Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Agitation, Arthralgia, Burning sensation, Diarrhoea
Clinical narrative: Irritability; Impatience; Agitation; Inability to eat; Inability to sleep; Aggression; Mania; General burning sensation over the whole body; Rash on Arm; Headache; Swelling over the area; Rash over the area; Sore joints; Sore muscles; Neuropathy; Systemic Inflammation; Diarrhea; Hasn't Felt Well; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL from 01-Mar-2020 to an unknown date for HRT.    On 23-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 01-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), INFLAMMATION (Systemic Inflammation), DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Hasn't Felt Well), BURNING SENSATION (General burning sensation over the whole body), RASH (Rash on Arm), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling over the area), VACCINATION SITE RASH (Rash over the area), ARTHRALGIA (Sore joints) and MYALGIA (Sore muscles). On 05-Apr-2021, the patient experienced IRRITABILITY (Irritability), IMPATIENCE (Impatience), AGITATION (Agitation), EATING DISORDER (Inability to eat), INSOMNIA (Inability to sleep), AGGRESSION (Aggression) and MANIA (Mania). On 09-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), INFLAMMATION (Systemic Inflammation), DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Hasn't Felt Well), IRRITABILITY (Irritability), IMPATIENCE (Impatience), AGITATION (Agitation), EATING DISORDER (Inability to eat), INSOMNIA (Inability to sleep), AGGRESSION (Aggression), MANIA (Mania), BURNING SENSATION (General burning sensation over the whole body), RASH (Rash on Arm), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling over the area), VACCINATION SITE RASH (Rash over the area), ARTHRALGIA (Sore joints) and MYALGIA (Sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  The patient was able to sleep with the lorazepam and was able to discontinue it on 13 Apr 2021 and never needed gabapentin. Mania and agitation increased as the day progressed.  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. On 15 Apr 2021, The patient mood felt better and upbeat again. Still had burning limbs and diarrhea.  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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up contains other events and incorporated in the narrative. On 19-Apr-2021: Concomitant medication added, seriousness of the event neuropathy and clinical course of narrative was updated; 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.