chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Nausea
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 Fahrenheit); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; 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: 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 Fahrenheit)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; 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. 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, Vomiting
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 Fahrenheit); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; 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: 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 Fahrenheit)"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; 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. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Headache; 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"; 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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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)"; 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. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Headache; 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"; 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 ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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)"; 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. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site tenderness (tender to touch); Mild injection site redness; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site tenderness (tender to touch)".  Additional Information: Events were experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Mild muscle pain and no interference with activity; 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: ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Moderate fatigue with some interference with activity; Moderate malaise/feeling sick present with some interference with activity; Mild muscle pain and no interference with activity; 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: ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some interference with activity"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious) all with onset Dec2023, outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; 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 21Dec2023, outcome "unknown", described as "Headache and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)". Additional information: reported as 'recoded all events experienced anytime during the 2 days after patient COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023'  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Significant injection site tenderness (tenderness during rest); Mild injection site redness; Moderate 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 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 prevented daily activity OR required any use of a prescription pain reliver; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 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 prevented daily activity OR required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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"; 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/Significant injection site tenderness (tenderness during rest)"; 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". 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/Significant injection site tenderness (tenderness during rest); Mild injection site redness; Moderate 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 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 prevented daily activity OR required any use of a prescription pain reliver; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 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 prevented daily activity OR required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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"; 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/Significant injection site tenderness (tenderness during rest)"; 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". 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/Significant injection site tenderness (tenderness during rest); Mild injection site redness; Moderate 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 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 prevented daily activity OR required any use of a prescription pain reliver; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 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 prevented daily activity OR required any use of a prescription pain reliver"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain with some 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"; 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/Significant injection site tenderness (tenderness during rest)"; 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". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Vaccination site erythema
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain 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 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: Events "mild injection site pain, mild injection site tenderness, mild injection site redness, mild injection site swelling, mild fatigue, mild muscle pain, joint pain, and headache" also reported to have occurred on 21Dec2023. There were no fever, no malaise/feeling sick, and no nausea/vomiting.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild muscle pain 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 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site pain and no interference with activity"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site swelling"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild injection site tenderness (tender to touch)"; MYALGIA (non-serious) with onset 20Dec2023, 2 days after the suspect product(s) administration, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: Events "mild injection site pain, mild injection site tenderness, mild injection site redness, mild injection site swelling, mild fatigue, mild muscle pain, joint pain, and headache" also reported to have occurred on 21Dec2023. There were no fever, no malaise/feeling sick, and no nausea/vomiting.
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 23Dec2023, it was noted that after COVID-19 vaccination, which occurred on Thursday, 21Dec2023 and Friday, 22Dec2023, the patient experienced 1 - Mild injection site pain and no interference with activity/1 - 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, 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 fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023 and Friday, Dec 22, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; 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)"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Mild injection site swelling".  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
Clinical narrative: Moderate injection site pain/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 "Moderate injection site pain/Mild injection site tenderness (tender to touch)".   Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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: It was reported that the patient had experienced the events anytime during the 2 days after the COVID-19 vaccination which occurred on Monday (18Dec2023) and Tuesday (19Dec2023).  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 erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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: It was reported that the patient had experienced the events anytime during the 2 days after the COVID-19 vaccination which occurred on Monday (18Dec2023) and Tuesday (19Dec2023).  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: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild muscle pain and no interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate fatigue with some interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A female patient (unknown if pregnant) 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: MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 21Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MYALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 21Dec2023, outcome "unknown", described as "Headache and no interference with activity"; FATIGUE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/Moderate injection site tenderness (tenderness with movement)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site swelling"; MYALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 22Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious) with onset 22Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; INJECTION SITE PAIN (non-serious) with onset 22Dec2023, 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, injection site tenderness, mild fatigue, mild malaise and feeling sick, which the patient experienced anytime during the 2 days after their COVID-19 vaccination, which occurred on Friday, 22Dec2023 and Saturday, 23Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.