chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site redness; Mild fever (100.4 to 101.2 °F); Mild muscle pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: mild fever (100.4 to 101.2 Degree F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.    No concomitant medications were reported. It was reported that the patient experienced Mild injection site pain and no interference with activity, Mild injection site redness, Mild fever, Mild muscle pain and no interference with activity and Headache and no interference with activity, anytime during the 2 days after your COVID-19 vaccination, which occurred Saturday, 16-Dec-2023 and Sunday, 17-Dec-2023. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 °F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported. Patient had experienced injection site tenderness, fever, fatigue, nausea and vomiting anytime during the 2 days after your COVID-19 vaccination, which occurred on Saturday, 16-Dec-2023 and Sunday, 17-Dec-2023. Treatment medication was not reported.  The Subject ID was reported. The Subject ID was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 °F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported. Patient had experienced injection site tenderness, fever, fatigue, nausea and vomiting anytime during the 2 days after your COVID-19 vaccination, which occurred on Saturday, 16-Dec-2023 and Sunday, 17-Dec-2023. Treatment medication was not reported.  The Subject ID was reported. The Subject ID was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Myalgia, Vaccination site erythema
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: No fever (less than 100.4 degree F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Subject ID was reported. The Subject ID was reported. Concomitant medication was not reported. Patient had experienced injection site pain, injection site tenderness, injection site redness, fatigue, malaise/feeling sick and muscle pain anytime during the 2 days after your COVID-19 vaccination, which occurred on Saturday, 16-dec-2023 and Sunday, 17-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: No fever (less than 100.4 degree F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Subject ID was reported. The Subject ID was reported. Concomitant medication was not reported. Patient had experienced injection site pain, injection site tenderness, injection site redness, fatigue, malaise/feeling sick and muscle pain anytime during the 2 days after your COVID-19 vaccination, which occurred on Saturday, 16-dec-2023 and Sunday, 17-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Severe muscle pain significantly interfering with activity; Headache that prevented daily activity OR required any use of a prescription pain reliver; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Severe muscle pain significantly interfering with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain reliver). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain reliver) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Database Subject ID was reported as 5472095. The Health Authority Subject ID was reported as 96202-13682. Concomitant medication was not reported. Patient had experienced injection site pain, injection site tenderness, injection site swelling, fatigue, malaise/feeling sick, muscle pain and headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Monday, 18-Dec-2023 and Tuesday, 19-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Severe muscle pain significantly interfering with activity; Headache that prevented daily activity OR required any use of a prescription pain reliver; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Severe muscle pain significantly interfering with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain reliver). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Significant injection site pain preventing daily activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Severe muscle pain significantly interfering with activity) and HEADACHE (Headache that prevented daily activity OR required any use of a prescription pain reliver) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Database Subject ID was reported as 5472095. The Health Authority Subject ID was reported as 96202-13682. Concomitant medication was not reported. Patient had experienced injection site pain, injection site tenderness, injection site swelling, fatigue, malaise/feeling sick, muscle pain and headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Monday, 18-Dec-2023 and Tuesday, 19-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Subject ID was reported as 10635-96803 and Agency Subject ID was reported as 5472043. No concomitant medication was reported. Patient had experienced events anytime during the 2 days after your COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023. No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case (Patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Health Authority Subject ID was reported as 66225-81565 and Database Subject ID was reported as 5472122.  No concomitant medication was reported. Patient had experienced events anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Pateint 46 out of 49
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and VACCINATION SITE SWELLING (Mild injection site swelling) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and VACCINATION SITE SWELLING (Mild injection site swelling). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)) and VACCINATION SITE SWELLING (Mild injection site swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: less than 100.4 degree F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Subject ID was reported and the Subject ID was reported. No concomitant medications were reported. Patient had experienced the symptoms during the 2 days after COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023, and Monday, Dec 18, 2023. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 83
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fever (100.4 to 101.2 degree F); Mild fatigue and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 degree F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Subject ID was reported as 5470933.  The Agency Subject ID was reported as 55259-57074.  Concomitant medications were not reported.  Patient had experienced vaccination site pain, pyrexia, fatigue, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 19, 2023 and Friday, Dec 20, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient no 39
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Joint pain and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported.  Patient experienced Injection site pain, Fatigue, Joint pain, Headache events anytime during the 2 days after vaccination which occurred on 17-Dec-2023 and 18-Dec-2023 and no interference with activity.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 25 out of49
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Skin burning sensation
Clinical narrative: Extreme facial flushing and burning skin sensation going on 30+ hours; Extreme facial flushing and burning skin sensation going on 30+ hours; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (Extreme facial flushing and burning skin sensation going on 30+ hours) and SKIN BURNING SENSATION (Extreme facial flushing and burning skin sensation going on 30+ hours) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 07-Jan-2024, the patient experienced FLUSHING (Extreme facial flushing and burning skin sensation going on 30+ hours) and SKIN BURNING SENSATION (Extreme facial flushing and burning skin sensation going on 30+ hours). At the time of the report, FLUSHING (Extreme facial flushing and burning skin sensation going on 30+ hours) and SKIN BURNING SENSATION (Extreme facial flushing and burning skin sensation going on 30+ hours) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Extreme facial flushing and burning skin sensation going on 30+ hours. No concomitant and treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm 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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid from 22Dec2023 to 27Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Increased cholesterol" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PRAVASTATIN; HCTZ. Past drug history included: Ciprofloxacin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacture Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacture Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 6 (Booster), single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 5 (Booster), single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, single, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1, single, Unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2023) Negative; (02Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer (patient). A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. Patient has no known allergies. Patient received Paxlovid as COVID-19 Treatment from 22Dec2023 to 26Dec2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Negative; (28Dec2023) Negative; (29Dec2023) Negative; (30Dec2023) Negative; (31Dec2023) Negative; (01Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Outcome of the events was not recovered.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with nirmatrelvir, ritonavir (PAXLOVID) in Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. COVID 19 Treatment included Paxlovid.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Nurse.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient was treated wit h Paxlovid from 19Dec2023 to 23Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 23Dec2023. Treatment stop date: 27Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 12:00 as dose 1, single at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Taking ai meds for breast cancer" (ongoing). Concomitant medication(s) included: EXEMESTANE taken for breast cancer, start date: 12Sep2021 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative; (Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment, brand: Paxlovid. Treatment start date: 24Dec2023, treatment stop date: 28Dec2023.  No follow-up attempts are possible.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: VOMITING (non-serious), 12 hrs after the suspect product(s) administration, outcome "recovered", described as "throwing up".  Additional information: the patient was throwing up about 12 hours after taking the shot. The patient threw up for a whole day and finally fell asleep to rest  Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 14:00 as dose 1, single at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "bee stings" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/ Lot number not reported), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient was treated with Paxlovid from 21Dec2023 to 25Dec2023.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment, brand: Paxlovid, treatment start date: 22Dec2023, treatment stop date: 26Dec2023. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Vaccination Failure and COVID-19 cannot be ruled out.