Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Illness, Injection site nodule
Clinical narrative: I felt very sick; It had turned some weird colors like reddish purple with a knot under my skin but that has changed now just to redness again / peeling.; fatigue; it hurts into my shoulder and upper back like sharp pains between my shoulder blades that comes and goes.; arm was swollen worse / Swelling of arm, neck and lower jaw; Swelling of arm, neck and lower jaw/ Swelling of upper airway; Swelling of arm, neck and lower jaw; I developed a real hard lump under the vaccination site; I feel tingling and a lot of weakness I thought it was supposed to clear up in a week /Prickling/Tinglingsensation; Diarrhea; bright red all the way down into my left hand / Local Redness/erythema; itching was horrific / Generalized itching; Unusual taste; weakness; My left arm started swelling at injection site; I felt very sick with nausea; was running a fever over 102 / high fever; generalized Hives/urticaria; feeling pain / severe pain; i felt very hot / feeling hot; Generalized rash; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (I developed a real hard lump under the vaccination site), PARAESTHESIA (I feel tingling and a lot of weakness I thought it was supposed to clear up in a week /Prickling/Tinglingsensation), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (arm was swollen worse / Swelling of arm, neck and lower jaw) and SWELLING FACE (Swelling of arm, neck and lower jaw/ Swelling of upper airway) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine on 01-Jan-1977, Arthritis on 01-Jan-1977, Leg cramps on 01-Jan-2018, Ringing in ears on 01-Jan-2018, High cholesterol on 01-Jan-2012, Depression on 01-Jan-2012, Anxiety on 01-Jan-2012, Syncope on 01-Jan-2014, Dizziness on 01-Jan-2014 and Tachycardia on 01-Jan-2014. Concurrent medical conditions included Drug allergy (Ultram/Tramadol.    (Hives itching)) since 01-Jan-2005, Latex allergy (Skin eczema, redness, peeling, rawness) since 01-Jan-1980, Drug allergy (Nausea, vomiting, severe headache, hives all over) since 01-Jan-2010, Drug allergy (Hives all over, itching, nausea) since 01-Jan-2014, Asthma, Osteoporosis on 01-Jan-1977 and COPD on 01-Jan-2015. Concomitant products included CLONAZEPAM (KLONOPIN) from 01-Jan-2019 to an unknown date for Anxiety, SIMVASTATIN (ZOCOR) from 01-Jan-2000 to an unknown date for Cholesterol, FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Jan-2000 to an unknown date for Depression, VALPROATE SEMISODIUM (DEPAKOTE) from 01-Jan-1980 to an unknown date for Migraine, CEFIXIME (FLEXERIL [CEFIXIME]) from 01-Jan-2017 to an unknown date for Night cramps, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced INJECTION SITE NODULE (I developed a real hard lump under the vaccination site), PARAESTHESIA (I feel tingling and a lot of weakness I thought it was supposed to clear up in a week /Prickling/Tinglingsensation), DIARRHOEA (Diarrhea), SWELLING FACE (Swelling of arm, neck and lower jaw/ Swelling of upper airway), SWELLING (Swelling of arm, neck and lower jaw), ERYTHEMA (bright red all the way down into my left hand / Local Redness/erythema), PRURITUS (itching was horrific / Generalized itching), TASTE DISORDER (Unusual taste), ASTHENIA (weakness), URTICARIA (generalized Hives/urticaria), PAIN (feeling pain / severe pain), FEELING HOT (i felt very hot / feeling hot), RASH (Generalized rash), CHILLS (chills), VACCINATION SITE SWELLING (My left arm started swelling at injection site ), NAUSEA (I felt very sick with nausea) and PYREXIA (was running a fever over 102 / high fever). On 04-Aug-2021 at 3:30 AM, the patient experienced PERIPHERAL SWELLING (arm was swollen worse / Swelling of arm, neck and lower jaw). On an unknown date, the patient experienced ILLNESS (I felt very sick ), SKIN EXFOLIATION (It had turned some weird colors like reddish purple with a knot under my skin but that has changed now just to redness again / peeling. ), FATIGUE (fatigue) and ARTHRALGIA (it hurts into my shoulder and upper back like sharp pains between my shoulder blades that comes and goes.). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing from 04-Aug-2021 for Adverse reaction, at a dose of 1 dosage form, as needed; IBUPROFEN (ADVIL [IBUPROFEN]) (oral) ongoing from 04-Aug-2021 for Adverse reaction, at a dose of 1 dosage form, as needed; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 04-Aug-2021 for Adverse reaction, at a dose of 25 mg/2*days; ACETYLSALICYLIC ACID (BABY ASPIRIN) (oral) ongoing from 04-Aug-2021 for Adverse reaction, at a dose of 1 dosage form, as needed; HYDROCORTISONE (topical) from 04-Aug-2021 to 30-Aug-2021 for Adverse reaction, at a dose of 1 dosage form, as needed and METOPROLOL TARTRATE (oral) ongoing from 01-Jan-2017 for Tachycardia, at a dose of 25 mg. At the time of the report, INJECTION SITE NODULE (I developed a real hard lump under the vaccination site), PARAESTHESIA (I feel tingling and a lot of weakness I thought it was supposed to clear up in a week /Prickling/Tinglingsensation), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (arm was swollen worse / Swelling of arm, neck and lower jaw), SWELLING FACE (Swelling of arm, neck and lower jaw/ Swelling of upper airway), SWELLING (Swelling of arm, neck and lower jaw), ERYTHEMA (bright red all the way down into my left hand / Local Redness/erythema), PRURITUS (itching was horrific / Generalized itching), TASTE DISORDER (Unusual taste), ASTHENIA (weakness), URTICARIA (generalized Hives/urticaria), PAIN (feeling pain / severe pain), FEELING HOT (i felt very hot / feeling hot), RASH (Generalized rash), CHILLS (chills), FATIGUE (fatigue), VACCINATION SITE SWELLING (My left arm started swelling at injection site ), PYREXIA (was running a fever over 102 / high fever) and ARTHRALGIA (it hurts into my shoulder and upper back like sharp pains between my shoulder blades that comes and goes.) had not resolved and ILLNESS (I felt very sick ), SKIN EXFOLIATION (It had turned some weird colors like reddish purple with a knot under my skin but that has changed now just to redness again / peeling. ) and NAUSEA (I felt very sick with nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Body temperature: high (High) 102.5 Degree F. On 05-Aug-2021, Body temperature: high (High) 101.0 Degree F. On 06-Aug-2021, Body temperature: high (High) 101.5 Degree F. On 07-Aug-2021, Body temperature: high (High) 99.8 Degree F. On 08-Aug-2021, Body temperature: high (High) 99.9 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Fiorinal as concomitant medication, Used warm compresses for adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Updated patient pregnancy condition, height and weight. Added allergy conditions: Vicodin, Zithromax, current condition : asthma, added concomitant medications: Depakote, treatment medications: Tylenol, Advil, Benadryl, baby aspirin, hydrocortisone. added events: erythema, feeling hot, fatigue, vaccination sit swelling, nausea, pyrexia, arthralgia, swelling face, rash, urticaria, chills, taste disorder, illness, skin exfoliation. and updated event out comes.