chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. 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.  Company Comment: 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.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-245527 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284015 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: Sick all weekend; Chills on the body; A little fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick all weekend), CHILLS (Chills on the body) and PYREXIA (A little fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ILLNESS (Sick all weekend), CHILLS (Chills on the body) and PYREXIA (A little fever). At the time of the report, ILLNESS (Sick all weekend), CHILLS (Chills on the body) and PYREXIA (A little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got Pfizer and Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer and Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer and Moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer and Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.; This is not normal; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (This is not normal), HEADACHE (Severe headache) and HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 044A21A) 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 18-Mar-2021, the patient experienced FEELING ABNORMAL (This is not normal) and HEADACHE (Severe headache). On 04-Sep-2021, the patient experienced HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.). At the time of the report, FEELING ABNORMAL (This is not normal) outcome was unknown, HEADACHE (Severe headache) had resolved and HEADACHE (patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10)/pulsating headache on the left side of cranium, about 2 inches of the left eye, with 0.5 out of 10 pain level.) had not resolved.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Patient experienced severe headache started on the second vaccination, and lasted for more than 5 weeks. Severe headaches from 1 in the morning to 6 in the morning, everyday. Patient said that it was not normal. On 04 Sep 2021, patient experienced a severe headache at 11:30 that was over 10 times hundred in pain level (patient mentioned 20 out of 10). Patient had to put pressure with his hand on the left side the cranium. Patient said that he went through hell and back on Saturday. His girlfriend was ready to call the paramedics, that was how bad it was. Patient said that he never had this in his life. As of now, patient had pulsating headache on the left side of my cranium, about 2 inches of the left eye, with 0.5 / 10 pain level.   This case was linked to MOD-2021-310582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up contains no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pain, Vaccination site pain
Clinical narrative: pain; lmited strength in right arm; right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.; sore arm limited strength in right arm,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ASTHENIA (lmited strength in right arm), VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) and MYALGIA (sore arm limited strength in right arm,) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 012A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, SIMVASTATIN and GLIPIZIDE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain), ASTHENIA (lmited strength in right arm), VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) and MYALGIA (sore arm limited strength in right arm,). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), ASTHENIA (lmited strength in right arm) and MYALGIA (sore arm limited strength in right arm,) outcome was unknown and VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) had not resolved.            Treatment medication included oils for injection site.  It was reported that patient is very active and still working.   This case was linked to MOD-2021-311219 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant FU received on 14-SEP-2021,contain Reporter Address,Patient Height,Weight,Race and AE Outcome. On 14-Sep-2021: Contains NNI
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lethargy, Rash, Somnolence
Clinical narrative: Second dose after more than 35 days; same rash came back; Slept all day; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of receiving second dose after more than 35 days, Slept all day, Lethargic, and RASH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced SOMNOLENCE and Lethargic. On 04-Sep-2021, the patient experienced RASH. On an unknown date, the patient experienced receiving second dose after more than 35 days. On 03-Sep-2021, SOMNOLENCE and Lethargic had resolved. At the time of the report, second dose after more than 35 days and RASH had resolved.            Patient stated that she also felt wiped out. No Concomitant and Treatment medication were reported.   This case was linked to MOD-2021-310797 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Vaccination complication
Clinical narrative: did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of did not feel well in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 010M20A and 0062G21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ADENOSINE, METOPROLOL and ELIQUIS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced did not feel well. At the time of the report, did not feel well outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Heart rate: 135 beats per minute (High).         Treatment information was not provided.    This case was linked to MOD-2021-311007, MOD-2021-311047 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes On 13-Sep-2021 Significant Follow up, Concomitants were added.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 35 days for 2nd dose) had resolved.            It was also reported that the patient has taken the second dose and had no issues  Concomitant medication information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received contained: Updated second dose; No AE experienced - Confirmation;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Chronic head pain/ my head had been hurting since April 30th; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Chronic head pain/ my head had been hurting since April 30th) 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Chronic head pain/ my head had been hurting since April 30th). At the time of the report, HEADACHE (Chronic head pain/ my head had been hurting since April 30th) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: Tested positive for COVID; Cough; Nasal congestion; Loss of taste; Loss of smell; Chills; Muscle ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 26-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing from 07-Sep-2021 for SARS-CoV-2 infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headache) had not resolved and AGEUSIA (Loss of taste) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported  Treatment medications for SARS-CoV-2 infection included:Musinex All in One Cold/Flu-20 ML: Mornings from 08-SEP-2021 to till date. Musinex Nightshift Cold/Flu-20 ML: Evenings from 08-SEP-2021 to till date. Goodie Powder from 07-SEP-2021 to till date. Nose spray 2 times a day from 08-SEP-2021 to till date   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received and it contains no new information On 12-Sep-2021: Follow up received: Patient initials, gender, age, events event outcome  and treatment medications added.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Cough; Nasal congestion; Loss of taste; Loss of smell; Chills; Muscle ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 26-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with IBUPROFEN ongoing from 07-Sep-2021 for SARS-CoV-2 infection, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID), COUGH (Cough), NASAL CONGESTION (Nasal congestion), ANOSMIA (Loss of smell), CHILLS (Chills) and HEADACHE (Headache) had not resolved and AGEUSIA (Loss of taste) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications reported  Treatment medications for SARS-CoV-2 infection included:Musinex All in One Cold/Flu-20 ML: Mornings from 08-SEP-2021 to till date. Musinex Nightshift Cold/Flu-20 ML: Evenings from 08-SEP-2021 to till date. Goodie Powder from 07-SEP-2021 to till date. Nose spray 2 times a day from 08-SEP-2021 to till date   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received and it contains no new information On 12-Sep-2021: Follow up received: Patient initials, gender, age, events event outcome  and treatment medications added.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: if i had my 1st dose on 7/28/21 can I still get my second dose within the next few days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (if i had my 1st dose on 7/28/21 can I still get my second dose within the next few days) 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 28-Jul-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 PRODUCT DOSE OMISSION ISSUE (if i had my 1st dose on 7/28/21 can I still get my second dose within the next few days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (if i had my 1st dose on 7/28/21 can I still get my second dose within the next few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported.  No Treatment information  were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in both feet, bilateral paresthesia in feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M2A and 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, GERD, BPH and Erectile dysfunction. Concomitant products included TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for BPH, TADALAFIL for Erectile dysfunction, OMEPRAZOLE for GERD, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE) for Hypertension, FLUTICASONE PROPIONATE for Sinus congestion, ATORVASTATIN and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet). At the time of the report, HYPOAESTHESIA (Numbness in both feet, bilateral paresthesia in feet) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the first vaccine in January, then five weeks later, the patient had numbness in both feet. Patient had underwent several lab tests- X-rays, bloodwork and all sorts of test run and still was not able to explain why the both feet were numb. The both feet were numb and he had an electromyograph done, very symetric, the numbness developed after the second vaccine, this was a fast gradual onset. No treatment information was provided. Medical history also include unspecified prostate.  Lab test done:  EMG- June 14 2021 Heavy Metal Scan- May 19,2021 HGB A1C- May 19,2021 Immunofixation Screen- May 19 2021 Vitamin B12- April 2021 TSH BLD- April 15 2021 T4 Free/ Free Thyrox- April 15 2021 T# BLD- April 2021 XR Sacrum/Coccyx 3V AP/LAT- April 15 2021 XR Lumbar General 3V AP/LAT/L5-S1- April 15 2021   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Patient details, Medical history, Concomitant medication, Event start date and Outcome updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Myalgia
Clinical narrative: Changed my whole attitude, making me mean; Sore left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MOOD ALTERED (Changed my whole attitude, making me mean) and MYALGIA (Sore left arm at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Sleeplessness (inability to sleep on her left side because of dizziness after shingles diagnosis) and Osteopenia. Concomitant products included APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Sore left arm at injection site). On an unknown date, the patient experienced MOOD ALTERED (Changed my whole attitude, making me mean). At the time of the report, MOOD ALTERED (Changed my whole attitude, making me mean) and MYALGIA (Sore left arm at 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.   Treatment information was not provided.   This case was linked to MOD-2021-312939.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021.  includes new event as vaccine series ulter whole attitude, Patient age, Medical history.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Painful arm; Headache/head feels like it's about to explode; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache/head feels like it's about to explode) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache/head feels like it's about to explode). At the time of the report, PAIN IN EXTREMITY (Painful arm) and HEADACHE (Headache/head feels like it's about to explode) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was reported by reporter.   Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Myalgia, Nausea
Clinical narrative: feeling miserable; aches; nausea; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness) and CHILLS (chills) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medications was reported. No treatment information was provided.    This case was linked to MOD-2021-313344 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling miserable; aches; nausea; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness) and CHILLS (chills) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 939893) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, FEELING ABNORMAL (feeling miserable), MYALGIA (aches), NAUSEA (nausea), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided          No concomitant medications was reported. No treatment information was provided.    This case was linked to MOD-2021-313344 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema
Clinical narrative: injection site had turned red with the other 2 doses.; low grade fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA and PYREXIA in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (She's in reminiscent for 10 years for a cancer.). Concomitant products included TIMOLOL for Glaucoma, ATORVASTATIN, ZOLPIDEM, and LATANOPROST for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA and PYREXIA. At the time of the report, VACCINATION SITE ERYTHEMA outcome was unknown and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade fever (High).         The concomitant drug Denlafaxine is used as substitute drug.  Treatment information was not provided.   This case was linked to MOD-2021-313629, MOD-2021-313718, MOD-2021-312651 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness in left arm; tiredness, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included METOPROLOL for Blood pressure high, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness in left arm) and FATIGUE (tiredness, fatigue) 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 medication included Low Dose Aspirin   This case was linked to MOD-2021-313941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up received and contains NNI
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: pain in lower right quadrant of the abdomen/Pain persist and comes and goes / sever and last for long period of time/pain scale she ranks it an 7 and sometimes 8 out of 10; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN LOWER (pain in lower right quadrant of the abdomen/Pain persist and comes and goes / sever and last for long period of time/pain scale she ranks it an 7 and sometimes 8 out of 10) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced ABDOMINAL PAIN LOWER (pain in lower right quadrant of the abdomen/Pain persist and comes and goes / sever and last for long period of time/pain scale she ranks it an 7 and sometimes 8 out of 10). At the time of the report, ABDOMINAL PAIN LOWER (pain in lower right quadrant of the abdomen/Pain persist and comes and goes / sever and last for long period of time/pain scale she ranks it an 7 and sometimes 8 out of 10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        lab data included Appendicitis and tested for pregnancy, other gynecological conditions and UTI with unknown results.  No concomitant medications reported. No treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-314573, MOD-2021-314570.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Start date of drug, event and batch number were updated. On 15-Sep-2021: Possible NNI.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Small muscle twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Small muscle twitching) 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 MUSCLE TWITCHING (Small muscle twitching). At the time of the report, MUSCLE TWITCHING (Small muscle twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: arm hurts, first time hurts more; felt poor, not good; weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak). At the time of the report, PAIN IN EXTREMITY (arm hurts, first time hurts more), FEELING ABNORMAL (felt poor, not good) and ASTHENIA (weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-314593 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: flu-like symptoms; was hurting; she had a fever of 101F; she had nausea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (was hurting), PYREXIA (she had a fever of 101F), NAUSEA (she had nausea) and VOMITING (throwing up) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (was hurting), PYREXIA (she had a fever of 101F), NAUSEA (she had nausea) and VOMITING (throwing up). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (was hurting), PYREXIA (she had a fever of 101F), NAUSEA (she had nausea) and VOMITING (throwing up) 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.   Patient reported that she is on many concomitant medications but does not remember any names.  No treatment medications were reported.   This case was linked to MOD-2021-314587 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Inappropriate schedule of product administration, Pain
Clinical narrative: Joint pain intensified, after 2nd dose; It intensifies after 2 dose; pain all day long. still hurts; got 2nd dose 40 days later; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose), PAIN (pain all day long. still hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose), PAIN (pain all day long. still hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and MARIJUANA for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Joint pain intensified, after 2nd dose), CONDITION AGGRAVATED (It intensifies after 2 dose) and PAIN (pain all day long. still hurts) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got 2nd dose 40 days later) had resolved.            Concomitant medication included  asthma inhaler (as needed).   This case was linked to MOD-2021-229286 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effec; 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 VACCINATION COMPLICATION (side effec) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (side effec). At the time of the report, VACCINATION COMPLICATION (side effec) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Lymphadenopathy, Respiratory rate increased, Vaccination site erythema
Clinical narrative: thought I was going to die; breathing hasn't subsided; chest pain; everything was coming up, could not hold nothing, nothing stays in my body; left arm redness/red circle was worse than after 2nd dose; left arm had swelling/arm got big and swollen; a lot of pain in left arm; baseball-size bump or ball under left arm, against breast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body) and VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast). At the time of the report, FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast) outcome was unknown.            .Concomitant product usage include steroids. Treatment medications was not reported.   This case was linked to MOD-2021-314562, MOD-2021-314597 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: thought I was going to die; breathing hasn't subsided; chest pain; everything was coming up, could not hold nothing, nothing stays in my body; left arm redness/red circle was worse than after 2nd dose; left arm had swelling/arm got big and swollen; a lot of pain in left arm; baseball-size bump or ball under left arm, against breast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body) and VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast). At the time of the report, FEELING ABNORMAL (thought I was going to die), RESPIRATORY RATE INCREASED (breathing hasn't subsided), CHEST PAIN (chest pain), VOMITING (everything was coming up, could not hold nothing, nothing stays in my body), VACCINATION SITE ERYTHEMA (left arm redness/red circle was worse than after 2nd dose), VACCINATION SITE SWELLING (left arm had swelling/arm got big and swollen), VACCINATION SITE PAIN (a lot of pain in left arm) and LYMPHADENOPATHY (baseball-size bump or ball under left arm, against breast) outcome was unknown.            .Concomitant product usage include steroids. Treatment medications was not reported.   This case was linked to MOD-2021-314562, MOD-2021-314597 (Patient Link).