Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Transient ischaemic attack
Clinical narrative: Ministroke; Red spots on her legs/ nickle-sized red spot on her leg/ she has other spot in her leg/ spot on her left leg/ 3 nickel size spot/ on the right leg tiny spot; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Prurigo and TICAGRELOR (BRILINTA) for Arterial stent insertion.    The patient's past medical history included Anxiety ('stress test done due to some anxiety; Corrective treatment: acetylsalicylic acid (baby aspirin) for anxiety and arterial stent insertion') in October 2020 and Arterial stent insertion ('Corrective treatment: acetylsalicylic acid (baby aspirin) for anxiety and arterial stent insertion) on 15-Dec-2020. Previously administered products included for Drug use for unknown indication: PLAVIX ('Corrective treatment: clopidogrel bisulfate (plavix) for mouth haemorrhage and contusion) on 15-Dec-2020 and BABY ASPIRIN (blood thinner) on 15-Dec-2020. Past adverse reactions to the above products included No adverse event with BABY ASPIRIN and PLAVIX.   On 01-Oct-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. In October 2020, the patient started TICAGRELOR (BRILINTA) (unknown route) 90 milligram twice a day. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Ministroke) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH MACULAR (Red spots on her legs/ nickle-sized red spot on her leg/ she has other spot in her leg/ spot on her left leg/ 3 nickel size spot/ on the right leg tiny spot). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministroke) outcome was unknown and RASH MACULAR (Red spots on her legs/ nickle-sized red spot on her leg/ she has other spot in her leg/ spot on her left leg/ 3 nickel size spot/ on the right leg tiny spot) had resolved.       Company commen: This spontaneous case concerns an 82-year-old, female patient with medical history of Transient Ischemic Attack status post Cardiac catheterization (Oct2020) of Left Anterior descending artery treated with the co-suspect product Brilinta (ticagrelor), medical history of Besnier's Prurigo (Atopic Dermatitis) treated with the co-suspect product Dupixent (dupilumab), and previous occurrence of nickle-sized red spots on both legs, who experienced the unexpected, serious (medically significant) of transient ischaemic attack (mini-stroke) and the unexpected, non-serious event of rash macular. The event transient ischaemic attack occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start date of the event of rash macular was not provided, hence, the onset latency could not be assessed. On an unspecified date in 2021, it was reported that the patient had a mini-stroke. No further details were provided and the outcome of the event was unknown at the time of the report. On an unspecified date, the patient developed red spots on her left leg, three nickle-sized red spot, and a tiny spot on her right leg which she kept waiting to go away. It was reported that the spots were much better than last year. The patient used an unspecified cream given by a health care provider. The red spots lasted for 3 months. The medical history of Transient Ischemic Attack remains a confounder for the event transient ischaemic attack. The medical history of Besnier's Prurigo remains a confounder for the event rash macular which is a common symptom of this medical condition. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.     No concomitant medication was provided. No treatment information was mentioned.  Patient took Moderna dose on an unknown date and they found out in follow up that patient did have a mini stroke. After the second dose of vaccine also got spots on leg, 3 nickel size spots and a tiny spot on right leg. She did not have spots for over a year, and they had gone away at some point but came back.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Sender's Comments: This spontaneous case concerns an 82-year-old, female patient with medical history of Transient Ischemic Attack status post Cardiac catheterization (Oct2020) of Left Anterior descending artery treated with the co-suspect product Brilinta (ticagrelor), medical history of Besnier's Prurigo (Atopic Dermatitis) treated with the co-suspect product Dupixent (dupilumab), and previous occurrence of nickle-sized red spots on both legs, who experienced the unexpected, serious (medically significant) of transient ischaemic attack (mini-stroke) and the unexpected, non-serious event of rash macular. The event transient ischaemic attack occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. The start date of the event of rash macular was not provided, hence, the onset latency could not be assessed. On an unspecified date in 2021, it was reported that the patient had a mini-stroke. No further details were provided and the outcome of the event was unknown at the time of the report. On an unspecified date, the patient developed red spots on her left leg, three nickle-sized red spot, and a tiny spot on her right leg which she kept waiting to go away. It was reported that the spots were much better than last year. The patient used an unspecified cream given by a health care provider. The red spots lasted for 3 months. The medical history of Transient Ischemic Attack remains a confounder for the event transient ischaemic attack. The medical history of Besnier's Prurigo remains a confounder for the event rash macular which is a common symptom of this medical condition. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.