chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram T wave inversion, Fibrin D dimer normal, Painful respiration
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Pericarditis, Pyrexia, SARS-CoV-2 test negative, Tachycardia, Troponin normal
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Cough, Dyspnoea, Full blood count
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Glomerular filtration rate, Heart rate irregular, Metabolic function test, Painful respiration, Pregnancy test
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 21.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Serum ferritin, Troponin I
Clinical narrative: Chest pain, shortness of breathe, cough, hurt breathe, heart beating irregular
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Brain death, Cerebral haemorrhage, Computerised tomogram head normal, Dizziness
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Seizure, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary tract infection, Vertigo, Vision blurred, Vomiting
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head normal, Death, Dizziness, Endotracheal intubation
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Headache, Laboratory test, Nausea, Seizure
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subarachnoid haemorrhage, Venous haemorrhage, Vertigo, Vomiting
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Cerebral venous sinus thrombosis, Computerised tomogram, Death, Thrombocytopenia
Clinical narrative: Patient presented to the ED 10/19 with c/o headache, dizziness, nausea and vomiting (was also seen at another facility the day before). Head CT done and showed no acute intracranial abnormality, was given med, vertigo resolved, headache present but better, was discharged. The patient returned 10/20 with the same complaints.  The patient appeared to have a seizure.  Neurology saw and made recommendation for MRI of the brain and lumbar puncture. patient also reported she had a miscarriage prior to the start of the headaches and did not provide this information before.  The patient's condition deteriorated and she needed to be intubated; CT head showed acute parasagittal frontal parenchymal and subarachnoid hemorrhage.  Additional testing was done and neurosurgery saw and the patient was transferred to another hospital for endovascular procedure due to venous hemorrhage.  Information also that she had a J&J COVID vaccine immunization 2 weeks ago.  It was noted her prognosis was poor. patient expired at the other facility.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Brain death, Cerebral haemorrhage, Computerised tomogram head normal, Dizziness
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Seizure, Subarachnoid haemorrhage, Superior sagittal sinus thrombosis
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urinary tract infection, Vertigo, Vision blurred, Vomiting
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head normal, Death, Dizziness, Endotracheal intubation
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Headache, Laboratory test, Nausea, Seizure
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subarachnoid haemorrhage, Venous haemorrhage, Vertigo, Vomiting
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Cerebral venous sinus thrombosis, Computerised tomogram, Death, Thrombocytopenia
Clinical narrative: Cerebral sagittal sinus thrombosis resulting in death. Thrombocytopenia
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy, Appendicitis, Flank pain, Gastrointestinal disorder
Clinical narrative: Had my first Pfizer vaccine on 1/13/21 started feeling pain and burning within 48 hours of the injection that went into the right flank and stomach area. An ultrasound was performed and later had a appendicitis, appendectomy and later a CT scan showed Colits.  All stemmed from or happened after a very short time window of receiving my first vaccine. I am still experiencing colits, spastic colon with IBD, IBS-C and have not worked since February.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Appendicectomy, Appendicitis, Blood test
Clinical narrative: Had my first Pfizer vaccine on 1/13/21 started feeling pain and burning within 48 hours of the injection that went into the right flank and stomach area. An ultrasound was performed and later had a appendicitis, appendectomy and later a CT scan showed Colits.  All stemmed from or happened after a very short time window of receiving my first vaccine. I am still experiencing colits, spastic colon with IBD, IBS-C and have not worked since February.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Computerised tomogram abnormal, Condition aggravated, Flank pain, Impaired work ability
Clinical narrative: Had my first Pfizer vaccine on 1/13/21 started feeling pain and burning within 48 hours of the injection that went into the right flank and stomach area. An ultrasound was performed and later had a appendicitis, appendectomy and later a CT scan showed Colits.  All stemmed from or happened after a very short time window of receiving my first vaccine. I am still experiencing colits, spastic colon with IBD, IBS-C and have not worked since February.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Stool analysis, Ultrasound abdomen abnormal, X-ray
Clinical narrative: Had my first Pfizer vaccine on 1/13/21 started feeling pain and burning within 48 hours of the injection that went into the right flank and stomach area. An ultrasound was performed and later had a appendicitis, appendectomy and later a CT scan showed Colits.  All stemmed from or happened after a very short time window of receiving my first vaccine. I am still experiencing colits, spastic colon with IBD, IBS-C and have not worked since February.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood glucose normal, Chest X-ray normal, Chest pain
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Full blood count, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, Metabolic function test, Monocyte count increased, Myocarditis, Nausea
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count normal, SARS-CoV-2 test negative, Sinus bradycardia, Troponin increased, White blood cell count normal
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood cholesterol decreased, Blood creatine phosphokinase, Blood triglycerides normal, Brain natriuretic peptide normal
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment abnormal
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeding disorder, Haematocrit increased, Haemoglobin normal, Headache, Hyperhidrosis
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Monocyte percentage increased, Nausea, Platelet count normal, QRS axis abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sinus arrhythmia, Sinus bradycardia, Sleep disorder, Troponin I increased
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased, White blood cell count normal
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Admitted to Hospital at as a transfer from for chest pain that began the day prior to admission. The patient indicates that two days prior to admission that he received his 2nd COVID vaccine. On 10/22/2021. He woke up with a sharp chest pain in the center of his chest that did not radiate anywhere.  The patient worsened. He said he was nauseous, not able to eat, and was sweaty. Father called EMS night on 10/22/2021 and was checked out and told that he was fine.  He also had a headache and took some Tylenol around 1700 on 10/22/2021 and it resolved. The chest pain stopped around 1900  on 10/22/2021. On 10/23/2021, he woke up with the same sharp chest pain in the center of his chest. Per mother patient received meningococcal B vaccine 1 week prior to 1st COVID vaccine. Denies sore throat, cough, rhinorrhea, and is otherwise healthy.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: red itchy arm. fever; very fatigued
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Fatigue, Pruritus, Pyrexia
Clinical narrative: red itchy arm. fever; very fatigued
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pyrexia, Secretion discharge
Clinical narrative: fever, joint pain, sore throat
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pyrexia
Clinical narrative: fever, joint pain, sore throat
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: joint pain, fever, body cough, increased blood pressure
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Cough, Pyrexia
Clinical narrative: joint pain, fever, body cough, increased blood pressure
Age: 14.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; Inappropriate Schedule; Product origin unknown; This spontaneous report was received from a nurse concerning a 14 years old female patient. No information about her current condition, medical history or concomitant therapy was reported.  On 22-AUG-2012, the patient received her first dose of unspecified quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route and lot# were not reported) as prophylaxis (the specific HPV vaccine type was not reported; product origin unknown). The patient was still eligible and requested to complete series.  On 24-SEP-2021, the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and lot# were not reported) as prophylaxis (inappropriate schedule of product administration). The vaccine was purchased with public funds and vaccinated at public health clinic/hospital. There was no temperature excursion. She scheduled for final injection in 2 months. No additional adverse event was reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no additional adverse events reported; dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report has been received from a vaccine coordinator referring to a 12-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) once (route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T030749 has been verified to be valid, expiration date was reported as 09-AUG-2021 but upon internal verification was established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 35.3 degrees Fahrenheit (F) during a time frame of 195 hours and 38 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events reported; dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report has been received from a vaccine coordinator referring to a 14-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) once (route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T030749 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 35.3 degrees Fahrenheit (F) during a time frame of 195 hours and 38 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; A dose of PNEUMOVAX 23 expired on 8/23/2021 and was administered on 10/14/2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 (units not provided), with lot number T007383 (verified to be a valid for vial formulation), expiration date on 23-AUG-2021, for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported) (expired product administered). No adverse events were reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo reconstituted with non-GSK diluent; received Menveo reconstituted with non-GSK diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 10th August 2021, the patient received Menveo. On 10th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received a Menveo vaccine reconstituted with a non-GSK diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. No information about lot number at the moment of the call.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019/Patient was willing to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019, batch number 79E7B, expiry date 30th Apr 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix and wanted to know how to proceed with schedule since the patient was willing to get 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a late second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number z4427, expiry date 31st January 2031) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st September 2018).   On 19th October 2021, the patient received the 2nd dose of Shingrix. On 19th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient had received a late second dose of Shingrix on the same day of the report, which led to lengthening of vaccination schedule. No further events were reported. The reporter agreed to be contacted for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 1 dose of Shingrix and second dose was not administered till the time of reporting, which led to incomplete course of vaccination. The reporter did not had more information regarding the situation as the patient contact them by phone to ask for recommendation. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: requesting 2nd dose, 1 year since 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient came in to pharmacy requesting second dose of Shingrix series, however it had been a year since the first dose was administered. Till the time off reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have lot number or expiration date for first dose. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter was office manager. The age at vaccination was not reported. The reporter called to report that, the patient was administered an expired dose (10 days after expiration date) of Boostrix, which led to expired vaccine used. The reporter did not consent to follow-up. The reporter stated that she did not want to report anything.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-b; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HBV (Engerix B pediatric) (batch number yl2l3, expiry date 14th October 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. but it could be 2 or 3 years The patient received an expired dose of Engerix-b, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg; Tingling in leg; Walking on it feels weak; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak). At the time of the report, HYPOAESTHESIA (I have numbness and tingling in leg, walking on it feels weak/ I cant put pressure on my leg/bottom part of leg), PARAESTHESIA (Tingling in leg) and ASTHENIA (Walking on it feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.  The patient had numbness and tingling in her leg, along with weakness. The patient wanted to know if this was a normal side effect of the Moderna COVID-19 vaccine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Influenza like illness, Lymph node pain, Myalgia
Clinical narrative: Patient thought she had a flu; Freezing and couldn't get warm; Her arm was about to kill her; Fever of 101; Chills; Nauseated; Body aches from her toes to her head; The lymph node under her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101), CHILLS (Chills), NAUSEA (Nauseated), MYALGIA (Body aches from her toes to her head) and LYMPH NODE PAIN (The lymph node under her left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101), CHILLS (Chills), NAUSEA (Nauseated), MYALGIA (Body aches from her toes to her head) and LYMPH NODE PAIN (The lymph node under her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.  Patient  thought she was going to die Saturday and yesterday(Friday). patient thought she had COVID. The patient states she is feeling better today 18Oct2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient thought she had a flu; Freezing and couldn't get warm; Her arm was about to kill her; Fever of 101; Chills; Nauseated; Body aches from her toes to her head; The lymph node under her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101), CHILLS (Chills), NAUSEA (Nauseated), MYALGIA (Body aches from her toes to her head) and LYMPH NODE PAIN (The lymph node under her left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Patient thought she had a flu), FEELING COLD (Freezing and couldn't get warm), PAIN IN EXTREMITY (Her arm was about to kill her), PYREXIA (Fever of 101), CHILLS (Chills), NAUSEA (Nauseated), MYALGIA (Body aches from her toes to her head) and LYMPH NODE PAIN (The lymph node under her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.  Patient  thought she was going to die Saturday and yesterday(Friday). patient thought she had COVID. The patient states she is feeling better today 18Oct2021.
Age: 62.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: FLUZONE HIGH DOSE QUADRIVALENT was administered to a patient instead of FLUBLOK QUADRIVALENT; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00816793) and transmitted to Sanofi on 18-Oct-2021.  This case involves a 62-year-old female patient who received a 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ747AB and expiry date 30-Jun-2022) via intramuscular route in the left deltoid on 01-Oct-2021 for prophylactic vaccination instead of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered multiple FLUZONE QUADRIVALENT vaccines that were expired at an employee health clinic with no adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00817224.  This case involves an unknown age and unknown gender patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Expired product administered).   The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Solution for injection   lot number and expiry date not reported via unknown route in unknown administration site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "He states that none of the employees received any other vaccines concomitantly. He does not have individual patient information or lot number at hand, accepts follow-up contact to provide details if desired."  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.