Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: ministroke; had Covid; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (ministroke) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Family history included Stroke (grandmother had stroke). Concurrent medical conditions included Diabetes (on all kinds of medicine), Unspecified disorder of thyroid (thyroid condition, on all kinds of medicine) and Blood pressure high (on all kinds of medicine).   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (ministroke) (seriousness criterion medically significant) and COVID-19 (had Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 31-Oct-2023 for COVID-19, at an unspecified dose and frequency; NIRMATRELVIR, RITONAVIR (PAXLOVID) in November 2023 for COVID-19, at a dose of UNK UNK, bid (morning dose: 1 tablet 150mg, another 150mg, 1  100mg tablet afternoon same thing) and APIXABAN (ELIQUIS) for Ministroke, at a dose of 5 milligram twice a day. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (ministroke) and COVID-19 (had Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2023, SARS-CoV-2 test: Negative. On 14-Nov-2023, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  Patient took Paxlovid 31 Oct 2023. That time, tested negative for Covid, had Covid.  Patient tested positive with Covid on the day of reporting, was prescribed Paxlovid again. Patient was advised to take her Eliquis half a dose, twice a day which was not advised to do that the first time took Paxlovid.  Patient started Eliquis probably been a couple of years at least, had mini stroke, then they put on it. Patient had mini stroke after receiving the Covid vaccine, which also happened to be Pfizer. Patient received first 2 Covid vaccines of Moderna. Last one was Pfizer and did not take any more after that.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a female patient of unknown age, with relevant medical conditions of diabetes, unspecified thyroid disorder and high blood pressure, and family history of grandmother with a stroke, who experienced the unexpected and serious (due to medically significant) AESI of Transient ischaemic attack, which occurred on an unknown date primary vaccination with mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included Tozinameran, administered as third dose within COVID-19 vaccination schedule. Patient also experienced COVID-19 on an unknown date and received Paxlovid. Apixaban was indicated for ministroke. No information disclosed about other diagnostic tests performed and clinical course. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.