Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, COVID-19, Heart rate
Clinical narrative: Had covid; Vaccination failure; TIA / small stroke; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA / small stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu Vaccine in 1987 and Flu Vaccine in 1987. Past adverse reactions to the above products included Vaccination site erythema with Flu Vaccine; and Vaccination site pruritus with Flu Vaccine. Concurrent medical conditions included Asthma, Hay fever, Hypersensitivity reaction, Hives, Drug allergy (Simvastatin allergy rash all over, joint pain, felt weak) since 2008, Sulfonamide allergy (rash, joint pain) since 1990, Blood pressure high since 1980, Arthritis and Urinary incontinence. Concomitant products included MELOXICAM for Arthritis, ALPRENOLOL HYDROCHLORIDE (ATENENOL) for Hypertension, OXYBUTYNIN for Urinary incontinence, ASPIRIN [ACETYLSALICYLIC ACID] from an unknown date to 06-Jan-2021 for an unknown indication.    On 16-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 10:15 PM, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA / small stroke) (seriousness criterion medically significant). On 11-Aug-2022, the patient experienced COVID-19 (Had covid) and VACCINATION FAILURE (Vaccination failure). On 15-Apr-2021 at 12:01 PM, TRANSIENT ISCHAEMIC ATTACK (TIA / small stroke) had resolved. On 22-Aug-2022, COVID-19 (Had covid) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood pressure measurement: high BP. On 14-Apr-2021, Body temperature: 97.3. On 14-Apr-2021, Heart rate: 49 per minute. On 15-Apr-2021, Platelet count: 138 thousand per cubic millimetre. On an unknown date, Blood test: NORMAL. On an unknown date, Platelet count: 161 thousand per cubic millimetre. On an unknown date, Weight: lost weight.         Patient lost feeling and use of left hand 30 days after second vaccination.  Seen at ER department and diagnosed with transient ischemic attack. Patient reported that one month after 2nd vaccination patient has small stroke. Reason for small stroke was unknown. There was no lasting effects.  There was no other potential causes. Patient reported that adverse event most likely caused by mRNA-1273. Patient stated that the blood work was all normal and had lost a lot of weight and started to exercise regularly before the stroke happened. she also stated that the platelets dropped the day following the stroke. Patient was taking atenolol but a lower dose (25 mg). No treatment medication reported.  Company Comment: This spontaneous case reported by a patient concerns a 71-year-old female patient, obese with a body mass index of 39, with relevant concurrent hypertension, who experienced unexpected, serious (medically significant) AESI transient ischemic attack, around 1 month after receiving a second dose of mRNA-1273.  She lost feeling and use of her left hand and was seen at the emergency department.  At the time, blood pressure was high.  Other relevant diagnostic evaluation like brain imaging was not reported.  Treatment was not reported.  The event recovered the next day.  The patient's age, obesity and concurrent hypertension could be risk factors for the transient ischemic attack.  Additionally, she had Covid19 around one year and four months later.  Vaccination failure was also reported.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-026900 (Patient Link).; Sender's Comments: This spontaneous case reported by a patient concerns a 71-year-old female patient, obese with a body mass index of 39, with relevant concurrent hypertension, who experienced unexpected, serious (medically significant) AESI transient ischemic attack, around 1 month after receiving a second dose of mRNA-1273.  She lost feeling and use of her left hand and was seen at the emergency department.  At the time, blood pressure was high.  Other relevant diagnostic evaluation like brain imaging was not reported.  Treatment was not reported.  The event recovered the next day.  The patient's age, obesity and concurrent hypertension could be risk factors for the transient ischemic attack.  Additionally, she had Covid19 around one year and four months later.  Vaccination failure was also reported.  The benefit risk relationship of mRNA-1273 is not affected by this report.