept monitoring blood pressures. They took blood. They did not give a diagnosis in the hospital. They told her to not stop taking the COVID-19 vaccine comparing risks and benefits. They told her she passed out like when someone sees blood. Diagnosis at discharge was 1. syncope, unspecified syncope type and 2. dizziness. Thinks that this was vasovagal syncope on discharge paperwork. Discharged her with a heart monitor. It wouldn't stay on because she was perspiring so bad. This repeated a couple times. It was recommended she take it off to let it dry then put it back on. It has continued to slide on her. She mailed it back, which they are hoping to collect enough data to identify the cause of her symptoms. Labs included ICG, EKG, sinus tach, otherwise WNL.   This case was linked to US-MODERNATX, INC.-MOD-2023-746761 (E2B Linked Report).  Company Comment: This spontaneous case concerns a 75-year-old female patient, with no relevant medical history reported, who experienced the unexpected and serious (hospitalization) events of DIZZINESS, HYPERTENSION, VISION BLURRED and SYNCOPE, among other non-serious events, in context with the fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine. Three days after vaccination she experienced syncope, and two days later she was admitted for two days due to vision blurred, dizziness and hypertension that she experienced during the week after vaccination. Blood test revealed glucose of 101, and heart monitoring was performed but no result was disclosed. Since the events were reported with no exact onset date, latency could not be properly assessed. Paracetamol was taken as treatment on an unknown date. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746761:Same reporter Husband case