chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: 2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement); 2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement); 1-Mild injection site swelling; 2-Moderate fatigue with some interference with activity; 1-Mild malaise/feeling sick and no interference with activity; 1-Mild muscle pain and no interference with activity; 2-Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; 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: VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild muscle pain and no interference with activity"; HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) all with onset Dec2023, outcome "unknown" and all described as "2-Moderate injection site pain interfering with activity/2-Moderate injection site tenderness (tenderness with movement)". Therapeutic measures were taken as a result of headache.  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: 1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch); 1-Mild injection site redness; 2-Moderate injection site swelling; 2-Moderate fever (101.3 to 102 °F); 1-Mild fatigue and no interference with activity; 2-Moderate malaise/feeling sick present with some interference with activity; 1-Mild muscle pain and no interference with activity; 1-Joint pain and no interference with activity; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 1-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 "1-Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site redness"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild muscle pain and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate fever (101.3 to 102 °F)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate malaise/feeling sick present with some interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset Dec2023, outcome "unknown" and all described as "2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Events were recorded with the worst level/intensity patient experienced anytime during the 2 days after vaccination which were Sunday, Dec 24, 2023 and Monday, Dec 25, 2023.  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: 1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch); 1-Mild injection site redness; 2-Moderate injection site swelling; 2-Moderate fever (101.3 to 102 °F); 1-Mild fatigue and no interference with activity; 2-Moderate malaise/feeling sick present with some interference with activity; 1-Mild muscle pain and no interference with activity; 1-Joint pain and no interference with activity; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 1-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 "1-Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site redness"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild muscle pain and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate fever (101.3 to 102 °F)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate malaise/feeling sick present with some interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset Dec2023, outcome "unknown" and all described as "2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Events were recorded with the worst level/intensity patient experienced anytime during the 2 days after vaccination which were Sunday, Dec 24, 2023 and Monday, Dec 25, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: 1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch); 1-Mild injection site redness; 2-Moderate injection site swelling; 2-Moderate fever (101.3 to 102 °F); 1-Mild fatigue and no interference with activity; 2-Moderate malaise/feeling sick present with some interference with activity; 1-Mild muscle pain and no interference with activity; 1-Joint pain and no interference with activity; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; 1-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 "1-Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site pain and no interference with activity/1-Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild injection site redness"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "1-Mild muscle pain and no interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate fever (101.3 to 102 °F)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "2-Moderate malaise/feeling sick present with some interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset Dec2023, outcome "unknown" and all described as "2-Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Events were recorded with the worst level/intensity patient experienced anytime during the 2 days after vaccination which were Sunday, Dec 24, 2023 and Monday, Dec 25, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint 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)), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Moderate muscle pain with some interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain with some interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity". 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: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint 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)), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Moderate muscle pain with some interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain with some interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity". 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: Headache, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); 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)), 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 19Dec2023, outcome "unknown", described as "Headache and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset 19Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: Event onset reported to occur on 19Dec2023 and 20Dec2023.  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: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: 1 - Mild injection site pain and no interference with activity/2 - Moderate injection site tenderness (tenderness with movement); Moderate fatigue with some 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: VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "1 - Mild injection site pain and no interference with activity/2 - Moderate injection site tenderness (tenderness with movement)"; 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".  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: Body temperature, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); 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: 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), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: all events occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023, during the 2 days after vaccination.  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: Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); 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: 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), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; HEADACHE (non-serious), outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: all events occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023, during the 2 days after vaccination.  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: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild fatigue 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain/Mild injection site tenderness (tender to touch); 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: VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain/Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: On a COVID-19 survey safety notification completed on 24Dec2023, it was noted that after COVID-19 vaccination, which occurred on Wednesday, 20Dec2023 and Thursday 21Dec2023, the patient experienced 1 - Mild injection site pain and no interference with activity/1 - Mild injection site tenderness (tender to touch) and 1 - Mild muscle pain and no interference with activity.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Headache and no interference with activity; 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 with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This 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"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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 °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"; 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"; VOMITING (non-serious), NAUSEA (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".  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: Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headache and no interference with activity; 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 with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This 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"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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 °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"; 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"; VOMITING (non-serious), NAUSEA (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".  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: Vomiting
Clinical narrative: Headache and no interference with activity; 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 with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This 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"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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 °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"; 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"; VOMITING (non-serious), NAUSEA (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".  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, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; FATIGUE (non-serious), outcome "unknown", described as "Severe fatigue with significant interference with activity"; MALAISE (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Moderate muscle pain with some interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of"; HEADACHE (non-serious), outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; FATIGUE (non-serious), outcome "unknown", described as "Severe fatigue with significant interference with activity"; MALAISE (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Moderate muscle pain with some interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious), outcome "unknown" and all described as "Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of"; HEADACHE (non-serious), outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: 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; 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: 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". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity". 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 pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity". 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: Body temperature, Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Moderate fatigue with some 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: 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: it reported that "Moderate injection site pain interfering with activity", "Moderate injection site tenderness (tenderness with movement)", "Moderate fatigue with some interference with activity", "Mild malaise/feeling sick and no interference with activity", "Mild muscle pain and no interference with activity", all occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023, during the 2 days after your vaccination.  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, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fatigue and no interference with activity; Mild malaise/feeling sick 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)), 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: ARTHRALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: The patient experienced mild injection site pain and no interference with activity; mild injection site tenderness (tender to touch); 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; patient had no injection site redness; no injection site swelling; no fever (< 100.4 °F); No nausea/vomiting present; no headache during the 2 days after your COVID-19 vaccination, which occurred on Thursday 21Dec2023 and Friday 22Dec2023.   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, 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 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; This is a spontaneous report received from a Consumer or other non HCP (patient).  An adult patient 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"; 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"; 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"; 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"; VOMITING (non-serious), NAUSEA (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".  Additional information: Record your worst pain/worst tenderness/worst redness/worst swelling/highest recorded temperature/worst intensity of fatigue/the worst intensity of feeling unwell/worst intensity of pain/worst intensity of joint pain/worst level of nausea and/or vomiting/maximum headache severity experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Thursday, 21Dec2023 and Friday, 22Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.