Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Slight strange sensation; Itchy; Bumps on skin, in her upper torso/Like a pimple size; Tiny small bumps on upper front and back, shoulders & upper arms. Somer were itchy and not like hives; Soreness in both lower shins/arm; Sore arm; Lips and mouth area had a slight numbness feeling; Hardness; Vaccination related malaise; Heart palpitation (sporadic); Pinkish in color; Slight fever (99.4); Chills; Flu-like symptons; Tingling around mouth; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Bumps on skin, in her upper torso/Like a pimple size), PRURITUS (Itchy), ERYTHEMA (Pinkish in color), HYPOAESTHESIA (Lips and mouth area had a slight numbness feeling) and FEELING ABNORMAL (Slight strange sensation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Penicillin allergy, Blood pressure high, High cholesterol and Pre-diabetes. Concomitant products included LISINOPRIL for Blood pressure high, ESTRADIOL (VAGIFEM) for Estrogen, SIMVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and NATURE'S BOUNTY ADULT MULTIVITAMIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Pinkish in color), PALPITATIONS (Heart palpitation (sporadic)), INFLUENZA LIKE ILLNESS (Flu-like symptons), PARAESTHESIA ORAL (Tingling around mouth), RASH (Rash), PYREXIA (Slight fever (99.4)) and CHILLS (Chills). On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (Vaccination related malaise). On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Lips and mouth area had a slight numbness feeling). 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE INDURATION (Hardness). On 19-Feb-2021, the patient experienced LIMB DISCOMFORT (Soreness in both lower shins/arm). On 20-Feb-2021, the patient experienced SKIN REACTION (Bumps on skin, in her upper torso/Like a pimple size) and RASH PAPULAR (Tiny small bumps on upper front and back, shoulders & upper arms. Somer were itchy and not like hives). On 22-Feb-2021, the patient experienced PRURITUS (Itchy). On an unknown date, the patient experienced FEELING ABNORMAL (Slight strange sensation). On 12-Feb-2021, ERYTHEMA (Pinkish in color) had resolved. On 12-Mar-2021, PALPITATIONS (Heart palpitation (sporadic)), INFLUENZA LIKE ILLNESS (Flu-like symptons), PARAESTHESIA ORAL (Tingling around mouth), RASH (Rash) and PYREXIA (Slight fever (99.4)) had resolved. At the time of the report, SKIN REACTION (Bumps on skin, in her upper torso/Like a pimple size), PRURITUS (Itchy), HYPOAESTHESIA (Lips and mouth area had a slight numbness feeling), FEELING ABNORMAL (Slight strange sensation), PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Vaccination related malaise), LIMB DISCOMFORT (Soreness in both lower shins/arm), RASH PAPULAR (Tiny small bumps on upper front and back, shoulders & upper arms. Somer were itchy and not like hives), VACCINATION SITE INDURATION (Hardness) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIMB DISCOMFORT (Soreness in both lower shins/arm), INFLUENZA LIKE ILLNESS (Flu-like symptons), PARAESTHESIA ORAL (Tingling around mouth), RASH (Rash) and PYREXIA (Slight fever (99.4)) to be possibly related. No further causality assessments were provided for SKIN REACTION (Bumps on skin, in her upper torso/Like a pimple size), PRURITUS (Itchy), ERYTHEMA (Pinkish in color), HYPOAESTHESIA (Lips and mouth area had a slight numbness feeling), FEELING ABNORMAL (Slight strange sensation), PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Heart palpitation (sporadic)), VACCINATION COMPLICATION (Vaccination related malaise), RASH PAPULAR (Tiny small bumps on upper front and back, shoulders & upper arms. Somer were itchy and not like hives), VACCINATION SITE INDURATION (Hardness) and CHILLS (Chills).    Treatment for the event included acetaminophen, Benadryl, Steroid cream.  Patient states that her physician said the slight numbness in her mouth area was due to Anxiety (from breathing faster)   Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated Patient demographics, Medical history Updated outcome of event Skin reaction, Pruititus, Erythema, Hypoesthesia, feeling abnormal, pain in extremity, palpitations, malaise, rash, pyrexia from Unknown to Recovered New Events Limb discomfort, Rash papular, Vaccination site induration, Influenza like illness, paresthesia's oral, rash addedUpdated Reporter Causality for Influenza like illness, pyrexia, Paresthesia's oral, Palpitations, rash, Limb discomfort from Not Provided to Possible