chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood pressure increased, Heart rate increased, Nausea
Clinical narrative: Nausea; Anxiety Attacks; Pulse rate goes up; Blood pressure goes up; Whole body shaky; Weak; This spontaneous case was reported by a reporter of unknown type and describes the occurrence of ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency. At the time of the report, ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment with CBD oil, Beta blocker and pertained to the symptoms were provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Nausea; Anxiety Attacks; Pulse rate goes up; Blood pressure goes up; Whole body shaky; Weak; This spontaneous case was reported by a reporter of unknown type and describes the occurrence of ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky) and ASTHENIA (Weak). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency. At the time of the report, ANXIETY (Anxiety Attacks), HEART RATE INCREASED (Pulse rate goes up), BLOOD PRESSURE INCREASED (Blood pressure goes up), TREMOR (Whole body shaky), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment with CBD oil, Beta blocker and pertained to the symptoms were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: swelling of the feet; lower back pain; tingling sensation in fingers; chills; fever; headache; joint pain; knee pain/ elbow pain/ wrist pain; fatigue/ Feels very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-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) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired). On 15-Mar-2021, PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired) had not resolved.            No concomitant medication was provided by the reporter. Patient called in to give some updates about the side effects that she was still experiencing until now. It was her second time to call Moderna and she said she still have symptoms.  She said she already went to her two primary doctors but had not figured out yet as to what was going on with her. She was planning to visit her rheumatologist anytime this week for her third consultation. No treatment medication was provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received contains significant information: Events added: Swelling of the feet, knee pain/elbow pain/wrist pain,  fatigue/ Feels very tired, lower back pain, tingling sensation in fingers. Outcome of Chills was updated to not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: swelling of the feet; lower back pain; tingling sensation in fingers; chills; fever; headache; joint pain; knee pain/ elbow pain/ wrist pain; fatigue/ Feels very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-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) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired). On 15-Mar-2021, PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired) had not resolved.            No concomitant medication was provided by the reporter. Patient called in to give some updates about the side effects that she was still experiencing until now. It was her second time to call Moderna and she said she still have symptoms.  She said she already went to her two primary doctors but had not figured out yet as to what was going on with her. She was planning to visit her rheumatologist anytime this week for her third consultation. No treatment medication was provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received contains significant information: Events added: Swelling of the feet, knee pain/elbow pain/wrist pain,  fatigue/ Feels very tired, lower back pain, tingling sensation in fingers. Outcome of Chills was updated to not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included Anaphylaxis (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Anaphylaxis (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Itching (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Confusion (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Electrolyte imbalance (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Consciousness decreased (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Pricking skin sensation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Tingling sensation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Hospitalization (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Hospitalization (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Swelling (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Disorientation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Upper airway obstruction (swelling of lips, tongue, throat, uvula, or larynx. Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Throat tightness (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Red eye (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019 and Itchy eyes (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019. Concurrent medical conditions included Drug allergy (Anaphylaxis Reactions, Hypersensitivity, Hospitalized, itching, confusion, electrolyte imbalance) since 2005 and Drug allergy (Anaphylaxis Reactions, Hypersensitivity, Hospitalized, Swelling, disorientation, throat) since 2019. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 11-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: On additional information received on 09 Jun 2021 had  patient demographics, updated patient's relevant medical history and reactions. Added updated event description.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: diarrhea; dizziness; headaches; feeling little nauseous; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), HEADACHE (headaches) and NAUSEA (feeling little nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-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) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), HEADACHE (headaches) and NAUSEA (feeling little nauseous). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. On 03-May-2021, DIZZINESS (dizziness) had resolved. At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headaches) and NAUSEA (feeling little nauseous) had not resolved. Not Provided          Concomitant medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Elevated blood sugar level at over 200/A1C Spike; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 4031A21A and 4002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteomyelitis (Both knees) since 01-Jan-2003, Diabetes (Managed by increased after injections) since 15-Sep-2018, Drug allergy (Allergic to Lisinopril) and Blood sugar abnormal since 01-Jan-2017. Concomitant products included LOSARTAN, EMPAGLIFLOZIN (JARDIANCE), METFORMIN and LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike). At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood sugar level at over 200/A1C Spike) had not resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Before the vaccine Patient had digestive distress due to Metformin.So that patient was using Empagliflozin and Glipizide .Blood Glucose was low 100's and A1C was 7.2 Other Concomitant medications includes NSAIDS, Zypon for  digestion and Mag R & R for leg cramps   It was reported that Patient was also taking Probiotics,Magnesium,Calcium-D Gluconate,Oregano oil,Digestive enzymes   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Additional information received and patient demographics details, medical history, second dose details, outcome of the events and treatment details were updated. On 22-Jul-2021: Follow-up information received on 22-JUL-2021, updated relevant history and concomitant medications.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swelling lymth node left area neck; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache) and LYMPHADENOPATHY (Swelling lymth node left area neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (body ache). On 28-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling lymth node left area neck). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 doses. At the time of the report, PAIN (body ache) and LYMPHADENOPATHY (Swelling lymth node left area neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Gait disturbance, Gout
Clinical narrative: Arthritis; Gout; pain had affected his ankle, knees, hand; Can't hardly walk; he was still sick; joints and knees were hurting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk) and ILLNESS (he was still sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS, Diabetes and Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-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 ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever). The patient was treated with CELECOXIB (CELEBREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication includes Diabetes Medication, Blood Pressure Medication, Cholesterol Medication and Thyroid Medication.   This case was linked to MOD-2021-101730, MOD-2021-101589 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated reporter contact information, suspect product information, events
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: Arthritis; Gout; pain had affected his ankle, knees, hand; Can't hardly walk; he was still sick; joints and knees were hurting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk) and ILLNESS (he was still sick) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder NOS, Diabetes and Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-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 ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever). The patient was treated with CELECOXIB (CELEBREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis), GOUT (Gout), PAIN (pain had affected his ankle, knees, hand), GAIT DISTURBANCE (Can't hardly walk), ILLNESS (he was still sick), ARTHRALGIA (joints and knees were hurting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant medication includes Diabetes Medication, Blood Pressure Medication, Cholesterol Medication and Thyroid Medication.   This case was linked to MOD-2021-101730, MOD-2021-101589 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated reporter contact information, suspect product information, events
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Improper preparation of thawed vial; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Improper preparation of thawed vial) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Improper preparation of thawed vial). At the time of the report, PRODUCT STORAGE ERROR (Improper preparation of thawed vial) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Serology test
Clinical narrative: Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 10/Mar/2021) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Augmentin), Drug allergy (Neosporin) and Drug allergy (Codeine). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills). On 08-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Serology test: negative negative (Negative) negative.         No treatment medications provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Nausea
Clinical narrative: Brown/green discharge from breasts; Feeling of nausea; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCHARGE (Brown/green discharge from breasts) and NAUSEA (Feeling of nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025-B21A and 048-A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis, Postmenopausal symptoms, Hysterectomy and Fusion of vertebra. Concurrent medical conditions included Blood pressure fluctuation, Acid reflux (esophageal) and Thyroid disorder NOS. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), LISINOPRIL and CARVEDILOL for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, PARACETAMOL (TYLENOL), GUAIFENESIN (MUCINEX), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (Feeling of nausea). On 30-Apr-2021, the patient experienced BREAST DISCHARGE (Brown/green discharge from breasts). On 10-Apr-2021, NAUSEA (Feeling of nausea) had resolved. On 30-Apr-2021, BREAST DISCHARGE (Brown/green discharge from breasts) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-101727 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Fever 101F after Second Shot; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, ESTRADIOL (ESTRACE), TACROLIMUS, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea). On 02-Apr-2021, PYREXIA (Fever 101F after Second Shot), CHILLS (Chills) and NAUSEA (Nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101 (High) 101 Fahrenheit.         Treatment information, if any, was not provided by the reporter.   This case was linked to MOD-2021-037370 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information included patient demographics (race, height, ethnic group, weight), medical historyand concomitant medications.; Sender's Comments:  MOD-2021-037370:1st dose
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Headache
Clinical narrative: little headache; stomach pain; constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), CONSTIPATION (constipated) and HEADACHE (little headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), CARVEDILOL, ENALAPRIL, AMITRIPTYLINE, LISINOPRIL, MEMANTINE, DILTIAZEM, ASPIRIN [ACETYLSALICYLIC ACID], ROSUVASTATIN and CHLORTHALIDONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced CONSTIPATION (constipated). On 29-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced HEADACHE (little headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) had not resolved and HEADACHE (little headache) outcome was unknown.            Treatment included:  laxative medication ,patient  ate grains with vinegar for constipation and no improvement according to the patient.  Action taken with mRNA-1273 in response to the event was Not Applicable.  Upon internal review on 04-AUG-2021, the age was corrected to 65 years.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-MAY-2021 and contain now new information. The consumer does not have an email id
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: Extremely weak; Trouble lifting her own body weight up off the cough; Fatigue; Fever of 102 degrees; received the vaccination on April 1st (1st shot) and April 12 (2nd Shot); cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) and COUGH (cough). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) outcome was unknown. On 16-Apr-2021, ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), PYREXIA (Fever of 102 degrees) and COUGH (cough) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extremely weak; Trouble lifting her own body weight up off the cough; Fatigue; Fever of 102 degrees; received the vaccination on April 1st (1st shot) and April 12 (2nd Shot); cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), FATIGUE (Fatigue), PYREXIA (Fever of 102 degrees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) and COUGH (cough). On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the vaccination on April 1st (1st shot) and April 12 (2nd Shot)) outcome was unknown. On 16-Apr-2021, ASTHENIA (Extremely weak), MOBILITY DECREASED (Trouble lifting her own body weight up off the cough), PYREXIA (Fever of 102 degrees) and COUGH (cough) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gingival pain, Toothache
Clinical narrative: mild upper back pain; a pain in her teeth and gums; a pain in her teeth and gums; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (mild upper back pain), TOOTHACHE (a pain in her teeth and gums) and GINGIVAL PAIN (a pain in her teeth and gums) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced BACK PAIN (mild upper back pain), TOOTHACHE (a pain in her teeth and gums) and GINGIVAL PAIN (a pain in her teeth and gums). On 02-Apr-2021, BACK PAIN (mild upper back pain) had resolved. At the time of the report, TOOTHACHE (a pain in her teeth and gums) and GINGIVAL PAIN (a pain in her teeth and gums) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-101761 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information received on 31-MAY-2021, contains no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation
Clinical narrative: stomach pain; constipated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN ASPART (NOVOLOG), CARVEDILOL, ENALAPRIL, AMITRIPTYLINE, LISINOPRIL, MEMANTINE, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN and CHLORTHALIDONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and CONSTIPATION (constipated) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did receive laxative medication and ate grains with vinegar for constipation and no improvement according to the patient.  Action taken with mRNA-1273 in response to the events was not applicable.  Follow-up received on 31-MAY-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-MAY-2021 and does not contain any new information
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing sound in her left ear and it is still with her; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing sound in her left ear and it is still with her) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 008B2112A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-Apr-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) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced TINNITUS (ringing sound in her left ear and it is still with her). At the time of the report, TINNITUS (ringing sound in her left ear and it is still with her) outcome was unknown.            Concomitant medication includes Birth control pills. Patient did not take any medication to treat these symptom.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (leg cramps) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal disorder and Gastrointestinal disorder (Patient has medical condition where the pressure on his intestine causes the cramps.).    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 MUSCLE SPASMS (leg cramps). At the time of the report, MUSCLE SPASMS (leg cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Collar bone little inflamed; Pain in underarm; Diarrhoea; Headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-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 15-Apr-2021, the patient experienced OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 25-Apr-2021, OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment for the event included clear broths.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Osteitis
Clinical narrative: Collar bone little inflamed; Pain in underarm; Diarrhoea; Headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-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 15-Apr-2021, the patient experienced OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 25-Apr-2021, OSTEITIS (Collar bone little inflamed), AXILLARY PAIN (Pain in underarm), DIARRHOEA (Diarrhoea), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment for the event included clear broths.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain, Weight decreased
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of decreased weight (weight loss), pyrexia (fever 102), vaccination site pain (pain at injection site), headache and chills in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002C21) for COVID-19 immunization. No medical history reported. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 28, 2021, patient had pyrexia (fever 102), vaccination site pain (pain at injection site), headache and chills. On May 3, 2021, patient experienced decreased weight (weight loss). On May 1, 2021, pyrexia (fever 102), vaccination site pain (pain at injection site) outcome: unknown. At the time of the report, decreased weight (weight loss), headache and chills outcome: unknown. The reporter did not provide any causality assessments. Treatment information was included Tylenol and ice packs on face. Action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gingival pain, Headache, Nausea
Clinical narrative: mild upper back pain; pain in teeths and gums; pain in teeths and gums; pain radiating to shoulder; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums), ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums) and NAUSEA (nausea). 30-Apr-2021, the patient experienced ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 03-May-2021, TOOTHACHE (pain in teeths and gums) and GINGIVAL PAIN (pain in teeths and gums) had resolved. At the time of the report, BACK PAIN (mild upper back pain), ARTHRALGIA (pain radiating to shoulder), HEADACHE (headache) and NAUSEA (nausea) had resolved. Not Provided          Treatment information was included Ibuprofen.  No concomitant  product was reported   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: mild upper back pain; pain in teeths and gums; pain in teeths and gums; pain radiating to shoulder; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums), ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums) and NAUSEA (nausea). 30-Apr-2021, the patient experienced ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 03-May-2021, TOOTHACHE (pain in teeths and gums) and GINGIVAL PAIN (pain in teeths and gums) had resolved. At the time of the report, BACK PAIN (mild upper back pain), ARTHRALGIA (pain radiating to shoulder), HEADACHE (headache) and NAUSEA (nausea) had resolved. Not Provided          Treatment information was included Ibuprofen.  No concomitant  product was reported   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Narrative was updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: pins and needles in whole his lower body; Itchy in whole his lower body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21) for COVID-19 vaccination.     No past medical history was provided.     On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body). At the time of the report, PARAESTHESIA (pins and needles in whole his lower body) and PRURITUS (Itchy in whole his lower body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant  product was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Followup received was received from the initial reporter and does not contain new information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm soreness and pain; Swollen red hot to touch injection site like a knot; Swollen red hot to touch injection site like a knot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness and pain), VACCINATION SITE ERYTHEMA (Swollen red hot to touch injection site like a knot) and VACCINATION SITE WARMTH (Swollen red hot to touch injection site like a knot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness and pain), VACCINATION SITE ERYTHEMA (Swollen red hot to touch injection site like a knot) and VACCINATION SITE WARMTH (Swollen red hot to touch injection site like a knot). At the time of the report, PAIN IN EXTREMITY (Arm soreness and pain), VACCINATION SITE ERYTHEMA (Swollen red hot to touch injection site like a knot) and VACCINATION SITE WARMTH (Swollen red hot to touch injection site like a knot) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.