chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 39 out of 68 described by the reporter. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 39 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 40th patient out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 40 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 44th out of 68 patients.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 44 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 41 out of 68 described by the reporter. Company comment-This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported who experienced the serious (medically significant and death) unexpected event of death. A dose of mRNA-1273 vaccine (unknown dose) was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. It was reported that 68 people died with the same lot number. It is unknown if autopsy was performed. No further details on cause of death were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 41 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 47 out of 68 patients.  Company comment:  This spontaneous case was reported by a consumer and describes the occurrence of DEATH in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 47 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 48th out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 48 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 49th out of 68 patients.  Company comment:  This spontaneous case was reported by a consumer and describes the occurrence of DEATH in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 49 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 50 out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Master case; Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 51 patient out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 51 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 54th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history information reported, who experienced the unexpected serious (death and medically significant) event of death. The event occurred on an unknown date after a dose of mRNA-1273. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 54 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 55th out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 55 out of 68; Reported Cause(s) of Death: Patient had died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 56 out of 68 patients.  Company Comment: This is a Spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected event of Death which occurred on an unknown date and onset latency with an unspecified dose number of mRNA-1273 vaccine. Very limited information regarding this event has been provided at this time, the cause of death was not reported, and it is unknown if an autopsy was performed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 56 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 42 patient out of 68 patients.  Company comment:  This spontaneous case was reported by a consumer and describes the occurrence of DEATH in a patient of an unknown age and gender who received mRNA-1273 vaccine for COVID-19 prophylaxis. Neither vaccination date nor the date of death has been reported, hence latency could not be assessed. No further information is available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 42 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 43 out of 68 described by the reporter.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (due to medically significant and Fatal) unexpected event of Death. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. Reason, date for death, whether an autopsy was performed or not, dates for vaccination and dose numbers, circumstances leading to death, supportive diagnostic procedures, treatment, medical history and concomitant medications were not provided. The outcome of the event was reported as fatal. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 43 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 57th out of 68 patients.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (due to medically significant), Fatal, unexpected, event of Death, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 57 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 58th out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 58 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect product dosage text was reported as unknown. No treatment medication was reported. This case is reported for patient 59 out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 59 of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 60 patient out of 68 patients. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 60 of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Breast cancer stage IV, COVID-19, Dizziness, Haemangioma
Clinical narrative: HEMANGIOMA; DIAGNOSED WITH COVID; DIZZINESS; HIVES; STAGE IV BREAST CANCER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 (dose series 1), and dose was not reported, administered on NOV-2021 (dose series 2) for covid-19 prophylaxis. No concomitant medications were reported. The patient was diagnosed with breast cancer after she received the COVID19 vaccine through a clinical trial. She reported she received her first vaccine dose in APR-2021, followed by a second dose in NOV-2021. She reported she discovered a lump on 06-MAY-2022 and was scheduled for a biopsy later in the same month. She stated she saw her health care professional (HCP) in JUN-2022 and was diagnosed with Stage IV Breast Cancer (dose series 2). She reported she has cancer in her spine, pelvis, bone, and tumors under her left arm and left breast at T6 in the back on the left. She was due for her next PET scan in May. Patient also reported she developed COVID (dose series 2) at an undisclosed time, but reported "it was not that bad, she only got hives (dose series 2). The patient additionally reported she had a hemangioma removed (dose series 2) at an undisclosed time from an undisclosed location and stated 'but that had nothing to do with that'. Additionally, patient reported unspecified dizziness (dose series 2) by stating 'If you say you have dizziness they check your brain'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stage IV breast cancer, diagnosed with covid, hemangioma, dizziness and hives was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Breast cancer stage IV, Haemangioma - The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HEMANGIOMA; DIAGNOSED WITH COVID; DIZZINESS; HIVES; STAGE IV BREAST CANCER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 (dose series 1), and dose was not reported, administered on NOV-2021 (dose series 2) for covid-19 prophylaxis. No concomitant medications were reported. The patient was diagnosed with breast cancer after she received the COVID19 vaccine through a clinical trial. She reported she received her first vaccine dose in APR-2021, followed by a second dose in NOV-2021. She reported she discovered a lump on 06-MAY-2022 and was scheduled for a biopsy later in the same month. She stated she saw her health care professional (HCP) in JUN-2022 and was diagnosed with Stage IV Breast Cancer (dose series 2). She reported she has cancer in her spine, pelvis, bone, and tumors under her left arm and left breast at T6 in the back on the left. She was due for her next PET scan in May. Patient also reported she developed COVID (dose series 2) at an undisclosed time, but reported "it was not that bad, she only got hives (dose series 2). The patient additionally reported she had a hemangioma removed (dose series 2) at an undisclosed time from an undisclosed location and stated 'but that had nothing to do with that'. Additionally, patient reported unspecified dizziness (dose series 2) by stating 'If you say you have dizziness they check your brain'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stage IV breast cancer, diagnosed with covid, hemangioma, dizziness and hives was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Breast cancer stage IV, Haemangioma - The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 61 out of 68 described by the reporter. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the Fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 61 of total 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 62nd out of 68 patients.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Reporter's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the fatal event of Death, which occurred on an unknown date related to an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 62 of total 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. As date of death was reported as 01-Jan-1990 which was a discrepancy, and no dates were reported in the narrative, so date of death was captured as unknown. The treatment medication was not reported by reporter. This case contains information for patient 65 out of 68 described by the reporter.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the fatal serious (medically significant) unexpected, event of death, which occurred associated to the first mRNA-1273 vaccine, dose number not provided. The cause of death was not reported. It is unknown if an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 65 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 66th out of 68 patients. Company comment-This is a fatal spontaneous case concerning a patient of unknown age and gender with no medical history reported who experienced the serious (medically significant and death) unexpected event of death. A dose of mRNA-1273 vaccine (unknown dose) was administered. Onset date of the event and vaccination date were not provided hence latency cannot be assessed. It was reported that 68 people died with the same lot number. It is unknown if autopsy was performed. No further details on cause of death were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 66 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient had died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 67th out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 67 out of 68; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 68 people died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (68 people died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter. It was reported that, a 52-year-old female reported 68 people die with that lot number (012L20A). "So, she dodged a bullet. No other details were provided. The treatment medication was not reported by reporter. This case contains information about 68 patient out of 68 patients.  Company Comment This spontaneous case concerns an unknown age and gender patient, with no medical history reported, who experienced the unexpected, medically significant and death seriousness criteria event of death unknown days after a dose of mRNA-1273 vaccine.  Concomitant medication nor Treatment details were reported. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-761576 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761576:Patient 68 out of 68; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: get a vaccine since they previously got four Pfizer vaccines in 2022 in September then, in 2023, they still got covid.; get a vaccine since they previously got four Pfizer vaccines in 2022 in September then, in 2023, they still got covid.; This is a spontaneous report received from a Consumer or other non HCP, Program ID: 159558.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "get a vaccine since they previously got four Pfizer vaccines in 2022 in September then, in 2023, they still got covid.". Clinical course: The reporter and her husband both trying to get a vaccine since they previously got four Pfizer vaccines in Sep2022 then, in 2023, they still got covid. The reporter was nervous about getting the vaccine since before, many people were getting it because of how it was being stored. She stated that she was confused about how people were getting the single-dose vials with gray caps, plastic filled, and glass manufactured fill because she called someplace and told her that there was a multi-dose vial. She was asking if both kinds were available with Pfizer which was the multi-dose or single dose as she was nervous that Pfizer was using the multi-dose and did not threw it out. And she added that she was looking for a single dose.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400050477 same reporter/product, different patient;