chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, 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; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; 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; 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 18Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain 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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; 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)"; 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: Events were experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
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 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; 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 18Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain 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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; 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)"; 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: Events were experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 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: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fever (100.4 to 101.2 F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 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/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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events occurred 2 days after vaccination, between 16Dec2023 and 17Dec2023. The patient had no injection site redness, no injection site swelling, malaise/feeling sick not present, and joint pain not present.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild fever (100.4 to 101.2 F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 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/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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events occurred 2 days after vaccination, between 16Dec2023 and 17Dec2023. The patient had no injection site redness, no injection site swelling, malaise/feeling sick not present, and joint pain not present.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, 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 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 15Dec2023 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/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: Vaccination site pain
Clinical narrative: 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)), on 15Dec2023 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)". Additional information: Event onset reported to occur between 16Dec2023 and 17Dec2023.  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, Pyrexia
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no interference with activity; Joint pain and no interference with activity; 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)), on 17Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain 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)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity".  Additional information: the patient experienced the events during the 2 days after your COVID-19 vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no interference with activity; Joint pain and no interference with activity; 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)), on 17Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain 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)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity".  Additional information: the patient experienced the events during the 2 days after your COVID-19 vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023.   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; 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)), on 15Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity".  Additional information: the patient experienced the events during the 2 days after your COVID-19 vaccination, which occurred on Saturday, Dec 16, 2023 and Sunday, Dec 17, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 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)".  Additional information: On a COVID-19 survey safety notification completed on 20Dec2023, it was noted that after COVID-19 vaccination, which occurred on Monday, 18Dec2023 and Tuesday, 19Dec2023, the patient experienced Mild injection site pain and no interference with activity and Mild injection site tenderness (tender to touch).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild malaise/feeling sick and no interference with activity; 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)), on 18Dec2023 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 interfered with activity OR required repeated use of a nonprescription pain reliever"; 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)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity".  Additional Information: Events were experienced anytime during the 2 days after vaccination which were Tuesday, Dec 19, 2023 and Wednesday, Dec 20, 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, 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 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 19Dec2023, outcome "unknown", described as "Mild fatigue 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, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; 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 16Dec2023 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 SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; 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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  Additional information: the patient experienced events during the 2 days after your COVID-19 vaccination, which occurred on Sunday, 17Dec2023 and Monday, 18Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; 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 16Dec2023 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 SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; 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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting".  Additional information: the patient experienced events during the 2 days after your COVID-19 vaccination, which occurred on Sunday, 17Dec2023 and Monday, 18Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, 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 fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate muscle pain with some 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: 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue 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. 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 fever (100.4 to 101.2 °F); Moderate fatigue with some interference with activity; Moderate muscle pain with some 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: 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue 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. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Mild fever (100.4 to 101.2 F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; 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"; 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Record of patient's worst events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Tuesday, Dec 19,2023 and Wednesday, Dec 20, 2023: Mild injection site pain and no interference with activity, mild injection site tenderness (tender to touch), mild injection site redness, moderate injection site swelling, mild fever (100.4 to 101.2 F), mild fatigue and no interference with activity, mild malaise/feeling sick and no interference with activity, muscle pain not present, joint pain and no interference with activity, no nausea/vomiting present, headache and no interference with activity.  No follow-up attempts are possible. 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: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Mild fever (100.4 to 101.2 F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; 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"; 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site swelling". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Record of patient's worst events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Tuesday, Dec 19,2023 and Wednesday, Dec 20, 2023: Mild injection site pain and no interference with activity, mild injection site tenderness (tender to touch), mild injection site redness, moderate injection site swelling, mild fever (100.4 to 101.2 F), mild fatigue and no interference with activity, mild malaise/feeling sick and no interference with activity, muscle pain not present, joint pain and no interference with activity, no nausea/vomiting present, headache and no interference with activity.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); 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)), on 17Dec2023 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"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity".  Additional information: the patient experienced events during the 2 days after your COVID-19 vaccination, which occurred on Monday,18Dec2023 and Tuesday,19Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); 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)), on 17Dec2023 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"; PYREXIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity".  Additional information: the patient experienced events during the 2 days after your COVID-19 vaccination, which occurred on Monday,18Dec2023 and Tuesday,19Dec2023.  Batch/lot number is not provided, and it cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Lip blister, Mouth swelling
Clinical narrative: Next day no strength, feeling sluggish , sore stiff arm, cold chills feverish next day  sore arm, itchy face burning like frostbite, uncontrollable, day three blisters on lip itching face  day four more blisters on mouth very puffy an sore called pharmacy where I got vaccinated and had urgent care virtual appointment
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Oral mucosal blistering, Oral pain, Pain in extremity, Pruritus
Clinical narrative: Next day no strength, feeling sluggish , sore stiff arm, cold chills feverish next day  sore arm, itchy face burning like frostbite, uncontrollable, day three blisters on lip itching face  day four more blisters on mouth very puffy an sore called pharmacy where I got vaccinated and had urgent care virtual appointment
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Next day no strength, feeling sluggish , sore stiff arm, cold chills feverish next day  sore arm, itchy face burning like frostbite, uncontrollable, day three blisters on lip itching face  day four more blisters on mouth very puffy an sore called pharmacy where I got vaccinated and had urgent care virtual appointment
Age: 44.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions on vaccinationsonly to early addinistration of shingrix vaccine (age 44) to patient.
Sex: U
Vaccine: RSV
Symptoms: Cardiac disorder
Clinical narrative: have a heart condition; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "have a heart condition". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: she has the covid vaccine but still gets very sick with covid and pneumonia; she has the covid vaccine but still gets very sick with covid and pneumonia; she has the covid vaccine but still gets very sick with covid and pneumonia; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 42-year-old female patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "she has the covid vaccine but still gets very sick with covid and pneumonia". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, pneumonia includes Paxlovid. Clinical Course: Reporters did not consider event as caused by suspect product.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: she was diagnosed with type 1 diabetes; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no history of type 1 in her family. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant), outcome "unknown", described as "she was diagnosed with type 1 diabetes". Clinical course: Reporter wanted to let know that her daughter took two doses of Pfizer covid vaccine in 2021. And after a few weeks she was diagnosed with type 1 diabetes. While no one could prove it but also could not said for sure the vaccine did not cause it. Reporter deeply regretted giving vaccine to her daughter trusting Pfizer ads and the government. Reporter had also read other people getting type 1 post vaccine. Vaccine might have ruined her daughter's life.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria
Clinical narrative: slurred speech; This is a spontaneous report received from a Nurse. Other Case identifier(s): 2023NVX-US-000002001.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose number unknown, single (Lot number: FC8184/FC3187) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSARTHRIA (non-serious), outcome "unknown", described as "slurred speech".  Additional information: The reported lot number was FC8184 (reporter stated it may also be FC3187 and the writing was difficult to read). It was also reported the patient began experiencing slurred speech after a couple of months. In JAN-2022, the patient was driving her car and ran into a ditch in her front yard. The patient stated she lost consciousness and woke up in a ditch. It was reported the speech issues had gotten progressively worse. The patient has seen a neurologist, and received an EEG, MRI, and CT with no findings. The neurologist was chalking it up to a "bad batch" of COVID-19 vaccine. The patient was receiving speech therapy, but had not been helping, as the symptoms were getting progressively worse.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Optic neuritis
Clinical narrative: optic nerve inflammation; This is a spontaneous report received from a Nurse.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OPTIC NEURITIS (medically significant), outcome "unknown", described as "optic nerve inflammation". Clinical course: Lot number FC8184 (patient stated it may also be FC3187 and the writing was difficult to read). On 27Dec2023, it was reported that a patient started treatment on 27Sep2021 with Pfizer BioNTech COVID-19 vaccine at an unspecified dose/frequency for COVID-19 vaccination. It was reported the patient's eye was affected and he was found to have optic nerve inflammation. There was no vision loss. No further follow-up is anticipated. Reporter was Nurse (Patient's Wife)  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect vaccine BNT162b2 cannot be completely excluded for the reported event of Optic neuritis. The detailed clinical course with patient complete medical history and concomitant medications would be helpful for further assessment. The case will be reassessed based on the follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I caught COVID twice; I caught COVID twice; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An adult patient 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. Patient stated to take the original, then three more boosters. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I caught COVID twice". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Multiple allergies
Clinical narrative: he is allergic to everything since after the Covid-19 shot.; This is a spontaneous report received from a Consumer or other non HCP.  A 29-year-old male patient 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: MULTIPLE ALLERGIES (non-serious), outcome "unknown", described as "he is allergic to everything since after the Covid-19 shot.". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.