chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid). At the time of the report, COVID-19 (tested positive for covid after that he had a Moderna COVID-19 booster shot/So he had covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported No treatment details were reported.  Patient had both Moderna COVID-19 vaccine shots then he contracted covid in September. After that he had a Moderna COVID-19 booster shot and then on 22-Nov-2021 he had another positive test. So he had covid twice now. Patient denied any other information about his case.   This case was linked to MOD-2021-404022 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no relevant medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred in unknown period of time after the third dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster) 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 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster). At the time of the report, COVID-19 (Patient tested positive for the coronavirus three days after receiving the Moderna vaccine booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19.         No concomitant medications were reported.  No treatment information was provided. Company comment:This spontaneous case is concerning a female patient of unknown age with no medical history reported, experienced the unexpected, AESI of COVID-19, which occurred 3 days after receiving third dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a female patient of unknown age with no medical history reported, experienced the unexpected, AESI of COVID-19, which occurred 3 days after receiving third dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough COVID case about 6 months after vaccination; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Dec-2021 and was forwarded to Moderna on 09-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (breakthrough COVID case about 6 months after vaccination) 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 (breakthrough COVID case about 6 months after vaccination). The patient was treated with Immunotherapy (Regeneron monoclonal antibodies as treatment) for COVID-19. At the time of the report, COVID-19 (breakthrough COVID case about 6 months after vaccination) 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.   Symptoms: It was reported that the patient had experienced Breakthrough COVID-19 infection after 6 months of vaccination and wanted to knew when should they get booster dose of vaccine.  No concomitant medications were reported  The patient was received the Regeneron monoclonal antibodies as treatment.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I feel like I got COVID after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine) 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 SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine). At the time of the report, SUSPECTED COVID-19 (I feel like I got COVID after receiving the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment This case concerns a female patient of an unknown age with no reported medical history, who experienced the non serious, unexpected AESI of Suspected COVID-19. The event of occurred on an unspecified date after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the non serious, unexpected AESI of Suspected COVID-19. The event of occurred on an unspecified date after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The patient received 2 doses of the Moderna vaccine greater than 6 months ago and nowhas Covid-19  Company comment: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date, more than 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was not reported. Very limited information is available regarding clinical manifestations and course of the disease. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no medical history reported, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date, more than 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was not reported. Very limited information is available regarding clinical manifestations and course of the disease. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lose her taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lose her taste) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Back disorder NOS (Back issues). Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for Back disorder NOS.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced AGEUSIA (Lose her taste). At the time of the report, AGEUSIA (Lose her taste) had not resolved.            In early April 2021, the patient started to lose her taste. She currently still has this problem. She can taste a little bit of sweetness and saltiness. No treatment medications were reported.  On 17-Nov-2021, the patient received the third dose of Moderna vaccine (Lot 058F21A).  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history reported who experienced the unexpected non-serious AESI of Ageusia approximately one month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable, as the event had not resolved. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-409951 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history reported who experienced the unexpected non-serious AESI of Ageusia approximately one month after the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable, as the event had not resolved. The patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Melanoma (Melanoma in left arm).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information included patient received  BAM infusion on 27-Jan-2021 as outpatient.   This case was linked to MOD-2021-408503 (Patient Link).; Sender's Comments: This case concerns a patient, with medical history (Melanoma), who experienced the serious unexpected event(s) of Covid-19. The event(s) started occurring approximately within 16 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Severe COVID-19 (14 Days Post-Dose 2); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)). At the time of the report, COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient, with medical history (not reported), who experienced the non-serious unexpected event(s) of Covid-19. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced COVID-19 . The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID after vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID after vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID after vaccine). At the time of the report, COVID-19 (COVID after vaccine) 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.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Information regarding schedule of vaccination was not disclosed. Very limited information is available regarding this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Reporter's Comment : How long should one wait to get the booster vax after having the covid infection   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Very limited information is available regarding this event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: lost sense of taste; 102 fever; chills; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (lost sense of taste), PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A and 012A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), ROSUVASTATIN CALCIUM (CRESTOR) and TESTOSTERONE CIPIONATE (DEPO-TESTOSTERONE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache). On 03-Dec-2021, the patient experienced AGEUSIA (lost sense of taste). At the time of the report, AGEUSIA (lost sense of taste) had not resolved and PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 102 (abnormal) 102 fever. On 11-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: lost sense of taste; 102 fever; chills; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (lost sense of taste), PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A and 012A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included METOPROLOL SUCCINATE (TOPROL XL), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), ROSUVASTATIN CALCIUM (CRESTOR) and TESTOSTERONE CIPIONATE (DEPO-TESTOSTERONE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache). On 03-Dec-2021, the patient experienced AGEUSIA (lost sense of taste). At the time of the report, AGEUSIA (lost sense of taste) had not resolved and PYREXIA (102 fever), CHILLS (chills) and MYALGIA (body ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 102 (abnormal) 102 fever. On 11-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  Company comment: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 54-year-old, male patient with no medical history reported who experienced the unexpected non-serious AESI of Ageusia with concurrent expected non-serious events of Pyrexia, Chills and Myalgia. The events Pyrexia, Chills and Myalgia occurred one day and the event Ageusia two days after the boost dose of mRNA-1273 Vaccine. COVID-19 was excluded as the test was negative. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Nausea, Retching, Vaccination site pain
Clinical narrative: Slept a lot; Dry heaves; Arm was killing; Chills a lot; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-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 experienced HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not provided. Reporter stated that after booster patient also experienced bile.  Company comment: This spontaneous case concerns a 102-year-old female patient with no details relevant medical history, who experienced the unexpected non serious event/AESI of Sleep excessive (PT: Hypersomnia) after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the booster dose of mRNA- 1273 vaccine. It was reported that after the vaccination, the patient slept a lot. The non serious expected events of Vaccination site pain, Chills and Nausea were also reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-417671 (Patient Link).; Sender's Comments: This spontaneous case concerns a 102-year-old female patient with no details relevant medical history, who experienced the unexpected non serious event/AESI of Sleep excessive (PT: Hypersomnia) after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the booster dose of mRNA- 1273 vaccine. It was reported that after the vaccination, the patient slept a lot. The non serious expected events of Vaccination site pain, Chills and Nausea were also reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Mild COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Mild COVID) 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, 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 COVID-19 (Mild COVID). At the time of the report, COVID-19 (Mild COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  Company comment: This case concerns a male patient of an unknown age, with no reported medical history, who experienced the serious, unexpected AESI event of COVID-19 after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient experienced mild covid and managing it at home. The onset latency of event is unknown since the date of the vaccine and the event was not specified. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age, with no reported medical history, who experienced the serious, unexpected AESI event of COVID-19 after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient experienced mild covid and managing it at home. The onset latency of event is unknown since the date of the vaccine and the event was not specified. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 screening
Clinical narrative: TESTED POSITIVE FOR COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (TESTED POSITIVE FOR COVID19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure med). Concomitant products included AMLODIPINE for Blood pressure high.    On 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced COVID-19 (TESTED POSITIVE FOR COVID19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (TESTED POSITIVE FOR COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, COVID-19 screening: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by the reporter. Company comment: This is a spontaneous case concerning a 61-year-old, female patient with a history of hypertension with concomitant use of amlodipine, who experienced the non-serious unexpected AESI of COVID-19. The event occurred 18 days after the first dose of mRNA 1273 vaccine. The patient started experiencing symptoms such as throat irritation and nasal congestion and tested positive for COVID-19, 3 days later. The rechallenge was not applicable. The medical history of hypertension remains a confounder in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Dec-2021: Significant follow-up received. Information on patient's lab data, suspect product, concomitant medications and treatment medications were updated, and new events were added according to follow-up document. On 22-Dec-2021: Follow up document received, contains Non-Significant information On 22-Dec-2021: Follow up document received, contains Non-Significant information; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with a history of hypertension with concomitant use of amlodipine, who experienced the non-serious unexpected AESI of COVID-19. The event occurred 18 days after the first dose of mRNA 1273 vaccine. The patient started experiencing symptoms such as throat irritation and nasal congestion and tested positive for COVID-19, 3 days later. The rechallenge was not applicable. The medical history of hypertension remains a confounder in this case. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after vaccination; Fever  101F from COVID-19 disease after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination) in a 25-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 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. In December 2021, the patient experienced COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination). At the time of the report, COVID-19 (Tested positive for COVID-19 after vaccination) and PYREXIA (Fever  101F from COVID-19 disease after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 101 (High) Fever of 101F. In December 2021, SARS-CoV-2 test: positive (Positive) Tested Positive.         No Concomitant product use was reported.  The reporter stated that their granddaughter who was the patient had a fever of 101F and tested positive for COVID. The patient was coming over to get together in December. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine.  No treatment information was provided. Company comment This case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19. The event occurred on an unknown day after the administration of the second dose of mRNA-1273 vaccine. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-426765 (Patient Link).; Sender's Comments: This case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19. The event occurred on an unknown day after the administration of the second dose of mRNA-1273 vaccine. The reporter does not have the patient's vaccination card or information and was not sure if the granddaughter had Moderna COVID-19 vaccine, but the reporter was sure that the patient had 2 doses of the COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Feeling cold, SARS-CoV-2 test
Clinical narrative: COVID-19; Coughing; Felling cold; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING COLD (Felling cold) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol.   On 24-Mar-2021, the patient received first 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced COUGH (Coughing) and FEELING COLD (Felling cold). On 22-Dec-2021, the patient experienced COVID-19 (COVID-19). On 26-Dec-2021, COUGH (Coughing) and FEELING COLD (Felling cold) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) positive COVID rapid antigen COVID test.         No medical history was provided. No treatment medications were reported. Company comment This case concerns a male patient of an unknown age, with no reported relevant medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 11 days after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age, with no reported relevant medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 11 days after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Suspected COVID-19
Clinical narrative: Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID). At the time of the report, SUSPECTED COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood test: abnormal (abnormal) End Protein - Antibody was 0, Spike protein was 700. On 23-Nov-2021, Blood test: high (High) End Protein - Antibody was 20.1, Spike protein gone up to greater than 2500..     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.  Company Comment  This case concerns a 78-year-old male patient with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 78-year-old male patient with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after having vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after having vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID after having vaccine). At the time of the report, COVID-19 (Tested positive for COVID after having vaccine) 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) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). It's unclear if it was the first or second dose.  The rechallenge was not applicable as event occurred after a dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19) is not affected by this report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chills, Feeling abnormal, Illness, Pyrexia
Clinical narrative: like covid symptoms after dose 2; sick after dose 2; really bad after dose 2; chills; fever after dose 2\fever, like covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Hypertension.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms). At the time of the report, SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Antibody test: positive (Positive) Tested positive for antibodies back in march right before the second vaccine.         Concomitant medications included ADH for unknown indication. No treatment medications were reported. It was reported the patient  first dose was in March and had no side effects. After his second dose the patient was sick, chills, fever, like covid symptoms, really bad. The symptoms eventually went away. Tested positive for antibodies back in march right before the second vaccine.  Company comment: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-429358 (Patient Link).; Sender's Comments: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: like covid symptoms after dose 2; sick after dose 2; really bad after dose 2; chills; fever after dose 2\fever, like covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Hypertension.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms). At the time of the report, SUSPECTED COVID-19 (like covid symptoms after dose 2), ILLNESS (sick after dose 2), FEELING ABNORMAL (really bad after dose 2), CHILLS (chills) and PYREXIA (fever after dose 2\fever, like covid symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Antibody test: positive (Positive) Tested positive for antibodies back in march right before the second vaccine.         Concomitant medications included ADH for unknown indication. No treatment medications were reported. It was reported the patient  first dose was in March and had no side effects. After his second dose the patient was sick, chills, fever, like covid symptoms, really bad. The symptoms eventually went away. Tested positive for antibodies back in march right before the second vaccine.  Company comment: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-429358 (Patient Link).; Sender's Comments: This case concerns a 49-year-old male patient, with medical history of hypertension, who experienced the non serious unexpected AESI of Suspected COVID-19 after the second dose of mRNA-1273. No information regarding start date of the event. It was reported that symptoms recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Sick for three and a half weeks; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for 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 first 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. On an unknown date, the patient experienced ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for COVID-19). At the time of the report, ILLNESS (Sick for three and a half weeks) and COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was provided by the reporter  No treatment information was provided by the reporter.  Patient had primary vaccination series more than 6 months ago. The Sunday after the holiday patient tested positive for COVID-19.  Company comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the non serious unexpected AESI of COVID-19 after the second dose of mRNA-1273. The patient reported that tested positive for COVID-19 and was sick for 3.5 weeks, after primary vaccination series which received 6 months ago. No more information provided.  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 non serious unexpected AESI of COVID-19 after the second dose of mRNA-1273. The patient reported that tested positive for COVID-19 and was sick for 3.5 weeks, after primary vaccination series which received 6 months ago. No more information provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.