chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm the next day; got what they expected; werent feeling well; 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 PAIN IN EXTREMITY (Sore arm the next day), ASTHENIA (got what they expected) and FEELING ABNORMAL (werent feeling well) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm the next day), ASTHENIA (got what they expected) and FEELING ABNORMAL (werent feeling well). At the time of the report, PAIN IN EXTREMITY (Sore arm the next day), ASTHENIA (got what they expected) and FEELING ABNORMAL (werent feeling well) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: huge swelling hard and red, and hot; arm blew up; 2 and a half for 3 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) 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) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (huge swelling hard and red, and hot), VACCINATION SITE INDURATION (arm blew up) and VACCINATION SITE ERYTHEMA (2 and a half for 3 and a half inches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: abnormal (abnormal) Abnormal.         No concomitant was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received and test  added (Highest level of antibodies)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Swelling at the injection site; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches in all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches in all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches in all over the body). At the time of the report, MYALGIA (Aches in all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness at the injection site,; Circular redness of two and half inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site). On 22-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site,) and VACCINATION SITE ERYTHEMA (Circular redness of two and half inches at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Hydrocortisone 1%cream. No relevant concomitant medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is really sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is really sore at the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm is really sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm is really sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were provided by reporter.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: soreness in the arm; fever; chills; excessive tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (excessive tiredness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (excessive tiredness). On 24-Feb-2021, PAIN IN EXTREMITY (soreness in the arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (excessive tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feels extremely tired, fatigued and lifeless; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feels extremely tired, fatigued and lifeless) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-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 an unknown date, the patient experienced FATIGUE (Feels extremely tired, fatigued and lifeless). At the time of the report, FATIGUE (Feels extremely tired, fatigued and lifeless) outcome was unknown.            Treatment details were not provided. No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: Trouble with eyes focusing; Brain burning; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VISION BLURRED (Trouble with eyes focusing) and HEADACHE (Brain burning) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Trouble with eyes focusing) and HEADACHE (Brain burning). At the time of the report, VISION BLURRED (Trouble with eyes focusing) and HEADACHE (Brain burning) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: has a reaction in her arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (has a reaction in her arm) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (has a reaction in her arm). At the time of the report, VACCINATION SITE REACTION (has a reaction in her arm) 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.   No concomitant medications were reported.  The patient had a reaction in her arm. It had been two weeks since her first shot  No treatment medications were reported
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included ADHD (No medications since pregnant) in 1992. Concomitant products included DIPHENHYDRAMINE HCL for Allergy, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy.    On 25-Feb-2021 at 1:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 09-Jul-2020 and the estimated date of delivery was 15-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Scan: (normal) normal. On 20-Jan-2021, Glucose tolerance test: (normal) normal. On 14-Sep-2021, Blood test: (normal) normal.     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.   Treatment medications were not provided by reporter.  The patient's estimated date of conception was 23-Jul-2020.  The patient was 33 weeks pregnant.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: Swelling the size of an egg; Hard at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling the size of an egg) and VACCINATION SITE INDURATION (Hard at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling the size of an egg) and VACCINATION SITE INDURATION (Hard at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling the size of an egg) and VACCINATION SITE INDURATION (Hard at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Nausea, Pyrexia, Sinusitis
Clinical narrative: elevated temperature (99.5°F was the highest); irritated sinus; intermediate nausea; congestion; coughing; Is not feeling good ever since getting the vaccine; Wakes up feeling fine, but during the day feels worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion) and COUGH (coughing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse). At the time of the report, PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included flonaze. Concomitant medication also included medications for High blood pressure.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep inertia, Vaccination complication
Clinical narrative: elevated temperature (99.5°F was the highest); irritated sinus; intermediate nausea; congestion; coughing; Is not feeling good ever since getting the vaccine; Wakes up feeling fine, but during the day feels worse; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion) and COUGH (coughing) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse). At the time of the report, PYREXIA (elevated temperature (99.5°F was the highest)), SINUSITIS (irritated sinus), NAUSEA (intermediate nausea), NASAL CONGESTION (congestion), COUGH (coughing), VACCINATION COMPLICATION (Is not feeling good ever since getting the vaccine) and SLEEP INERTIA (Wakes up feeling fine, but during the day feels worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included flonaze. Concomitant medication also included medications for High blood pressure.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Periorbital swelling, Visual impairment
Clinical narrative: my eyes have been puffy; my vision was kind of weird.; I've also felt fatigued; numbing that went from  jawline /earlobe up to face, across cheek.; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbing that went from  jawline /earlobe up to face, across cheek.), PERIORBITAL SWELLING (my eyes have been puffy), VISUAL IMPAIRMENT (my vision was kind of weird.) and FATIGUE (I've also felt fatigued) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA) and METOPROLOL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HYPOAESTHESIA (numbing that went from  jawline /earlobe up to face, across cheek.). On an unknown date, the patient experienced PERIORBITAL SWELLING (my eyes have been puffy), VISUAL IMPAIRMENT (my vision was kind of weird.) and FATIGUE (I've also felt fatigued). On 10-Feb-2021, HYPOAESTHESIA (numbing that went from  jawline /earlobe up to face, across cheek.) had resolved. At the time of the report, PERIORBITAL SWELLING (my eyes have been puffy) and VISUAL IMPAIRMENT (my vision was kind of weird.) outcome was unknown and FATIGUE (I've also felt fatigued) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-April-2021 contains non-significant information. Contact information was updated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Disorientation, Headache, Muscular weakness
Clinical narrative: No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder on that day). On 19-Feb-2021, the patient experienced BACK PAIN (Sore back, got progressively worse) and MUSCULAR WEAKNESS (Still experiencing muscle weakness in lower back). On 23-Feb-2021, the patient experienced HEADACHE (Headaches). On 24-Feb-2021, the patient experienced DISORIENTATION (Little disoriented). On 23-Feb-2021, BACK PAIN (Sore back, got progressively worse) had resolved. At the time of the report, DISORIENTATION (Little disoriented), MUSCULAR WEAKNESS (Still experiencing muscle weakness in lower back), ARTHRALGIA (Sore shoulder on that day) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Advil, Tylenol and Arthritis cream. No concomitant medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: sore arm the next day; weren't feeling well; got what they expected; 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 PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected). At the time of the report, PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AZELASTINE, PROGESTERONE and CICLOSPORIN (RESTASIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included Tylenol, and Excedrin.   This case was linked to US-MODERNATX, INC.-MOD-2021-026796 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026796:2nd dose case
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Redness; Hard lump- 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump- 2 inch diameter) and VACCINATION SITE ERYTHEMA (Redness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M204) for COVID-19 vaccination.     The patient's past medical history included Cystitis (Radiation induced cystitis) in 2013. Concurrent medical conditions included Hypertension since 1975, High cholesterol since 1980 and Type II diabetes mellitus since 1980. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON) for Cystitis, ROSUVASTATIN for High cholesterol, TELMISARTAN, CARVEDILOL and AMLODIPINE for Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE MASS (Hard lump- 2 inch diameter). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 25-Feb-2021, VACCINATION SITE MASS (Hard lump- 2 inch diameter) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended on 16-Jul-2021 and obtained information about patient initials, demographics, medical history, concomitant medications, start date and outcome of events
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Malaise, Nausea
Clinical narrative: nauseate; sweating; feeling like a flu; not felling well; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseate), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (feeling like a flu) and MALAISE (not felling well) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 007M20A) 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) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (nauseate), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (feeling like a flu) and MALAISE (not felling well). At the time of the report, NAUSEA (nauseate), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (feeling like a flu) and MALAISE (not felling well) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Sinus disorder, Vaccination site pain
Clinical narrative: Very tired; nauseous; a little achy around the area; trouble with sinuses; diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Very tired), NAUSEA (nauseous), VACCINATION SITE PAIN (a little achy around the area), SINUS DISORDER (trouble with sinuses) and DIARRHOEA (diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergies to dust/seasonal allergies). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, GLUCOSAMINE for Arthritic pains, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), VITAMIN D NOS, CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]), PROBIOTIC COMPLEX and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2020, the patient experienced DIARRHOEA (diarrhea). On 27-Jan-2021, the patient experienced SINUS DISORDER (trouble with sinuses). On 29-Jan-2021, the patient experienced FATIGUE (Very tired), NAUSEA (nauseous) and VACCINATION SITE PAIN (a little achy around the area). At the time of the report, FATIGUE (Very tired), NAUSEA (nauseous), VACCINATION SITE PAIN (a little achy around the area), SINUS DISORDER (trouble with sinuses) and DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: difficulty swallowing after 1st dose; Sores in throat; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPHAGIA (difficulty swallowing after 1st dose) and OROPHARYNGEAL PAIN (Sores in throat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), ATORVASTATIN and HYDROXYZINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing after 1st dose) and OROPHARYNGEAL PAIN (Sores in throat). At the time of the report, DYSPHAGIA (difficulty swallowing after 1st dose) and OROPHARYNGEAL PAIN (Sores in throat) 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.   Treatment medications were not provided by reporter.; 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. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash at the injection site after receiving the first dose of Moderna COVID-19 vaccine; little soreness after receiving the second dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PAIN (little soreness after receiving the second dose of Moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 003A21A) 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) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PAIN (little soreness after receiving the second dose of Moderna COVID-19 vaccine). At the time of the report, VACCINATION SITE RASH (Rash at the injection site after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PAIN (little soreness after receiving the second dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol. No concomitant medications were not provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: Hard lump at injection site reappeared; Itching at injection site; rash on her left arm/ red rash on left arm reappeared; Very hard lump on injection site; redness at the injection site; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash on her left arm/ red rash on left arm reappeared), INJECTION SITE MASS (Very hard lump on injection site), INJECTION SITE MASS (Hard lump at injection site reappeared), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE MASS (Very hard lump on injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (Injection site rash). On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (rash on her left arm/ red rash on left arm reappeared), INJECTION SITE MASS (Hard lump at injection site reappeared) and INJECTION SITE PRURITUS (Itching at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (rash on her left arm/ red rash on left arm reappeared), INJECTION SITE MASS (Hard lump at injection site reappeared) and INJECTION SITE PRURITUS (Itching at injection site) had not resolved and INJECTION SITE MASS (Very hard lump on injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (Injection site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pain, Pain in extremity
Clinical narrative: swollen arm; sore arm; bodyaches; redness; head ache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm), PAIN (bodyaches), ERYTHEMA (redness) and HEADACHE (head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm), PAIN (bodyaches), ERYTHEMA (redness), HEADACHE (head ache), CHILLS (chills) and PYREXIA (fever). On 28-Feb-2021, PERIPHERAL SWELLING (swollen arm), PAIN (bodyaches), HEADACHE (head ache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swollen arm; sore arm; bodyaches; redness; head ache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm), PAIN (bodyaches), ERYTHEMA (redness) and HEADACHE (head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (sore arm), PAIN (bodyaches), ERYTHEMA (redness), HEADACHE (head ache), CHILLS (chills) and PYREXIA (fever). On 28-Feb-2021, PERIPHERAL SWELLING (swollen arm), PAIN (bodyaches), HEADACHE (head ache), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes, swelling in her arm in the lymphatic reason; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason) 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 Mastectomy bilateral.    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 LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason) 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.   Treatment and concomitant medications were not provided by reported.   This case was linked to MOD21-038326 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: injection arm swelling; injection arm itching; injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection arm itching), INJECTION SITE ERYTHEMA (injection arm red) and INJECTION SITE SWELLING (injection arm swelling) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection arm itching) and INJECTION SITE ERYTHEMA (injection arm red). On 21-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection arm swelling). At the time of the report, INJECTION SITE PRURITUS (injection arm itching), INJECTION SITE ERYTHEMA (injection arm red) and INJECTION SITE SWELLING (injection arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on collar bone of the left side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on collar bone of the left side of the injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on collar bone of the left side of the injection). At the time of the report, LYMPHADENOPATHY (swollen lymph node on collar bone of the left side of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Ibuprofen. No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: fever; injection site tender; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and INJECTION SITE PAIN (injection site tender) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and INJECTION SITE PAIN (injection site tender). At the time of the report, PYREXIA (fever) and INJECTION SITE PAIN (injection site tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: A little soreness after receiving the second dose of Moderna COVID-19 vaccine; Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine) and INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 032L20A) 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) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine). 26-Feb-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, INJECTION SITE PAIN (A little soreness after receiving the second dose of Moderna COVID-19 vaccine) and INJECTION SITE RASH (Rash at the injection site after receiving the first dose of moderna COVID-19 vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) had not resolved.            No concomitant was provided. Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Rash
Clinical narrative: Pain on the face; Side rash upper face area; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy to Sulphur). Concomitant products included CLOPIDOGREL, FAMOTIDINE, CARVEDILOL, LAMOTRIGINE, TOPIRAMATE, ROSUVASTATIN and FELODIPINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area). At the time of the report, FACIAL PAIN (Pain on the face) and RASH (Side rash upper face area) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: sore arm the next day; weren't feeling well; got what they expected; 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 PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected). At the time of the report, PAIN IN EXTREMITY (sore arm the next day), MALAISE (weren't feeling well) and FEELING ABNORMAL (got what they expected) outcome was unknown.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.