chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored). On 27-Oct-2021, PRODUCT STORAGE ERROR (She received her booster of the Moderna vaccine/  received a dose from a lot that might have been improperly stored) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:(Privacy)    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 LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant product use was not provided by the reporter.    ?No treatment information was provided.  Company Comment: This literature case concerns a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-419607, MOD-2021-419608, MOD-2021-419609 (Patient Link).; Sender's Comments: This literature case concerns a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 68-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant and treatment medication were not reported  Company comment: This is a literature case concerning a 68 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, AESI of Liver injury. The event occurred on an unknown date after mRNA-1273 vaccine, dose number and date not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419607, MOD-2021-419558, MOD-2021-419609 (Patient Link).; Sender's Comments: This is a literature case concerning a 68 year-old, female patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, AESI of Liver injury. The event occurred on an unknown date after mRNA-1273 vaccine, dose number and date not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 65-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant product use was not provided by the reporter.    ?No treatment information was provided. Company Comment: This literature case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-419607, MOD-2021-419608, MOD-2021-419558 (Patient Link).; Sender's Comments: This literature case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Nasal congestion, Oropharyngeal pain
Clinical narrative: experiencing sore throat; congestion; metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, INSULIN and METFORMIN for an unknown indication.    On 22-Dec-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 OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste). At the time of the report, OROPHARYNGEAL PAIN (experiencing sore throat), NASAL CONGESTION (congestion) and DYSGEUSIA (metallic taste) had not 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.   Treatment medication Includes:Homeopathic Medicine  Concomitant  medication:Iodine IV Contrast for CT Scan  Anatomical location;left arm non dominant
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Illness
Clinical narrative: "I get sick every time I get a Shot"; "I have to stay at home for probably 36 hours"; back pain; weak; diarrhea; "I get sick every time I get a Shot"; dizzy; sore all over; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender 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.    In February 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 the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the second episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the last episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-427003, MOD-2021-427001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: "I get sick every time I get a Shot"; "I have to stay at home for probably 36 hours"; back pain; weak; diarrhea; "I get sick every time I get a Shot"; dizzy; sore all over; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender 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.    In February 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 the first episode of ILLNESS ("I get sick every time I get a Shot"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the second episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), BACK PAIN (back pain), ASTHENIA (weak), DIARRHOEA (diarrhea), the last episode of ILLNESS ("I get sick every time I get a Shot"), DIZZINESS (dizzy) and MYALGIA (sore all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-427003, MOD-2021-427001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Illness
Clinical narrative: weak; back pain; diarrhea; feeling dizzy; sore all over; I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot; I have to stay at home for probably 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) in a  patient of an unknown age and gender 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy), ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) and MYALGIA (sore all over). At the time of the report, ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and MYALGIA (sore all over) outcome was unknown and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) had resolved.            Concomitant medication of the patient was not reported.  The patient would like to know if a 4th dose came up and if patient have it, will get sick as well. The patient would also like to know if can switch the vaccines to avoid being sick.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-427003, MOD-2021-427000.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: weak; back pain; diarrhea; feeling dizzy; sore all over; I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot; I have to stay at home for probably 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) in a  patient of an unknown age and gender 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy), ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) and MYALGIA (sore all over). At the time of the report, ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and MYALGIA (sore all over) outcome was unknown and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) had resolved.            Concomitant medication of the patient was not reported.  The patient would like to know if a 4th dose came up and if patient have it, will get sick as well. The patient would also like to know if can switch the vaccines to avoid being sick.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-427003, MOD-2021-427000.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Illness
Clinical narrative: "I get sick every time I get a Shot"; weak; back pain; "I have to stay at home for probably 36 hours"; diarrhea; dizzy; sore all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours") and DIARRHOEA (diarrhea) in a  patient of an unknown age and gender 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and MYALGIA (sore all over). At the time of the report, ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and MYALGIA (sore all over) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-427000, MOD-2021-427001 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: "I get sick every time I get a Shot"; weak; back pain; "I have to stay at home for probably 36 hours"; diarrhea; dizzy; sore all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours") and DIARRHOEA (diarrhea) in a  patient of an unknown age and gender 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and MYALGIA (sore all over). At the time of the report, ILLNESS ("I get sick every time I get a Shot"), ASTHENIA (weak), BACK PAIN (back pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have to stay at home for probably 36 hours"), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and MYALGIA (sore all over) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-427000, MOD-2021-427001 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Palpitations (heart palpitations).    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) outcome was unknown.            Concomitant medications were not provided Treatment medications were not provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was kept in the refrigerator longer than it supposed to , and it was giving to us; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was kept in the refrigerator longer than it supposed to , and it was giving to us) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was kept in the refrigerator longer than it supposed to , and it was giving to us). In October 2021, EXPIRED PRODUCT ADMINISTERED (Was kept in the refrigerator longer than it supposed to , and it was giving to us) had resolved.            No Treatment medications were provided.  No  Concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Dec-2021: Follow-up received include no new information.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient received half a dose instead of full first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received half a dose instead of full first dose) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received half a dose instead of full first dose). On 24-Dec-2021, ACCIDENTAL UNDERDOSE (Patient received half a dose instead of full first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. In May 2021, patient received second dose of Moderna COVID 19 Vaccine.   This case was linked to MOD-2021-427018, MOD-2021-427829, MOD-2021-427849 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive Heart Failure; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure). At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive Heart Failure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.  Treatment medications were not provided.  Patient stated that she had first set of vaccine one month ago and was asked if it was ok to get the second shot of vaccine if she had Congestive Heart failure.  Company comment: This case concerns a female patient, with no medical history reported in this case, who experienced the non-serious AESI of Cardiac failure congestive. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. No further information was provided.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.; Sender's Comments: This case concerns a female patient, with no medical history reported in this case, who experienced the non-serious AESI of Cardiac failure congestive. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine. No further information was provided.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concomitant products included NORETHISTERONE (SHAROBEL) for Birth control pill, FLUOXETINE, VITAMIN D [VITAMIN D NOS], ASCORBIC ACID, RUTOSIDE (VITAMIN C COMPLEX [ASCORBIC ACID;RUTOSIDE]) and VITAMIN B COMPLEX for an unknown indication.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Dec-2021, the patient experienced CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) from 22-Dec-2021 to 23-Dec-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CONTUSION (Patient reports noticing little bruises not like petechia, a little bit bigger but really small in weird spots first noticed 25DEC2021 yesterday and then noticed a couple more on the upper body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is not on any blood thinners.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Dyspnoea, Fatigue, Musculoskeletal chest pain
Clinical narrative: moving hurts; left side of her rib is hurt; Breathing hurts; everyday is a little bit worse,more tired than before; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (moving hurts), MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 004M20A and 025L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for Cholesterol, DONEPEZIL for Memory loss, UBIDECARENONE (COQ-10), CALCIUM, COLECALCIFEROL (VITAMIN D3), IRON, FISH OIL and PANTOPRAZOLE for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In December 2021, the patient experienced DYSKINESIA (moving hurts), MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before). At the time of the report, DYSKINESIA (moving hurts) had not resolved and MUSCULOSKELETAL CHEST PAIN (left side of her rib is hurt), DYSPNOEA (Breathing hurts) and FATIGUE (everyday is a little bit worse,more tired than before) outcome was unknown.            Patient reports her body was normally healthy.   No past medical history for heart conditions was reported.   Patient has not tested positive for Covid.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: General discomfort; Sore throat; Soreness; Joint pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (General discomfort), OROPHARYNGEAL PAIN (Sore throat), PAIN (Soreness), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm is quite sore and red and hot; Arm is quite sore and red and hot; Arm is quite sore and red and hot; Her arm has been getting less inflamed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is quite sore and red and hot), VACCINATION SITE PAIN (Arm is quite sore and red and hot), VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot) and VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcer colon. Concomitant products included GOLIMUMAB (SIMPONI) for Colitis ulcerative.    On 24-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 VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed). On 26-Dec-2021, the patient experienced VACCINATION SITE WARMTH (Arm is quite sore and red and hot), VACCINATION SITE PAIN (Arm is quite sore and red and hot) and VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot). The patient was treated with IBUPROFEN in December 2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is quite sore and red and hot) and VACCINATION SITE PAIN (Arm is quite sore and red and hot) had not resolved and VACCINATION SITE ERYTHEMA (Arm is quite sore and red and hot) and VACCINATION SITE INFLAMMATION (Her arm has been getting less inflamed) was resolving.            Non drug treatment include icepackinet. Patient reached out to her doctor and had an appointment on 28 Dec 2021. Patient treated the inflammation with Tylenol and icepacks.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up received include Patient demographic details, medical condition, concomitant medication, treatment medication and updated outcome to recovering, added event - vaccination site inflammation.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion
Clinical narrative: very minor, diminishing fatigue; has had minor nasal congestion; headache first day only; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue) in a 54-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue). At the time of the report, NASAL CONGESTION (has had minor nasal congestion), HEADACHE (headache first day only) and FATIGUE (very minor, diminishing fatigue) had resolved.            No relevant concomitant and treatment medications were reported. The patient was average build and in good health. It was reported patient had minor nasal congestion, headache first day only, very minor, diminishing fatigue, for 3-4 days total. Patient gave credit Moderna for his better condition because his family who took Pfizer got COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness, Nasopharyngitis, Rhinorrhoea
Clinical narrative: feel like she has a horrible cold; Runny nose; like a bad cold; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for No adverse event: Pfizer BioNTech COVID-19 Vaccine (First dose) in May 2021 and Pfizer BioNTech COVID-19 Vaccine (Second dose) in 2021. Past adverse reactions to the above products included Product used for unknown indication with Pfizer BioNTech COVID-19 Vaccine and Pfizer BioNTech COVID-19 Vaccine.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with VITAMIN C [ASCORBIC ACID] in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (feel like she has a horrible cold), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (like a bad cold) and INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.            she got the booster dose of the Moderna COVID-19 vaccine (Lot number not provided in the card). About 2 days after the Moderna booster she started to feel like she has a horrible cold, runny nose, like a bad cold (agent asked her to repeat other side effects she mentioned that made her feel like she had a cold but she did not repeat them).  She was taking Vitamin C and cold meds and tried to get rest. This flu like symptoms have been non stop. It's not so severe to go to a doctor  No concomitant medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Swelling
Clinical narrative: redness occurred the day after I received  the Moderna booster; swelling; been experiencing pain in my arm pit area,; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,). At the time of the report, ERYTHEMA (redness occurred the day after I received  the Moderna booster), SWELLING (swelling) and AXILLARY PAIN (been experiencing pain in my arm pit area,) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: started feeling headache; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (started feeling headache) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced HEADACHE (started feeling headache) and FATIGUE (tiredness). At the time of the report, HEADACHE (started feeling headache) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Receiving a Moderna COVID Booster and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding) in a 38-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Receiving a Moderna COVID Booster and is breastfeeding) had resolved. Not Provided          No Concomitant and treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Received a Cortisone injection in toe after first dose for unknown cause; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Received a Cortisone injection in toe after first dose for unknown cause) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Received a Cortisone injection in toe after first dose for unknown cause). The patient was treated with CORTISONE on 01-Mar-2021 for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (Received a Cortisone injection in toe after first dose for unknown cause) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was due to receive the second dose of the Moderna Covid-19 vaccine on 03 Mar 2021.  No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Patient has hives in different parts of the body, they are very itchy and painfull; they are very itchy and painful; painful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful). At the time of the report, URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful) had not resolved.            No Concomitant product use was reported.  The patient stated that they got the Moderna covid-19 Booster shot on 07-DEC-2021 and now they had hives in different parts of their body and those were very itchy and painful.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: my arm is swelling, and moving down towards my elbow; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm is swelling, and moving down towards my elbow) 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 PERIPHERAL SWELLING (my arm is swelling, and moving down towards my elbow). At the time of the report, PERIPHERAL SWELLING (my arm is swelling, and moving down towards my elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Patient reported that they had the Moderna shot on Thursday at noon.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Night sweats
Clinical narrative: Night sweeting; Night Chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills) 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 16-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 NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills). At the time of the report, NIGHT SWEATS (Night sweeting) and CHILLS (Night Chills) had not resolved.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial that was kept in the refrigerator too long; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long). In November 2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was kept in the refrigerator too long) had resolved.       No concomitant medication were reported.   No Treatment drug were reported.  Patient received her booster dose about one week after 26-Oct-2021 and was notified by the same vaccination site that she received a dose from a vial that was kept in the refrigerator too long.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Moderna COVID-19 vaccine raises blood sugar; This spontaneous case was reported by a pharmacist and describes the occurrence of BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Moderna COVID-19 vaccine raises blood sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) raised blood sugar.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.