chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Headache and no interference with activity; 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)), 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), outcome "unknown", described as "Headache and no interference with activity"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no 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: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest); Significant injection site redness; Significant injection site swelling; Severe fatigue with significant 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; Headache that prevented daily activity OR required any use of a prescription pain reliver; 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 2023 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 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Severe muscle pain significantly interfering with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site swelling".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.  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
Clinical narrative: Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest); Significant injection site redness; Significant injection site swelling; Severe fatigue with significant 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; Headache that prevented daily activity OR required any use of a prescription pain reliver; 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 2023 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 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Severe muscle pain significantly interfering with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site pain preventing daily activity/Significant injection site tenderness (tenderness during rest)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Significant injection site swelling".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Wednesday, Dec 20, 2023 and Thursday, Dec 21, 2023.  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 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), outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness". 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, Headache, Malaise, Pyrexia, Vaccination site erythema
Clinical narrative: Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Headache and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fever (101.3 to 102 °F)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Headache and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fever (101.3 to 102 °F)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Significant injection site tenderness (tenderness during rest); Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present 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)), 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Significant injection site tenderness (tenderness during rest)"; 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.  Additional information: Record the worst level/intensity experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 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: Fatigue, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild fatigue 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 pain and no interference with activity". Additional information: On a COVID-19 survey safety notification completed on 25Dec2023, it was noted that after COVID-19 vaccination, which occurred on Tuesday, 19Dec2023 and Wednesday 20Dec2023, the patient experienced 1 - Mild injection site pain and no interference with activity and 1 - Mild fatigue and no interference with activity.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: 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)), on 20Dec2023 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: INJECTION 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".  Additional information: Recorded events experienced anytime during the 2 days after patient's vaccination which were Thursday, Dec 21, 2023 and Friday, Dec 22, 2023: Mild injection site tenderness (tender to touch) and Mild muscle pain and no 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, Illness, Malaise
Clinical narrative: Headache and no interference with activity; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Significant fever (> 102 °F); 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; 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: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache 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)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; MALAISE (non-serious), ILLNESS (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant fever (> 102 °F)". 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, Pyrexia, Vaccination site pain
Clinical narrative: Headache and no interference with activity; Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Significant fever (> 102 °F); 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; 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: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache 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)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; MALAISE (non-serious), ILLNESS (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Moderate malaise/feeling sick present with some interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Significant fever (> 102 °F)". 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, Headache, Malaise, Vaccination site erythema
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 fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Joint 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 Dec2023, outcome "unknown", described as "Headache and no interference with activity"; 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 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". 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 pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Joint 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 Dec2023, outcome "unknown", described as "Headache and no interference with activity"; 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 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". 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, Malaise, Pyrexia
Clinical narrative: Headache and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick 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 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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 erythema, Vaccination site pain
Clinical narrative: Headache and no interference with activity; Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick 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 °F)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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: Fatigue, Headache, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Mild injection site swelling; Mild fatigue and no 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"; 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 / Moderate injection site tenderness (tenderness with movement)"; 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"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Additional information: Events reported to occur between 20Dec2023 and 21Dec2023 (unspecified).  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
Clinical narrative: Mild injection site pain and no interference with activity / Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Mild injection site swelling; Mild fatigue and no 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"; 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 / Moderate injection site tenderness (tenderness with movement)"; 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"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Additional information: Events reported to occur between 20Dec2023 and 21Dec2023 (unspecified).  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, Malaise, 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 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)), on 21Dec2023 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 "recovered", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; 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"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: one adverse event Mild injection site pain and no interference with activity, one adverse event Mild injection site tenderness (tender to touch), No injection site redness, one adverse event Mild injection site swelling, No fever, one adverse event Mild fatigue and no interference with activity, one adverse event Mild malaise/feeling sick and no interference with activity, one adverse event Mild muscle pain and no interference with activity, Joint pain not present, No nausea/vomiting present, No headache; all these events occurred Friday, Dec 22, 2023 and Saturday, Dec 23, 2023. On 09Jan2024, the same reporter reported that record your worst pain experienced anytime during the 2 days after your COVID-19 vaccination which occurred on Thursday, Dec21, 2023 and Friday, Dec22, 2023 was reported as no injection site pain.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: moderate injection site pain interfering with activity/mild injection site tenderness (tender to touch); moderate injection site redness; moderate injection site swelling; moderate fever (101.3 to 102 °F); moderate fatigue with some interference with activity; moderate malaise/feeling sick present with some 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. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 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 and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fatigue with some interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fever (101.3 to 102 °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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "moderate injection site swelling"; 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 "moderate muscle pain with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred Sunday, 24Dec2023 and Monday, 25Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: moderate injection site pain interfering with activity/mild injection site tenderness (tender to touch); moderate injection site redness; moderate injection site swelling; moderate fever (101.3 to 102 °F); moderate fatigue with some interference with activity; moderate malaise/feeling sick present with some 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. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 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 and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fatigue with some interference with activity"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "moderate fever (101.3 to 102 °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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "moderate injection site swelling"; 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 "moderate muscle pain with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred Sunday, 24Dec2023 and Monday, 25Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fatigue 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; 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 interfered with activity OR required repeated use of a nonprescription pain reliever; interfering with activity/ some interference with activity/ interfered 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 19Dec2023, outcome "unknown" described as "Headache that interfered with activity or required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Mild injection site redness"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 19Dec2023, 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 19Dec2023, outcome "unknown" described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate muscle pain with some interference with activity"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 19Dec2023, outcome "unknown", described as "interfering with activity/ some interference with activity/ interfered with activity." Relevant laboratory tests and procedures are available in the appropriate section. 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: Malaise, Myalgia, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fatigue 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; 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 interfered with activity OR required repeated use of a nonprescription pain reliever; interfering with activity/ some interference with activity/ interfered 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 19Dec2023, outcome "unknown" described as "Headache that interfered with activity or required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Mild injection site redness"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 19Dec2023, 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 19Dec2023, outcome "unknown" described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate muscle pain with some interference with activity"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 19Dec2023, outcome "unknown", described as "interfering with activity/ some interference with activity/ interfered with activity." Relevant laboratory tests and procedures are available in the appropriate section. 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: Vaccination site swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fatigue 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; 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 interfered with activity OR required repeated use of a nonprescription pain reliever; interfering with activity/ some interference with activity/ interfered 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 19Dec2023, outcome "unknown" described as "Headache that interfered with activity or required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Mild injection site redness"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 19Dec2023, 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 19Dec2023, outcome "unknown" described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE SWELLING (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate injection site swelling"; MALAISE (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 19Dec2023, outcome "unknown" described as "Moderate muscle pain with some interference with activity"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 19Dec2023, outcome "unknown", described as "interfering with activity/ some interference with activity/ interfered with activity." Relevant laboratory tests and procedures are available in the appropriate section. 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.