chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Parent reported pt only had 1 dose of covid vaccine, Nurse checked in system vaccine record showed pt had 1 dose of covid19 vaccine Dad brought vaccine record back to the office after visit and nurse noticed that pt already received the 2nd dose of covid vaccine. pt received the booster 5 weeks earlier than protocol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Cough, Decreased appetite, Fatigue
Clinical narrative: I had a scratchy throat on July 11th and then on the 12th I was feeling very bad and took a home test and it came out positive. I called my primary care office after testing positive. However they stated that I needed to be seen by a physician before being able to be given PAXLOVID. We talked about options and once she found out that I was on XARELTO I could not do that and then instead I was given the monoclonal antibodies. I did have a fever, low grade, terrible headache, and fatigue. I had no appetite, and I did start to vomit from Wednesday the 13th of July to the 15th of July. I was kept in bed for the whole day each day. Temperature got up to about 101 and on Friday the 15th I was able to receive the infusion. I am still having some symptoms such as coughing, and constantly trying to clear my throat. I did see my primary care doctor again and they stated that they did hear some wheezing so I did receive a steroid inhaler that doesn't help much. The general fatigue is unfortunately still lingering as well. I did retest myself and they came out negative twice.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Mobility decreased, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a scratchy throat on July 11th and then on the 12th I was feeling very bad and took a home test and it came out positive. I called my primary care office after testing positive. However they stated that I needed to be seen by a physician before being able to be given PAXLOVID. We talked about options and once she found out that I was on XARELTO I could not do that and then instead I was given the monoclonal antibodies. I did have a fever, low grade, terrible headache, and fatigue. I had no appetite, and I did start to vomit from Wednesday the 13th of July to the 15th of July. I was kept in bed for the whole day each day. Temperature got up to about 101 and on Friday the 15th I was able to receive the infusion. I am still having some symptoms such as coughing, and constantly trying to clear my throat. I did see my primary care doctor again and they stated that they did hear some wheezing so I did receive a steroid inhaler that doesn't help much. The general fatigue is unfortunately still lingering as well. I did retest myself and they came out negative twice.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Throat clearing, Throat irritation, Vomiting, Wheezing
Clinical narrative: I had a scratchy throat on July 11th and then on the 12th I was feeling very bad and took a home test and it came out positive. I called my primary care office after testing positive. However they stated that I needed to be seen by a physician before being able to be given PAXLOVID. We talked about options and once she found out that I was on XARELTO I could not do that and then instead I was given the monoclonal antibodies. I did have a fever, low grade, terrible headache, and fatigue. I had no appetite, and I did start to vomit from Wednesday the 13th of July to the 15th of July. I was kept in bed for the whole day each day. Temperature got up to about 101 and on Friday the 15th I was able to receive the infusion. I am still having some symptoms such as coughing, and constantly trying to clear my throat. I did see my primary care doctor again and they stated that they did hear some wheezing so I did receive a steroid inhaler that doesn't help much. The general fatigue is unfortunately still lingering as well. I did retest myself and they came out negative twice.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 11 years old at time of vaccine administration. Patient received the Pfizer Covid vaccine for ages 12 and up.  Patient's mother listed incorrect DOB on consent form, this mistake made him 12 years old when he was actually 11 years old.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed acute tinnitus in right ear which is constant ringing noise. The start was since Feb 2022
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received 2nd booster when not indicated for her age group
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Feeling hot, Malaise, Pain in extremity
Clinical narrative: Patient stated his arm was already sore and that he didn't feel very well. He stated he was short of breath and feeling hot. He tried to stand up and fell to the ground. He did not lose consciousness and was immediately given a dose of PO diphenhydramine liq 50 mg. He was taken to the ER for further observation. The ER doctor states that his diagnosis is a non-anaphylactic allergic reaction to the vaccine.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Patient reports continuous pain at the injection site for over 8 months now. She reports that some days are good and she doesn't feel anything but most days she is experiencing some level of pain and discomfort since the injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The Healthcare facility is working with the local dept. of health on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Full blood count, Headache, Injection site pain
Clinical narrative: Sudden nausea, headache, shaking 40 mins after vaccine Vomiting x1  Slight decreased in baseline BP 106/50 Reports injection was painful  NO LOC  Sx Resolved after NS Bolus 1000ml NO Epinephrine given Suspect vasovagal response
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Metabolic function test, Nausea, Presyncope, Tremor, Vomiting
Clinical narrative: Sudden nausea, headache, shaking 40 mins after vaccine Vomiting x1  Slight decreased in baseline BP 106/50 Reports injection was painful  NO LOC  Sx Resolved after NS Bolus 1000ml NO Epinephrine given Suspect vasovagal response
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, Cardiac disorder, Cardiac function test, Cardiac operation
Clinical narrative: August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Computerised tomogram, Cough, Dizziness
Clinical narrative: August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Fibrin D dimer increased, Gait disturbance
Clinical narrative: August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Implantable defibrillator insertion, Laboratory test abnormal, Myocardial infarction
Clinical narrative: August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Oxygen saturation decreased, Pyrexia, X-ray
Clinical narrative: August 23rd I came down with a high fever, cough, chills, hard to breath, low oxygen levels, joint pain, dizziness. Hard to walk. August 28th wife called an ambulance due to breathing, was admitted which followed testing and labs with ekg, blood work and remdesivir. Which information wasn?t identified as harmful longtime to my health, nor was the vaccine for Covid-19. Notes state myocarditis occurred and caused heart attack, that later my wife found after reviewing medical records. I have went through numerous testing with my heart. I?ve accumulated hospital bills and medical. I?ve had three heart procedures that have resulted in a defibrillator and pacemaker for permanent heart damage since my janssen shot. I continue to stay fatigue, have joint pain, headaches that have intensived daily, chest pain. This has caused me my health and work that I?ve done since high school. EDM Machines that is my lively hood, that I can no longer operate with my ICD, which I?ve never had any heart problems and had been tested in 2019 for without any problems.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Pain in extremity
Clinical narrative: On 07/14/2022 few minutes of the vaccine I had a sore arm ; fatigue; dry cough and on 07/15/2022 low grade fever and headache.  I tested positive on 07/15/2022  with a PCR test at work . On the same day 07/15/2022  I did a telehealth with a nurse. She didn't prescribed me with any medication but she advised me to  treat it as a cold. So, I  took Tylenol for 3 days it depended on the symptoms I had.  When my symptoms were gone I stopped taking Tylenol.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On 07/14/2022 few minutes of the vaccine I had a sore arm ; fatigue; dry cough and on 07/15/2022 low grade fever and headache.  I tested positive on 07/15/2022  with a PCR test at work . On the same day 07/15/2022  I did a telehealth with a nurse. She didn't prescribed me with any medication but she advised me to  treat it as a cold. So, I  took Tylenol for 3 days it depended on the symptoms I had.  When my symptoms were gone I stopped taking Tylenol.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Cellulitis, Erythema, Inflammation, Oedema
Clinical narrative: Progressively enlarging area of erythematous inflammation on the L upper arm with accompanying fever, occurring within two days after administration of the pneumococcal vaccine to the LUE (8/5/2022). Physical exam findings (erythema with poorly demarcated borders, overlying area of small blisters (which developed 8/8), warmth to touch, mildly edematous) most consistent with cellulitis with vaccination as suspected nidus for infection. Patient prescribed a 10-day course of antibiotics, with plan for close follow up in clinic in 2 weeks. Patient provided with strict return precautions.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Skin warm
Clinical narrative: Progressively enlarging area of erythematous inflammation on the L upper arm with accompanying fever, occurring within two days after administration of the pneumococcal vaccine to the LUE (8/5/2022). Physical exam findings (erythema with poorly demarcated borders, overlying area of small blisters (which developed 8/8), warmth to touch, mildly edematous) most consistent with cellulitis with vaccination as suspected nidus for infection. Patient prescribed a 10-day course of antibiotics, with plan for close follow up in clinic in 2 weeks. Patient provided with strict return precautions.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Health Dept. and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient states had a seizure after 3rd Pfizer dose based on what her husband observed. She went to the doctors office and they found nothing.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical facility consulted with the Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: None Diagnosed with COVID, 9 months after administration of vaccine #3. Diagnosed with COVID, 5 months after administration of vaccine #4.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Influenza like illness, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Posive COD Rapid test from a pharmacy 5/7/2021  sore throat, flu like symptomes elivated temperature
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Pallor, Vomiting
Clinical narrative: Approximately 5 minutes after receiving patient vomited x1, became pale, dizzy. She also was slightly hypotensive with BP 85/62, pulse 60-88 BPM. Patient was monitored for 30 minutes, rechecking vital signs every 5 minutes and monitored with a continuous pulse  ox. Oxygen saturation remained 98-99 % throughout, RR 18-20. 10:30 AM Patient's symptoms resolved and she reported feeling better. Patient left clinic with dad.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Rash, Tachycardia
Clinical narrative: Bilateral purpuric rash of lower legs; mild tachycardia.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient came to the pharmacy and said she wants to get her second shingrix dose and said she had her first dose in March. Patient called later to say that she had received a 3rd dose of the vaccine because she had received the first dose in December 2021 at another location. Patient was asked how she was doing today and she said she is ok, her arm is sore, but she is fine. She said she does not have a primary care physician.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Physician ordered HPV9 but immunization nurse administered Hep A. This error became evident during documentation. Dr. contacted patient's guardian to inform her of administration error and advised  guardian to RTC with patient to get HPV9 vaccine.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Has had memory lapses a few times during the 3:00pm hour.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: I had swollen lymph nodes in my neck and other areas of my body for 7 months or more after the booster shot.  I had to get 2 or 3 MRIs and at least two CT scans because the lymph nodes were bigger than normal.  The doctor did not do anything.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Per patient, he had not received any COVID-19 vaccines yet and this would be his first dose. After the mobile clinic, when entering the patient's information, it was found the patient was not truthful in regards to his vaccination status. He had actually received his primary series, 1st booster, and 2nd booster with Pfizer through a different pharmacy. His second booster was 7/23/2021 per the Immunization Registry.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Foreign travel, Malaise, SARS-CoV-2 test positive
Clinical narrative: Returned from away on Wednesday 7/27/22, I felt fine. On Saturday 7/30/22 I started coughing (dry hacking cough -on occasion). On Sunday 7/31/22 I was also coughing (dry hacking cough - on occasion but a little more frequent) I took an at-home covid test on 7/31/22 but it was negative. On Monday 8/1/22 still coughing, I took another at-home covid test - it was positive. On  Tuesday 8/2/22 I had a telehealth meeting with my Primary Care Physician,  I was prescribed a 5-day regiment of Merck's  Lagevrio 200mg. My coughing symptoms improved overnight and improved by next morning. Saturday 8/6/22 my symptoms are very mild, but I still tested positive. It is Tuesday 8/9/22 and I still have mild coughing on occasion.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Given second booster shot outside of protocol - no adverse events reported by patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Mild shortness of breath chest tightening sore arm sore throat fever bodyaches chills tingling in left arm where vaccine was given in the fingers stomach upset diarrhea
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Mild shortness of breath chest tightening sore arm sore throat fever bodyaches chills tingling in left arm where vaccine was given in the fingers stomach upset diarrhea
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received the vaccination indicated for children aged 6-11 instead of the one for 12 and older.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Blood thyroid stimulating hormone, Full blood count, Metabolic function test, Vitamin D
Clinical narrative: Pt reports hair thinning and falling out starting approx 2 months after getting the vaccine in 4/2020. Ongoing issue for which I saw him for the first time today.
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Blood creatine phosphokinase, Blood test
Clinical narrative: tendinitis and joint point not connected to current injury or overuse beginning with feet and ankles, then hands and wrists by 8/7, throughout body by 8/8. Dx 8/9 as polymyalgia rheumatica, blood work drawn and sent to lab; started diclofenac 75mg bid
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: C-reactive protein, Full blood count, Injury, Metabolic function test, Polymyalgia rheumatica
Clinical narrative: tendinitis and joint point not connected to current injury or overuse beginning with feet and ankles, then hands and wrists by 8/7, throughout body by 8/8. Dx 8/9 as polymyalgia rheumatica, blood work drawn and sent to lab; started diclofenac 75mg bid
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Tendonitis
Clinical narrative: tendinitis and joint point not connected to current injury or overuse beginning with feet and ankles, then hands and wrists by 8/7, throughout body by 8/8. Dx 8/9 as polymyalgia rheumatica, blood work drawn and sent to lab; started diclofenac 75mg bid
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary, Blood magnesium, Blood test abnormal, Blood thyroid stimulating hormone decreased, Cardiac monitoring
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Coronavirus test, Differential white blood cell count, Electrocardiogram, Full blood count
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Immunisation reaction, Influenza virus test, Pleurisy, SARS-CoV-2 test
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin I
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aortic disorder, Atelectasis, Dyspnoea, Myocardial infarction, Nasopharyngeal swab
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pericarditis, Pleurisy
Clinical narrative: Had COVID ARM immediately. It lasted one week. Second, more serious reaction occurred, unexpectedly, on August 6, 2022, it resulted in pleurisy in both lungs, with possible arteroseptal infarction, or myocardial infarction.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Oedema, Skin disorder
Clinical narrative: Severe edema with skin breakage
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Biopsy liver abnormal, Cardiac stress test abnormal, Catheterisation cardiac abnormal, Coronary artery bypass
Clinical narrative: 1.) Ischemic heart disease; abnormal stress test and cardiac cath; 3 vessel coronary artery by-pass graft surgery. 2.) Autoimmune hepatitis
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test abnormal, Myocardial ischaemia, Stress echocardiogram abnormal
Clinical narrative: 1.) Ischemic heart disease; abnormal stress test and cardiac cath; 3 vessel coronary artery by-pass graft surgery. 2.) Autoimmune hepatitis
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus
Clinical narrative: Patient started itching all over
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: 1 inch blister right lower leg, and 1/2 inch blister center upper back
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hyperhidrosis, Pain, Quarantine
Clinical narrative: I had congestions on my throat and back of my throat; very severe body aches. My body temperature remained normal throughout the disease. I had a lot of sweating. I was extremely tired. 07/19/2022 I went to the doctors office  where he did a COVID-19 test. On the 07/21/2022 I got the result which was positive and along with a prescription with PAXLOVID for 5 days. I started taking the medication on 07/22/2022. I also drank plenty of fluid including soups with fresh garlic. I had to quarantine for 10 days. I did a rapid test at a local country clinic after 10 day which was negative.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I had congestions on my throat and back of my throat; very severe body aches. My body temperature remained normal throughout the disease. I had a lot of sweating. I was extremely tired. 07/19/2022 I went to the doctors office  where he did a COVID-19 test. On the 07/21/2022 I got the result which was positive and along with a prescription with PAXLOVID for 5 days. I started taking the medication on 07/22/2022. I also drank plenty of fluid including soups with fresh garlic. I had to quarantine for 10 days. I did a rapid test at a local country clinic after 10 day which was negative.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chest pain, Laboratory test normal, Myocarditis, Pain
Clinical narrative: patient reported chest pain since couple of days after receiving vaccine. She did feel achy the following day. md had her take meloxicam for pain.  It was not helping so md gave rx for colchicine. She stated she is doing better but still having chest pain. Pt was diagnosed with pericarditis. She has experienced some abdominal pain possibly due to meloxicam. md is treating for 3 months to control inflammation around heart.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pericardial rub, Pericarditis
Clinical narrative: patient reported chest pain since couple of days after receiving vaccine. She did feel achy the following day. md had her take meloxicam for pain.  It was not helping so md gave rx for colchicine. She stated she is doing better but still having chest pain. Pt was diagnosed with pericarditis. She has experienced some abdominal pain possibly due to meloxicam. md is treating for 3 months to control inflammation around heart.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Feeling abnormal, Presyncope, Seizure
Clinical narrative: Patient received the vaccine. Patient got up, took a picture of the form she filled out with her phone to print out for school. Patient and her mother went to another isle in the pharmacy. After about 2 minutes, the pharmacy staff noticed that she was sitting on the ground holding her head. She stated that she felt funny, dizzy and about to pass out. We moved her to the pharmacy shot booth where she had about a 20-30 second seizure. We contacted EMS during this time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, exhaustion, headache
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: The patient on days 3-5 of receiving vaccine notice hives, itching occurring and outbreaks on arms, back legs, and buttocks.  Patient referred to PCP for follow up. Also recommended Benadryl or Claritin and Aveeno Oatmeal Colloidal Shower Gel and Lotion to be administered until further discussion with PCP.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Sore throat  fever cough   treated with Prednisone 10 Mg for 7 days andPromethazine 5 Ml  as needed
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative
Clinical narrative: Sore throat  fever cough   treated with Prednisone 10 Mg for 7 days andPromethazine 5 Ml  as needed
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Urticaria
Clinical narrative: Approximately 3-4 hours post injection I experienced hives, shortness of breath, extreme dizziness and a very high heart rate of 120. I am still currently experiencing those symptoms.
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site mass, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Sore arm to touch 5 days after vaccination, warm to touch, lump near injection site, headache
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Cognitive disorder, Computerised tomogram thorax, Dysgraphia
Clinical narrative: Stroke affecting speech & cognitive thinking.  A Thrombectomy was performed by a doctor at hospital.  I was not able to speak, write, or type in any way that was understandable by anyone.  I also had weakness on the right side of my body.  After the procedure, I was kept in the hospital for 5 days to try determine the cause & to evaluate any necessary therapy needs.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Hemiparesis, Implantable cardiac monitor insertion, Mental impairment, Speech disorder
Clinical narrative: Stroke affecting speech & cognitive thinking.  A Thrombectomy was performed by a doctor at hospital.  I was not able to speak, write, or type in any way that was understandable by anyone.  I also had weakness on the right side of my body.  After the procedure, I was kept in the hospital for 5 days to try determine the cause & to evaluate any necessary therapy needs.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombectomy
Clinical narrative: Stroke affecting speech & cognitive thinking.  A Thrombectomy was performed by a doctor at hospital.  I was not able to speak, write, or type in any way that was understandable by anyone.  I also had weakness on the right side of my body.  After the procedure, I was kept in the hospital for 5 days to try determine the cause & to evaluate any necessary therapy needs.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery stenosis, Condition aggravated, Lumbar spinal stenosis, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: Right Carotid Artery Stenosis Lumbar Stenosis
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Vaccination error
Clinical narrative: patient did not have an adverse reaction.  he was received a vaccine that he was not due for. he had been vaccinated in feb of 2022
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered 2nd booster to patient under age 50 (43yrs).  No resulting adverse event known.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered second booster dose to pt under age 50 (44 yrs) - no adverse outcomes known
Age: 60.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient had swelling, Redness and a large know at site of injection. It had grown in area over 5 days. Patient was treated by a Dr with a steroid and antibiotic.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo administered after freezing exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The patient received Menveo that had been stored in the freezer. The reporter did not want MI to store information in MI database. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo that had been stored in the freezer, which led to incorrect storage of vaccine. This case had been linked with US2022AMR115730 and US2022AMR115729, reported by the same reporter.  ; Sender's Comments:  US-GSK-US2022AMR115730:Same reporter. Patient 3 US-GSK-US2022AMR115729:Same reporter. Patient 2
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness, Vaccination site reaction
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 07-APR-2021, the patient experienced adverse reaction at vaccination site. On an unspecified date, the patient experienced trouble breathing, and felt my throat like closing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reaction at vaccination site, trouble breathing and felt my throat like closing up was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Blood immunoglobulin A increased, Chills, Electromyogram normal
Clinical narrative: 4 days after vaccine developed pins and needles, numbness on day 7, muscle twitching, chills, insomnia, tremors, pain right side of neck, skin rash on face which persists  IMPORTANT: It is not clear that the vaccine caused these symptoms directly but patient feels symptoms started soon after J&J vaccine above
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin normal, Hypoaesthesia, Insomnia, Intervertebral disc protrusion, Laboratory test abnormal
Clinical narrative: 4 days after vaccine developed pins and needles, numbness on day 7, muscle twitching, chills, insomnia, tremors, pain right side of neck, skin rash on face which persists  IMPORTANT: It is not clear that the vaccine caused these symptoms directly but patient feels symptoms started soon after J&J vaccine above
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Muscle twitching, Neck pain, Pain in extremity
Clinical narrative: 4 days after vaccine developed pins and needles, numbness on day 7, muscle twitching, chills, insomnia, tremors, pain right side of neck, skin rash on face which persists  IMPORTANT: It is not clear that the vaccine caused these symptoms directly but patient feels symptoms started soon after J&J vaccine above
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Scan with contrast normal, Small fibre neuropathy, Tremor
Clinical narrative: 4 days after vaccine developed pins and needles, numbness on day 7, muscle twitching, chills, insomnia, tremors, pain right side of neck, skin rash on face which persists  IMPORTANT: It is not clear that the vaccine caused these symptoms directly but patient feels symptoms started soon after J&J vaccine above
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B1, Vitamin B12 normal
Clinical narrative: 4 days after vaccine developed pins and needles, numbness on day 7, muscle twitching, chills, insomnia, tremors, pain right side of neck, skin rash on face which persists  IMPORTANT: It is not clear that the vaccine caused these symptoms directly but patient feels symptoms started soon after J&J vaccine above
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: I got fainted after the vaccine; Fevers; COVID-19 Rapid positive/ Covid; COVID-19 Rapid positive/ Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0167) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "COVID-19 Rapid positive/ Covid"; SYNCOPE (medically significant), outcome "unknown", described as "I got fainted after the vaccine"; PYREXIA (non-serious), outcome "recovered", described as "Fevers". The events "covid-19 rapid positive/ covid" and "fevers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (09Aug2021) Negative; (20Jan2022) Negative; (02Jun2021) Negative; (20Jan2022) Positive; X-ray: (22Dec2021) everything looks good; (18Jan2022) everything looks good. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia.  Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0167 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of for the reported lot. The final scope included the reported finished goods lot EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: I got fainted after the vaccine; Fevers; COVID-19 Rapid positive/ Covid; COVID-19 Rapid positive/ Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0167) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "COVID-19 Rapid positive/ Covid"; SYNCOPE (medically significant), outcome "unknown", described as "I got fainted after the vaccine"; PYREXIA (non-serious), outcome "recovered", described as "Fevers". The events "covid-19 rapid positive/ covid" and "fevers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (09Aug2021) Negative; (20Jan2022) Negative; (02Jun2021) Negative; (20Jan2022) Positive; X-ray: (22Dec2021) everything looks good; (18Jan2022) everything looks good. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia.  Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0167 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of for the reported lot. The final scope included the reported finished goods lot EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 28.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope, X-ray
Clinical narrative: I got fainted after the vaccine; Fevers; COVID-19 Rapid positive/ Covid; COVID-19 Rapid positive/ Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 29Apr2021 as dose 1, single (Lot number: EW0167) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "recovered" and all described as "COVID-19 Rapid positive/ Covid"; SYNCOPE (medically significant), outcome "unknown", described as "I got fainted after the vaccine"; PYREXIA (non-serious), outcome "recovered", described as "Fevers". The events "covid-19 rapid positive/ covid" and "fevers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (09Aug2021) Negative; (20Jan2022) Negative; (02Jun2021) Negative; (20Jan2022) Positive; X-ray: (22Dec2021) everything looks good; (18Jan2022) everything looks good. Therapeutic measures were not taken as a result of drug ineffective, covid-19, pyrexia.  Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EW0167 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of for the reported lot. The final scope included the reported finished goods lot EW0167, fill lot EP8698, and the formulated drug product lot EP8595. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Illness, Memory impairment, Mental impairment, Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick everyday ever since) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick everyday ever since). At the time of the report, ILLNESS (Sick everyday ever since) had not resolved. Concomitant product use was not provided by the reporter. Patient reported feeling sick the next morning after second primary dose of vaccine. He was sick everyday ever since. Patient was not diagnosed with or tested positive for COVID-19. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not receive any booster doses. Adverse event caused patient to seek primary care doctor and ER. The patient had not experienced a similar event in the past. Treatment information was not provided.