chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Difficulty breathing; Throat pain; Fever; contracted COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046321A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy and Contrast media allergy (Allergic to contrast.). Concomitant products included ROSUVASTATIN CALCIUM (LUSTATIN) and CARVEDILOL for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and PYREXIA (Fever). On 20-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (Throat pain). On 24-Jan-2022, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and OXYGEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Zpack.  Company Comment: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Difficulty breathing; Throat pain; Fever; contracted COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046321A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Iodine allergy and Contrast media allergy (Allergic to contrast.). Concomitant products included ROSUVASTATIN CALCIUM (LUSTATIN) and CARVEDILOL for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and PYREXIA (Fever). On 20-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (Throat pain). On 24-Jan-2022, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with ALBUTEROL [SALBUTAMOL] (nasal) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and OXYGEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID-19), DRUG INEFFECTIVE (Lack of drug effect), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Throat pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Zpack.  Company Comment: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 3 months 13 days after the second dose of mRNA-1273 vaccine administered on 1-Oct-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 14-Jan-22 was positive. At the time of report outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: died of heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (died of heart attack) 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 MYOCARDIAL INFARCTION (died of heart attack) (seriousness criteria death and medically significant). The reported cause of death was died of heart attack. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment medications were reported. Reported that patient had the vaccine and died of heart attack. Also mentioned people having heart problem after getting the vaccine.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the fatal event of MYOCARDIAL INFARCTION. Vaccination date and onset date of the event were not reported; hence, latency cannot be assessed. Very limited information was provided for medical reviewing and no consent for follow-up was obtained. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460399 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the fatal event of MYOCARDIAL INFARCTION. Vaccination date and onset date of the event were not reported; hence, latency cannot be assessed. Very limited information was provided for medical reviewing and no consent for follow-up was obtained. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died of heart attack
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Drug ineffective, Fatigue
Clinical narrative: getting sick from covid19; diarrhea; body aches; chills; nausea; tiredness, fatigue; tested positive for COVID19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID19), DRUG INEFFECTIVE (lack of drug effect), ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea) and MYALGIA (body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, the patient experienced COVID-19 (tested positive for COVID19) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue). The patient was treated with DEXAMETHASONE for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB) for Adverse event, at an unspecified dose and frequency and BENZONATATE (TESSALON) for Cough, at an unspecified dose and frequency. On 16-Jan-2022, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and ILLNESS (getting sick from covid19) outcome was unknown and DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. On 16-Jan-2022, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication was not provided.  Company Comment: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: getting sick from covid19; diarrhea; body aches; chills; nausea; tiredness, fatigue; tested positive for COVID19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID19), DRUG INEFFECTIVE (lack of drug effect), ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea) and MYALGIA (body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, the patient experienced COVID-19 (tested positive for COVID19) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced ILLNESS (getting sick from covid19), DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue). The patient was treated with DEXAMETHASONE for Adverse event, at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB) for Adverse event, at an unspecified dose and frequency and BENZONATATE (TESSALON) for Cough, at an unspecified dose and frequency. On 16-Jan-2022, COVID-19 (tested positive for COVID19) had resolved. At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and ILLNESS (getting sick from covid19) outcome was unknown and DIARRHOEA (diarrhea), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and FATIGUE (tiredness, fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. On 16-Jan-2022, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medication was not provided.  Company Comment: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a 48-year-old female patient, with no medical history reported, who experienced the unexpected events of COVID-19 (AESI), Drug ineffective, Illness, Diarrhea, Myalgia, Chills, Nausea and Fatigue. The events occurred approximately 7 months and 22 days after receiving the first dose of mRNA-1273 Vaccine.  The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got the covid after having the booster in November; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got the covid after having the booster in November) 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 November 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 COVID-19 (Got the covid after having the booster in November). At the time of the report, COVID-19 (Got the covid after having the booster in November) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter  Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: patient reported adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (patient reported adverse event) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (patient reported adverse event). At the time of the report, ADVERSE EVENT (patient reported adverse event) 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.  The patient asked whether it hurts or not to take second booster or not.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: i have all 3 got COVID-19 really bad; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (i have all 3 got COVID-19 really bad) 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 COVID-19 (i have all 3 got COVID-19 really bad). At the time of the report, COVID-19 (i have all 3 got COVID-19 really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after an unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. 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 unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred an unknown duration after an unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the event was Unknown. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Company comment: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred after the first dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460571 (Patient Link). Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred after the first dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: bad bad angina; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (bad bad angina) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (bad bad angina) (seriousness criterion medically significant). At the time of the report, ANGINA PECTORIS (bad bad angina) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported as the patient got bad bad angina from Moderna shots and the doctors were afraid to report it.  Relevant concomitant medications were not reported.  Treatment information was not provided.  Company comment: This case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected event of angina pectoris. The event occurred after a dose of mRNA-1273. As reported, the patient got bad bad angina from Moderna shots and the doctors were afraid to report it. It is unclear what type of angina the patient experienced. No information regarding diagnostics or treatment was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected event of angina pectoris. The event occurred after a dose of mRNA-1273. As reported, the patient got bad bad angina from Moderna shots and the doctors were afraid to report it. It is unclear what type of angina the patient experienced. No information regarding diagnostics or treatment was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got covid) 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 May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (got covid). At the time of the report, COVID-19 (got covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported. Patient had had first 2 doses of the vaccine in May and  got COVID in December. Patient was scheduled for the booster on 24-Jan-2022 but the pharmacist said that patient had to wait 6 months after having COVID to get the booster.  Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred approximately 6 months after the second dose of mRNA-1273. As reported, patient had had first 2 doses of the vaccine in May and got COVID in December. Patient was scheduled for the booster in January but the pharmacist told the patient that the patient had to wait 6 months after having COVID to get the booster. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected non serious event of COVID 19. The event occurred approximately 6 months after the second dose of mRNA-1273. As reported, patient had had first 2 doses of the vaccine in May and got COVID in December. Patient was scheduled for the booster in January but the pharmacist told the patient that the patient had to wait 6 months after having COVID to get the booster. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: Anaphylactic shot; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shot) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. The patient reports that the vaccine has made the life to be living in pure hell.  Company comment:  This case concerns a female patient with no reported medical history who experienced serious unexpected event of anaphylactic shock, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The symptoms were facial angioedema  and hives all over her body. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced serious unexpected event of anaphylactic shock, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The symptoms were facial angioedema  and hives all over her body. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Pruritus, Skin exfoliation, Swelling, Urticaria
Clinical narrative: Angioedema; Hives all over body; crazy itching; skin peeling; difficulty swelling; red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21A, 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling), SWELLING (difficulty swelling) and VACCINATION SITE RASH (red spots around injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling) and VACCINATION SITE RASH (red spots around injection site) outcome was unknown and SWELLING (difficulty swelling) had resolved.            Concomitant medication was not reported. No pre-existing condition or allergy was reported.  A week later after receiving booster dose patient experienced AE. Patient was on Prednisone and taking Benadryl which did not helped. Patient experienced difficulty swelling but it improved later.  Company comment:  This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460663 (Patient Link).; Sender's Comments: This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Angioedema; Hives all over body; crazy itching; skin peeling; difficulty swelling; red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21A, 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling), SWELLING (difficulty swelling) and VACCINATION SITE RASH (red spots around injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling) and VACCINATION SITE RASH (red spots around injection site) outcome was unknown and SWELLING (difficulty swelling) had resolved.            Concomitant medication was not reported. No pre-existing condition or allergy was reported.  A week later after receiving booster dose patient experienced AE. Patient was on Prednisone and taking Benadryl which did not helped. Patient experienced difficulty swelling but it improved later.  Company comment:  This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460663 (Patient Link).; Sender's Comments: This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congestion every morning and evening; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion every morning and evening) 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 July 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 NASAL CONGESTION (Congestion every morning and evening). At the time of the report, NASAL CONGESTION (Congestion every morning and evening) had not resolved.            No concomitant medications were reported. No treatment medications were reported. Patient did not go to doctors.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Product storage error
Clinical narrative: Healthcare provider had not stored the vaccine properly; She never got to her second Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Healthcare provider had not stored the vaccine properly) and PRODUCT DOSE OMISSION ISSUE (She never got to her second Moderna shot) 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 July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PRODUCT STORAGE ERROR (Healthcare provider had not stored the vaccine properly) and PRODUCT DOSE OMISSION ISSUE (She never got to her second Moderna shot). In July 2021, PRODUCT STORAGE ERROR (Healthcare provider had not stored the vaccine properly) and PRODUCT DOSE OMISSION ISSUE (She never got to her second Moderna shot) had resolved.            No concomitant medications were provided.  No treatment medications were reported.  The patient had received the first shot of Moderna vaccine in July 2021. Following that, she received the shingles shot and she never got to her second Moderna shot. The caller mentioned that she was not going to receive the second dose.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Respiratory disorder
Clinical narrative: I haven't received the 3rd dose of the vaccine because of respiratory conditions.; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (I haven't received the 3rd dose of the vaccine because of respiratory conditions.) and COVID-19 (COVID-19) 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 RESPIRATORY DISORDER (I haven't received the 3rd dose of the vaccine because of respiratory conditions.) and COVID-19 (COVID-19). At the time of the report, RESPIRATORY DISORDER (I haven't received the 3rd dose of the vaccine because of respiratory conditions.) and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was not reported. No treatment medications were provided.  Patient had not received the 3rd dose of the vaccine because of respiratory conditions.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI) and respiratory disorder. Vaccination date and start date of the events were not provided. Clinical course and treatment details were not disclosed. 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 unknown age and gender with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI) and respiratory disorder. Vaccination date and start date of the events were not provided. Clinical course and treatment details were not disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Musculoskeletal discomfort, Neck pain, Swelling
Clinical narrative: Fluid filled swelling at her neck that is very sore and limiting her motion; Fluid filled swelling at her neck that is very sore; Fluid filled swelling at her neck; Administered too high up/Missed the deltoid; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Fluid filled swelling at her neck that is very sore and limiting her motion), NECK PAIN (Fluid filled swelling at her neck that is very sore), SWELLING (Fluid filled swelling at her neck) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered too high up/Missed the deltoid) 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 25-Jan-2022, the patient 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, the patient experienced MUSCULOSKELETAL DISCOMFORT (Fluid filled swelling at her neck that is very sore and limiting her motion), NECK PAIN (Fluid filled swelling at her neck that is very sore), SWELLING (Fluid filled swelling at her neck) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered too high up/Missed the deltoid). On 25-Jan-2022, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered too high up/Missed the deltoid) had resolved. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Fluid filled swelling at her neck that is very sore and limiting her motion), NECK PAIN (Fluid filled swelling at her neck that is very sore) and SWELLING (Fluid filled swelling at her neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient had not applied any treatment on it. It was reported that, this did not happen to her for the first two doses of the Moderna vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. The patient's past medical history included Abdominal pain, Diarrhea and Constipation. Previously administered products included for Abdominal pain: Tylenol (Patient has IBS and sometimes she would have abdominal pain and diarrhea or constipation which would be relieved by Tylenol). Past adverse reactions to the above products included No adverse event with Tylenol. Concurrent medical conditions included Irritable bowel syndrome (Patient has IBS which was diagnosed long before to getting the 1st dose of the vaccine). On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 31-Dec-2021, PAIN IN EXTREMITY (very sore arm) 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 medication was not provided by the reporter. Patient is scheduled to have her 2nd dose on 26-JAN-2022. This case was linked to MOD-2022-461324 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: feeling sick; small fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control pill.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills). At the time of the report, MALAISE (feeling sick), PYREXIA (small fever) and CHILLS (chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2022-461233 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (I just had a second booster shot of Moderna vaccine 60 days after my first booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (I just had a second booster shot of Moderna vaccine 60 days after my first booster.). On 25-Jan-2022, EXTRA DOSE ADMINISTERED (I just had a second booster shot of Moderna vaccine 60 days after my first booster) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment information were given. Reporter did not allow further contact.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a vial that was exposed to room temperature range for 26 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a vial that was exposed to room temperature range for 26 hours) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a vial that was exposed to room temperature range for 26 hours). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (a vial that was exposed to room temperature range for 26 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. The vial was exposed to room temperature range for 26 hours.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: sore arm; "little red" on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site) 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 October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA ("little red" on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported after getting the 1st dose of the Moderna Covid-19 vaccine in Oct-2021 had a sore arm and a little red on the injection site.   This case was linked to MOD-2022-461199 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Sensitive skin, Skin burning sensation
Clinical narrative: Hypersensitive skin; Burning sensation of the skin; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Hypersensitive skin) and SKIN BURNING SENSATION (Burning sensation of the skin) 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 SENSITIVE SKIN (Hypersensitive skin) and SKIN BURNING SENSATION (Burning sensation of the skin). At the time of the report, SENSITIVE SKIN (Hypersensitive skin) and SKIN BURNING SENSATION (Burning sensation of the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long do side effects last? This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (How long do side effects last?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (How long do side effects last?). At the time of the report, VACCINATION COMPLICATION (How long do side effects last?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact