Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Prickling sensation on arms and legs; I had a rash on my arms from my elbows to my wrist; Burning (pins) feeling in my lower arms/ burning on my arms and legs; Bottom lip feeling numb/ my lips were numb, lips felt numb; Tongue was tingling/ tingling of my tongue/tongue felt funny, prickling on arm and legs; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning (pins) feeling in my lower arms/ burning on my arms and legs), HYPOAESTHESIA ORAL (Bottom lip feeling numb/ my lips were numb, lips felt numb), PARAESTHESIA ORAL (Tongue was tingling/ tingling of my tongue/tongue felt funny, prickling on arm and legs), DYSPNOEA (Difficulty breathing) and PARAESTHESIA (Prickling sensation on arms and legs) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 0L17AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included UTI from 04-Mar-2021 to 10-May-2021, Thyroiditis (Improved and not evident at present time) in 2001, Mitral valve disease (Mitral valve repair in 1997; Re-repair 2004 at CCF) in 1997, Atrial arrhythmia (Stable) since 02-May-2021 and Hay fever. Concurrent medical conditions included Penicillin allergy (Had a rash from Pennicilin, but not on the arms.), Drug allergy (Allergy to Sulfa), Drug allergy (Allergy to Lovinox) since 2003, Drug allergy (Allergy to Fentanyl), Allergic reaction to bee sting and Allergy NOS (Unspecified more allergies.). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CROMOGLICATE SODIUM (NASALCROM) for Allergy, PROPAFENONE (RYTHMOL [PROPAFENONE]) and LORAZEPAM (ATIVAN) for Arrhythmia, VITAMIN C [ASCORBIC ACID], DOXYCYCLINE HYCLATE from an unknown date to 28-Mar-2021, VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS], ASPIRIN [ACETYLSALICYLIC ACID] and MACROGOL 3350 (MIRALAX) for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced BURNING SENSATION (Burning (pins) feeling in my lower arms/ burning on my arms and legs), HYPOAESTHESIA ORAL (Bottom lip feeling numb/ my lips were numb, lips felt numb), PARAESTHESIA ORAL (Tongue was tingling/ tingling of my tongue/tongue felt funny, prickling on arm and legs) and DYSPNOEA (Difficulty breathing). On 28-Apr-2021, the patient experienced RASH (I had a rash on my arms from my elbows to my wrist). On an unknown date, the patient experienced PARAESTHESIA (Prickling sensation on arms and legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Difficulty breathing, at a dose of UNK dosage form. On 03-May-2021, RASH (I had a rash on my arms from my elbows to my wrist) had resolved. At the time of the report, BURNING SENSATION (Burning (pins) feeling in my lower arms/ burning on my arms and legs), HYPOAESTHESIA ORAL (Bottom lip feeling numb/ my lips were numb, lips felt numb), PARAESTHESIA ORAL (Tongue was tingling/ tingling of my tongue/tongue felt funny, prickling on arm and legs), DYSPNOEA (Difficulty breathing) and PARAESTHESIA (Prickling sensation on arms and legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unspecified date, the patient experienced breathing difficulty was advised by his internist and allergist to got to the ER (emergency room).   This case was linked to MOD-2021-062509 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contain significant information. Other medical history and concomitant medication updated.