chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Vertigo
Clinical narrative: passed out on bed; eyes were spinning around; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache). On 05-Apr-2021, LOSS OF CONSCIOUSNESS (passed out on bed), VERTIGO (eyes were spinning around) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       CC: This is a spontaneous case concerning a 81-year-old female patient with Hashimoto´s disease, who experienced the non-serious unexpected event loss of consciousness, the same day after receiving the first dose of mRNA-1273. Patient describes that the reaction lasted for about 10-15 minutes and felt better the following day. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No treatment medications were provided.  The patient received the first dose on 05-Apr-2021and the second one on 05-May-2021 (Lot: 005C21A, Expiration date: Unknown).The patient had a reaction to the first dose. The day she received the first dose, she started experiencing a headache and passed out on her bed. Her eyes were spinning around. The reactions lasted for about 10-15 minutes and she felt better the following day. She stated that she doesn't think she needs the booster. She had read about the Moderna vaccine and that it was still experimental. She also reported that because she had a reaction to the first dose, she doesn't think she should get the booster shot of Moderna.   This case was linked to MOD-2021-403727 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 81-year-old female patient with Hashimoto´s disease, who experienced the non-serious unexpected event loss of consciousness, the same day after receiving the first dose of mRNA-1273. Patient describes that the reaction lasted for about 10-15 minutes and felt better the following day. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Period immediately following vaccination had more blood clots; period immediately following vaccination had more cramps; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Period immediately following vaccination had more blood clots) and DYSMENORRHOEA (period immediately following vaccination had more cramps) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 004M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Period immediately following vaccination had more blood clots) and DYSMENORRHOEA (period immediately following vaccination had more cramps). At the time of the report, HEAVY MENSTRUAL BLEEDING (Period immediately following vaccination had more blood clots) and DYSMENORRHOEA (period immediately following vaccination had more cramps) outcome was unknown.            CC: This is a spontaneous case concerning a 42-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events on the same day after receiving the third   dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2021-405203, MOD-2021-405201 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 42-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events on the same day after receiving the third   dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Vaccination site lymphadenopathy
Clinical narrative: period immediately following vaccination had more blood clots, darker blood; period immediately following vaccination had more cramps; lymph node under her left armpit was inflamed.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-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 MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.). At the time of the report, MENSTRUAL DISORDER (period immediately following vaccination had more blood clots, darker blood), DYSMENORRHOEA (period immediately following vaccination had more cramps) and VACCINATION SITE LYMPHADENOPATHY (lymph node under her left armpit was inflamed.) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  The patient took Moderna Booster dose on 27Nov2021, batch number 014F21A, on Right Arm.   This case was linked to MOD-2021-405167, MOD-2021-405203 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: period immediately following vaccination had more blood clots; more cramps; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-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 HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps). At the time of the report, HEAVY MENSTRUAL BLEEDING (period immediately following vaccination had more blood clots) and DYSMENORRHOEA (more cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events occurred on the same day after receiving the first  dose of mRNA-1273. Rechallenge is positive, since patient experienced the same symptoms after second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. No relevant concomitant medications were reported. Treatment information was unknown. It was stated that after all 3 Moderna doses, patient period immediately following vaccination had more blood clots, darker blood and she had more cramps.   This case was linked to MOD-2021-405167, MOD-2021-405201 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events Heavy menstrual bleeding and dysmenorrea . The events occurred on the same day after receiving the first  dose of mRNA-1273. Rechallenge is positive, since patient experienced the same symptoms after second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Loss of consciousness, Myalgia, Pain
Clinical narrative: it knocked out; After the booster dose the side effects were worse; still sore/body aches were so bad, it seems to attack your weak points; tired; Mucousy in the lungs; body aches were so bad, hurting head to toe, achy; coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy) and COUGH (coughing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Asthma.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse) and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points). At the time of the report, LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired) outcome was unknown and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  After the booster dose, patient experienced the side effects and were worse, the body aches were so bad, it seemed to attack weak points. It was hurting head to toe, achy, coughing, tired, & mucousy in the lungs. Patient was still sore, out of it, said it knocked out the patient.   This case was linked to MOD-2021-405703 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Vaccination complication
Clinical narrative: it knocked out; After the booster dose the side effects were worse; still sore/body aches were so bad, it seems to attack your weak points; tired; Mucousy in the lungs; body aches were so bad, hurting head to toe, achy; coughing; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy) and COUGH (coughing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Asthma.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse) and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points). At the time of the report, LOSS OF CONSCIOUSNESS (it knocked out), VACCINATION COMPLICATION (After the booster dose the side effects were worse), PRODUCTIVE COUGH (Mucousy in the lungs), PAIN (body aches were so bad, hurting head to toe, achy), COUGH (coughing) and FATIGUE (tired) outcome was unknown and MYALGIA (still sore/body aches were so bad, it seems to attack your weak points) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  After the booster dose, patient experienced the side effects and were worse, the body aches were so bad, it seemed to attack weak points. It was hurting head to toe, achy, coughing, tired, & mucousy in the lungs. Patient was still sore, out of it, said it knocked out the patient.   This case was linked to MOD-2021-405703 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: she became violently ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she became violently ill) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (one year ago) in 2020.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 ILLNESS (she became violently ill). At the time of the report, ILLNESS (she became violently ill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications details were not reported by the reporter. Treatment details were reported by the reporter.  The patient received the first dose of Moderna vaccine on 26Apr2021. She stated that 14 hours later, she became 'violently ill' for 3 days. The patient received the second dose of Moderna vaccine on 26May2021 and the same thing happened again. She became very sick.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the second dose of the Moderna mRNA-1273 vaccine on 26May2021. The start date of the event was not provided. The report stated that the patient became very sick. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable for the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405713, MOD-2021-405744 (Patient Link).; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the second dose of the Moderna mRNA-1273 vaccine on 26May2021. The start date of the event was not provided. The report stated that the patient became very sick. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable for the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: She became violently ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She became violently ill) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (She became violently ill). In April 2021, ILLNESS (She became violently ill) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  The patient received the first dose of Moderna vaccine on 26Apr2021. She stated that 14 hours later, she became 'violently ill' for 3 days. The patient received the second dose of Moderna vaccine on 26May2021 and the same thing happened again. She became very sick.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the first dose of the Moderna mRNA-1273 vaccine on 26Apr2021. The report stated that the patient became 'violently ill' 14 hours after vaccination. No further details were provided. Treatment information was also not provided. The event had resolved at the time of the report. The rechallenge was positive for the first dose since the event resolved after 3 days and the patient experienced 'the same thing' after administration of the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405737, MOD-2021-405713 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the first dose of the Moderna mRNA-1273 vaccine on 26Apr2021. The report stated that the patient became 'violently ill' 14 hours after vaccination. No further details were provided. Treatment information was also not provided. The event had resolved at the time of the report. The rechallenge was positive for the first dose since the event resolved after 3 days and the patient experienced 'the same thing' after administration of the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: presumed myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (presumed myocarditis) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (presumed myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (presumed myocarditis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (presumed myocarditis) to be related.    Concomitant information were not provided. Treatment information was not Reported.  Company comment: This case concerns a 52-year-old, male patient, with no reported medical history, who experienced the serious, expected, AESI event of myocarditis. The patient was presumed to have myocarditis 3 days after second dose of mRNA 1273 vaccine. No lab data or clinical course provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 52-year-old, male patient, with no reported medical history, who experienced the serious, expected, AESI event of myocarditis. The patient was presumed to have myocarditis 3 days after second dose of mRNA 1273 vaccine. No lab data or clinical course provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Muscle tightness, Skin cancer
Clinical narrative: Skin cancer; 1st dose: 22Apr2021, 2nd dose 03Jun2021; Tightening of the neck muscles; A lot of headaches; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (Skin cancer) in a male 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 22Apr2021, 2nd dose 03Jun2021). In June 2021, the patient experienced MUSCLE TIGHTNESS (Tightening of the neck muscles) and HEADACHE (A lot of headaches). In September 2021, the patient experienced SKIN CANCER (Skin cancer) (seriousness criterion medically significant). The patient was treated with MARIJUANA for Adverse event, at an unspecified dose and frequency and Surgery (Removal surgery) for Skin cancer. On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 22Apr2021, 2nd dose 03Jun2021) had resolved. At the time of the report, SKIN CANCER (Skin cancer), MUSCLE TIGHTNESS (Tightening of the neck muscles) and HEADACHE (A lot of headaches) outcome was unknown.            No concomitant medications were provided.  Company comment: This Spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) event of skin cancer. Inappropriate schedule of product administration is also reported. The patient experienced tightening of the neck muscles and headaches on an unknown date after the second dose of mRNA-1273 vaccine. He took OTC marijuana which helped him relieve the symptoms. He also stated that he had skin cancer in 3 months after vaccination and had removal surgery. The patient denied providing further information. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405966 (Patient Link).; Sender's Comments: This Spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, serious (Medically significant) event of skin cancer. Inappropriate schedule of product administration is also reported. The patient experienced tightening of the neck muscles and headaches on an unknown date after the second dose of mRNA-1273 vaccine. He took OTC marijuana which helped him relieve the symptoms. He also stated that he had skin cancer in 3 months after vaccination and had removal surgery. The patient denied providing further information. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Illness, Lung disorder, Myalgia
Clinical narrative: Cardio pulmonary; Completely out of energy; He is sleeping more then usual; Snoring; Cardiopulmonary event; After the second dose he was very sick for 3 days; Light fever; Ache all over; Left deltoid at the injection site hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Cardio pulmonary) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Cardio pulmonary) (seriousness criterion medically significant), ASTHENIA (Completely out of energy), SOMNOLENCE (He is sleeping more then usual), SNORING (Snoring), LUNG DISORDER (Cardiopulmonary event), ILLNESS (After the second dose he was very sick for 3 days), PYREXIA (Light fever), MYALGIA (Ache all over) and VACCINATION SITE PAIN (Left deltoid at the injection site hurt a lot). At the time of the report, CARDIAC DISORDER (Cardio pulmonary), ASTHENIA (Completely out of energy), SOMNOLENCE (He is sleeping more then usual), SNORING (Snoring), LUNG DISORDER (Cardiopulmonary event), ILLNESS (After the second dose he was very sick for 3 days), PYREXIA (Light fever), MYALGIA (Ache all over) and VACCINATION SITE PAIN (Left deltoid at the injection site hurt a lot) outcome was unknown.            Patient was taking other medication.   Patient reported that he experienced sleep all night now he was sleeping 9:30 to 10 hours of sleep, he could not run half mile for like 4 months. But now he can run again.   No treatment medication information was mentioned by reporter; Sender's Comments: This case concerns a 67 year old male patient with no relevant medical history, who experienced the expected event of cardiac disorder. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Snoring, Somnolence, Vaccination site pain
Clinical narrative: Cardio pulmonary; Completely out of energy; He is sleeping more then usual; Snoring; Cardiopulmonary event; After the second dose he was very sick for 3 days; Light fever; Ache all over; Left deltoid at the injection site hurt a lot; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Cardio pulmonary) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Cardio pulmonary) (seriousness criterion medically significant), ASTHENIA (Completely out of energy), SOMNOLENCE (He is sleeping more then usual), SNORING (Snoring), LUNG DISORDER (Cardiopulmonary event), ILLNESS (After the second dose he was very sick for 3 days), PYREXIA (Light fever), MYALGIA (Ache all over) and VACCINATION SITE PAIN (Left deltoid at the injection site hurt a lot). At the time of the report, CARDIAC DISORDER (Cardio pulmonary), ASTHENIA (Completely out of energy), SOMNOLENCE (He is sleeping more then usual), SNORING (Snoring), LUNG DISORDER (Cardiopulmonary event), ILLNESS (After the second dose he was very sick for 3 days), PYREXIA (Light fever), MYALGIA (Ache all over) and VACCINATION SITE PAIN (Left deltoid at the injection site hurt a lot) outcome was unknown.            Patient was taking other medication.   Patient reported that he experienced sleep all night now he was sleeping 9:30 to 10 hours of sleep, he could not run half mile for like 4 months. But now he can run again.   No treatment medication information was mentioned by reporter; Sender's Comments: This case concerns a 67 year old male patient with no relevant medical history, who experienced the expected event of cardiac disorder. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis pseudo relapse
Clinical narrative: Pseudoexacerbation; This spontaneous case was reported by a non-health professional and describes the occurrence of MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Colon cancer. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS PSEUDO RELAPSE (Pseudoexacerbation) had resolved.            Treatment information was not provided.  Company comment included This is a spontaneous case concerning a 46-year-old male patient with concurrent medical conditions of Multiple sclerosis and Colon cancer, who experienced unexpected event of Multiple sclerosis pseudo relapse. It was reported that patient received third dose of mRNA-1273 . It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Further information has been requested. Concurrent medical condition of colon cancer remains a confounder for the event Multiple sclerosis pseudo relapse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old male patient with concurrent medical conditions of Multiple sclerosis and Colon cancer, who experienced unexpected event of Multiple sclerosis pseudo relapse. It was reported that patient received third dose of mRNA-1273 . It is not possible to establish a temporal relationship as vaccination date and start date of the event were not provided. Clinical course and treatment details were not disclosed. Further information has been requested. Concurrent medical condition of colon cancer remains a confounder for the event Multiple sclerosis pseudo relapse. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm deltoid muscle after first shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Sore left arm deltoid muscle after first shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore left arm deltoid muscle after first shot). On 01-Jan-2021, VACCINATION SITE PAIN (Sore left arm deltoid muscle after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-406568, MOD-2021-406569 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Have A Fib; This spontaneous case was reported by a pharmacist and describes the occurrence of ATRIAL FIBRILLATION (Have A Fib) 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.   In 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. In 2021, the patient experienced ATRIAL FIBRILLATION (Have A Fib). At the time of the report, ATRIAL FIBRILLATION (Have A Fib) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were provided.  Case narrative: I want to know if I need the booster because it has not been 6 months but I have A Fib A.  Company comment: This is a spontaneos case concerning a patient of an unknown age and gender who wants to know if she/he needs the booster because it has not been 6 months but she/he have A Fib. It is not clear if atrial fibrillation was reported as an adverse event or if the patient refers to a concurrent medical condition for which she/he would have an indication of a booster dose. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender who wants to know if she/he needs the booster because it has not been 6 months but she/he have A Fib. It is not clear if atrial fibrillation was reported as an adverse event or if the patient refers to a concurrent medical condition for which she/he would have an indication of a booster dose. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Illness
Clinical narrative: super sick; digestive issues after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (super sick) and DYSPEPSIA (digestive issues after the 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 ILLNESS (super sick) and DYSPEPSIA (digestive issues after the vaccine). At the time of the report, ILLNESS (super sick) and DYSPEPSIA (digestive issues after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity, SARS-CoV-2 test, Swelling, Vascular pain
Clinical narrative: after the first dose of the vaccine was administered, I began to have pain in my legs; have pain in my legs and between my bones.; The veins began to swell and caused me more pain.; The veins began to swell and caused me more pain.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after the first dose of the vaccine was administered, I began to have pain in my legs), BONE PAIN (have pain in my legs and between my bones.), SWELLING (The veins began to swell and caused me more pain.) and VASCULAR PAIN (The veins began to swell and caused me more pain.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.    On 25-May-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (after the first dose of the vaccine was administered, I began to have pain in my legs) and BONE PAIN (have pain in my legs and between my bones.). May 2021, the patient experienced SWELLING (The veins began to swell and caused me more pain.) and VASCULAR PAIN (The veins began to swell and caused me more pain.). At the time of the report, PAIN IN EXTREMITY (after the first dose of the vaccine was administered, I began to have pain in my legs), BONE PAIN (have pain in my legs and between my bones.), SWELLING (The veins began to swell and caused me more pain.) and VASCULAR PAIN (The veins began to swell and caused me more pain.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2020, SARS-CoV-2 test: positive (Positive) positive Type of test-Nasal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided. Patient height reported as 5'6"   This case was linked to MOD-2021-395604 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Translation received on 15-Dec-2021 contains Additional Comments in English.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac murmur
Clinical narrative: Heart murmur; Prolapse valve heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-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 CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition). At the time of the report, CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment drugs were reported.  It was reported that patient had (heart murmur) prolapse heart valve condition and concerned to know before the booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: Not feeling good; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good) and MYALGIA (Body aches) 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 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced FEELING ABNORMAL (Not feeling good) and MYALGIA (Body aches). At the time of the report, FEELING ABNORMAL (Not feeling good) and MYALGIA (Body aches) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE PAIN (Sore left arm injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-410457 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Myalgia, Pruritus
Clinical narrative: Itching on her scalp; After that until today she has skin itching, it is a 5-6; muscle pain on the right arm, pain in the left thigh, muscle pain,muscle pain in the calf on her left leg; too much pain in her breast area; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (too much pain in her breast area), PRURITUS (Itching on her scalp), PRURITUS (After that until today she has skin itching, it is a 5-6) and MYALGIA (muscle pain on the right arm, pain in the left thigh, muscle pain,muscle pain in the calf on her left leg) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 022C21A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BREAST PAIN (too much pain in her breast area). In December 2021, the patient experienced PRURITUS (Itching on her scalp), PRURITUS (After that until today she has skin itching, it is a 5-6) and MYALGIA (muscle pain on the right arm, pain in the left thigh, muscle pain,muscle pain in the calf on her left leg). In December 2021, BREAST PAIN (too much pain in her breast area), PRURITUS (Itching on her scalp) and MYALGIA (muscle pain on the right arm, pain in the left thigh, muscle pain,muscle pain in the calf on her left leg) had resolved. At the time of the report, PRURITUS (After that until today she has skin itching, it is a 5-6) had not resolved.            It was reported that patient experienced breast pain that  lasted  for a week. Muscle pain on the right arm  lasted  for 4 days. Then for 4 days patient  had pain in the left thigh, muscle pain and in the calf on the left leg Patient experienced  itching on her scalp, her head for 2 days.After that until today she had skin itching, itching hands, shoulder, back, everywhere.  No concomitant information provided by the reporter No treatment information provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the 1st dose but did not receive the 2nd dose. Patient described the events as severe side effects.  No concomitant and treatment information were reported by the reporter.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Vaccination site pain
Clinical narrative: currently has a head cold; nasal congestion; sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (currently has a head cold), NASAL CONGESTION (nasal congestion) and VACCINATION SITE PAIN (sore left arm injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm injection site). On 14-Dec-2021, the patient experienced NASOPHARYNGITIS (currently has a head cold) and NASAL CONGESTION (nasal congestion). At the time of the report, NASOPHARYNGITIS (currently has a head cold) and NASAL CONGESTION (nasal congestion) had not resolved and VACCINATION SITE PAIN (sore left arm injection site) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-410410, MOD-2021-410335, MOD-2021-410313 (Patient Link).