chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); 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 pain and no interference with activity/ Mild injection site tenderness (tender to touch)) 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)) 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)) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.  Also, it has been reported that the symptom vaccination site pain, vaccination site tenderness, and headache were experienced anytime during the 2 days after vaccination on either Dec 22, 2023, or Dec 23, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle 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 (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: No fever (< 100.4 °F).         No concomitant medications were reported. The events anytime during the 2 days after your vaccination on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; 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 MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 Degree F)) and FATIGUE (Mild fatigue 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. 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), 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, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), 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: 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 worst pain, tenderness, redness, highest fever, worst intensity of fatigue, worst intensity of feeling unwell and maximum headache severity experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023 was recorded.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; 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 MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 Degree F)) and FATIGUE (Mild fatigue 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. 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), 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, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), 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: 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 worst pain, tenderness, redness, highest fever, worst intensity of fatigue, worst intensity of feeling unwell and maximum headache severity experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023 was recorded.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fatigue 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)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue 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)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue 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)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.      Subject ID was reported and Subject ID was reported.  Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756004 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756004:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site swelling; Mild fatigue and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Moderate injection site swelling) and FATIGUE (Mild fatigue 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 (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Moderate injection site swelling) and FATIGUE (Mild fatigue and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Moderate injection site swelling) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: less than 100.4 °F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that patient's body temperature was less than 100.4 °F.  No treatment information was provided.  Subject ID was reported and Subject ID was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Malaise, Myalgia
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 fever (100.4 to 101.2 °F); 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 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), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Mild fatigue 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. 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 (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), 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, 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), PYREXIA (Mild fever (100.4 to 101.2 °F)), 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.      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 not reported.   Treatment medication not reported.  Also, it has been reported that the symptom of moderate injection site pain, moderate injection site tenderness, injection site redness, mild fever, malaise/feeling sick, muscle pain, joint pain and fatigue were experienced anytime during the 2 days after vaccination on either Dec 19, 2023, or Dec 20, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, 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 fever (100.4 to 101.2 °F); 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 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), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Mild fatigue 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. 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 (Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), 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, 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), PYREXIA (Mild fever (100.4 to 101.2 °F)), 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.      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 not reported.   Treatment medication not reported.  Also, it has been reported that the symptom of moderate injection site pain, moderate injection site tenderness, injection site redness, mild fever, malaise/feeling sick, muscle pain, joint pain and fatigue were experienced anytime during the 2 days after vaccination on either Dec 19, 2023, or Dec 20, 2023.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Malaise, Myalgia
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Mild injection site pain and no interference with activity; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: No fever (< 100.4 °F).         Patient had experienced malaise, vaccination site pain, fatigue, myalgia, arthralgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.. The Subject ID was reported. The Subject ID was reported. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Mild injection site pain and no interference with activity; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: No fever (< 100.4 °F).         Patient had experienced malaise, vaccination site pain, fatigue, myalgia, arthralgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.. The Subject ID was reported. The Subject ID was reported. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild muscle 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) and MYALGIA (Mild muscle 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) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medications were not reported.   Patient had experienced vaccination site pain and muscle pain 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 provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Nausea, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity; Mild fatigue and no interference with activity; Moderate muscle pain with some 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 MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) 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. 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 (Moderate injection site pain interfering with activity), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). 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), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced malaise, Vaccination site pain, fatigue, Myalgia, nausea and vomiting anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 2023. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity; Mild fatigue and no interference with activity; Moderate muscle pain with some 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 MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) 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. 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 (Moderate injection site pain interfering with activity), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting). 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), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity), NAUSEA (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) and VOMITING (Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced malaise, Vaccination site pain, fatigue, Myalgia, nausea and vomiting anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 2023. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, 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; 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)) and FATIGUE (Mild fatigue 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)) and FATIGUE (Mild fatigue 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)) and FATIGUE (Mild fatigue and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: No fever (< 100.4 °F).         Patient had experienced fatigue and vaccination site pain anytime during the 2 days after your vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The pharmacist stated that a patient received a dose of GARDASIL 9 on 03-JUN-2022 and a second dose on 05-JUL-2022 realize she needed to came back for a third dose until 02-JAN-2024; No adverse event; This spontaneous report was received from a Pharmacist referring to a currently 17-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 03-JUN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters, lot #U019413, expiration date: 01-NOV-2023, administered for prophylaxis (strength and route of administration were not provided).  On 05-JUL-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters, lot #1780876, expiration date: 09-NOV-2023, administered for prophylaxis (strength and route of administration were not provided).  On 02-JAN-2024, the patient realized that she needed to come back for a third dose.  The pharmacist wanted to know if she needed to restart the vaccination series since the third dose was significantly delayed.  No adverse issues or side effects were reported by the patient from the administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia, 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; Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue 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), VACCINATION SITE SWELLING (Moderate injection site swelling) and PYREXIA (Mild fever (100.4 to 101.2 °F)) 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 (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Moderate fatigue 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), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Moderate fatigue with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: fever (100.4 to 101.2 °F).         Health Authority Subject ID was reported as 89864-47599 and Database Subject ID was reported as 5472781.  Concomitant medications were not reported.  It was reported that worst pain, worst tenderness, worst redness, worst swelling, highest fever, worst intensity of fatigue and worst intensity of feeling unwell experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Monday, 18 Dec 2023 and Tuesday, 19 Dec 2023 was recorded.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
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; Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue 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), VACCINATION SITE SWELLING (Moderate injection site swelling) and PYREXIA (Mild fever (100.4 to 101.2 °F)) 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 (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Moderate fatigue 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), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)) and FATIGUE (Moderate fatigue with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: fever (100.4 to 101.2 °F).         Health Authority Subject ID was reported as 89864-47599 and Database Subject ID was reported as 5472781.  Concomitant medications were not reported.  It was reported that worst pain, worst tenderness, worst redness, worst swelling, highest fever, worst intensity of fatigue and worst intensity of feeling unwell experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Monday, 18 Dec 2023 and Tuesday, 19 Dec 2023 was recorded.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling) and PYREXIA (Moderate fever (101.3 to 102 °F)) 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 101.3 to 102 degree F.         Subject ID was reported Subject ID was reported  Concomitant medications were not reported.  The patient experieced symptoms anytime during the 2 days after your COVID-19 vaccination, which occurred on Monday, 18-Dec-2023 and Tuesday, 19-Dec-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling) and PYREXIA (Moderate fever (101.3 to 102 °F)) 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 (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Moderate injection site swelling), PYREXIA (Moderate fever (101.3 to 102 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 101.3 to 102 degree F.         Subject ID was reported Subject ID was reported  Concomitant medications were not reported.  The patient experieced symptoms anytime during the 2 days after your COVID-19 vaccination, which occurred on Monday, 18-Dec-2023 and Tuesday, 19-Dec-2023.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756041:Same reporter