chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood albumin decreased, Blood immunoglobulin G, Blood iron decreased, Blood test
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid, Burning sensation, C-reactive protein increased, Carbon dioxide increased, Complement factor C4
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Computerised tomogram pelvis abnormal, Computerised tomogram thorax abnormal, Dizziness, Eosinophil count increased
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Erythema nodosum, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hepatic lesion, Immune-mediated adverse reaction, Inflammatory marker increased, Insomnia
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Iron binding capacity total decreased, Laboratory test abnormal, Lethargy, Lymphocyte count decreased, Mean cell haemoglobin concentration normal
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count increased, Musculoskeletal stiffness, Neutrophil count increased, Nodule, Pain in extremity
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pericardial effusion, Peripheral swelling, Platelet count decreased, Platelet count increased
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, Rash, Red blood cell count decreased, Red blood cell sedimentation rate increased, Retroperitoneal lymphadenopathy
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Skin discolouration, Tenderness, Transferrin saturation decreased, Vitamin D
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: About 1 1/2 months after my vaccine, I started having a severe headache just over my left eye. The area of pain never moved. About three weeks after that, I still had the headache but also started having a racing heart and palpitations. I went in to an urgent care clinic on November 24, 2021 and it showed my labs were off. My primary care doctor received a copy of my labs and then messaged me and told me to go to the ER if I experienced any problems with dizziness, lethargy. The doctor gave me a referral to a hematologist and rheumatologist. I saw the hematologist on 12-28 and at that time I had burning and very swollen hands and feet with my hands being white and stiff, especially at night. I also had small tender nodules with rash on my lower legs. He ordered CT scan of my chest, neck, abdomen and pelvis as well as ordering labs. He diagnosed me as having erythema nodosum on lower legs. On 1-7-2022 I went to the rheumatologist and she said said it was possible that I was having some kind of post viral hyperactive immune response. She said I needed further workup for Sarcoidosis or other auto immune disease. She ordered bloodwork. I had a telehealth visit with the hematologist on 1-28-2022. He had me take oral iron but I could not tolerate it well so i was given the iron by IV. On April 18, 2022 I went to the local ER with continued burning and pain at joints in ankles, feet and hands and a headache. They prescribed gabapentin but I did not ever start taking that. I did have blood drawn. They suggested neurology on an outpatient basis. I still suffer from headaches, insomnia, burning pain at my joints in my hands, ankles, feet and wrist. I am still having labs drawn periodically due to continued high levels of inflammation markers.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: the Moderna  vial was taken out of the fridge and left at room temperature for about 25 hours and got injected to patient by accident. Patient has not experienced any side effect yet
Age: 39.0
Sex: F
Vaccine: HPV9, PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Joint range of motion decreased, Sleep disorder
Clinical narrative: The day after vaccination, the patient felt pain in her left shoulder and "couldn't move [her] shoulder" for a few days. Over time, she was able to elevate and abduct her arm to about 90 degrees, but not further. Now 3 months out, she has full ROM of her arm with only intermittent pain, but cannot sleep on her left side due to shoulder pain.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Musculoskeletal disorder, Spinal operation, Walking aid user
Clinical narrative: In april my right leg began dropping out from under me frequently. Had back surgery on may 12, 21 with minimal relief. Havd been in physical therapy times 1-year with only fair tesults. Now walk with walker.
Age: 19.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Cold sweat, Loss of consciousness, Nausea
Clinical narrative: As patient was waiting the required 15 minutes after receiving her COVID booster, the patient reported passing out in her chair. Neither her nor her companion alerted staff until she came to. The patient stated she did not fall out of her chair but slumped in it, came to, had cold sweats and felt like she need to vomit but did not. Once staff was alerted, we went straight to her to see how she was doing. Patient said she was "fine." Companion stated she had not eaten anything since early this morning. Gave patient a sucker for sugar and asked her to wait an additional 15 minutes. After the additional 15 minutes patient stated she felt better and left the property.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Feeling cold, Nausea, Pallor
Clinical narrative: 2 minutes after immunization patient became pale, cool, clammy and nauseous. No LOC Patient was placed in recovery position to rest. Approx 15 minutes later patient was able to drink water, sit up and ambulate with out assistance. Mother advised to take child to ER or call EMS should symptoms return. VAERS report completed.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: The wrong pfizer vial was grabbed from the refrigerator and a pediatric pfizer dose was administered to an adult this morning. When the wrong vial was drawn up, the regular pfizer vaccine label was attached to the syringe. The patient received less than the recommended 30mcg per dose of the adult vaccine. Based on CDC Interim Clinical Considerations, we told the patient that she can return for a repeat dose today. Pt said she will come back tonight.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Erythema, Fatigue, Nausea, Pain
Clinical narrative: REDNESS, SWELLING, ITCHING, PAIN OCCURRED WITHIN 10 HOURS OF THE VACCINE. DIARRHEA, NAUSEA, FATIGUE
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHING, PAIN OCCURRED WITHIN 10 HOURS OF THE VACCINE. DIARRHEA, NAUSEA, FATIGUE
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PFIZER 12+ VACCINES DOSE ADMINISTERED PAST APPROVED EUA EXPIRATION/BEYOND USED DATE
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Laboratory test, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Ear infection within a few days; amoxicillin did not clear up, needed a second antibiotic, 2 week dose of cefprozil
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PFIZER 12+ VACCINES DOSE ADMINISTERED PAST APPROVED EUA EXPIRATION/BEYOND USED DATE
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The wrong pfizer vial was grabbed from the refrigerator and an undiluted pediatric pfizer dose was administered to an adult. When the wrong vial was drawn up, the regular pfizer vaccine label was attached to the syringe. Pt received less than the recommended 30mcg per dose of the adult vaccine. Based on CDC Interim Clinical Considerations, we told the patient that she can return for a repeat dose today. Pt said she will come back tonight.
Age: 55.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Discharge, Injection site pruritus, Injection site pustule, Injection site reaction, Rash pustular
Clinical narrative: redness, itching, small pustules in a 1" diameter circle at injection site lasting more than 4 days;  on 4th day, pustules erupted leaking clear fluid.  At this time patient is performing self care with antibiotic ointment and keeping site clean and covered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: The wrong pfizer vial was grabbed from the refrigerator and an undiluted pediatric pfizer dose was administered to an adult. When the wrong vial was drawn up, the regular pfizer vaccine label was attached to the syringe. Pt received less than the recommended 30mcg per dose of the adult vaccine. Based on CDC Interim Clinical Considerations, we told the patient that he can return for a repeat dose today. Pt said he will come back tonight.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse gave dose from the Moderna 6 years to 11-year-old COVID-19 vaccine vial. Dose given was correct at 0.25mL. Parent consulted and understood.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Crying, Diarrhoea, Vomiting
Clinical narrative: The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis.  Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home.  Baby was seen in the office today and appeared happy with a normal abdominal exam.  Passed a normal BM today.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months . Dose given was correct at 0.25 mL. Parent has been consulted and understands.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: About 5 minutes following administration of the vaccine, patient was walking and fainted. Quickly came to after lying down, taking soda and crackers.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months -5 years old. Dose given was correct at 0.25 mL. Parent was attempted to be contacted but does not answer the phone and does not have a voicemail box which has been set up.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Drooling, Seizure, Unresponsive to stimuli
Clinical narrative: He got a seizure on august 13, 2022. He was just staring at one place and then went unresponsive for few minutes. His right did not respond and started drooling. The whole seizure lasted for about 5 minutes.
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Injection site: pain, redness ? 100 mm, swelling ? 100 mm, a hard lump, and itching; fatigue; chills; a small amount of rash and on the body The side effects went away after around two weeks
Age: 28.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Injection site: pain, redness ? 100 mm, swelling ? 100 mm, a hard lump, and itching; fatigue; chills; a small amount of rash and on the body The side effects went away after around two weeks
Age: 19.0
Sex: F
Vaccine: YF, YF
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: YF incident. Faulty syringe. As soon as the plunger was pushed, the syringe started leaking and the syringe was immediately pulled out by pharmacist #1. Spoke to manufacturer and confirmed most likely patient did not get the vaccine. Confirmed patient and family to proceed ahead with a full dose (2nd shot) from pharmacist #2. Informed family of all the risks of not repeating a dose or getting shot #2 even if there was a slight chance of getting a bit of the vaccine from shot 1.
Age: 19.0
Sex: F
Vaccine: YF, YF
Symptoms: Peripheral swelling, Swelling, Syringe issue
Clinical narrative: YF incident. Faulty syringe. As soon as the plunger was pushed, the syringe started leaking and the syringe was immediately pulled out by pharmacist #1. Spoke to manufacturer and confirmed most likely patient did not get the vaccine. Confirmed patient and family to proceed ahead with a full dose (2nd shot) from pharmacist #2. Informed family of all the risks of not repeating a dose or getting shot #2 even if there was a slight chance of getting a bit of the vaccine from shot 1.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear, nose and throat examination, Fall, Gait disturbance
Clinical narrative: Have started falling and unstable. Went to doctor and referred me to PT. Pt has referred me to ENT. I am concerned the vaccine has started some kind of autoimmune process where autoantibodies are attacking vestibular nerve.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blood test, Disturbance in attention, Dry mouth, Fatigue
Clinical narrative: red rashes upper chest fron t and upper back, red rashes on neck and face dry mouth (no salaviya) excess was on face, on nose, and on ear fatigue and tiredoness loss of focus and memory loss declining vision
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Visual impairment
Clinical narrative: red rashes upper chest fron t and upper back, red rashes on neck and face dry mouth (no salaviya) excess was on face, on nose, and on ear fatigue and tiredoness loss of focus and memory loss declining vision
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: About a month after I got my booster, I started breaking out in hives daily on different parts of my body. It happened every evening for a few months. I started taking Claratin and that stopped the outbreaks but if I don't take that daily, they come back. They are gone by morning.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nervousness, Swelling
Clinical narrative: Pt states she felt shakey immediately after receiving vaccines. Later the same dat her Left arm became red, swollen and warm at injection site.  08/12/2022 UPDATED *Pt went to Emergency dept for continued swelling yesterday 08/11. Today improving
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Narrative: Pt received a zoster vaccine on 3/17/2016 at Primary Care Clinic. On 3/18/2016 pt presented to ER with swollen upper lip. Pt was given oral prednisone & oral diphenhydramine to continue at home for 5 days and discharge home. Condition resolved. Primary Care provider flagged pt's chart on 7/28/2022 with history of this ADR.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis, Housebound, Peripheral swelling, Vomiting
Clinical narrative: Narrative:  Patient 93 year old home bound - received 4th dose on 7/22/22. Had very swollen arm after injection, ws admitted to hospital 3 days later with vomitting due to colitis exacerbation
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Narrative:  hospice
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Hyperlipidaemia, Intensive care unit acquired weakness
Clinical narrative: Narrative: 76yo male patient died on 7/6/2022 of unknown cause. Pt was last known to have transfered to community nursing facility on 6/14/2022 per medical chart note on 6/14/22 to medical facility. Pt with the following problem list: PROBLEM LAST PROVIDER Seen by palliative care medicine service (03/10/2022) (ICD-10-CM Z51.5) Critical illness myopathy 02/25/2022 (ICD-10-CM G72.81) Hyperlipidemia (ICD-10-CM E78.5) 12/15/2016 Cardiomyopathy (ICD-10-CM I42.9) 12/07/2016 Chronic atrial fibrillation 08/10/2016 (ICD-10-CM I48.1) Diabetic neuropathy (ICD-10-CM 06/02/2016 E11.40) Type 2 diabetes mellitus 11/30/2015 (ICD-10-CM E11.65) Male hypogonadism (ICD-10-CM 11/30/2015 E29.1) Chronic post-traumatic stress disorder (11/03/2015) (ICD-10-CM F43.12) Degeneration of lumbar intervertebral disc (11/02/2015) (ICD-10-CM M51.36) Iron deficiency anemia (ICD-10-CM 03/28/2018 D50.9) Congestive heart failure 12/19/2015 (ICD-10-CM I50.42) Spinal stenosis of lumbar region 06/13/2019 (ICD-10-CM M48.062) Osteoarthrosis, unspecified whether generalized 11/27/2017 or localized, involving lower leg (ICD-10-CM M17.9) Major Depressive Disorder, Recurrent Episode, 05/03/2016 Moderate Degree (ICD-10-CM F33.1) Coronary Atherosclerosis (unspecified type 01/14/2016 vessel, native or graft) (ICD-10-CM I44.0) (ICD-10-CM E66.9); Obesity 11/30/2015 (ICD-10-CM I25.10); Coronary artery disease 12/19/2015 (ICD-10-CM N18.3); Chronic kidney disease 12/15/2016 (ICD-9-CM V45.81); Postsurgical Aortocoronary 10/19/2011 Bypass Status (ICD-9-CM V45.81) (ICD-10-CM G47.30); Sleep apnea 12/15/2016) Essential Hypertension (ICD-10-CM 11/30/2015 I10) Gout (ICD-10-CM M10.9), Onset 02/15/2019 00/00/1992 Diverticulosis, colon (ICD-9-CM 562.10), Onset 02/16/1996 00/00/1992 Acute myocardial infarction, of other inferior 02/16/1996 wall, initial episode of care (ICD-9-CM 410.41), Onset 00/00/1992 Pt had received a covid vaccine on 5/26/2021 (Covid Vaccine EUA J&J). Death appears unrelated to patient's death given pt's age, medical problem list & long length of time between death & date covid vaccine was given.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Rash
Clinical narrative: Narrative:  Pt received Zoster Shingles vaccine on 7/15/22. On 7/15/22. On 7/17/22 around midnight pt experienced lip swelling and rash. Pt presented to ER dept early morning of 7/18/22. Pt was treated with famotidine iv, diphenhydramine iv, & methylprednisolone ivp. Pt was admitted to hospital for monitoring but discharged home with EpiPen & Oral Prednisone Rx same day. MD flagged chart with ADR.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Chest wall mass
Clinical narrative: Narrative: had lumps all over his chest and his axilla after receiving vaccine. he did not receive second dose as he was against it by his provider.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: Narrative: Patient says he got the 1st Pfizer COVID vaccine 10/6/21, then went in to respiratory arrest 10/9/2021. He says he was admitted to an outside hospital for 3 days and will have records sent to the hospital. He says he was treated with steroids and a zpak. He says he was not intubated.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Narrative: unknown cause of death
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Nasal congestion, Productive cough, Pyrexia
Clinical narrative: Narrative: 63 year old male admitted on July 31 2022 with cough, clear sputum, low graede fever and nasal congestion. He had received Moderna vaccine x 4 on December 28 2020, January 25 2021, October 29 2021, June 9 2022. He was treated with remdesivie 200 mg IV x 1 then 100 mg daily x 2 days and dexamethamethasone 6 mg daily x 5 days. He rapidly improved and transferred from acute care unit on 8/2/22.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Vomiting
Clinical narrative: Narrative: Pt experienced n/v and arm swelling after vaccine
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Batch/Lot number: unknown), in Sep2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Aug2022, outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: did a home test that was positive in less than a minute.  Clinical course: Warm transfer from (Withheld) with Database of caller who mentioned had overdosed in his first COVID-19 vaccine booster and was advised he doesn't need a second booster and now he tested positive for COVID. Caller confirms above details and said he did report the overdose previously. He said the first two Pfizer vaccines were given in Sep2021 and he got the booster and was given accidental overdose equivalent to four doses of Pfizer, which was fine with him, and he felt like he was the most vaccinated person on the planet. He says when the second booster became available no one there in Pfizer Medical Information would give him a yes or no answer and told him to consult his doctor who said it was probably not a good idea for him to get the booster. Somewhere between that the CDC was contacted last year when it happened and either Pfizer or his doctor said if he gets COVID to call you guys, and he has it. He said his girlfriend has COVID and is on antiviral and a Z-pak and cough medicine already, no further details provided about his girlfriend. He says this morning he woke up sick and did a home test that was positive in less than a minute. so his doctor was calling all that stuff in for him, he was very sick. He said he hoped having had a quadruple booster dose would lessen symptoms or keep him from getting it but he is aching, coughing, and sick. Caller doesn't clarify what other symptoms he was having for call handler as he abruptly had to go and was unable to complete report at this time after providing contact details.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101278205 same patient, different vaccine dose/event;US-PFIZER INC-202101278057 same patient, different vaccine dose/event;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blister, Compression garment application, Diuretic therapy, Erythema
Clinical narrative: Got shot on Monday. On Wednesday she noticed a sudden pain in her back that spread all over and became worse thru the night. The next morning it was worse, especially in her feet.  She also experienced a terrible headache that lasted for days.  Then her legs began to swell so severely that she went to the local Med Center where she was treated with daily injections of Rocephin and oral antibiotics.  They tried other antibiotics over the next few months.   The swelling never improved and she describes blisters that arose on the tops of her feet.  Since then she has had to continuously wear compression wraps and a tall 'boot' with a compression pump to help relieve the swelling.  In addition, she has to take diuretics on a daily basis to help lessen the swelling.  She notices that during the worst episodes of swelling the leg becomes very red and inflamed.  Since the condition has worsened over the past several months the doctors have diagnosed her with lymphedema and have prescribed the compression wraps and 'boot' for another 6 months in an attempt to get the swelling to subside.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Lymphoedema, Pain, Pain in extremity
Clinical narrative: Got shot on Monday. On Wednesday she noticed a sudden pain in her back that spread all over and became worse thru the night. The next morning it was worse, especially in her feet.  She also experienced a terrible headache that lasted for days.  Then her legs began to swell so severely that she went to the local Med Center where she was treated with daily injections of Rocephin and oral antibiotics.  They tried other antibiotics over the next few months.   The swelling never improved and she describes blisters that arose on the tops of her feet.  Since then she has had to continuously wear compression wraps and a tall 'boot' with a compression pump to help relieve the swelling.  In addition, she has to take diuretics on a daily basis to help lessen the swelling.  She notices that during the worst episodes of swelling the leg becomes very red and inflamed.  Since the condition has worsened over the past several months the doctors have diagnosed her with lymphedema and have prescribed the compression wraps and 'boot' for another 6 months in an attempt to get the swelling to subside.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Got shot on Monday. On Wednesday she noticed a sudden pain in her back that spread all over and became worse thru the night. The next morning it was worse, especially in her feet.  She also experienced a terrible headache that lasted for days.  Then her legs began to swell so severely that she went to the local Med Center where she was treated with daily injections of Rocephin and oral antibiotics.  They tried other antibiotics over the next few months.   The swelling never improved and she describes blisters that arose on the tops of her feet.  Since then she has had to continuously wear compression wraps and a tall 'boot' with a compression pump to help relieve the swelling.  In addition, she has to take diuretics on a daily basis to help lessen the swelling.  She notices that during the worst episodes of swelling the leg becomes very red and inflamed.  Since the condition has worsened over the past several months the doctors have diagnosed her with lymphedema and have prescribed the compression wraps and 'boot' for another 6 months in an attempt to get the swelling to subside.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Laboratory test, Motor dysfunction, Neuropathy peripheral, Vomiting
Clinical narrative: Developed idiopathic neuropathy after receiving booster; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "polycythemia" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; METOPROLOL. Vaccination history included: BNT162b2 (dose number=2, lot number=EL0142, administration date=05Jan2021, vaccine location=Right arm), administration date: 05Jan2021, when the patient was 67-year-old, for COVID-19 immunization; coviD-19 vaccine (dose number=1, lot number=EH9899, administration date=18Dec2020, vaccine location=Right arm), administration date: 18Dec2020, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (hospitalization, disability, medically significant) with onset 15Oct2021, outcome "not recovered", described as "Developed idiopathic neuropathy after receiving booster". The patient was hospitalized for neuropathy peripheral (hospitalization duration: 30 day(s)). The event "developed idiopathic neuropathy after receiving booster" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical course: it was reported that, Other vaccine same date details [{other vaccine same date product= Pfizer, other vaccine same date lot number=F1E3590, other vaccine same date vaccine date=14Oct2021, other vaccine same date dose number=1, other vaccine same date vaccine location=Right arm}]. Patient did not received any other vaccine in four weeks. AE was resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Patient was in hospital for a month. Had to take physical therapy in order to walk.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event NEUROPATHY PERIPHERAL and BNT162B2.  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.