Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site vesicles, Vaccination site warmth, Vision blurred
Clinical narrative: Bluish purple spot at injection site; Vision was blurry; Tingling in her feet/ tingling started in calf of the left leg moving up to the left arm and hand; Numbness; Bumps on legs turned dark purple today; 50 dark purple welts on one leg, fewer on the other/Welts on hands are flattening out; itches and burns at the same time; small red painful bumps on my hands and feet; arm itching at injection site; area of the arm around the injection site became red; injection site became red, swollen, hot; blisters spreading down both arms and legs involving the hands and feet; injection site became red, swollen, hot; blisters did appear on tongue and face; bumpy with little blisters; small purple welts; Pelvic cramps; menstrual-like stomach cramps; diarrhea all day; Could not walk, been in bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea all day), ABDOMINAL PAIN UPPER (menstrual-like stomach cramps), VACCINATION SITE VESICLES (bumpy with little blisters), URTICARIA (small purple welts) and GAIT DISTURBANCE (Could not walk, been in bed) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis since 2009. Concomitant products included MESALAMINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could not walk, been in bed). On 01-Apr-2021, the patient experienced DIARRHOEA (diarrhea all day). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (menstrual-like stomach cramps). On 04-Apr-2021, the patient experienced MUSCLE SPASMS (Pelvic cramps). On 07-Apr-2021, the patient experienced VACCINATION SITE VESICLES (bumpy with little blisters), URTICARIA (small purple welts), BLISTER (blisters spreading down both arms and legs involving the hands and feet), STOMATITIS (blisters did appear on tongue and face), VACCINATION SITE WARMTH (injection site became red, swollen, hot), VACCINATION SITE ERYTHEMA (area of the arm around the injection site became red) and VACCINATION SITE SWELLING (injection site became red, swollen, hot). On 08-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching at injection site). On 10-Apr-2021, the patient experienced RASH MACULO-PAPULAR (small red painful bumps on my hands and feet). On 12-Apr-2021, the patient experienced SKIN DISCOLOURATION (Bumps on legs turned dark purple today), URTICARIA (50 dark purple welts on one leg, fewer on the other/Welts on hands are flattening out) and PRURITUS (itches and burns at the same time). On 20-Apr-2021, the patient experienced PARAESTHESIA (Tingling in her feet/ tingling started in calf of the left leg moving up to the left arm and hand) and HYPOAESTHESIA (Numbness). On 26-Apr-2021, the patient experienced VISION BLURRED (Vision was blurry). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Bluish purple spot at injection site). The patient was treated with PREDNISONE ongoing since an unknown date for Urticaria, at a dose of 20 mg daily; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date for Cramps, at an unspecified dose and frequency and Bed rest (been in bed for 12 days) for Gait disturbance. On 01-Apr-2021, DIARRHOEA (diarrhea all day) had resolved. On 06-Apr-2021, ABDOMINAL PAIN UPPER (menstrual-like stomach cramps) had resolved. On 07-Apr-2021, MUSCLE SPASMS (Pelvic cramps) had resolved. On 12-Apr-2021, GAIT DISTURBANCE (Could not walk, been in bed) and STOMATITIS (blisters did appear on tongue and face) had resolved. On 03-May-2021, PARAESTHESIA (Tingling in her feet/ tingling started in calf of the left leg moving up to the left arm and hand) and HYPOAESTHESIA (Numbness) had resolved. At the time of the report, VACCINATION SITE VESICLES (bumpy with little blisters), URTICARIA (small purple welts), SKIN DISCOLOURATION (Bumps on legs turned dark purple today), URTICARIA (50 dark purple welts on one leg, fewer on the other/Welts on hands are flattening out), PRURITUS (itches and burns at the same time), VACCINATION SITE DISCOLOURATION (Bluish purple spot at injection site), RASH MACULO-PAPULAR (small red painful bumps on my hands and feet), VACCINATION SITE WARMTH (injection site became red, swollen, hot), VACCINATION SITE PRURITUS (arm itching at injection site), VACCINATION SITE ERYTHEMA (area of the arm around the injection site became red) and VACCINATION SITE SWELLING (injection site became red, swollen, hot) was resolving, BLISTER (blisters spreading down both arms and legs involving the hands and feet) had resolved and VISION BLURRED (Vision was blurry) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Blood glucose: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported steroids for the treatment of rash. She received two doses of steroids. Patient reported antihistamines for the treatment of red itchy bumps. She reported that the bumps were very painful. She reported that due to pelvic cramps she was constipated so she took laxatives. Patient reported that she took heating pad  as treatment for pain due to cramps. Patient reported that she took antidiarrheal medicine for the treatment of diarrhea.   This case was linked to MOD21-078781 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Added concomitant medications, events, updated batch number patient demographics and event outcome. On 12-Apr-2021: Added events, treatment details, updated formulation of concomitant medication, dose 1 details, event start date. On 27-May-2021: Added facility information, medical history, event, updated patient demographics and event outcome. On 28-May-2021: Added treatment details, lab test, updated event outcome and resolution date.; Sender's Comments:  MOD21-078781:FOLLOW UP