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; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild injection site 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). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not provided. During the 2 days after COVID-19 vaccination, i.e., 17-Dec-2023 and 18-Dec-2023, patient experienced Mild injection site pain and no interference with activity. Treatment information was not reported.     This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue 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 MALAISE (Mild malaise/feeling sick and no 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), VACCINATION SITE SWELLING (Mild 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/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache 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/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °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.       The Subject ID was reported as 5470398. The Agency Subject ID was reported as 87303-96970.  Concomitant medications were not reported.  Patient had experienced malaise, vaccination site pain, vaccination site erythema, vaccination site swelling, pyrexia, fatigue, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 28 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue 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 MALAISE (Mild malaise/feeling sick and no 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), VACCINATION SITE SWELLING (Mild 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/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache 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/Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °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.       The Subject ID was reported as 5470398. The Agency Subject ID was reported as 87303-96970.  Concomitant medications were not reported.  Patient had experienced malaise, vaccination site pain, vaccination site erythema, vaccination site swelling, pyrexia, fatigue, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 28 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild fatigue and no interference with activity; Mild muscle pain 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 (Moderate injection site pain interfering 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 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 (Moderate injection site pain interfering 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 HEADACHE (Headache 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)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and HEADACHE (Headache 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, fatigue, myalgia, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 51 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Moderate fatigue with some interference with activity; Mild muscle pain 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-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some 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. 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 (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle pain 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, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced vaccination site pain, vaccination site swelling, fatigue, malaise, myalgia, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 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-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 52 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Moderate fatigue with some interference with activity; Mild muscle pain 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-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some 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. 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 (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle pain 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, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint pain and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced vaccination site pain, vaccination site swelling, fatigue, malaise, myalgia, headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 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-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 52 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site redness; 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 tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) 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 tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE SWELLING (Mild injection site swelling). At the time of the report, VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness) and VACCINATION SITE SWELLING (Mild injection site swelling) 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.       Patient had experienced vaccination site pain, vaccination site swelling, vaccination site erythema anytime during the 2 days after your COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023. The Database Subject ID was reported as 5473893. The Health Authority Subject ID was reported as 52556-97832. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 29 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild fatigue 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 MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference 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 (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 MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site pain and no interference 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 (Mild muscle 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 (Mild injection site pain and no interference 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 (Mild muscle pain and no interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The Database Subject ID was reported as 5470735. The Health Authority Subject ID was reported as 51609-16220. Concomitant medications were not reported.   Patient had experienced vaccination site pain, vaccination site erythema, fatigue, malaise, myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 30 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; 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 (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), 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 (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), 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 (Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced malaise, vaccination site pain, vaccination site swelling, fatigue, myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023.  The Subject ID was reported as 5472231.  The Agency Subject ID was reported as 42793-37363.  Concomitant medications were not reported.  Treatment information was not 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
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Mild injection site pain and no interference with activity; 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; 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), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 °F)), 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. 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 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)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain 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), 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), ARTHRALGIA (Joint 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 °F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced vaccination site pain, vaccination site swelling, fever, fatigue, muscle pain, joint pain and headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023.   The Subject ID was reported as 5469917.  The Agency Subject ID was reported as 30729-33164.  Concomitant medications were not reported.  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:Master case
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, 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 fatigue and no interference with activity; Mild muscle pain 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-health 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)), 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. 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 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)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain 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), 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), ARTHRALGIA (Joint 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 °F).     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Patient had experienced vaccination site pain, vaccination site swelling, fever, fatigue, muscle pain, joint pain and headache anytime during the 2 days after your COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023.   The Subject ID was reported as 5469917.  The Agency Subject ID was reported as 30729-33164.  Concomitant medications were not reported.  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:Master case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient states that she had 2 bouts of Covid-19, one on 15Jan2023 and the other one in Sep2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient states that she had 2 bouts of Covid-19, one on 15Jan2023 and the other one in Sep2023) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. A57145B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose-1 and lot number - 032L20A) on 03-Feb-2021; for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 2, lot number - 011A21A) on 03-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, lot number 051F211A) on 03-Nov-2021, Moderna COVID-19 Vaccine (Dose 4 and lot number - 057M21A) on 25-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Sep-2022, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2023, the patient experienced COVID-19 (Patient states that she had 2 bouts of Covid-19, one on 15Jan2023 and the other one in Sep2023). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in January 2023 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient states that she had 2 bouts of Covid-19, one on 15Jan2023 and the other one in Sep2023) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   This case was linked to MOD-2023-706387 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild muscle pain 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-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild 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 (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain 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, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint 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): 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.       The Subject ID was reported.  The Subject ID was reported.  Concomitant medication use information was not provided by reporter.  Patient had experienced malaise, vaccination site pain, vaccination site erythema, vaccination site swelling, pyrexia, headache, arthralgia and myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 10 out of 49
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild muscle pain 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-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild 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 (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain 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, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), MYALGIA (Mild muscle pain and no interference with activity), ARTHRALGIA (Joint 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): 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.       The Subject ID was reported.  The Subject ID was reported.  Concomitant medication use information was not provided by reporter.  Patient had experienced malaise, vaccination site pain, vaccination site erythema, vaccination site swelling, pyrexia, headache, arthralgia and myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Sunday, Dec 17, 2023 and Monday, Dec 18, 2023  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 10 out of 49
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild malaise/feeling sick and no interference with activity; 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; Headache 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 (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 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 MALAISE (Mild malaise/feeling sick and no interference with activity), 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 HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), 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 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: 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 as 5472909.  The Agency Subject ID was reported as 42916-85540.  Concomitant medication use information was not provided by reporter.  Patient had experienced malaise, vaccination site pain, fatigue, headache and myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 11
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild malaise/feeling sick and no interference with activity; 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; Headache 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 (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 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 MALAISE (Mild malaise/feeling sick and no interference with activity), 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 HEADACHE (Headache and no interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), 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 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: 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 as 5472909.  The Agency Subject ID was reported as 42916-85540.  Concomitant medication use information was not provided by reporter.  Patient had experienced malaise, vaccination site pain, fatigue, headache and myalgia anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 11
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, 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 redness; Mild injection site swelling; 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 / Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) 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 / Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) 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 / Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), VACCINATION SITE SWELLING (Mild injection site swelling) 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 medication use information was not provided by reporter.  Patient had experienced vaccination site pain, vaccination site erythema, vaccination site swelling, and myalgia 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 as 5472276.  The Agency Subject ID was reported as 36300-97205.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Patient 56 out of 87
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia, Vaccination site erythema
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: