chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); 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; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; Moderate nausea/vomiting and some interference with activity or greater than 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 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: 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 "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/Mild injection site tenderness (tender to touch)"; 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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting".  Additional Information: Events were 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: Nausea, Vaccination site pain, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); 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; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; Moderate nausea/vomiting and some interference with activity or greater than 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 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: 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 "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/Mild injection site tenderness (tender to touch)"; 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"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting".  Additional Information: Events were 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, Myalgia, Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; 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 16Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; MYALGIA (non-serious) with onset 16Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)".  Additional information: The patient had moderate injection site pain interfering with activity, injection site tenderness (tenderness with movement), mild fatigue and no interference with activity and Mild muscle pain and no interference with activity, which the patient experienced anytime during the 2 days after your vaccination, which occurred on Saturday, 16Dec2023 and Sunday, 17Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Headache that interfered with activity or required repeated use of a nonprescription pain reliever; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild 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; Joint pain with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 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 with some interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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 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. Therapeutic measures were taken as a result of headache.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Headache that interfered with activity or required repeated use of a nonprescription pain reliever; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild 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; Joint pain with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 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 with some interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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 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. Therapeutic measures were taken as a result of headache.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Headache that interfered with activity or required repeated use of a nonprescription pain reliever; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild 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; Joint pain with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 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 with some interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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 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. Therapeutic measures were taken as a result of headache.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick 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)), 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 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"; 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)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Record of patient's worst event experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023: Moderate injection site pain interfering with activity, moderate injection site tenderness (tenderness with movement), moderate injection site redness, mild injection site swelling, mild fever (100.4 to 101.2 F), moderate fatigue with some interference with activity, mild malaise/feeling sick and no interference with activity, muscle pain not present, joint pain not present, mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting, no headache.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick 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)), 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 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"; 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)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site redness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Record of patient's worst event experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023: Moderate injection site pain interfering with activity, moderate injection site tenderness (tenderness with movement), moderate injection site redness, mild injection site swelling, mild fever (100.4 to 101.2 F), moderate fatigue with some interference with activity, mild malaise/feeling sick and no interference with activity, muscle pain not present, joint pain not present, mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting, no headache.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My wife and i have the vaccine now and were away new years with her sister and husband/ All 3 have covid; My wife and i have the vaccine now and were away new years with her sister and husband/ All 3 have covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: I have never had covid, My wife had it 2 times before the vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and i have the vaccine now and were away new years with her sister and husband/ All 3 have covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: All 3 have covid and i test negative. Clinical course: Reporter stated, "I have never had covid, my wife had it 2 times before the vaccine. I was in contact with 4 people one different date who had covid before vaccine and never caught it. My wife and i have the vaccine now and were away New Year's with her sister and husband. All 3 have covid and I tested negative. Would you like to pay for testing on my blood for research."  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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)), 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/Mild injection site tenderness (tender to touch)".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with significant interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 with significant interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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/Moderate injection site tenderness (tenderness with movement)"; 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity". Additional information: Events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 °F); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with significant interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 with significant interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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/Moderate injection site tenderness (tenderness with movement)"; 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity". Additional information: Events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: 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 fever (101.3 to 102 °F); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with significant interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 with significant interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; 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"; 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/Moderate injection site tenderness (tenderness with movement)"; 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"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity". Additional information: Events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; 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 20Dec2023 as dose number unknown, 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity".  Additional information: These events were experienced during the 2 days after COVID-19 vaccination, which occurred Thursday, 21Dec2023 and Friday, 22Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Moderate 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 and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE SWELLING (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 18Dec2023, 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 18Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site redness"; MALAISE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 18Dec2023, 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: 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); Moderate 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 and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE SWELLING (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 18Dec2023, 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 18Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site redness"; MALAISE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 18Dec2023, 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 swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Moderate 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 and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; PYREXIA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE SWELLING (non-serious) with onset 18Dec2023, outcome "unknown", described as "Mild injection site swelling"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 18Dec2023, 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 18Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate injection site redness"; MALAISE (non-serious) with onset 18Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 18Dec2023, 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: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; 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 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: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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"; 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/Significant injection site tenderness (tenderness during rest)"; 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Therapeutic measures were taken as a result of headache. Additional information: Event onset reported to occur between 22Dec2023 and 23Dec2023 (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: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Moderate injection site redness; Moderate injection site swelling; Moderate fever (101.3 to 102 F); Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; 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 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: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache that interfered with activity OR required repeated use of a nonprescription pain reliever"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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"; 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/Significant injection site tenderness (tenderness during rest)"; 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Therapeutic measures were taken as a result of headache. Additional information: Event onset reported to occur between 22Dec2023 and 23Dec2023 (unspecified).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.