Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Wheezing
Clinical narrative: mini-strokes which have increased in frequency; placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures; Wheezing; Shortness of breath; Headaches; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), COLECALCIFEROL (VITAMIN D3) and AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) (seriousness criterion medically significant), SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) (seriousness criterion medically significant), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Seizure prophylaxis, at a dose of 325 dosage form and ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date for Seizure prophylaxis, at a dose of 200 milligram. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) had not resolved and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: mini-strokes (abnormal) mini-strokes were confirmed via MRI.         The patient's caregiver reported the patient stopped taking amoxicillin 875-125 prior to receiving the second dose of the vaccine. After receiving the second vaccine, he began to experience a repeat of symptoms similar to those after the first dose which were described as a number of mini-strokes which increased in frequency. The patient was treated and released in an emergency room (less than 24-hour stay). It was reported the mini-strokes occurred within 24 to 72 hours post-vaccination.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-207709 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.