Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Headache, Inflammation, Paralysis
Clinical narrative: a TIA/thought it was a mini stroke; feel like you are paralized; ended up with a large feeling in her body and right hand, elbow to her right hand/it started growing up for a hour or a half.; losing body control/she couldn't even hold her body up/her friend had to hold her up to throw up,; diarrhea; under her armpit she felt like if she had inflammation in that area.; still having headaches from time to time/she had terrible headaches even in the hospital; She threw up all the food; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (a TIA/thought it was a mini stroke), PARALYSIS (feel like you are paralized), PERIPHERAL SWELLING (ended up with a large feeling in her body and right hand, elbow to her right hand/it started growing up for a hour or a half.), BALANCE DISORDER (losing body control/she couldn't even hold her body up/her friend had to hold her up to throw up,), DIARRHOEA (diarrhea), INFLAMMATION (under her armpit she felt like if she had inflammation in that area.), HEADACHE (still having headaches from time to time/she had terrible headaches even in the hospital) and VOMITING (She threw up all the food) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (a TIA/thought it was a mini stroke) (seriousness criteria hospitalization and medically significant), PARALYSIS (feel like you are paralized) (seriousness criteria hospitalization and medically significant), PERIPHERAL SWELLING (ended up with a large feeling in her body and right hand, elbow to her right hand/it started growing up for a hour or a half.) (seriousness criterion hospitalization), BALANCE DISORDER (losing body control/she couldn't even hold her body up/her friend had to hold her up to throw up,) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), INFLAMMATION (under her armpit she felt like if she had inflammation in that area.) (seriousness criterion hospitalization), HEADACHE (still having headaches from time to time/she had terrible headaches even in the hospital) (seriousness criterion hospitalization) and VOMITING (She threw up all the food) (seriousness criterion hospitalization). The patient was hospitalized from 17-Aug-2021 to 18-Aug-2021 due to BALANCE DISORDER, DIARRHOEA, HEADACHE, INFLAMMATION, PARALYSIS, PERIPHERAL SWELLING, TRANSIENT ISCHAEMIC ATTACK and VOMITING. The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (a TIA/thought it was a mini stroke), PARALYSIS (feel like you are paralized), PERIPHERAL SWELLING (ended up with a large feeling in her body and right hand, elbow to her right hand/it started growing up for a hour or a half.), BALANCE DISORDER (losing body control/she couldn't even hold her body up/her friend had to hold her up to throw up,), DIARRHOEA (diarrhea), INFLAMMATION (under her armpit she felt like if she had inflammation in that area.) and VOMITING (She threw up all the food) outcome was unknown and HEADACHE (still having headaches from time to time/she had terrible headaches even in the hospital) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They did every test, ecography, EKG, blood work, and they were not sure on what it was, but thought it was a mini stroke, a TIA. Relevant concomitant medications were reported blood pressure medications, and cholesterol medications. Treatment included oxygen, and an IV which she thought was saline solution but was not sure. She was given some medication for the headache, one that had caffein, but it did not help her much.  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.  However, concomitant medication with blood pressure and cholesterol medications, which could be suggestive of hypertension and dyslipidemia, and patient´s age could be confounding factors for the event transient ischaemic attack.; 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.  However, concomitant medication with blood pressure and cholesterol medications, which could be suggestive of hypertension and dyslipidemia, and patient´s age could be confounding factors for the event transient ischaemic attack.