chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site pain
Clinical narrative: hot flushes; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushes) and VACCINATION SITE PAIN (arm soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Cholesterol, Penicillin allergy, Drug allergy (SULFA, CIPROFLOXACIN, CEFTRIAXONE) and Bee sting hypersensitivity. Concomitant products included LEVOTHYROXINE, SIMVASTATIN, ASCORBIC ACID, TOCOPHEROL (VITAMIN C + E), FishOIL, SILYBUM MARIANUM FRUIT, TAURINE (MILK THISTLE 35000 PLUS TAURINE), Cranberry Extract, BIFIDOBACTERIUM ANIMALIS, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS BIFIDUS) and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HOT FLUSH (hot flushes) and VACCINATION SITE PAIN (arm soreness). At the time of the report, HOT FLUSH (hot flushes) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19) and INJECTION SITE PAIN (Pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L02A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19). On 29-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection site). At the time of the report, EXPOSURE TO SARS-COV-2 (Possibly exposed 27JAN2021 to a person with COVID-19) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment included ice.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal
Clinical narrative: Weird blood pressure issues after first Moderna shot; 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 BLOOD PRESSURE ABNORMAL (Weird blood pressure issues after first Moderna shot) 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 BLOOD PRESSURE ABNORMAL (Weird blood pressure issues after first Moderna shot). At the time of the report, BLOOD PRESSURE ABNORMAL (Weird blood pressure issues after first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI, patient denied follow-up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness with a red rime around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness with a red rime around it) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness with a red rime around it). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (redness with a red rime around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: Rash Injection Site Post First Dose; Sore Arm Injection Site Post First Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore Arm Injection Site Post First Dose) and VACCINATION SITE RASH (Rash Injection Site Post First Dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm Injection Site Post First Dose). On 10-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash Injection Site Post First Dose). On 06-Jan-2021, PAIN IN EXTREMITY (Sore Arm Injection Site Post First Dose) had resolved. On 13-Jan-2021, VACCINATION SITE RASH (Rash Injection Site Post First Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   This case was linked .
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: rash all over me/rash covered my upper legs, hips, lower back, upper arms on the inside, and tummy; I was so dizzy that I was walking sideways; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (I was so dizzy that I was walking sideways) and RASH (rash all over me/rash covered my upper legs, hips, lower back, upper arms on the inside, and tummy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2020, the patient experienced DIZZINESS (I was so dizzy that I was walking sideways). On 25-Jan-2021, the patient experienced RASH (rash all over me/rash covered my upper legs, hips, lower back, upper arms on the inside, and tummy). At the time of the report, DIZZINESS (I was so dizzy that I was walking sideways) and RASH (rash all over me/rash covered my upper legs, hips, lower back, upper arms on the inside, and tummy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient reported no treatment, but she has been taking aspirin and a sleeping pill (no drug name provided) to get through it.  24-Jun-2021 - Telephone Contact Report stated that the patient is feeling completely well, she doesn't have symptoms anymore, and would like to have the second shot.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient not administered 2nd dose On 24-Jun-2021: Follow-up information received on 24-Jun-2021: Outcome of events updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria
Clinical narrative: welt on her arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Redness from elbow to shoulder all the way around arm; Swelling at injection site the size of quarter; Second week her arm  began itching; Second week her arm  began burning; Fisrt week she had little bump; First week she had redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Fisrt week she had little bump), BURNING SENSATION (Second week her arm  began burning), ERYTHEMA (Redness from elbow to shoulder all the way around arm), INJECTION SITE ERYTHEMA (First week she had redness) and INJECTION SITE PRURITUS (Second week her arm  began itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 22-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 INJECTION SITE MASS (Fisrt week she had little bump) and INJECTION SITE ERYTHEMA (First week she had redness). On 28-Jan-2021, the patient experienced BURNING SENSATION (Second week her arm  began burning) and INJECTION SITE PRURITUS (Second week her arm  began itching). On 03-Feb-2021, the patient experienced ERYTHEMA (Redness from elbow to shoulder all the way around arm) and INJECTION SITE SWELLING (Swelling at injection site the size of quarter). At the time of the report, INJECTION SITE MASS (Fisrt week she had little bump), BURNING SENSATION (Second week her arm  began burning), ERYTHEMA (Redness from elbow to shoulder all the way around arm), INJECTION SITE ERYTHEMA (First week she had redness), INJECTION SITE PRURITUS (Second week her arm  began itching) and INJECTION SITE SWELLING (Swelling at injection site the size of quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamins, Heart burn medication and Thyroid medication.  No treatment medications were reported.  The patient reported that everyday her condition progressed.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Redness from elbow to shoulder all the way around arm; Swelling at injection site the size of quarter; Second week her arm  began itching; Second week her arm  began burning; Fisrt week she had little bump; First week she had redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Fisrt week she had little bump), BURNING SENSATION (Second week her arm  began burning), ERYTHEMA (Redness from elbow to shoulder all the way around arm), INJECTION SITE ERYTHEMA (First week she had redness) and INJECTION SITE PRURITUS (Second week her arm  began itching) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 22-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 INJECTION SITE MASS (Fisrt week she had little bump) and INJECTION SITE ERYTHEMA (First week she had redness). On 28-Jan-2021, the patient experienced BURNING SENSATION (Second week her arm  began burning) and INJECTION SITE PRURITUS (Second week her arm  began itching). On 03-Feb-2021, the patient experienced ERYTHEMA (Redness from elbow to shoulder all the way around arm) and INJECTION SITE SWELLING (Swelling at injection site the size of quarter). At the time of the report, INJECTION SITE MASS (Fisrt week she had little bump), BURNING SENSATION (Second week her arm  began burning), ERYTHEMA (Redness from elbow to shoulder all the way around arm), INJECTION SITE ERYTHEMA (First week she had redness), INJECTION SITE PRURITUS (Second week her arm  began itching) and INJECTION SITE SWELLING (Swelling at injection site the size of quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Vitamins, Heart burn medication and Thyroid medication.  No treatment medications were reported.  The patient reported that everyday her condition progressed.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I did get covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I did get covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I did get covid). At the time of the report, COVID-19 (I did get covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: red lump; black and red bruising; red; upper arm is still bruised; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (upper arm is still bruised), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE BRUISING (black and red bruising), VACCINATION SITE MASS (red lump) and VACCINATION SITE ERYTHEMA (red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O13L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE BRUISING (upper arm is still bruised), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE ERYTHEMA (red). On 27-Jan-2021, the patient experienced VACCINATION SITE BRUISING (black and red bruising). On an unknown date, the patient experienced VACCINATION SITE MASS (red lump). At the time of the report, VACCINATION SITE BRUISING (upper arm is still bruised), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE ERYTHEMA (red) outcome was unknown, VACCINATION SITE BRUISING (black and red bruising) had not resolved and VACCINATION SITE MASS (red lump) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient did not receive any treatment. Reportedly, the patient denied bumping against anything.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: NNI-TCR (reporter provided email address)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: severe redness; swelling; Itchiness; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness) in a 75-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 17-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 HYPERSENSITIVITY (Allergic reaction). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction) was resolving and VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness) 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.  Treatment for the event included cetirizine and ice pack.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate increased, Sleep disorder
Clinical narrative: cardiac/heart - pulse concern; heartbeats increased; sleep about 10 hours/night; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC DISORDER (cardiac/heart - pulse concern), HEART RATE INCREASED (heartbeats increased) and SLEEP DISORDER (sleep about 10 hours/night) 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 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 CARDIAC DISORDER (cardiac/heart - pulse concern), HEART RATE INCREASED (heartbeats increased) and SLEEP DISORDER (sleep about 10 hours/night). At the time of the report, CARDIAC DISORDER (cardiac/heart - pulse concern), HEART RATE INCREASED (heartbeats increased) and SLEEP DISORDER (sleep about 10 hours/night) 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 concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: started to itch; arm was red at injection site; swollen; fever 100.2F; Arm started to hurt at night/arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore), VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE ERYTHEMA (arm was red at injection site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever 100.2F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0280L20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes, Blood pressure high, High cholesterol, Cardiac arrhythmia, Mitral valve prolapse, Hyperaldosteronism, Anemia, Neuropathy, Diverticulitis, Sleep apnea, Gout, Occlusion retinal vein (in right eye), Goiter, GERD and COVID-19 (tested positive for COVID-19 in November 2020) in November 2020. Concurrent medical conditions included Allergic reaction to drug (Propulsid) since January 2021 and Allergic reaction to drug (Bactrim) since January 2021. Concomitant products included ALOPURINOL, ATENOLOL, GLIMEPIRIDE (AMARYL), SPIRONOLACTONE (ALDACTONE A), WARFARIN SODIUM (COUMADIN) and PRAVASTATIN SODIUM (PRAVACHOL) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore). On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was red at injection site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever 100.2F). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (started to itch). On 28-Jan-2021, PYREXIA (fever 100.2F) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started to hurt at night/arm was sore), VACCINATION SITE PRURITUS (started to itch), VACCINATION SITE ERYTHEMA (arm was red at injection site) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Tylenol.   This case was linked to MOD-2021-091979 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information, address and second dose details updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle tightness, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tightness of the muscle from the neck into the shoulder; Swelling of the glands under their jaw, being much worse on the opposite side of the injection; A little tender; A little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A little itchy), LYMPHADENOPATHY (Swelling of the glands under their jaw, being much worse on the opposite side of the injection), VACCINATION SITE PAIN (A little tender) and MUSCLE TIGHTNESS (Tightness of the muscle from the neck into the shoulder) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A little itchy). On 27-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of the glands under their jaw, being much worse on the opposite side of the injection) and VACCINATION SITE PAIN (A little tender). On 28-Jan-2021, the patient experienced MUSCLE TIGHTNESS (Tightness of the muscle from the neck into the shoulder). At the time of the report, VACCINATION SITE PRURITUS (A little itchy) and MUSCLE TIGHTNESS (Tightness of the muscle from the neck into the shoulder) outcome was unknown and LYMPHADENOPATHY (Swelling of the glands under their jaw, being much worse on the opposite side of the injection) and VACCINATION SITE PAIN (A little tender) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment medication was reported as sucking on a lemon.; 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus
Clinical narrative: headache; injection area itch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection area itch) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy and Drug allergy (Anti-Itch cream allergy.).    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection area itch). On 28-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (injection area itch) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Patient did not seek medical attention but treated events with Advil, dose not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: broke up with a rash; really itchy; redness; little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE RASH (broke up with a rash), VACCINATION SITE PRURITUS (really itchy) and VACCINATION SITE ERYTHEMA (redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node dissection since an unknown date. Concurrent medical conditions included Breast cancer. Concomitant products included CALCIUM and KRILL OIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (little itchy). On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (broke up with a rash), VACCINATION SITE PRURITUS (really itchy) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with CORTISONE for Itching, at a dose of 1 dosage form. In February 2021, VACCINATION SITE ERYTHEMA (redness) had resolved. On 20-Feb-2021, VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE RASH (broke up with a rash) and VACCINATION SITE PRURITUS (really itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Prickly sensation in the middle of the upper arm in a certain area; they had erythema, skin is like stained red; increase on the temperature of their arm which lasted about 3 days and started on day 8; it was swollen; Increasing pain; pain in the  arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen) and PAIN (Increasing pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy. Concomitant products included LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXLANSOPRAZOLE (DEXILANT) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red) and FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8) was resolving and SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: Prickly sensation in the middle of the upper arm in a certain area; they had erythema, skin is like stained red; increase on the temperature of their arm which lasted about 3 days and started on day 8; it was swollen; Increasing pain; pain in the  arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen) and PAIN (Increasing pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy. Concomitant products included LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXLANSOPRAZOLE (DEXILANT) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red) and FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8) was resolving and SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: bleeding at the injection site and a bruise the size of an apple.; bleeding at the injection site and a bruise the size of an apple.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at the injection site and a bruise the size of an apple.) and VACCINATION SITE BRUISING (bleeding at the injection site and a bruise the size of an apple.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site and a bruise the size of an apple.) and VACCINATION SITE BRUISING (bleeding at the injection site and a bruise the size of an apple.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at the injection site and a bruise the size of an apple.) and VACCINATION SITE BRUISING (bleeding at the injection site and a bruise the size of an apple.) had resolved. Unknown          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Outcome of the events was updated to recovered/resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; Two days of night sweats; Aching all over her body; Arm was sore; Hgh temperate / fever; Felt tired; Chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore) and PYREXIA (Hgh temperate / fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101.5 101.5 F. On 25-Jan-2021, Heart rate: 115.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Night sweats, Pyrexia, Vaccination site pain
Clinical narrative: Rapid heart rate; Two days of night sweats; Aching all over her body; Arm was sore; Hgh temperate / fever; Felt tired; Chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore) and PYREXIA (Hgh temperate / fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Rapid heart rate), NIGHT SWEATS (Two days of night sweats), MYALGIA (Aching all over her body), VACCINATION SITE PAIN (Arm was sore), PYREXIA (Hgh temperate / fever), FATIGUE (Felt tired) and CHILLS (Chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101.5 101.5 F. On 25-Jan-2021, Heart rate: 115.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Presyncope, Vaccination site bruising, Vaccination site erythema
Clinical narrative: injection site was black and bluish; itched all day - at injection site; hot; pain down my arm - left arm; felt something in throat; red at the injection site about the size of a quarter appeared and very red; lump at the injection site about the size of a quarter, lump got bigger - size of baseball; felt as if going to faint; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site) and VACCINATION SITE WARMTH (hot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LL0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LOSARTAN, METFORMIN, RIZATRIPTAN BENZOATE (MAXALT), ONDANSETRON (ZOFRAN MELT), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PROBIOTIC 10, ESCITALOPRAM OXALATE (LEXAPRO), VITAMIN D3 and SUCRALFATE (CARAFATE) 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 13-Jan-2021, the patient experienced PRESYNCOPE (felt as if going to faint). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red) and VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm) and OROPHARYNGEAL DISCOMFORT (felt something in throat). On 25-Jan-2021, the patient experienced VACCINATION SITE BRUISING (injection site was black and bluish). At the time of the report, PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm), OROPHARYNGEAL DISCOMFORT (felt something in throat) and VACCINATION SITE BRUISING (injection site was black and bluish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Benadryl and Famotidine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site was black and bluish; itched all day - at injection site; hot; pain down my arm - left arm; felt something in throat; red at the injection site about the size of a quarter appeared and very red; lump at the injection site about the size of a quarter, lump got bigger - size of baseball; felt as if going to faint; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site) and VACCINATION SITE WARMTH (hot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LL0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LOSARTAN, METFORMIN, RIZATRIPTAN BENZOATE (MAXALT), ONDANSETRON (ZOFRAN MELT), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), PROBIOTIC 10, ESCITALOPRAM OXALATE (LEXAPRO), VITAMIN D3 and SUCRALFATE (CARAFATE) 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 13-Jan-2021, the patient experienced PRESYNCOPE (felt as if going to faint). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red) and VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm) and OROPHARYNGEAL DISCOMFORT (felt something in throat). On 25-Jan-2021, the patient experienced VACCINATION SITE BRUISING (injection site was black and bluish). At the time of the report, PRESYNCOPE (felt as if going to faint), VACCINATION SITE ERYTHEMA (red at the injection site about the size of a quarter appeared and very red), VACCINATION SITE MASS (lump at the injection site about the size of a quarter, lump got bigger - size of baseball), VACCINATION SITE PRURITUS (itched all day - at injection site), VACCINATION SITE WARMTH (hot), PAIN (pain down my arm - left arm), OROPHARYNGEAL DISCOMFORT (felt something in throat) and VACCINATION SITE BRUISING (injection site was black and bluish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Benadryl and Famotidine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargies) and PYREXIA (Fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced LETHARGY (Lethargies) and PYREXIA (Fever). At the time of the report, LETHARGY (Lethargies) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 102 (High) 102°F. 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. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching; Round red rash at the injection site/ COVID arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Vaccination site rash and Vaccination site pruritus, at an unspecified dose and frequency and TRIAMCINOLONE for Vaccination site rash and Vaccination site pruritus, at an unspecified dose and frequency. On 21-Jan-2021, VACCINATION SITE RASH (Round red rash at the injection site/ COVID arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching) outcome was unknown.        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.   Concomitant information not provided.     Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Updated patient demographics and reported COVID arm; 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.