chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Feeding disorder
Clinical narrative: Dizzy; could not drink or eat properly for the whole weak; Dehydrated; UTI; diarrhea; Nauseous; Chills; Fever high upto 102 degree; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI) and DIARRHOEA (diarrhea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 319B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 01-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) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI), DIARRHOEA (diarrhea), NAUSEA (Nauseous), CHILLS (Chills) and PYREXIA (Fever high upto 102 degree). At the time of the report, DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI), DIARRHOEA (diarrhea), NAUSEA (Nauseous), CHILLS (Chills) and PYREXIA (Fever high upto 102 degree) was resolving. Not Provided          Concomitant medication information was not reported. Treatment include antibiotics
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Urinary tract infection
Clinical narrative: Dizzy; could not drink or eat properly for the whole weak; Dehydrated; UTI; diarrhea; Nauseous; Chills; Fever high upto 102 degree; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI) and DIARRHOEA (diarrhea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 319B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 01-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) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI), DIARRHOEA (diarrhea), NAUSEA (Nauseous), CHILLS (Chills) and PYREXIA (Fever high upto 102 degree). At the time of the report, DIZZINESS (Dizzy), FEEDING DISORDER (could not drink or eat properly for the whole weak), DEHYDRATION (Dehydrated), URINARY TRACT INFECTION (UTI), DIARRHOEA (diarrhea), NAUSEA (Nauseous), CHILLS (Chills) and PYREXIA (Fever high upto 102 degree) was resolving. Not Provided          Concomitant medication information was not reported. Treatment include antibiotics
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Headache, Inappropriate schedule of product administration, Nasal discomfort
Clinical narrative: Drainage from left nostril; Burning sensation in left nostril; Mild headache; Joint pain; Fever; patient called at day 36 from 1st dose and would like to know when she should receive her second injection; Tested positive for COVID; arm pain; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection), RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril) and PAIN IN EXTREMITY (arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection). On an unknown date, the patient experienced RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril), HEADACHE (Mild headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection), RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril), PAIN IN EXTREMITY (arm pain), HEADACHE (Mild headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-1 test: positive Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was provided. Caller took 1st shot 10MAR2021. Was scheduled to receive second one on 09APR2021, but tested positive for COVID on 07APR2021. The side effects she experienced were mild headache, joint pain, and a burning sensation and drainage from her left nostril. These have been her COVID symptoms.. She has also been experiencing a fever.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, SARS-CoV-1 test
Clinical narrative: Drainage from left nostril; Burning sensation in left nostril; Mild headache; Joint pain; Fever; patient called at day 36 from 1st dose and would like to know when she should receive her second injection; Tested positive for COVID; arm pain; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection), RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril) and PAIN IN EXTREMITY (arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection). On an unknown date, the patient experienced RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril), HEADACHE (Mild headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive for COVID), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient called at day 36 from 1st dose and would like to know when she should receive her second injection), RHINORRHOEA (Drainage from left nostril), NASAL DISCOMFORT (Burning sensation in left nostril), PAIN IN EXTREMITY (arm pain), HEADACHE (Mild headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-1 test: positive Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was provided. Caller took 1st shot 10MAR2021. Was scheduled to receive second one on 09APR2021, but tested positive for COVID on 07APR2021. The side effects she experienced were mild headache, joint pain, and a burning sensation and drainage from her left nostril. These have been her COVID symptoms.. She has also been experiencing a fever.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Incorrect dose administered, Product dose omission in error
Clinical narrative: I still need my second shot; A little tired; headache; Possible partial dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination), PRODUCT DOSE OMISSION IN ERROR (I still need my second shot), FATIGUE (A little tired) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination), FATIGUE (A little tired) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (I still need my second shot). At the time of the report, INCORRECT DOSE ADMINISTERED (Possible partial dose of vaccination) and PRODUCT DOSE OMISSION IN ERROR (I still need my second shot) had resolved and FATIGUE (A little tired) and HEADACHE (headache) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Added Reporter contact information On 12-Aug-2021: Added New Reporter information and Patient demographic and narrative was update accordingly
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe case of hives all over her body; Itchy hives all over body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CYCLIZINE HYDROCHLORIDE (TRIAZINE), APIXABAN (ELIQUIS), POTASSIUM CHLORIDE (KLOR CON M20), ATORVASTATIN, BUMETANIDE, LETROZOLE (FEMARA), VENLAFAXINE, CALCIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) 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 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body). At the time of the report, URTICARIA (Severe case of hives all over her body) and PRURITUS (Itchy hives all over body) had not resolved. Not Provided          The patient called her doctor who prescribed Prednisone for five days and Diphenhydramine for itchiness. The symptoms improved but did not resolve completely so the doctor prescribed Prednisone again for 15 days with decreasing five days of two tablets of 0.5mg a day. The patient also visited her dermatologist who prescribed Fluocinonide 0.5% cream and it did not work. Other concomitant medication included Apulia injection for an unknown indication every six months.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mass, Rash, Rash erythematous, Vaccination site discomfort
Clinical narrative: red like a rash; its about 4 inches down to my injection site and its warm to touch; red like a rash /its going down to my arm; more prominent than it was before; about 4 inches down to my injection site; lump; discomfort where I got the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of MASS (lump), VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine), RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch) and RASH (red like a rash /its going down to my arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MASS (lump) and VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine). On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch), RASH (red like a rash /its going down to my arm), RASH (more prominent than it was before) and VACCINATION SITE RASH (about 4 inches down to my injection site). At the time of the report, MASS (lump), VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine), RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch), RASH (red like a rash /its going down to my arm), RASH (more prominent than it was before) and VACCINATION SITE RASH (about 4 inches down to my injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment details include, ice, antihistamines.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: red like a rash; its about 4 inches down to my injection site and its warm to touch; red like a rash /its going down to my arm; more prominent than it was before; about 4 inches down to my injection site; lump; discomfort where I got the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of MASS (lump), VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine), RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch) and RASH (red like a rash /its going down to my arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MASS (lump) and VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine). On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch), RASH (red like a rash /its going down to my arm), RASH (more prominent than it was before) and VACCINATION SITE RASH (about 4 inches down to my injection site). At the time of the report, MASS (lump), VACCINATION SITE DISCOMFORT (discomfort where I got the vaccine), RASH ERYTHEMATOUS (red like a rash), FEELING HOT (its about 4 inches down to my injection site and its warm to touch), RASH (red like a rash /its going down to my arm), RASH (more prominent than it was before) and VACCINATION SITE RASH (about 4 inches down to my injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment details include, ice, antihistamines.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Fear, Headache, Impaired driving ability, Pain in extremity
Clinical narrative: sore arm; Very scared; slight headache; little blurred vision; straight to double vision; very difficult to drive; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), IMPAIRED DRIVING ABILITY (very difficult to drive), PAIN IN EXTREMITY (sore arm) and FEAR (Very scared) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), IMPAIRED DRIVING ABILITY (very difficult to drive), FEAR (Very scared) and HEADACHE (slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Apr-2021, VISION BLURRED (little blurred vision) and DIPLOPIA (straight to double vision) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (very difficult to drive) had resolved and PAIN IN EXTREMITY (sore arm), FEAR (Very scared) and HEADACHE (slight headache) outcome was unknown. Not Provided          Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077883 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077883:Dose 1
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: sore arm; Very scared; slight headache; little blurred vision; straight to double vision; very difficult to drive; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), IMPAIRED DRIVING ABILITY (very difficult to drive), PAIN IN EXTREMITY (sore arm) and FEAR (Very scared) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), IMPAIRED DRIVING ABILITY (very difficult to drive), FEAR (Very scared) and HEADACHE (slight headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 13-Apr-2021, VISION BLURRED (little blurred vision) and DIPLOPIA (straight to double vision) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (very difficult to drive) had resolved and PAIN IN EXTREMITY (sore arm), FEAR (Very scared) and HEADACHE (slight headache) outcome was unknown. Not Provided          Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077883 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077883:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Headache, Nausea, Wrong product administered
Clinical narrative: Wrong vaccine and it was not Covid vaccine; Running low Temperature; Slight nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong vaccine and it was not Covid vaccine), BODY TEMPERATURE DECREASED (Running low Temperature), NAUSEA (Slight nausea) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ?26B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   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 14-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine and it was not Covid vaccine), BODY TEMPERATURE DECREASED (Running low Temperature), NAUSEA (Slight nausea) and HEADACHE (Headache). On 14-Apr-2021, WRONG PRODUCT ADMINISTERED (Wrong vaccine and it was not Covid vaccine) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (Running low Temperature), NAUSEA (Slight nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) Running slightly low body temperature.         Patient said that the batch number of the administered vaccine is not at all exist(26B21A) Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up was received on 15 APR 2021.Added new event Headache
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: hard spot that is sort red; sore arm/red spot hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/red spot hurts) and ERYTHEMA (hard spot that is sort red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm/red spot hurts). On 16-Apr-2021, the patient experienced ERYTHEMA (hard spot that is sort red). At the time of the report, PAIN IN EXTREMITY (sore arm/red spot hurts) and ERYTHEMA (hard spot that is sort red) outcome was unknown. Not Provided          No concomitant medication information was provided  No treatment product information was provided
Sex: U
Vaccine: COVID19
Symptoms: Gastroenteritis, Illness, Product dose omission in error
Clinical narrative: gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.; sick for awhile after first vaccine; cancelling second vaccine.First Vaccine given on 03MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis, Gastric disorder (Patient has a medical history with trouble with her belly, related to her with Esophagus and Gall Bladder) and Diabetes.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021). At the time of the report, GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter.  Treatment details not included.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: diagnosed as COVID-19 positive 5 days after her first vaccination; severe headaches; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination), HEADACHE (severe headaches) and FATIGUE (Fatigue) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (severe headaches) and FATIGUE (Fatigue). On 28-Mar-2021, the patient experienced COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination). At the time of the report, COVID-19 (diagnosed as COVID-19 positive 5 days after her first vaccination), HEADACHE (severe headaches) and FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Palpitations
Clinical narrative: heart flutters; Rush feeling almost like adrenaline rush; arm was sore for less than 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of PALPITATIONS (heart flutters), PAIN IN EXTREMITY (arm was sore for less than 24 hours) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for less than 24 hours). On 04-Apr-2021, the patient experienced PALPITATIONS (heart flutters) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush). On 03-Apr-2021, PAIN IN EXTREMITY (arm was sore for less than 24 hours) had resolved. At the time of the report, PALPITATIONS (heart flutters) and FEELING ABNORMAL (Rush feeling almost like adrenaline rush) 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.   Concomitant medications were not provided by the reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Headache, Influenza like illness
Clinical narrative: sore arm; headache; chills; Nausea; Diarrhea; body aches; feels like the flu; fever; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), PAIN (body aches), INFLUENZA LIKE ILLNESS (feels like the flu), PYREXIA (fever) and DYSPNOEA (difficulty breathing). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), PAIN (body aches), INFLUENZA LIKE ILLNESS (feels like the flu), PYREXIA (fever) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; headache; chills; Nausea; Diarrhea; body aches; feels like the flu; fever; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included INSULIN.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), PAIN (body aches), INFLUENZA LIKE ILLNESS (feels like the flu), PYREXIA (fever) and DYSPNOEA (difficulty breathing). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), PAIN (body aches), INFLUENZA LIKE ILLNESS (feels like the flu), PYREXIA (fever) and DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MYALGIA (Body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 848821A and 844A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm a little bit sore), feeling abnormal (my head not real good) and malaise (don't feel the best) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003A21A) for COVID-19 vaccination. The patient's past medical history included no adverse event. Concomitant products included high blood pressure and arthritis medication for an unknown indication. On Mar 10, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; at unspecified dose. On Apr 15, 2021, patient experienced pain in extremity (arm a little bit sore) and feeling abnormal (my head not real good). On an unknown date, patient experienced malaise (don't feel the best). At the time of the report, pain in extremity (arm a little bit sore), feeling abnormal (my head not real good) and malaise (don't feel the best) outcome: unknown/not provided. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstrual discomfort, Myalgia, Night sweats, Vaccination site discomfort
Clinical narrative: body soreness; terrible night sweats; soreness at the injection site; lost 10 pounds; rash at the injection site; menstruation while taking the active pills in their birth control pack; stinging at the injection site; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site) and WEIGHT DECREASED (lost 10 pounds) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site), WEIGHT DECREASED (lost 10 pounds), VACCINATION SITE RASH (rash at the injection site), MENSTRUAL DISCOMFORT (menstruation while taking the active pills in their birth control pack) and VACCINATION SITE DISCOMFORT (stinging at the injection site). At the time of the report, CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site), WEIGHT DECREASED (lost 10 pounds), VACCINATION SITE RASH (rash at the injection site), MENSTRUAL DISCOMFORT (menstruation while taking the active pills in their birth control pack) and VACCINATION SITE DISCOMFORT (stinging at the injection site) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Weight decreased
Clinical narrative: body soreness; terrible night sweats; soreness at the injection site; lost 10 pounds; rash at the injection site; menstruation while taking the active pills in their birth control pack; stinging at the injection site; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site) and WEIGHT DECREASED (lost 10 pounds) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site), WEIGHT DECREASED (lost 10 pounds), VACCINATION SITE RASH (rash at the injection site), MENSTRUAL DISCOMFORT (menstruation while taking the active pills in their birth control pack) and VACCINATION SITE DISCOMFORT (stinging at the injection site). At the time of the report, CHILLS (cold chills), MYALGIA (body soreness), NIGHT SWEATS (terrible night sweats), VACCINATION SITE PAIN (soreness at the injection site), WEIGHT DECREASED (lost 10 pounds), VACCINATION SITE RASH (rash at the injection site), MENSTRUAL DISCOMFORT (menstruation while taking the active pills in their birth control pack) and VACCINATION SITE DISCOMFORT (stinging at the injection site) 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Movement disorder, Neck pain, Pain
Clinical narrative: Arm being warm; Arm has a red streak across it like someone had grabbed her arm; Arm has a red streak on it; Headache (head, neck, shoulder and nose); Arm is swollen; It has been swollen/hard and difficult to move; Pain was in her head, neck, and across her nose; Neck Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm being warm), PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), PAIN (Pain was in her head, neck, and across her nose) and NECK PAIN (Neck Pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), PAIN (Pain was in her head, neck, and across her nose), NECK PAIN (Neck Pain) and HEADACHE (Headache (head, neck, shoulder and nose)). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm being warm), VACCINATION SITE STREAKING (Arm has a red streak across it like someone had grabbed her arm) and INJECTION SITE ERYTHEMA (Arm has a red streak on it). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 15-Apr-2021, PAIN (Pain was in her head, neck, and across her nose) and NECK PAIN (Neck Pain) had resolved, HEADACHE (Headache (head, neck, shoulder and nose)) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Arm being warm), PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), VACCINATION SITE STREAKING (Arm has a red streak across it like someone had grabbed her arm) and INJECTION SITE ERYTHEMA (Arm has a red streak on it) outcome was unknown.            No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MODERNATX, INC.-MOD-2021-079427 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-079427:First Dose
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site streaking, Vaccination site warmth
Clinical narrative: Arm being warm; Arm has a red streak across it like someone had grabbed her arm; Arm has a red streak on it; Headache (head, neck, shoulder and nose); Arm is swollen; It has been swollen/hard and difficult to move; Pain was in her head, neck, and across her nose; Neck Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm being warm), PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), PAIN (Pain was in her head, neck, and across her nose) and NECK PAIN (Neck Pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), PAIN (Pain was in her head, neck, and across her nose), NECK PAIN (Neck Pain) and HEADACHE (Headache (head, neck, shoulder and nose)). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm being warm), VACCINATION SITE STREAKING (Arm has a red streak across it like someone had grabbed her arm) and INJECTION SITE ERYTHEMA (Arm has a red streak on it). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 15-Apr-2021, PAIN (Pain was in her head, neck, and across her nose) and NECK PAIN (Neck Pain) had resolved, HEADACHE (Headache (head, neck, shoulder and nose)) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Arm being warm), PERIPHERAL SWELLING (Arm is swollen), MOVEMENT DISORDER (It has been swollen/hard and difficult to move), VACCINATION SITE STREAKING (Arm has a red streak across it like someone had grabbed her arm) and INJECTION SITE ERYTHEMA (Arm has a red streak on it) outcome was unknown.            No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MODERNATX, INC.-MOD-2021-079427 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-079427:First Dose
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Myalgia
Clinical narrative: No appetite; Headache; Whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetite), HEADACHE (Headache) and MYALGIA (Whole body hurts) outcome was unknown.            Concomitant product information. Action taken with mRNA-1273 in response to the events is not applicable.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Dyspnoea, Gait disturbance, Hypoaesthesia
Clinical narrative: Still has diarrhea 2 weeks later; Still has metallic taste in mouth; Breathing bad; Wheezing; Could not walk; Hands numb; Felt really sick; Can't stay awake; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Still has diarrhea 2 weeks later), DYSGEUSIA (Still has metallic taste in mouth), DYSPNOEA (Breathing bad), WHEEZING (Wheezing) and GAIT DISTURBANCE (Could not walk) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Still has diarrhea 2 weeks later), DYSGEUSIA (Still has metallic taste in mouth), DYSPNOEA (Breathing bad), WHEEZING (Wheezing), GAIT DISTURBANCE (Could not walk), HYPOAESTHESIA (Hands numb), ILLNESS (Felt really sick) and SOMNOLENCE (Can't stay awake). At the time of the report, DIARRHOEA (Still has diarrhea 2 weeks later) and DYSGEUSIA (Still has metallic taste in mouth) had not resolved and DYSPNOEA (Breathing bad), WHEEZING (Wheezing), GAIT DISTURBANCE (Could not walk), HYPOAESTHESIA (Hands numb), ILLNESS (Felt really sick) and SOMNOLENCE (Can't stay awake) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested 3 times,test were negative each time.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information includes Inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received and patient stated that still not feeling well