chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity".  Additional information: The events were experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec19, 2023 and Wednesday, Dec 20, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Moderate injection site tenderness (tenderness with movement); Moderate injection site redness; Moderate injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; 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"; VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity".  Additional information: The events were experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Tuesday, Dec19, 2023 and Wednesday, Dec 20, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anti-ganglioside antibody, CSF protein, Electromyogram, Guillain-Barre syndrome, Magnetic resonance imaging
Clinical narrative: Guillain-Barre syndrome/Acute inflammatory demyelinating polyneuropathy; This is a literature report.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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: GUILLAIN-BARRE SYNDROME (medically significant), 6 days after the suspect product(s) administration, outcome "recovering" (partial recovery), described as "Guillain-Barre syndrome/Acute inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: Anti-ganglioside antibody: Not reported; CSF protein: positive; Electromyogram: Not reported; Magnetic resonance imaging: positive; Nerve conduction studies: Not reported. Therapeutic measures were taken as a result of guillain-barre syndrome, treatment included Intravenous Immunoglobulin and Plasma exchange.; Sender's Comments: Based on the limited information available in the case, the relationship between the event Guillain-Barre syndrome  and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Nerve conduction studies
Clinical narrative: Guillain-Barre syndrome/Acute inflammatory demyelinating polyneuropathy; This is a literature report.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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: GUILLAIN-BARRE SYNDROME (medically significant), 6 days after the suspect product(s) administration, outcome "recovering" (partial recovery), described as "Guillain-Barre syndrome/Acute inflammatory demyelinating polyneuropathy". The patient underwent the following laboratory tests and procedures: Anti-ganglioside antibody: Not reported; CSF protein: positive; Electromyogram: Not reported; Magnetic resonance imaging: positive; Nerve conduction studies: Not reported. Therapeutic measures were taken as a result of guillain-barre syndrome, treatment included Intravenous Immunoglobulin and Plasma exchange.; Sender's Comments: Based on the limited information available in the case, the relationship between the event Guillain-Barre syndrome  and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Severe fatigue with significant interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; MALAISE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity"; FATIGUE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity". Therapeutic measures were taken as a result of headache.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Severe fatigue with significant interference with activity; Mild malaise/feeling sick and no interference with activity; Moderate muscle pain with some interference with activity; Joint pain and no interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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 that interfered with activity OR required repeated use of a nonprescription pain reliever"; ARTHRALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Joint pain and no interference with activity"; MALAISE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; MYALGIA (non-serious) with onset 21Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity"; FATIGUE (non-serious) with onset 21Dec2023, outcome "unknown", described as "Severe fatigue with significant interference with activity". Therapeutic measures were taken as a result of headache.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site swelling; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)"; VACCINATION SITE SWELLING (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site swelling". Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Moderate fatigue with some interference with activity; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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)"; FATIGUE (non-serious), outcome "unknown", described as "Moderate fatigue with some interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity".  Additional information: Injection site pain/ Injection site tenderness: Record your worst pain/ tenderness experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023. Response: 1 - Mild injection site pain and no interference with activity; 1 - Mild injection site tenderness (tender to touch). Fatigue: Record worst intensity of fatigue experienced anytime during the 2 days after your vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023. Response: 2 - Moderate fatigue with some interference with activity. Muscle pain: Record the worst intensity of pain you experienced anytime during the 2 days after your COVID-19 vaccination, which occurred on Friday, Dec 22, 2023 and Saturday, Dec 23, 2023. Response: 1 - Mild muscle pain and no interference with activity.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 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 20Dec2023, outcome "unknown" described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, 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.  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: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 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 20Dec2023, outcome "unknown" described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, 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.  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: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting; Headache 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Headache and no interference with activity"; ARTHRALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Joint pain and no interference with activity"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fatigue and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild fever (100.4 to 101.2 F)"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, 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 20Dec2023, outcome "unknown" described as "Mild injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild injection site swelling"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown" described as "Mild muscle pain and no interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 20Dec2023, 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.  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/Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no 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 interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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"; 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Additional information: Events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site redness; Moderate injection site swelling; Moderate fatigue with some interference with activity; Mild malaise/feeling sick and no 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 interfered with activity OR required repeated use of a nonprescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick 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"; 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"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Additional information: Events were experienced anytime during the 2 days after COVID-19 vaccination, which occurred on Monday, Dec 18, 2023 and Tuesday, Dec 19, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild injection site tenderness (tender to touch); Mild injection site redness; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP. AA patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 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: 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)"; MYALGIA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild muscle pain and no interference with activity". Additional information: It was reported that the patient had experienced the events anytime during the 2 days after your COVID-19 vaccination which occurred on Thursday (21Dec2023) and Friday (22Dec2023).  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, 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; Mild injection site swelling; Mild fatigue and no interference with activity; Mild malaise/feeling sick and no interference with activity; Mild muscle pain and no interference with activity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity".  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/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; 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"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; MYALGIA (non-serious), outcome "unknown", described as "Mild muscle pain and no interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; 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; 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, outcome "unknown", described as "Headache and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Event onset reported to occur on 20Dec2023 and 21Dec2023.  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
Clinical narrative: Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement); Mild injection site redness; 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; 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, outcome "unknown", described as "Headache and no interference with activity"; PYREXIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Mild injection site redness"; FATIGUE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate injection site pain interfering with activity/Moderate injection site tenderness (tenderness with movement)"; MALAISE (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate malaise/feeling sick present with some interference with activity"; MYALGIA (non-serious) with onset 20Dec2023, outcome "unknown", described as "Moderate muscle pain with some interference with activity". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Event onset reported to occur on 20Dec2023 and 21Dec2023.  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, 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 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick 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: 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"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: 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 °F); Mild fatigue and no interference with activity; Mild malaise/feeling sick 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: 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"; PYREXIA (non-serious), outcome "unknown", described as "Mild fever (100.4 to 101.2 °F)"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain and no interference with activity"; VOMITING (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Mild nausea/vomiting and no interference with activity or 1-2 episodes of nausea/vomiting"; HEADACHE (non-serious), outcome "unknown", described as "Headache and no interference with activity".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness; 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. The reporter is the patient.  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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Mild injection site pain and no interference with activity/Mild injection site tenderness"; FATIGUE (non-serious), outcome "unknown", described as "Mild fatigue and no interference with activity"; MALAISE (non-serious), outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site redness; Moderate 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; 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)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache 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"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; 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".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, Dec 24, 2023 and Monday, Dec 25, 2023.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity; Mild injection site redness; Moderate 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; 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)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Dec2023, outcome "unknown", described as "Headache 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"; VACCINATION SITE ERYTHEMA (non-serious) with onset Dec2023, outcome "unknown", described as "Mild injection site redness"; MALAISE (non-serious) with onset Dec2023, outcome "unknown", described as "Mild malaise/feeling sick and no interference with activity"; FATIGUE (non-serious) with onset Dec2023, outcome "unknown", described as "Moderate fatigue with some interference with activity"; 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".  Additional information: The patient recorded the events experienced anytime during the 2 days after the COVID-19 vaccination, which occurred on Sunday, Dec 24, 2023 and Monday, Dec 25, 2023.  Batch/lot number is not provided, and it cannot be obtained.