Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Sensation of foreign body, Throat irritation, Vaccination site reaction
Clinical narrative: itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area; itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area; Felt tingling sensation all over the body; I am now past the window to receive the 2nd dose; voice got a bit hoarse; slight sensation of a lump in my throat; my arm swelled up; my arm swelled up and became very itchy and sore; my arm swelled up and became very itchy; COVID Arm; chills; taking a sip of water and getting a very sudden strange sharp stomach cramp which subsided bu then reoccurred a few more times during first week or two; 15 minutes after the first dose I felt an unusual pinging intermittent needling sensation in my body (more located on the right side of body ); thin red line on my neck; tingling and numb sensation on upper right lip; a numbness on the right side of my face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (15 minutes after the first dose I felt an unusual pinging intermittent needling sensation in my body (more located on the right side of body )), ERYTHEMA (thin red line on my neck), PARAESTHESIA ORAL (tingling and numb sensation on upper right lip), HYPOAESTHESIA (a numbness on the right side of my face) and THROAT IRRITATION (itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST SODIUM (SINGULAIR) and PREDNISONE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (15 minutes after the first dose I felt an unusual pinging intermittent needling sensation in my body (more located on the right side of body )). 11-Feb-2021, the patient experienced ERYTHEMA (thin red line on my neck). 11-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling and numb sensation on upper right lip), HYPOAESTHESIA (a numbness on the right side of my face) and ABDOMINAL PAIN UPPER (taking a sip of water and getting a very sudden strange sharp stomach cramp which subsided bu then reoccurred a few more times during first week or two). On 17-Feb-2021, the patient experienced PERIPHERAL SWELLING (my arm swelled up), PAIN IN EXTREMITY (my arm swelled up and became very itchy and sore), PRURITUS (my arm swelled up and became very itchy), VACCINATION SITE REACTION (COVID Arm) and CHILLS (chills). On 20-Feb-2021, the patient experienced DYSPHONIA (voice got a bit hoarse) and SENSATION OF FOREIGN BODY (slight sensation of a lump in my throat). On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I am now past the window to receive the 2nd dose). On an unknown date, the patient experienced THROAT IRRITATION (itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area), PRURITUS (itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area) and PARAESTHESIA (Felt tingling sensation all over the body). On 11-Feb-2021, ERYTHEMA (thin red line on my neck) had resolved. On 18-Feb-2021, CHILLS (chills) had resolved. On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I am now past the window to receive the 2nd dose) had resolved. At the time of the report, PARAESTHESIA (15 minutes after the first dose I felt an unusual pinging intermittent needling sensation in my body (more located on the right side of body )), THROAT IRRITATION (itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area), PRURITUS (itchiness nose, ears, throat, and head, would subside then come back, spread to my vaginal and anal area), PARAESTHESIA (Felt tingling sensation all over the body), ABDOMINAL PAIN UPPER (taking a sip of water and getting a very sudden strange sharp stomach cramp which subsided bu then reoccurred a few more times during first week or two), DYSPHONIA (voice got a bit hoarse), SENSATION OF FOREIGN BODY (slight sensation of a lump in my throat), PERIPHERAL SWELLING (my arm swelled up) and VACCINATION SITE REACTION (COVID Arm) outcome was unknown, PARAESTHESIA ORAL (tingling and numb sensation on upper right lip) and HYPOAESTHESIA (a numbness on the right side of my face) had resolved and PAIN IN EXTREMITY (my arm swelled up and became very itchy and sore) and PRURITUS (my arm swelled up and became very itchy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Heart rate: increased (High) Heart beat feels faster than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was given.   This case was linked to US-MODERNATX, INC.-MOD-2021-046577, US-MODERNATX, INC.-MOD-2021-068643 (E2B Linked Report). This case was linked to MOD-2021-068643 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up document was received on 29-JUN-2021. Concomitant medication was added. Event details were updated. It contains significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046577: US-MODERNATX, INC.-MOD-2021-068643: