chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
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 fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Events occurred anytime during the 2 days after vaccination which was on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: 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 fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Events occurred anytime during the 2 days after vaccination which was on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
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 fever (100.4 to 101.2 °F); moderate fatigue with some interference with activity; moderate malaise/feeling sick present with some interference with activity; severe muscle pain significantly interfering with activity; joint pain with significant 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; headache that prevented daily activity or required any use of a prescription pain reliver; This is a spontaneous report received from a consumer. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "headache that prevented daily activity or required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "joint pain with significant interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site pain and no interference with activity/mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "severe muscle pain significantly interfering with activity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: Events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, 20Dec2023 and Thursday, 21Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, 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 injection site swelling; mild fever (100.4 to 101.2 °F); moderate fatigue with some interference with activity; moderate malaise/feeling sick present with some interference with activity; severe muscle pain significantly interfering with activity; joint pain with significant 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; headache that prevented daily activity or required any use of a prescription pain reliver; This is a spontaneous report received from a consumer. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "headache that prevented daily activity or required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "joint pain with significant interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site pain and no interference with activity/mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "severe muscle pain significantly interfering with activity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: Events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, 20Dec2023 and Thursday, 21Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
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 fever (100.4 to 101.2 °F); moderate fatigue with some interference with activity; moderate malaise/feeling sick present with some interference with activity; severe muscle pain significantly interfering with activity; joint pain with significant 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; headache that prevented daily activity or required any use of a prescription pain reliver; This is a spontaneous report received from a consumer. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 as dose 1, single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "headache that prevented daily activity or required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "joint pain with significant interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site pain and no interference with activity/mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "severe muscle pain significantly interfering with activity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional Information: Events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, 20Dec2023 and Thursday, 21Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Significant injection site redness; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate injection site swelling; Mild fever (100.4 to 101.2 degrees F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 degrees F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site redness". Additional information: It was reported that the patient had experienced the events anytime during the 2 days after the COVID-19 vaccination which occurred on Sunday (24Dec2023) and Monday (25Dec2023).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Significant injection site redness; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate injection site swelling; Mild fever (100.4 to 101.2 degrees F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 degrees F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site redness". Additional information: It was reported that the patient had experienced the events anytime during the 2 days after the COVID-19 vaccination which occurred on Sunday (24Dec2023) and Monday (25Dec2023).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
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 fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, 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 injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
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 fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: The events occurred 20Dec2023 and 21Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 17Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 17Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 17Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site redness; Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE 1, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; VACCINATION SITE PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site swelling." Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site redness; Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE 1, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; VACCINATION SITE PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site swelling." Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch); Moderate injection site redness; Moderate injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non-HCP. The reporter is the patient.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE 1, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; VACCINATION SITE PAIN (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Moderate injection site pain interfering with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Moderate injection site swelling." Relevant laboratory tests and procedures are available in the appropriate section.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Moderate injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Additional information: The events occurred at anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Moderate injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Additional information: The events occurred at anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Malaise, Myalgia
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 fever (100.4 to 101.2 °F); Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 20Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Event onset reported to occur on 20Dec2023 and 21Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.