Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Unruptured brain aneurysm; feeling non stop Vibrating/buzzing pins and needles on head and foot; Tremor; Lip swelling; terrible pain on my right wrist and elbow on my right side; arthritis type of pain; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (Unruptured brain aneurysm), PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) and TREMOR (Tremor) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold sores and Clipping intracerebral aneurysm on 02-Jun-2021. Concomitant products included BUDESONIDE (PULMICORT) from 05-Jan-2014 to an unknown date for Allergic asthma, ALBUTEROL [SALBUTAMOL] from 05-Jan-2014 to an unknown date for Asthma.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TREMOR (Tremor) (seriousness criterion hospitalization). On 29-Apr-2021, the patient experienced LIP SWELLING (Lip swelling). On 09-May-2021, the patient experienced PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANEURYSM (Unruptured brain aneurysm) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (terrible pain on my right wrist and elbow on my right side; arthritis type of pain). The patient was hospitalized from 09-May-2021 to 11-May-2021 due to ANEURYSM, PARAESTHESIA and TREMOR. On 03-May-2021, LIP SWELLING (Lip swelling) had resolved. On 16-May-2021, PAIN IN EXTREMITY (terrible pain on my right wrist and elbow on my right side; arthritis type of pain) had resolved. At the time of the report, ANEURYSM (Unruptured brain aneurysm) was resolving and PARAESTHESIA (feeling non stop Vibrating/buzzing pins and needles on head and foot) and TREMOR (Tremor) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: over 200 (High) high. On 09-May-2021, Computerised tomogram: abnormal (abnormal) unruptured brain aneurysm. On an unknown date, Angiogram: inconclusive (Inconclusive) Aneurysm 7mm.         Patient's primary care physician advised her that her lip swelling was a cold sore, but  the patient stated she did not get any blister nor pain.  It was reported that the vibration, pins and needle got much better but came back on 10-Jul-2021.  The vibration/ tremor is on both sides but mainly on the left.  Treatment included acupuncture.   Patient is currently recovering at home. She is scheduled to see a neurologist on 04-Aug-2021 to seek help for the internal tremor/ vibration on her feet.  Company comment: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: ADR Received.Significant FU-Case is upgraded to serious. Events, labs and medical history added.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.