chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Visual impairment
Clinical narrative: felt a little woozy; severe fatigue; a little nausea; could not see straight; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VISUAL IMPAIRMENT (could not see straight), FATIGUE (severe fatigue) and NAUSEA (a little nausea). On 24-Feb-2021, the patient experienced DIZZINESS (felt a little woozy). On 25-Feb-2021, VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia
Clinical narrative: severe cramps; chiils; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L2EA) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (severe cramps), CHILLS (chiils), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchy sensation near injection site; Injection site rash; swelling (hardness) near injection site; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site). The patient was treated with CORTISONE at a dose of 1 dosage form. On 31-Jan-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy sensation near injection site), VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE SWELLING (swelling (hardness) near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site rash
Clinical narrative: pain; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and VACCINATION SITE RASH (injection site rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (pain) and VACCINATION SITE RASH (injection site rash). At the time of the report, PAIN (pain) and VACCINATION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: follow up received on 08-feb-2021,Email address updated, 1st shot on 21-jan-2021 updated, batch no of drug updated , concomitant medication baby aspirin, vitamin d updated ,event rash from forage to forage of left arm site of injection on 7-feb-2021 updated On 09-Feb-2021: follow up recived on 9-feb-2021,Caller called to provide the correct date of vaccine administration which is 27Jan2021 instead of 21-jan-2021, On 21-Apr-2021: followup received on 21-apr-2021,Contact information updated
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Neck pain, Pyrexia
Clinical narrative: pain that goes up his neck; pain which went into his left shoulder in the joint; mild fever; gives a mild headache; sore at the injection site; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache) and VACCINATION SITE PAIN (sore at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, MULTIVITAMIN & MINERAL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Albuterol Inhaler, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache). At the time of the report, NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain that goes up his neck; pain which went into his left shoulder in the joint; mild fever; gives a mild headache; sore at the injection site; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache) and VACCINATION SITE PAIN (sore at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, MULTIVITAMIN & MINERAL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), Albuterol Inhaler, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache). At the time of the report, NECK PAIN (pain that goes up his neck), ARTHRALGIA (pain which went into his left shoulder in the joint), PYREXIA (mild fever), HEADACHE (gives a mild headache), VACCINATION SITE PAIN (sore at the injection site) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness
Clinical narrative: Flu like symptoms; Chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Teeth chattering; Fever of 103 Degree Fahrenheit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit). At the time of the report, CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 Fever 103 Degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: patients received the vaccine and were sick; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported Treatment information was not provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: turned red for a while; itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches) and ERYTHEMA (turned red for a while) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itches) and ERYTHEMA (turned red for a while). At the time of the report, PRURITUS (itches) and ERYTHEMA (turned red for a while) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itchy), ERYTHEMA (red) and URTICARIA (hives). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) for Itching, at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy) was resolving and ERYTHEMA (red) and URTICARIA (hives) had not resolved. Not Provided      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 concomitant medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: big rash; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (sore) and RASH (big rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, ROSUVASTATIN, DULOXETINE, ZINC, PROBIOTIC 10, UBIQUINOL and VITAMIN D2 for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (sore). On 03-Feb-2021, the patient experienced RASH (big rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. On 28-Jan-2021, PAIN (sore) had resolved. At the time of the report, RASH (big rash) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Flatulence, Nausea
Clinical narrative: Lot of gas; Bloating; Very nauseus; Lost appetite; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (Lost appetite), FLATULENCE (Lot of gas), ABDOMINAL DISTENSION (Bloating) and NAUSEA (Very nauseus) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DECREASED APPETITE (Lost appetite) and NAUSEA (Very nauseus). On 25-Jan-2021, the patient experienced FLATULENCE (Lot of gas) and ABDOMINAL DISTENSION (Bloating). At the time of the report, DECREASED APPETITE (Lost appetite), FLATULENCE (Lot of gas), ABDOMINAL DISTENSION (Bloating) and NAUSEA (Very nauseus) outcome was unknown.        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 provided.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Lump; Huge Red Welt; Super itchy; Tender; Super Red; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump), URTICARIA (Huge Red Welt), VACCINATION SITE ERYTHEMA (Super Red), VACCINATION SITE PRURITUS (Super itchy) and VACCINATION SITE PAIN (Tender) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Super Red) and VACCINATION SITE PAIN (Tender). On an unknown date, the patient experienced AXILLARY MASS (Lump), URTICARIA (Huge Red Welt) and VACCINATION SITE PRURITUS (Super itchy). At the time of the report, AXILLARY MASS (Lump), URTICARIA (Huge Red Welt), VACCINATION SITE ERYTHEMA (Super Red), VACCINATION SITE PRURITUS (Super itchy) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (A little bit of sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Physical aches; Just felt miserable; Extreme fatigue worse than COVID-19 just felt miserable; Higher fever 100.8; Some fatigue; Low grade fever 99.4; General ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4) and FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (On 14Dec21 he tested positive for COVID 19.) on 14-Dec-2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General ache), PYREXIA (Low grade fever 99.4) and FATIGUE (Some fatigue). On 06-Feb-2021, the patient experienced PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) and PYREXIA (Higher fever 100.8). On 07-Feb-2021, PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable), PYREXIA (Higher fever 100.8) and FATIGUE (Some fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2020, Body temperature: 99.4 °F (High) Low grade fever. On 06-Feb-2021, Body temperature: 100.8 °F (High) High grade fever. On 14-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Physical aches; Just felt miserable; Extreme fatigue worse than COVID-19 just felt miserable; Higher fever 100.8; Some fatigue; Low grade fever 99.4; General ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4) and FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (On 14Dec21 he tested positive for COVID 19.) on 14-Dec-2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General ache), PYREXIA (Low grade fever 99.4) and FATIGUE (Some fatigue). On 06-Feb-2021, the patient experienced PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable) and PYREXIA (Higher fever 100.8). On 07-Feb-2021, PAIN (General ache), PAIN (Physical aches), FEELING ABNORMAL (Just felt miserable), PYREXIA (Low grade fever 99.4), FATIGUE (Extreme fatigue worse than COVID-19 just felt miserable), PYREXIA (Higher fever 100.8) and FATIGUE (Some fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2020, Body temperature: 99.4 °F (High) Low grade fever. On 06-Feb-2021, Body temperature: 100.8 °F (High) High grade fever. On 14-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Hypertension
Clinical narrative: blood pressue 240; hand and foot wouldn't move; weakness; very sick nauseous; mass of diarrhea; bad headache; very dizzy; very cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (mass of diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, PROBIOTICS NOS, OMEPRAZOLE, METOPROLOL TARTRATE (LOPRESSOR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (mass of diarrhea). At the time of the report, DIARRHOEA (mass of diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Nasopharyngitis, Nausea
Clinical narrative: blood pressue 240; hand and foot wouldn't move; weakness; very sick nauseous; mass of diarrhea; bad headache; very dizzy; very cold; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (mass of diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, PROBIOTICS NOS, OMEPRAZOLE, METOPROLOL TARTRATE (LOPRESSOR) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (mass of diarrhea). At the time of the report, DIARRHOEA (mass of diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dry skin, Rash, Skin exfoliation
Clinical narrative: Skin rash all over body, followed by dry peeling skin, now acne on face
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Gait disturbance, Headache, Nausea
Clinical narrative: Nausea vomiting couldn't hardly walk hip pain legs ache n head pounding puking dehydration wheezing
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting, Wheezing
Clinical narrative: Nausea vomiting couldn't hardly walk hip pain legs ache n head pounding puking dehydration wheezing
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: INJECTION SITE ITCHING; rash around the injection site, getting worse, around 3-4 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, CLONIDINE, MACROGOL 3350 (MIRALAX), ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size). At the time of the report, INJECTION SITE PRURITUS (INJECTION SITE ITCHING) and INJECTION SITE RASH (rash around the injection site, getting worse, around 3-4 inches in size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Benadryl ointment
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity, Vaccination site induration, Vaccination site mass
Clinical narrative: rash at the injection site; injection site hard; injection site swelling; a bump at the injection site; itching at the injection site; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (a bump at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, SIMVASTATIN, ROPINIROLE and TRAMADOL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On 15-Jan-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment reported- Aleve for the symptoms Other concomitant medications included- medicine for constipation as needed and medicine for reflux.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR: 2 reactions from shot, call back.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; injection site hard; injection site swelling; a bump at the injection site; itching at the injection site; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (a bump at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, SIMVASTATIN, ROPINIROLE and TRAMADOL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site). On 15-Jan-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE INDURATION (injection site hard), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (a bump at the injection site) and INJECTION SITE PRURITUS (itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment reported- Aleve for the symptoms Other concomitant medications included- medicine for constipation as needed and medicine for reflux.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: TCR: 2 reactions from shot, call back.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pain on the injection site; more tired than normally do; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do). On 01-Feb-2021, VACCINATION SITE PAIN (pain on the injection site) and FATIGUE (more tired than normally do) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: area where vaccine was administered stareted to itch; VERY RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Mastectomy and Lymph nodes removal (Left.). Concurrent medical conditions included Drug allergy (Allergic to Sulfas, Penicillin, codeine, Iodine, Tetracycline) and Allergy (Dust and Sprouts).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) and VACCINATION SITE ERYTHEMA (VERY RED). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) at an unspecified dose and frequency. On 22-Jan-2021, VACCINATION SITE PRURITUS (area where vaccine was administered stareted to itch) had resolved and VACCINATION SITE ERYTHEMA (VERY RED) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.. The treatment Benadryl Skin Allergy was applied topically via spay.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Feeling abnormal
Clinical narrative: extremally dizzy; all of sudden felt down; felt icky; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM, MAGNESIUM and ZINC for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (extremally dizzy), FALL (all of sudden felt down), FEELING ABNORMAL (felt icky) and ASTHENIA (No energy). At the time of the report, DIZZINESS (extremally dizzy) and FALL (all of sudden felt down) had resolved and FEELING ABNORMAL (felt icky) and ASTHENIA (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included Vitamin C for an unknown indication.  Follow up received on April 30 included additional events of feeling abnormal(feeling icky) and asthenia (low energy) and dose 2 events which will be reported in  a  separate report with case # MOD-2021-100848.   Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-100848 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 30 Apr 2021 included New AE added
Sex: F
Vaccine: COVID19
Symptoms: Miosis, Pain in extremity, Tenderness
Clinical narrative: Tenderness; Pupil contracted to almost nothing; Arm hurting little bit; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit). On 04-Feb-2021, TENDERNESS (Tenderness), MIOSIS (Pupil contracted to almost nothing) and PAIN IN EXTREMITY (Arm hurting little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccination site rash; vaccination site pain; vaccination site pruritus; vaccination site warmth; vaccination site swelling; A report was received from a consumer concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site.  The patient's medical history was not reported . Concomitant medications were not reported.  On 08-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for COVID-19 prophylaxis.  On an undisclosed date, the patient experienced rash at the injection site, pain at the injection site, itching at the injection site, warmth at the injection site and swelling at the injection site and went to the Dermatologist.  The treatment given was not reported.   Action taken with mRNA-1273 in response to the event(s) was not reported.  The outcome of the event was unknown. Patient consented to follow-up.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: their upper arm was painful.; achy on the arm of the vaccine, their upper arm was painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, DILTIAZEM, LOSARTAN, ROSUVASTATIN, OMEPRAZOLE, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.). At the time of the report, PAIN IN EXTREMITY (their upper arm was painful.) and VACCINATION SITE PAIN (achy on the arm of the vaccine, their upper arm was painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Pain in extremity, Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Arm was hot to touch and itchy; Purple hue around the injection site; hot and warm from the elbow to her shoulder; Had inflammation; Arm was hot to touch and itchy; Sore arm; Welt that was hard and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation) and VACCINATION SITE PRURITUS (Arm was hot to touch and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Benadryl and advil.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Arm was hot to touch and itchy; Purple hue around the injection site; hot and warm from the elbow to her shoulder; Had inflammation; Arm was hot to touch and itchy; Sore arm; Welt that was hard and hot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation) and VACCINATION SITE PRURITUS (Arm was hot to touch and itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ATORVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site). At the time of the report, VACCINATION SITE WARMTH (Arm was hot to touch and itchy), VACCINATION SITE DISCOLOURATION (Purple hue around the injection site), FEELING HOT (hot and warm from the elbow to her shoulder), INFLAMMATION (Had inflammation), VACCINATION SITE PRURITUS (Arm was hot to touch and itchy), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE URTICARIA (Welt that was hard and hot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Benadryl and advil.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: bigger and bigger; little red (good size) and itch; Itch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371620A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ERYTHEMA (little red (good size) and itch) and PRURITUS (Itch). On an unknown date, the patient experienced PERIPHERAL SWELLING (bigger and bigger). At the time of the report, ERYTHEMA (little red (good size) and itch), PRURITUS (Itch) and PERIPHERAL SWELLING (bigger and bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.