Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Transient ischaemic attack, Ultrasound scan, Ventricular tachycardia
Clinical narrative: 2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian; 2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian; Covid-19; Blood vessels in left eye broke causing subconjunctival hemorrhage; Blindness in peripheral vision left eye (TIA); This spontaneous case was reported by a patient and describes the occurrence of ANEURYSM (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian), VENTRICULAR TACHYCARDIA (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian) and TRANSIENT ISCHAEMIC ATTACK (Blindness in peripheral vision left eye (TIA)) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7171B and AS716573) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (stayed home and isolated for approximately 2 years) in 2020 and COVID-19 on 01-Sep-2022. Concurrent medical conditions included Penicillin allergy, Blood pressure high since 2012, Psoriasis since 1990 and Neutropenia since 2012. Concomitant products included ATENOLOL from 01-Jan-2022 to an unknown date for Blood pressure high.   On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In April 2023, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Blindness in peripheral vision left eye (TIA)) (seriousness criterion medically significant). In May 2023, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Blood vessels in left eye broke causing subconjunctival hemorrhage). In July 2023, the patient experienced COVID-19 (Covid-19). In October 2023, the patient experienced ANEURYSM (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian) (seriousness criteria hospitalization and medically significant) and VENTRICULAR TACHYCARDIA (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in October 2023 due to ANEURYSM and VENTRICULAR TACHYCARDIA. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from September 2022 to October 2022 for COVID-19, at a dose of Packet; NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from July 2023 to July 2023 for COVID-19, at a dose of Packet and NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from September 2023 to September 2023 for COVID-19, at a dose of Packet. At the time of the report, ANEURYSM (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian), VENTRICULAR TACHYCARDIA (2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian), TRANSIENT ISCHAEMIC ATTACK (Blindness in peripheral vision left eye (TIA)), COVID-19 (Covid-19) and CONJUNCTIVAL HAEMORRHAGE (Blood vessels in left eye broke causing subconjunctival hemorrhage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive. In July 2023, SARS-CoV-2 test: Positive. In September 2023, SARS-CoV-2 test: Negative. On 17-Oct-2023, Magnetic resonance imaging: 2 aneurysms. On 17-Oct-2023, Ultrasound scan: mild plaque carotid. On an unknown date, Blood pressure measurement: raising to the 165-170 range after having a Covid vaccine for approximately 20 to 30 days.. On an unknown date, Body temperature: 101.         Patient received first dose on 17Feb2021  with lot number Lot 030M20A, second dose on 17Mar2021 with lot number Lot 04BA21A, third dose on 24Oct2021 with lot number Lot 017F21A, fourth dose on 03Apr2022 with lot number Lot 001M21A.   Prior to Covid and the Covid vaccine's, Patient had mild high blood pressure and mild neutropenia  Condition worsen during covid-19 illness was high blood pressure.  Patient experienced COVID-19 on sep 2022, July 2023 and beginning of Sep 2023. Blindness in peripheral vision left eye event was happened in April2023 and end of Sep2023.subconjunctival hemorrhage event occurred on May2023 and Aug2023. Patient was in hospital for dizziness in Oct2023.  Patient experienced COVID-19 symptoms, included  fever for 3 days duration. Temperature maximum was 101.Chills for 5 days Shortness of breath  for 5 days ,Muscle aches for 10 days, Headache for 5 days, Nasal congestion/ runny nose for 10 days, Loss of taste for 3 days, Loss of smell for 2 days, slept for 10 days.  It was unknown, patient had 2 TIA's,It was not caused by Aneurysms' per doctors, not caused by PFO, had TTE, it was Negative, Plaque in Carotid mild  was Possible,Loop Recorder placed in 1/2024 to determine if any AFIB was possible.  Covid and/or Covid and Vaccine's were causing patient current health issues with TIA and NSVT. Patient monitor BP when patient get a vaccine (and/or Covid and/or have to take Paxlovid) and ensure patient doctor provides extra medication to keep patient blood pressure stable during these times.  Company comment: This spontaneous case concerns a 66-year-old, female patient with medical history of blood pressure increased (Blood pressure high since 2012), who experienced the unexpected serious (medically significant and hospitalization) AESI of no sustained ventricular tachycardia, aneurysm and medically significant event of transient ischemic attack (described as blindness in peripheral vision left eye (TIA)) along with non serious events of COVID 19 and subconjunctival hemorrhage. The event of TIA occurred twice, first time in same month after sixth dose of Spikevax bivalent BA.4/5 and then approx. 5 months after 6th dose. Blood vessels in left eye broke causing subconjunctival hemorrhage twice first time one month after 6th dose and 4 months after 6th dose. COVID 19 occurred twice, 3 and 5 months after 6th dose. Patient was hospitalized for dizziness and after a MRI test was diagnosed with 2 2mm Aneurysms and NSVT  Left Cavernous and left subclavian, 6 months after 6th dose. Patient believed Covid and/or Covid and Vaccine's were causing patient current health issues with TIA and NSVT. Per doctor's it is unknown why patient had TIA. No further information about the events was provided. Patient medical history of blood pressure increased is a confounding factor. The benefit-risk relationship of Spikevax bivalent BA.4/5 is not affected by this report.   This case was linked to MOD-2023-754668, MOD-2023-753450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2024: Non-significant information received