chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Ischaemia, Pyrexia, Tinnitus, Ultrasound abdomen normal
Clinical narrative: BLOOD CLOT IN THE LOWER ARTERY THAT BLOCKED BLOOD SUPPLY TO THE DIGESTIVE SYSTEM, KIDNEY AND SOME OF THE OTHER ORGANS; INTESTINAL SWELLING; COULD NOT SLEEP; NOT FELT TOO WELL; RINGING IN BOTH EARS; FEVER; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient had no history of blood clot issues. The patient previously received covid-19 vaccine (manufacturer unspecified) in MAR-2021 and had no reported reactions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1822811, expiry: UNKNOWN) on 23-OCT-2021, 1 total administered to the left deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban. On 23-OCT-2021, later in the day after receiving the vaccination, patient developed a fever and took ibuprofen (Advil). The next day on 24-OCT-2021, he did not felt too well and later that night experienced stomach ache which worsened during the night and he could not sleep due to the pain. He also experienced nausea and vomiting and ringing in both ears. On 25-OCT-2021, the stomach pain was there along with nausea and vomiting at the time of reporting. He went to the Emergency Room (ER) where an ultrasound was performed which did not reveal any issues. A computed tomography (CT) showed a clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, as well as intestinal swelling and he was admitted the same day. He was kept on blood thinners via IV for 4 days and was also on painkillers. The stomach pain subsided and he was discharged from hospital after 4 days on 28-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, fever, and ringing in both ears, was recovering from intestinal swelling, and blood clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, and had not recovered from not felt too well. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211061177-covid-19 vaccine ad26.cov2.s-blood clot in the lower artery that was blocking blood supply to the digestive system, kidney and some of the other organs, and intestinal swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: BLOOD CLOT IN THE LOWER ARTERY THAT BLOCKED BLOOD SUPPLY TO THE DIGESTIVE SYSTEM, KIDNEY AND SOME OF THE OTHER ORGANS; INTESTINAL SWELLING; COULD NOT SLEEP; NOT FELT TOO WELL; RINGING IN BOTH EARS; FEVER; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient had no history of blood clot issues. The patient previously received covid-19 vaccine (manufacturer unspecified) in MAR-2021 and had no reported reactions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1822811, expiry: UNKNOWN) on 23-OCT-2021, 1 total administered to the left deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban. On 23-OCT-2021, later in the day after receiving the vaccination, patient developed a fever and took ibuprofen (Advil). The next day on 24-OCT-2021, he did not felt too well and later that night experienced stomach ache which worsened during the night and he could not sleep due to the pain. He also experienced nausea and vomiting and ringing in both ears. On 25-OCT-2021, the stomach pain was there along with nausea and vomiting at the time of reporting. He went to the Emergency Room (ER) where an ultrasound was performed which did not reveal any issues. A computed tomography (CT) showed a clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, as well as intestinal swelling and he was admitted the same day. He was kept on blood thinners via IV for 4 days and was also on painkillers. The stomach pain subsided and he was discharged from hospital after 4 days on 28-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, fever, and ringing in both ears, was recovering from intestinal swelling, and blood clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, and had not recovered from not felt too well. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211061177-covid-19 vaccine ad26.cov2.s-blood clot in the lower artery that was blocking blood supply to the digestive system, kidney and some of the other organs, and intestinal swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial thrombosis, Computerised tomogram abdomen, Gastrointestinal oedema, Insomnia, Malaise
Clinical narrative: BLOOD CLOT IN THE LOWER ARTERY THAT BLOCKED BLOOD SUPPLY TO THE DIGESTIVE SYSTEM, KIDNEY AND SOME OF THE OTHER ORGANS; INTESTINAL SWELLING; COULD NOT SLEEP; NOT FELT TOO WELL; RINGING IN BOTH EARS; FEVER; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient had no history of blood clot issues. The patient previously received covid-19 vaccine (manufacturer unspecified) in MAR-2021 and had no reported reactions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1822811, expiry: UNKNOWN) on 23-OCT-2021, 1 total administered to the left deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban. On 23-OCT-2021, later in the day after receiving the vaccination, patient developed a fever and took ibuprofen (Advil). The next day on 24-OCT-2021, he did not felt too well and later that night experienced stomach ache which worsened during the night and he could not sleep due to the pain. He also experienced nausea and vomiting and ringing in both ears. On 25-OCT-2021, the stomach pain was there along with nausea and vomiting at the time of reporting. He went to the Emergency Room (ER) where an ultrasound was performed which did not reveal any issues. A computed tomography (CT) showed a clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, as well as intestinal swelling and he was admitted the same day. He was kept on blood thinners via IV for 4 days and was also on painkillers. The stomach pain subsided and he was discharged from hospital after 4 days on 28-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, fever, and ringing in both ears, was recovering from intestinal swelling, and blood clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, and had not recovered from not felt too well. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211061177-covid-19 vaccine ad26.cov2.s-blood clot in the lower artery that was blocking blood supply to the digestive system, kidney and some of the other organs, and intestinal swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tinnitus, Ultrasound abdomen
Clinical narrative: BLOOD CLOT IN THE LOWER ARTERY THAT BLOCKED BLOOD SUPPLY TO THE DIGESTIVE SYSTEM, KIDNEY AND SOME OF THE OTHER ORGANS; INTESTINAL SWELLING; COULD NOT SLEEP; NOT FELT TOO WELL; RINGING IN BOTH EARS; FEVER; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient had no history of blood clot issues. The patient previously received covid-19 vaccine (manufacturer unspecified) in MAR-2021 and had no reported reactions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, batch number: 1822811, expiry: UNKNOWN) on 23-OCT-2021, 1 total administered to the left deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban. On 23-OCT-2021, later in the day after receiving the vaccination, patient developed a fever and took ibuprofen (Advil). The next day on 24-OCT-2021, he did not felt too well and later that night experienced stomach ache which worsened during the night and he could not sleep due to the pain. He also experienced nausea and vomiting and ringing in both ears. On 25-OCT-2021, the stomach pain was there along with nausea and vomiting at the time of reporting. He went to the Emergency Room (ER) where an ultrasound was performed which did not reveal any issues. A computed tomography (CT) showed a clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, as well as intestinal swelling and he was admitted the same day. He was kept on blood thinners via IV for 4 days and was also on painkillers. The stomach pain subsided and he was discharged from hospital after 4 days on 28-OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep, fever, and ringing in both ears, was recovering from intestinal swelling, and blood clot in the lower artery that blocked blood supply to the digestive system, kidney and some of the other organs, and had not recovered from not felt too well. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211061177-covid-19 vaccine ad26.cov2.s-blood clot in the lower artery that was blocking blood supply to the digestive system, kidney and some of the other organs, and intestinal swelling. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, IVth nerve paralysis
Clinical narrative: 4th cranial nerve palsy/woke up with double vision; Booster; This is a spontaneous report from a contactable nurse. A 51-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 01Oct2021 at 10:45 (Lot Number: 30130BA) as dose 3 (BOOSTER), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received bnt162b2 on 18Dec2021 for the first dose and 08Jan2021 for the second dose on the right arm for COVID-19 immunization. On 02Oct2021, the day after the booster shot, the patient woke up with double vision and was eventually hospitalized to rule out stroke which was ruled out. The ophthalmologist diagnosed the patient's condition as 4th cranial nerve palsy. The patient was hospitalized for 2 days from an unknown date in Oct2021 to an unknown date in Oct2021. The event resulted in a visit to the emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The outcome of the event was not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events immunization, IVth nerve paralysis and the suspect drug BNT162B2 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, COVID19
Symptoms: IVth nerve paralysis, Immunisation
Clinical narrative: 4th cranial nerve palsy/woke up with double vision; Booster; This is a spontaneous report from a contactable nurse. A 51-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 01Oct2021 at 10:45 (Lot Number: 30130BA) as dose 3 (BOOSTER), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received bnt162b2 on 18Dec2021 for the first dose and 08Jan2021 for the second dose on the right arm for COVID-19 immunization. On 02Oct2021, the day after the booster shot, the patient woke up with double vision and was eventually hospitalized to rule out stroke which was ruled out. The ophthalmologist diagnosed the patient's condition as 4th cranial nerve palsy. The patient was hospitalized for 2 days from an unknown date in Oct2021 to an unknown date in Oct2021. The event resulted in a visit to the emergency room/department or urgent care. It was unknown if the patient received treatment for the events. The outcome of the event was not recovered.; Sender's Comments: Based on the available information in the case, the causal association between the events immunization, IVth nerve paralysis and the suspect drug BNT162B2 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basophil count, Basophil count increased, Basophil percentage, Blood alkaline phosphatase increased, Coagulation test normal
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Differential white blood cell count, Eosinophil percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Metabolic function test
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test abnormal, Monocyte percentage increased, Neutrophil count decreased, Neutrophil percentage decreased, Platelet count decreased
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Rash erythematous, Red blood cell count normal, Red cell distribution width normal, Reticulocyte percentage normal
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, White blood cell count decreased
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, SARS-CoV-2 test
Clinical narrative: Thrombocytopenia - ITP; This is a spontaneous report from a contactable physician. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 06Oct2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. Patient had no relevant medical history and known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced thrombocytopenia - ITP on 06Oct2021. The patient was hospitalized for thrombocytopenia - ITP for 2 days on an unspecified date. The patient underwent lab tests and procedures which included SARS-COV-2, NAA, CEpheid (Nasal Swab): negative on 30Oct2021. Event resulted to Emergency room/department or urgent care and in patient receiving IVIG as treatment. The outcome of event was recovering. Patient was reported to also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: FF8841, Expiration Date was not reported), intramuscularly on 27Oct2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunisation.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event immune thrombocytopenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Decreased appetite, Headache, Illness, Nausea, Rash
Clinical narrative: None stated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Vomiting
Clinical narrative: None stated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: part of it was covid; part of it was covid; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 61-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61-years-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer vaccine in Mar2021, and I got two and they gave me a little card and I actually been in the hospital in September like 15 out of 30 days, part of it was COVID. I lost my card saying I received those vaccines. The patient was hospitalized from an unspecified date in Sep2021 to an unknown date for 15 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test that was positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: part of it was covid; part of it was covid; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 61-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61-years-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the Pfizer vaccine in Mar2021, and I got two and they gave me a little card and I actually been in the hospital in September like 15 out of 30 days, part of it was COVID. I lost my card saying I received those vaccines. The patient was hospitalized from an unspecified date in Sep2021 to an unknown date for 15 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test that was positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: It was discovered after the vaccine dose was administered that a nurse at the clinic had mistakenly mixed and prepared the vaccine with only 0.8 mls of saline to reconstitute the vaccine rather than the recommended 1.8 mls. The student received 0.3 mls of the mixture, therefore receiving an incorrect, higher concentrated dose. The student was monitored for 30 minutes and no immediate adverse reaction was observed. The student's pediatrician and parents were notified by Dr.  at the  Health Dept.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: It was discovered after the vaccine dose was administered that a nurse at the clinic had mistakenly mixed and prepared the vaccine with only 0.8 mls of saline to reconstitute the vaccine rather than the recommended 1.8 mls. The student received 0.3 mls of the mixture, therefore receiving an incorrect, higher concentrated dose. The student was monitored for 30 minutes and no immediate adverse reaction was observed. The student's pediatrician and parents were notified by Dr.  at the  Health Dept.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: It was discovered after the vaccine dose was administered that a nurse at the clinic had mistakenly mixed and prepared the vaccine with only 0.8 mls of saline to reconstitute the vaccine rather than the recommended 1.8 mls. The student received 0.3 mls of the mixture, therefore receiving an incorrect, higher concentrated dose. The student was monitored for 30 minutes and no immediate adverse reaction was observed. The student's pediatrician and parents were notified by the Dr at a local health dept.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: It was discovered after the vaccine dose was administered that a nurse at the clinic had mistakenly mixed and prepared the vaccine with only 0.8 mls of saline to reconstitute the vaccine rather than the recommended 1.8 mls. The student received 0.3 mls of the mixture, therefore receiving an incorrect, higher concentrated dose. The student was monitored for 30 minutes and no immediate adverse reaction was observed. The student's pediatrician and parents were notified by the Dr at a local health dept.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient stated that around 2:30 am on 11/13/21 the day following her vaccine she experienced throbbing, mild swelling, and tenderness in all of her joints including fingers and toes. she stated that her pain was a 7/10 and was taking Tylenol and was feeling better. she is currently resting and using Tylenol to help with pain. she stated that she will see her doctor on Monday if the symptoms persist.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: patient stated that around 2:30 am on 11/13/21 the day following her vaccine she experienced throbbing, mild swelling, and tenderness in all of her joints including fingers and toes. she stated that her pain was a 7/10 and was taking Tylenol and was feeling better. she is currently resting and using Tylenol to help with pain. she stated that she will see her doctor on Monday if the symptoms persist.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram coronary normal, Deafness bilateral, Electrocardiogram normal, Troponin increased
Clinical narrative: Hearing loss, Right greater than left after 3rd vaccination. Might also have had a mild myocarditis  after 2nd vaccination
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful lymph node in left armpit
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was accidentally given  a booster dose 46 days early from her second covid shot. Upon discovery, the patient was contacted and informed and claims to be fine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: patient experienced dizziness immediately after receiving vaccine, patient was given an ice packed and was told to sit down. dizziness subsided within 3-5 mins and was monitored for 15 mins, once 15 mins were up patient  left with spouse.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My menstrual cycles have always been very consistent. After my first Pfizer shot I didn't get my period for around 2 months. I got it during the third month but after that I haven't gotten it in over 2 months. My periods have been very irregular after my first dose.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Blood test, Electrocardiogram, Scan brain
Clinical narrative: severe sudden hearing loss   loss of balance  severe tinnitus
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus, X-ray
Clinical narrative: severe sudden hearing loss   loss of balance  severe tinnitus
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: Mild Chest pains when even a little active. Severe tiredness / fatigue. Need to rest.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: On Friday, November 12, 2021 client came to  vaccination POD for a Covid-19 Moderna booster dose. Client received her first and second dose of Sinovac vaccine in April 2021 in Mexico. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history. Sinovac is an agency approved vaccine. Submitted medical consult via text to agency Operations Lead who consulted with Dr. Dr approved for client to receive Moderna booster dose with 30 minute observation. Client received her Covid-19 Moderna vaccine (LOT #: 066F21A) at approximately 1:54 PM in her right arm. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 2:30 PM.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fatigue, Nausea
Clinical narrative: Patient came to the clinic for her first dose of Pfizer, which she received at 0921 (lot# EWO185-H). Shortly after her vaccination, she c/o nausea to observation area RN. She reported that she hadn?t eaten anything yet today and accepted water and juice offered by RN, but she declined to lay down. RN took her vital signs at 0928, reporting that her BP sitting was 90/70, HR was 89, and SPO2 was 98% on RA. RN alerted this writer, RN, to assess the client. When asked, she denied dizziness, but did c/o feeling ?tired?. No diaphoresis or pallor was noted.  At 0930, patient transferred herself to the cot, rising and walking without difficulty and with a steady gait. At 0939 she was assisted to elevate her legs and reported that this positioning helped to reduce her nausea. At 0939, her BP laying was 90/50, HR was 74, and SPO2 was 98% RA. She and her father reported that they do not know her baseline BP. Her BP at 0943 was 94/60 laying. She was able to sit at 0945, reporting that she felt ?good? and continued to drink juice and water. She reported that her nausea was mostly resolved, but that she still felt tired (although she did note that she had been tired before vaccination r/t staying up late). She reported that she felt ?80% normal?. This writer obtained her vitals at 0951: BP sitting was 96/62, HR was 71, and SPO2 was 100% on RA.  She attempted to stand at 0954, but reported that this worsened her nausea, at which point she laid back down with feet elevated until 0957 when she elected to sit on the edge of the cot. She ultimately laid back down again a few minutes later. Her vitals at 1002 were: BP 104/64 sitting, HR 67, and SPO2 was 98% on RA. However, her BP fell to 96/58 when she stood a moment later, causing her to sit again. She continued PO intake of fluids and, by 1012, she reported that she felt ?fine? and rated her nausea at 4/10, compared to a peak of 7/10.  At 1012, she stood and walked without difficulty. Her BP standing was 98/60, HR was 92, and SPO2 was 99% RA. At 1013, her VS remained stable with a standing BP of 96/58, HR at 85, and SPO2 at 98% on RA. She reported that her nausea was mostly resolved, she denied dizziness, and she continued to present with no pallor or diaphoresis. She and her father were educated on vasovagal responses and when to seek out medical care, encouraged to eat breakfast after leaving the clinic, to report this reaction the next time she presented for vaccination, and to be sure to eat before vaccination. Both she and her father verbalized understanding. She exited facility at 1020, driven in a private vehicle by her father, who will monitor her throughout the day.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Sleep disorder
Clinical narrative: Tingling and numbness in left hand and leg. Numbness mostly in my fingers and feet, but tingling in my knee, fingers, and feet. Occurs intermittently, usually when sitting, driving, or walking. Occasionally when walking or jogging.  Extremely painful headaches/throbbing in head, either in the middle of the night (causing me to wake up) or upon waking in the morning.. One headache happened during the day, but most were upon waking. The headaches started about 2 weeks after vaccination, were happening daily for about a week, and have sense become more intermittent, happening only once or twice a week.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Endometrial hyperplasia, Menstrual disorder, Postmenopausal haemorrhage, Ultrasound scan vagina abnormal
Clinical narrative: 1.  Seven years post-menopausal:  started having REAL menstrual cycles  which lasted 7 days, every other week for 5 1/2 months, then stopped,
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Ear pain, Pain in jaw, Swelling of eyelid, Vomiting
Clinical narrative: Sharp recurring pain in right ear 36 hours after injection. Swolen right eyelid Sensitivity/pain in lower right jaw and center right jaw Vomiting 78 hours after injection
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cartilage injury, Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: I had strong reactions to both my vaccines and was in bed for two days following the first vaccination and three days following the second vaccination. Shortly after recovering from the second vaccination I started to have wandering pains that went up and down my legs and sometimes elsewhere, in my arms and shoulders. These pains would wake me up a night. I also lost strength in my right leg and had trouble lifting it to go up stairs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: I had strong reactions to both my vaccines and was in bed for two days following the first vaccination and three days following the second vaccination. Shortly after recovering from the second vaccination I started to have wandering pains that went up and down my legs and sometimes elsewhere, in my arms and shoulders. These pains would wake me up a night. I also lost strength in my right leg and had trouble lifting it to go up stairs.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: On Friday, November 12, 2021 patient came for a COVID-19 Moderna booster dose. He received his first and second dose of Sinovac vaccine in April 2021 in another country. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history.  Submitted medical consult via text to vaccine operations lead who consulted with the doctor, and approved for patient to receive Moderna booster dose with 30-minute observation. The patient received the COVID-19 Moderna vaccine (batch/lot# 066F21A) at approximately 2:00 pm in right arm. Client was educated by RN on signs/symptoms of adverse reactions and when to go to the ED/call MD. Client experienced no adverse reaction while waiting in observation area and left vaccination site with a steady gait at approximately 2:30 pm.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Disturbance in attention, Headache, Insomnia
Clinical narrative: Fever to 99,  chills,  muscle aches, arthralgias Severe headache insomnia twitching extremities at night difficulty concentrating
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Pyrexia
Clinical narrative: Fever to 99,  chills,  muscle aches, arthralgias Severe headache insomnia twitching extremities at night difficulty concentrating