chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: COVID-19 infection/Hospitalization due to COVID-19; DRUG INEFFECTIVE; Cancer; left arm turned red; left arm was sore; fever of 102.5  degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (Cancer) and COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.). On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (DRUG INEFFECTIVE). At the time of the report, NEOPLASM MALIGNANT (Cancer), COVID-19 (COVID-19 infection/Hospitalization due to COVID-19), DRUG INEFFECTIVE (DRUG INEFFECTIVE), VACCINATION SITE ERYTHEMA (left arm turned red), VACCINATION SITE PAIN (left arm was sore) and PYREXIA (fever of 102.5  degrees Farenheight.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-347627 (Patient Link).; Sender's Comments: This case concerns a  89 year-old, female subject  with no clinical history who experienced the unexpected events of COVID-19, and NEOPLASM MALIGNANT, DRUG INEFFECTIVE and other non-serious events. The events occurred on unknown days after two doses of [Spikevax]  The rechallenge is unknown as per no information is available at the time of the report. The benefit-risk relationship of the vaccine is not affected by this report
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: She began experiencing hot flashes about every two hours; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (She began experiencing hot flashes about every two hours) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) 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) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (She began experiencing hot flashes about every two hours). The patient was treated with AMBEREN for Hot flashes, at a dose of 1 dosage form once a day. At the time of the report, HOT FLUSH (She began experiencing hot flashes about every two hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was stated that, beginning July or August 2021 she started experiencing hot flashes. She further stated that she had not had a hot flash in years.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: arm was "a little red"; It itchiness a little; in the arm when got the vaccine, had a kind of rush/It was really big; It burns; It was an intense red color/Really big, 5 or 6 fingers; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was "a little red"), PRURITUS (It itchiness a little), VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers). On 06-Oct-2021, the patient experienced ERYTHEMA (arm was "a little red") and PRURITUS (It itchiness a little). At the time of the report, ERYTHEMA (arm was "a little red"), PRURITUS (It itchiness a little), VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Treatment medication included some body cream. On 06-Oct-2021, the patient left the shower a little red and it itchiness a little then applied some body cream. After that patient came back home at the afternoon, in the arm when got the vaccine patient had a kind of rush it was really big and it burns. It was a very red color really big, 5 or 6 fingers.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) 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 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 DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: second dose and is still feeling wonderful/feels wonderful/after the first dose noticed that the joints didn't hurt for a couple days/after first dose noticed that muscles didn't hurt for a couple days/"I don't ever feel good/I feel 20 years young; soreness at the site of injection after first dose; pain at the site of injection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderful/after the first dose noticed that the joints didn't hurt for a couple days/after first dose noticed that muscles didn't hurt for a couple days/"I don't ever feel good/I feel 20 years younger), MYALGIA (soreness at the site of injection after first dose) and VACCINATION SITE PAIN (pain at the site of injection after first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Concurrent medical conditions included Cramps, Coronary artery disease and Pain (before the vaccine). Concomitant products included AMLODIPINE BESILATE (NORVASC) for Coronary artery disease, OMEPRAZOLE for Stomach cramps, CLOPIDOGREL BISULFATE (PLAVIX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderful/after the first dose noticed that the joints didn't hurt for a couple days/after first dose noticed that muscles didn't hurt for a couple days/"I don't ever feel good/I feel 20 years younger), MYALGIA (soreness at the site of injection after first dose) and VACCINATION SITE PAIN (pain at the site of injection after first dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderful/after the first dose noticed that the joints didn't hurt for a couple days/after first dose noticed that muscles didn't hurt for a couple days/"I don't ever feel good/I feel 20 years younger) outcome was unknown and MYALGIA (soreness at the site of injection after first dose) and VACCINATION SITE PAIN (pain at the site of injection after first dose) was resolving.        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 was taking concomitant medications for cramps and coronary artery problems. No treatment medications were reported.   This case was linked to MOD-2021-346886 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Somnolence, Vaccination site erythema
Clinical narrative: rash is still there; chills; fever; big red spot on her arm; really sleep/slept all day yesterday; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (really sleep/slept all day yesterday), RASH (rash is still there), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2021, the patient experienced SOMNOLENCE (really sleep/slept all day yesterday), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm). On an unknown date, the patient experienced RASH (rash is still there). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (really sleep/slept all day yesterday), CHILLS (chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (big red spot on her arm) was resolving and RASH (rash is still there) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Patient experienced chills, fever, was really sleepy, and had a big red spot on her arm where she got the shot , 30 minutes after receiving the second dose. Her temperature was taken and it didn't increase over 100. She slept all day yesterday. Today she feels a little better, and is not as tired, but her rash is still there. She has taken some Tylenol, used ice on her arm, and drank lots of water which all seemed to help.; Sender's Comments: This case concerns a 92-year-old, female patient, with no disclosed medical history, who experienced the non-serious, unexpected events of somnolence, and expected events of chills, pyrexia, rash and vaccination site erythema. The events occurred on the same day after second dose of Moderna vaccine. The rechallenge is unknown as no details were given about the first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Chills, Fatigue, Gait disturbance
Clinical narrative: hard to walk; hard to do anything; allergic reaction; muscle pain / muscle pain still ongoing, still incredibly severe, if not worse; joint pain/ joint pain still ongoing incredibly severe, if not worse; threw up a little bit; Fever; Chills; exhaustion/ feels as if she had aged to a 95 years old woman; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), ALLERGY TO VACCINE (allergic reaction), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse), ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse), VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman). On an unknown date, the patient experienced GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything) and ALLERGY TO VACCINE (allergic reaction). On 25-Sep-2021, VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman) had resolved. At the time of the report, GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) had not resolved and ALLERGY TO VACCINE (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia, Vomiting
Clinical narrative: hard to walk; hard to do anything; allergic reaction; muscle pain / muscle pain still ongoing, still incredibly severe, if not worse; joint pain/ joint pain still ongoing incredibly severe, if not worse; threw up a little bit; Fever; Chills; exhaustion/ feels as if she had aged to a 95 years old woman; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), ALLERGY TO VACCINE (allergic reaction), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse), ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse), VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman). On an unknown date, the patient experienced GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything) and ALLERGY TO VACCINE (allergic reaction). On 25-Sep-2021, VOMITING (threw up a little bit), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (exhaustion/ feels as if she had aged to a 95 years old woman) had resolved. At the time of the report, GAIT DISTURBANCE (hard to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to do anything), MYALGIA (muscle pain / muscle pain still ongoing, still incredibly severe, if not worse) and ARTHRALGIA (joint pain/ joint pain still ongoing incredibly severe, if not worse) had not resolved and ALLERGY TO VACCINE (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lip discolouration, Loss of consciousness
Clinical narrative: Passed out; Lips got blue; Hands got sweaty and clammy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-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 LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), LIP DISCOLOURATION (Lips got blue) and HYPERHIDROSIS (Hands got sweaty and clammy). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), LIP DISCOLOURATION (Lips got blue) and HYPERHIDROSIS (Hands got sweaty and clammy) 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.  This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred on an unknown date after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative for event of loss of consciousness. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-348085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Follow up received included patient demographics, suspect vaccine details and adverse event details. Case was upgraded.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected event of loss of consciousness. The event occurred on an unknown date after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative for event of loss of consciousness. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: diarrhea; after first shot she got gastrointestinal problems; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome.    On 13-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 DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Glaucoma Eyedrops every morning one drop in each eye. No treatment medications were reported.   This case was linked to MOD-2021-346869 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: His knuckles had been very sore in both hands,Feels like he has arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (His knuckles had been very sore in both hands,Feels like he has arthritis) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (His knuckles had been very sore in both hands,Feels like he has arthritis). At the time of the report, ARTHRALGIA (His knuckles had been very sore in both hands,Feels like he has arthritis) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Diabetes.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 30-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (Tested positive for COVID-19) was resolving and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.         Concomitant medications included unspecified blood pressure medication and unspecified diabetes medication.  Patient had symptoms included cough, sore throat and sinus drainage. It was defined by patient like a normal cold. On 30-Sep-2021, patient lost taste and smell. Patient received monoclonal antibody infusion on 30-Sep-2021 for the treatment of symptoms. The only symptoms remaining were small cough and little bit of sinus drainage.; Sender's Comments: This report concerns a 65-year-old male patient with medical history of diabetes and abnormal blood pressure who experienced the unexpected non-serious event of COVID-19. Lack of efficacy was considered as an additional event. The patient had associated symptoms of cough, sore throat, rhinorrhea, loss of taste, smell and was tested positive for SARS-Cov-2. The patient was treated with monoclonal antibody infusion and the event was reported to be resolving. Re-challenge is not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Influenza like illness
Clinical narrative: fever; following second shot she had bad chills; muscle aches/bed ridden with body aches; head was pounding; like a horrible flu; felt weak/could not get up for 12 hours; diarrhea; 2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS), INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), DIARRHOEA (diarrhea) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (10 years back.).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), PYREXIA (fever), CHILLS (following second shot she had bad chills), MYALGIA (muscle aches/bed ridden with body aches) and HEADACHE (head was pounding). In May 2021, the patient experienced ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS) had not resolved and INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (following second shot she had bad chills), MYALGIA (muscle aches/bed ridden with body aches) and HEADACHE (head was pounding) outcome was unknown.            Concomitant medication included Glaucoma eye drops.  No treatment information provided.   This case was linked to MOD-2021-346814 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Myalgia, Pyrexia
Clinical narrative: fever; following second shot she had bad chills; muscle aches/bed ridden with body aches; head was pounding; like a horrible flu; felt weak/could not get up for 12 hours; diarrhea; 2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS), INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), DIARRHOEA (diarrhea) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome (10 years back.).   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), PYREXIA (fever), CHILLS (following second shot she had bad chills), MYALGIA (muscle aches/bed ridden with body aches) and HEADACHE (head was pounding). In May 2021, the patient experienced ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (2 weeks after second shot still has GI problems/had to eliminate a lot of foods she use to eat/feels Moderna vaccine amplified the IBS) had not resolved and INFLUENZA (like a horrible flu), ASTHENIA (felt weak/could not get up for 12 hours), DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (following second shot she had bad chills), MYALGIA (muscle aches/bed ridden with body aches) and HEADACHE (head was pounding) outcome was unknown.            Concomitant medication included Glaucoma eye drops.  No treatment information provided.   This case was linked to MOD-2021-346814 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: second dose and is still feeling wonderful/feels wonderfull/"I don't ever feel this good"/I feel 20 years younger/; soreness at the injection site after second dose/soreness: worse on the second day, can still feel a little tiny bit when moving the arm, almost gone; pain at the injection site after second dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderfull/"I don't ever feel this good"/I feel 20 years younger/), MYALGIA (soreness at the injection site after second dose/soreness: worse on the second day, can still feel a little tiny bit when moving the arm, almost gone) and VACCINATION SITE PAIN (pain at the injection site after second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concurrent medical conditions included Cramps, Coronary artery disease and Pain (before the vaccine). Concomitant products included AMLODIPINE BESILATE (NORVAC) for Coronary artery disease, OMEPRAZOLE for Stomach cramps, CLOPIDOGREL BISULFATE (PLAVIX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderfull/"I don't ever feel this good"/I feel 20 years younger/), MYALGIA (soreness at the injection site after second dose/soreness: worse on the second day, can still feel a little tiny bit when moving the arm, almost gone) and VACCINATION SITE PAIN (pain at the injection site after second dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (second dose and is still feeling wonderful/feels wonderfull/"I don't ever feel this good"/I feel 20 years younger/) outcome was unknown and MYALGIA (soreness at the injection site after second dose/soreness: worse on the second day, can still feel a little tiny bit when moving the arm, almost gone) and VACCINATION SITE PAIN (pain at the injection site after second dose) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking concomitant medications for cramps and coronary artery problems. No treatment medication were reported   This case was linked to MOD-2021-346776 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; Leg pains; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (Leg pains) and PYREXIA (FEVER) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diarrhea.   On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-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 IN EXTREMITY (sore arm), PAIN IN EXTREMITY (Leg pains) and PYREXIA (FEVER). At the time of the report, PAIN IN EXTREMITY (sore arm) and PAIN IN EXTREMITY (Leg pains) had not resolved and PYREXIA (FEVER) had resolved.            No concomitant medications were reported. No treatment medications were reported. Patient ended up with all the symptoms of COVID except diarrhea.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Everybody's arms hurt after these vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Everybody's arms hurt after these vaccine) 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 PAIN IN EXTREMITY (Everybody's arms hurt after these vaccine). At the time of the report, PAIN IN EXTREMITY (Everybody's arms hurt after these vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller states while reporting adverse events.Everybody's arms hurt after these vaccines.  No concomitant medication were reported  No treatment information was provided
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling underneath the arm that got the injection, in the pit area; sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection) and VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Hysterectomy (a year ago) in 2020. Concomitant products included METHOTREXATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FOLIC ACID and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection). On 09-Oct-2021, the patient experienced VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore at the injection site/pain under the arm that got the injection/pain in on top of the arm that got the injection) and VACCINATION SITE SWELLING (swelling underneath the arm that got the injection, in the pit area) 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 steroid low dose  was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects unspecified; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects unspecified) 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 VACCINATION COMPLICATION (side effects unspecified). At the time of the report, VACCINATION COMPLICATION (side effects unspecified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Headache; Boyfriend started with fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Boyfriend started with fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Boyfriend started with fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and PYREXIA (Boyfriend started with fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Blood thinners for an unknown indication. No treatment medications were reported.
Age: 46.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Interchange of vaccine products
Clinical narrative: Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to a patient today.; Interchange of vaccine products administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to a patient today.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products administered) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 18-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to a patient today.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products administered). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was punctured on Wed 06Oct2021 @ 2p, then placed in refrigerator. It was administered to a patient today.) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Had bottle of Moderna Covid-19 vaccine that was punctured on Wed 06 Oct 2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: the patient feels a little achy; Arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache) and MYALGIA (the patient feels a little achy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain and Inflammation. Concomitant products included CELECOXIB (CELOXIB) for Antiinflammatory therapy, DIAZEPAM (VALIUM) for Back pain.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm ache). On an unknown date, the patient experienced MYALGIA (the patient feels a little achy). At the time of the report, PAIN IN EXTREMITY (Arm ache) and MYALGIA (the patient feels a little achy) outcome was unknown.            No treatment details were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fall, Head injury
Clinical narrative: He contracted covid and died.; Hurt his head; Had fallen; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He contracted covid and died.), HEAD INJURY (Hurt his head) and FALL (Had fallen) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer (prostate cancer that was on remission).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (He contracted covid and died) (seriousness criteria death and hospitalization), HEAD INJURY (Hurt his head) (seriousness criterion hospitalization) and FALL (Had fallen) (seriousness criterion hospitalization). The patient died on an unknown date. The reported cause of death was covid-19. It is unknown if an autopsy was performed. At the time of death, HEAD INJURY (Hurt his head) and FALL (Had fallen) outcome was unknown.            No concomitant medication was given.  No treatment medication was given. It was reported that the patient received the first dose of Moderna Covid19 vaccine had certain medical conditions and had fallen and hurt his head. He was in the hospital because of hurting his head and there he contracted covid and died. He was 72 years old. He had prostate cancer that was on remission, but when contracted Covid, the cancer was activated and speed up the prostate cancer after having covid. This was directly related to getting Covid in the hospital.  Company comment This case concerns a 72-year-old, male patient, with medical history of Prostate cancer, who experienced the serious, unexpected, event of Covid-19, and other serious unexpected events Head injury and fall. The events occurred  on unknown date after first dose of Moderna vaccine. The reporter mentioned that patient had other medical conditions, was hospitalized and there he contracted Covid-19. The patient died on an unknown date. It is unknown if an autopsy was done. Patient's age, comorbidities and incomplete vaccine dose may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 72-year-old, male patient, with medical history of Prostate cancer, who experienced the serious, unexpected, event of Covid-19, and other serious unexpected events Head injury and fall. The events occurred  on unknown date after first dose of Moderna vaccine. The reporter mentioned that patient had other medical conditions, was hospitalized and there he contracted Covid-19. The patient died on an unknown date. It is unknown if an autopsy was done. Patient's age, comorbidities and incomplete vaccine dose may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: COVID-19
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: felt my lip tingle (after the first shot); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (felt my lip tingle (after the first shot)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PARAESTHESIA ORAL (felt my lip tingle (after the first shot)). At the time of the report, PARAESTHESIA ORAL (felt my lip tingle (after the first shot)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.   This case was linked to MOD-2021-347123 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2DA and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG) and LISINOPRIL for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-346598 (Patient Link).