chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Swelling, Vision blurred
Clinical narrative: blurred vision; fingers hurt; swelling; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, VISION BLURRED (blurred vision), PAIN IN EXTREMITY (fingers hurt), SWELLING (swelling), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Myalgia, Pyrexia
Clinical narrative: Hard to move arm; Arm is sore; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore), PYREXIA (Fever) and MYALGIA (Body ache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CANDESARTAN, AMLODIPINE BESYLATE, OMEPRAZOLE, PROBIOTICS NOS and CALCIUM for an unknown indication.    On 10-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 LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore), PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, LIMB DISCOMFORT (Hard to move arm), ARTHRALGIA (Arm is sore) and MYALGIA (Body ache) outcome was unknown and PYREXIA (Fever) had resolved.        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.   This case was linked to MOD-2021-258990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant Followup added on 16 Jul 2021  to include ,age,new reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pruritus
Clinical narrative: hives; chills; ache; fatigue; sore arm; itching on left arm; welt on right eyebrow; itchy on right eyebrow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache) and FATIGUE (fatigue) in a 55-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.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (welt on right eyebrow) and PRURITUS (itchy on right eyebrow). On an unknown date, the patient experienced CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives). At the time of the report, URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; chills; ache; fatigue; sore arm; itching on left arm; welt on right eyebrow; itchy on right eyebrow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache) and FATIGUE (fatigue) in a 55-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.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (welt on right eyebrow) and PRURITUS (itchy on right eyebrow). On an unknown date, the patient experienced CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives). At the time of the report, URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm was hot; arm was red; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red). On 17-Feb-2021, VACCINATION SITE WARMTH (arm was hot) and VACCINATION SITE ERYTHEMA (arm was red) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR was received on 13-JUL-2021 contains information about  Patient  Had the 2nd dose also without any issues
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Cough, Headache, Malaise
Clinical narrative: stomach upset; chest pain; cough; general malaise; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Migraine. Concomitant products included LEVOTHYROXINE and PROPRANOLOL 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 ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise), HEADACHE (Headache) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), MALAISE (general malaise), HEADACHE (Headache) and NAUSEA (nausea) had resolved and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided. Treatment medication was reported as migraine medication
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: stomach upset; chest pain; cough; general malaise; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Migraine. Concomitant products included LEVOTHYROXINE and PROPRANOLOL 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 ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), COUGH (cough), MALAISE (general malaise), HEADACHE (Headache) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), CHEST PAIN (chest pain), MALAISE (general malaise), HEADACHE (Headache) and NAUSEA (nausea) had resolved and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided. Treatment medication was reported as migraine medication
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: She took an antibody test, and it came back negative; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (She took an antibody test, and it came back negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (She took an antibody test, and it came back negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (She took an antibody test, and it came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: soreness at the injection site,; Headache that was off and on; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site,), HEADACHE (Headache that was off and on) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: did not receive second dose in recommended 42 day timeframe; Extreme muscle pain; fatigue; spikes in fever between 100 and 103.4 degrees Fahrenheit; felt strange; rise in temp/fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt strange), PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (rise in temp/fever), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit) and MYALGIA (Extreme muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 and Infection (Infection in March and it took months to get better.) in March 2021.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING ABNORMAL (felt strange) and PYREXIA (rise in temp/fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit), MYALGIA (Extreme muscle pain) and FATIGUE (fatigue). On 17-Jan-2021, PYREXIA (rise in temp/fever) had resolved. At the time of the report, FEELING ABNORMAL (felt strange), PRODUCT DOSE OMISSION ISSUE (did not receive second dose in recommended 42 day timeframe), PYREXIA (spikes in fever between 100 and 103.4 degrees Fahrenheit), MYALGIA (Extreme muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.  No treatment listed.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up included: Patient history, product information, adverse event information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain, Pain in extremity, Rash
Clinical narrative: rash; Feels crummy; Feels like the flu; Extreme arm soreness; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness), PAIN (Body Aches) and RASH (rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included SIMVASTATIN for Cholesterol, HCTZ for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness) and PAIN (Body Aches). On 18-Feb-2021, the patient experienced RASH (rash). On 23-Feb-2021, RASH (rash) had resolved. At the time of the report, MALAISE (Feels crummy), INFLUENZA LIKE ILLNESS (Feels like the flu), PAIN IN EXTREMITY (Extreme arm soreness) and PAIN (Body Aches) outcome was unknown.            No treatment medications were provided. Action taken with the product mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-140696, MOD-2021-030892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up included: Reporter demographics, and concomitant medications added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm hurts; felt pinched; heat; red spot on arm/pink spot now; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (poisoning were noted), Diabetic, Hypertension, High cholesterol and Drug allergy. Concomitant products included METFORMIN for Diabetes, COLESEVELAM HCL for High cholesterol, VERAPAMIL HCL for Hypertension, VITAMIN D [VITAMIN D NOS] for Vitamin D low.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen). At the time of the report, PAIN IN EXTREMITY (arm hurts), NERVE COMPRESSION (felt pinched), VACCINATION SITE WARMTH (heat), VACCINATION SITE ERYTHEMA (red spot on arm/pink spot now) and VACCINATION SITE SWELLING (swollen) had resolved.            As a treatment patient applied wet cloth with ice cubes to the area periodically.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received included patient medical history,concomitant drugs, allergy details, first dose information such as start date, Lot number, Location and outcome of events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Redness; Firmness; Elevated skin; felt itch like bug bite; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE PRURITUS (felt itch like bug bite), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN, METOPROLOL, CELECOXIB (CELEXA [CELECOXIB]), CALCIUM and VITAMIN D NOS for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (felt itch like bug bite). On 06-Feb-2021, the patient experienced ERYTHEMA (Redness), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin). The patient was treated with CETIRIZINE at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), VACCINATION SITE PRURITUS (felt itch like bug bite), VACCINATION SITE INDURATION (Firmness) and VACCINATION SITE SWELLING (Elevated skin) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included Ice.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: started as a pain but now it's a little worst today and more of a muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A or 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Cholesterol pills, 2 Blood Pressure pills, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 10-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 MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (started as a pain but now it's a little worst today and more of a muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Gastrointestinal infection
Clinical narrative: Intestinal virus; Stomach bug; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL INFECTION (Intestinal virus) and GASTROENTERITIS VIRAL (Stomach bug) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 GASTROINTESTINAL INFECTION (Intestinal virus) and GASTROENTERITIS VIRAL (Stomach bug). At the time of the report, GASTROINTESTINAL INFECTION (Intestinal virus) and GASTROENTERITIS VIRAL (Stomach bug) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cluster headache, Myalgia, Nausea, Pyrexia
Clinical narrative: HEADACHES; SEVERE NAUSEA; SEVERE VOMITING; FEVER; BODY ACHES; CHILLS; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER) and MYALGIA (BODY ACHES) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS). At the time of the report, CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: HEADACHES; SEVERE NAUSEA; SEVERE VOMITING; FEVER; BODY ACHES; CHILLS; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER) and MYALGIA (BODY ACHES) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS). At the time of the report, CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Sore right arm; Pump itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE PRURITUS (Pump itchy at the injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12M0AM0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, LISINOPRIL and METOPROLOL for Hypertension.    On 04-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 PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE PRURITUS (Pump itchy at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE PRURITUS (Pump itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient information, Product Information  and Event Pump itchy at the injection site is added. Action taken updated.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Hot to touch at injection site; flu like symptoms; Not feeling well; Rash at injection site; COVID ARM (Tropical red Puffy Hot Skin); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well), VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) and VACCINATION SITE RASH (Rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031620A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well), VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) and VACCINATION SITE RASH (Rash at injection site).   At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (Not feeling well) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown and VACCINATION SITE REACTION (COVID ARM (Tropical red Puffy Hot Skin)) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-086745 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient's mailing address updated, second dose details updated and event information added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Vaccination site pain
Clinical narrative: knot at right neck; Pain at injection, right arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (knot at right neck) and VACCINATION SITE PAIN (Pain at injection, right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection, right arm). On 20-Jan-2021, the patient experienced NECK MASS (knot at right neck). The patient was treated with Physical therapy (heating pad) for Neck mass and Physical therapy (heating pad) for Vaccination site pain. At the time of the report, NECK MASS (knot at right neck) and VACCINATION SITE PAIN (Pain at injection, right arm) outcome was unknown.            Treatment included physical therapy-heating pad   This case was linked to MOD-2021-120543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: patient contact details has been updated. a new event and outcome of the event has been updated based on initial source document.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: I noticed a large (maybe the size of a nickel) bruise at the vaccination site; Left arm is black and blue at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site) and VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to some Antibiotics), Age-related macular degeneration since 1980 and Premature atrial contraction since 1970. Concomitant products included ESTRADIOL (ESTRADIOL TRANSDERMAL) for Estrogen, PROPAFENONE and ATENOLOL for Premature beat atrial, ACICLOVIR for Viral infection.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site). On an unknown date, the patient experienced VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site). On 11-Apr-2021, VACCINATION SITE HAEMORRHAGE (Left arm is black and blue at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (I noticed a large (maybe the size of a nickel) bruise at the vaccination site) outcome was unknown.            No treatment medication was provided. Eye vitimain was used as concomitant mediacation. The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on contains significant information. Address, Demographic details, medical history, concomitant medications, dose 2 details updated. Added Event  Vaccination site hemorrhage start date and stop date, outcome were updated and new event was added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Diarrhea; Lots of pain; Fever; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN (Lots of pain), PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100.6 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on other medication.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: Bleeding gums; A spontaneous report  was received from a consumer, who was also a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bleeding gums.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, the patient experienced bleeding gums that lasted about twenty-four hours. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The event of bleeding gums was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Yawning
Clinical narrative: yawning; throat swollen; This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has history of Anaphylaxis.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen). At the time of the report, YAWNING (yawning) and PHARYNGEAL SWELLING (throat swollen) outcome was unknown.            No treatment and concomitant drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling in the nose; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling in the nose) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On an unknown date, the patient experienced SWELLING (swelling in the nose). At the time of the report, SWELLING (swelling in the nose) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Headache, Muscle tightness
Clinical narrative: Face Swelling; Eye felt weird; Soreness behind left ear; Stomach felt like "Someone punched her"; Achy Bones; Tightness on right side of body; Sore arm; Rash on Cheeks and Neck; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her") and BONE PAIN (Achy Bones) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Xanax.  Treatment medication included Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains non significant information. The primary reporter contact details were updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Pain, Pain in extremity, Rash, Swelling face
Clinical narrative: Face Swelling; Eye felt weird; Soreness behind left ear; Stomach felt like "Someone punched her"; Achy Bones; Tightness on right side of body; Sore arm; Rash on Cheeks and Neck; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her") and BONE PAIN (Achy Bones) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face Swelling), OCULAR DISCOMFORT (Eye felt weird), PAIN (Soreness behind left ear), ABDOMINAL PAIN UPPER (Stomach felt like "Someone punched her"), BONE PAIN (Achy Bones), MUSCLE TIGHTNESS (Tightness on right side of body), PAIN IN EXTREMITY (Sore arm), RASH (Rash on Cheeks and Neck), HEADACHE (Headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Xanax.  Treatment medication included Ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 contains non significant information. The primary reporter contact details were updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pain in extremity
Clinical narrative: Dizzy/lightheaded; Legs also hurt when she bends; Arms hurt from the shot; chills; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   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 DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache).   At the time of the report, DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Dizzy/lightheaded; Legs also hurt when she bends; Arms hurt from the shot; chills; body aches; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   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 DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache).   At the time of the report, DIZZINESS (Dizzy/lightheaded), PAIN IN EXTREMITY (Legs also hurt when she bends), VACCINATION SITE PAIN (Arms hurt from the shot), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: injection site is still a big square of red; At the injection site, there's extreme swelling, rash, and extreme itching; At the injection site, there's extreme swelling, rash, and extreme itching; At the injection site, there's extreme swelling, rash, and extreme itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE ERYTHEMA (injection site is still a big square of red) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching), VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (injection site is still a big square of red). At the time of the report, VACCINATION SITE PRURITUS (At the injection site, there's extreme swelling, rash, and extreme itching) and VACCINATION SITE SWELLING (At the injection site, there's extreme swelling, rash, and extreme itching) outcome was unknown, VACCINATION SITE RASH (At the injection site, there's extreme swelling, rash, and extreme itching) was resolving and VACCINATION SITE ERYTHEMA (injection site is still a big square of red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has been self-treating with an unspecified topical medication for the last 3 days and reports that it seems to be helping the rash. No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm got little sore; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events my arm got little sore.  The patient's medical history was not provided. Concomitant medications reported were Propranolol 10mg, Methimazole 5mg for drug use for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) my arm got little sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.