chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Full blood count, Headache, Nasal congestion, Pain
Clinical narrative: I had a really bad headache, deep crackling cough, short of breath. labored breathing a stuffy nose, fever. When I blew my nose nothing would come out. I hurt more than when I had open heart surgery. I got home from work on June 1, 2022 and took the COVID-19 test and it was an immediate positive. I went to the county drive through testing PCR COVID-19 test, I received my positive results on June 2, 2022. On June 2, 2022 I went to the Emergency Room because I was so short of breath and I had just had open heart surgery at the end of 2021. I was prescribed Paxlovid for my positive COVID-19 test results I started taking it that evening and am feeling better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, X-ray
Clinical narrative: I had a really bad headache, deep crackling cough, short of breath. labored breathing a stuffy nose, fever. When I blew my nose nothing would come out. I hurt more than when I had open heart surgery. I got home from work on June 1, 2022 and took the COVID-19 test and it was an immediate positive. I went to the county drive through testing PCR COVID-19 test, I received my positive results on June 2, 2022. On June 2, 2022 I went to the Emergency Room because I was so short of breath and I had just had open heart surgery at the end of 2021. I was prescribed Paxlovid for my positive COVID-19 test results I started taking it that evening and am feeling better.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient of 10 years of age was given the 12+ Pfizer Covid vaccine. Licensed Vocational Nurse administered vaccine on the left arm. Realized incorrect dosage when placing the vaccine. Failed to perform 3 safety checks per company policy. Patient did not experience any adverse affects. Patient was monitored for 15 min.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: WITHIN 5 MIN AFTER RECEIVING PEDIATRIC COVID-19 MODERNA VACCINE, PATIENT DEVELOPED SEVERAL RASH-LIKE RED SPOTS ON BOTH LOWER ARMS, BUT NOT AT THE INJECTION SITE. PATIENT SAID HIS BREATHING WAS FINE, AND NO ITCHINESS WHERE THE SPOTS WERE. MOM WAS ADVISED TO GIVE PATIENT BENADRYL WHEN GET HOME.   I SPOKE TO MOM ON THE PHONE AROUND 4PM--SHE SAID HER DAD GAVE PATIENT 2.5ML BENADRYL AND PATIENT IS DOING FINE.
Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills
Clinical narrative: CHILLS
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Differential white blood cell count, Electrocardiogram, Fibrin D dimer
Clinical narrative: Syncope, tachycardia, chest pain, began around 2:30am with syncope episode,  tachycardia and progressive chest pain followed, seen in ED for symptoms, treated with Tramadol and fluid bolus, referred for follow up
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Human chorionic gonadotropin, Metabolic function test, Syncope, Tachycardia
Clinical narrative: Syncope, tachycardia, chest pain, began around 2:30am with syncope episode,  tachycardia and progressive chest pain followed, seen in ED for symptoms, treated with Tramadol and fluid bolus, referred for follow up
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Syncope, tachycardia, chest pain, began around 2:30am with syncope episode,  tachycardia and progressive chest pain followed, seen in ED for symptoms, treated with Tramadol and fluid bolus, referred for follow up
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient is 6yo and was accidentally given a maroon cap pfizer dose of .2 which is meant for 6m-4yo patients. Patient should have received a 5yo-11yo pfizer orange cap vaccine due to her age group
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Consciousness fluctuating, Dyspnoea, Loss of consciousness, Pulse absent, Respiratory arrest
Clinical narrative: Pt presented to clinic for 3rd dose of Covid vaccine. After pt received the vaccine, she left the room and went to the front desk to talk to the PCT. She talked to the PCT for approx. 1-2 minutes and the PCT notified this NP that the Patient was saying she was Short of breath. I went to the front desk and the patient was in and out of consciousness. This NP, eased patient to the floor once patient went unconscious. This Np, examined pt for pulse using stethoscope and pulse oximeter, with no pulse noted or breathing. Next, I started CPR and told the PCT to call 911. I continued to perform high quality CPR for 2-3 minutes and the patient regained Consciousness almost simultaneous as the police and fire department arrived. Pt was alert, oriented, and talking with the police and her father arrived to the store. The patient  was confirmed to be breathing and noted to have a regular pulse prior to her being  placed on a stretcher by the fire and police department.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation
Clinical narrative: Pt presented to clinic for 3rd dose of Covid vaccine. After pt received the vaccine, she left the room and went to the front desk to talk to the PCT. She talked to the PCT for approx. 1-2 minutes and the PCT notified this NP that the Patient was saying she was Short of breath. I went to the front desk and the patient was in and out of consciousness. This NP, eased patient to the floor once patient went unconscious. This Np, examined pt for pulse using stethoscope and pulse oximeter, with no pulse noted or breathing. Next, I started CPR and told the PCT to call 911. I continued to perform high quality CPR for 2-3 minutes and the patient regained Consciousness almost simultaneous as the police and fire department arrived. Pt was alert, oriented, and talking with the police and her father arrived to the store. The patient  was confirmed to be breathing and noted to have a regular pulse prior to her being  placed on a stretcher by the fire and police department.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Discharge, Infection, Swelling
Clinical narrative: Stated as a bump that would not go away,  became infected June 1, 2022- w/puss.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test normal, Thyroid function test normal
Clinical narrative: Extreme hair loss has persisted since I received vaccination. No reasonable explanation for hair loss.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Anal pruritus, Swelling
Clinical narrative: On July 1 2022 I had the Shingrix shot and on July 2, 2022, I had severe, savage anal itching and the next day I had bumps on both buttocks. The savage itching lasted for about 4 days and then subsided. I went to Clinic on Thursday, July 07, 2022 and was examined by a nurse practitioner for intestinal worms and she said that I had none.  My illness was probably a reaction from the Shingrix injection. The NP prescribed a hydrochloride cream for my anal itching that had subsided, but I had a faint itch every now and then.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Catheterisation cardiac normal, Chest pain, Dyspnoea, Malaise
Clinical narrative: Developed chest pain, malaise and SOB in mid May seen in ER , MI ruled out, saw cardiologist and had cath which was negative,  continued symptoms, seen in ER again and  finally found to have pulmonary emboli.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Developed chest pain, malaise and SOB in mid May seen in ER , MI ruled out, saw cardiologist and had cath which was negative,  continued symptoms, seen in ER again and  finally found to have pulmonary emboli.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache lasting 2-3 days. Top of the head, back of the neck.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I was encouraged by a physician to report this interesting adverse event. I was diagnosed via rapid test with COVID-19 on June 29 and immediately began a course of Paxlovid. My symptoms were clear and I tested negative on day 5 after infection. On July 6th I received the Jynneos vaccine for monkeypox; I began feeling standard side effects the next day on July 7th. Shortly afterward, I experienced a "rebound" infection of COVID-19 which is ongoing; I suspect that the vaccination may have played a role in the rebound.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Fever Rapid heart beat
Age: 1.5
Sex: F
Vaccine: HEP, MMR
Symptoms: Crying, Decreased appetite, Drooling, Eye disorder, Fatigue
Clinical narrative: She came down with a fever (101) Sunday afternoon (May 22, 2022) and was acting like normal but she had less of an appetite and was more tired. On Monday, May 23, 2022 she was the same as yesterday and had no signs of a cold. At 2 PM she took a nap and had a 100.7 temperature. At 2:11 PM she began to have a febrile seizure. Her arms were rigid and she was shaking and drooling with her eyes fixed up and to the left. I removed her from her crib and laid her on her right side. The shaking lasted at least 3 minutes and during that time I called 911 and they were on the way. After the shaking, she still stayed laying on her right side with her eyes fixed up and to the left and she kept smacking her lips together and after 10 minutes she let out a cry and then continued to smack her lips. When the paramedics arrived she started crying and began yelling out baby (the word she knows how to say best) and mamamama (she never said the mmmm sounds) her arms were still slightly rigid and her eyes weren?t focused on anyone but still looking off to the left. We took the ambulance to our nearest hospital. Upon arrival, her temperature was101.7.  While in the care of the emergency room she finally snapped out of it and recognized me (this took almost 1 hour from the start of her seizure to her focusing on me and acting normal). They wanted to run tests to find the cause of the fever. They wanted to use a catheter to get a urine sample, blood draw from her arm, and an x ray. I declined all tests because she didn?t show any signs of a cold prior and I felt the cause of fever was from the MMR vaccine that she received 10 days prior to this incident. I told the doctor that the disease control says that a febrile seizure can happen 5-12 days after the first vaccine of the MMR but he refused to admit that could be the cause. By this time, they gave her some children?s tylenol (at 3:47 PM) and she was sleeping peacefully. We signed the needed paperwork to be discharged and went home. The next day, she was fever free and was back to her old self. She did not have any more seizures. She had a follow up appointment with her regular doctor and I filled him in with what happened. He agreed she had a febrile seizure but said it wasn?t because of the MMR vaccine because it was too far out from when she received it. I showed him what the disease control said about the 5-12 days after administration that a febrile seizure could happen and he finally said it was possible. He said usually when a child has one febrile seizure they could have another so now whenever she has a fever I am supposed to give her Tylenol to keep her temperature down.
Age: 1.5
Sex: F
Vaccine: HEP, MMR
Symptoms: Febrile convulsion, Muscle rigidity, Pyrexia, Screaming, Tardive dyskinesia
Clinical narrative: She came down with a fever (101) Sunday afternoon (May 22, 2022) and was acting like normal but she had less of an appetite and was more tired. On Monday, May 23, 2022 she was the same as yesterday and had no signs of a cold. At 2 PM she took a nap and had a 100.7 temperature. At 2:11 PM she began to have a febrile seizure. Her arms were rigid and she was shaking and drooling with her eyes fixed up and to the left. I removed her from her crib and laid her on her right side. The shaking lasted at least 3 minutes and during that time I called 911 and they were on the way. After the shaking, she still stayed laying on her right side with her eyes fixed up and to the left and she kept smacking her lips together and after 10 minutes she let out a cry and then continued to smack her lips. When the paramedics arrived she started crying and began yelling out baby (the word she knows how to say best) and mamamama (she never said the mmmm sounds) her arms were still slightly rigid and her eyes weren?t focused on anyone but still looking off to the left. We took the ambulance to our nearest hospital. Upon arrival, her temperature was101.7.  While in the care of the emergency room she finally snapped out of it and recognized me (this took almost 1 hour from the start of her seizure to her focusing on me and acting normal). They wanted to run tests to find the cause of the fever. They wanted to use a catheter to get a urine sample, blood draw from her arm, and an x ray. I declined all tests because she didn?t show any signs of a cold prior and I felt the cause of fever was from the MMR vaccine that she received 10 days prior to this incident. I told the doctor that the disease control says that a febrile seizure can happen 5-12 days after the first vaccine of the MMR but he refused to admit that could be the cause. By this time, they gave her some children?s tylenol (at 3:47 PM) and she was sleeping peacefully. We signed the needed paperwork to be discharged and went home. The next day, she was fever free and was back to her old self. She did not have any more seizures. She had a follow up appointment with her regular doctor and I filled him in with what happened. He agreed she had a febrile seizure but said it wasn?t because of the MMR vaccine because it was too far out from when she received it. I showed him what the disease control said about the 5-12 days after administration that a febrile seizure could happen and he finally said it was possible. He said usually when a child has one febrile seizure they could have another so now whenever she has a fever I am supposed to give her Tylenol to keep her temperature down.
Age: 1.5
Sex: F
Vaccine: HEP, MMR
Symptoms: Tremor
Clinical narrative: She came down with a fever (101) Sunday afternoon (May 22, 2022) and was acting like normal but she had less of an appetite and was more tired. On Monday, May 23, 2022 she was the same as yesterday and had no signs of a cold. At 2 PM she took a nap and had a 100.7 temperature. At 2:11 PM she began to have a febrile seizure. Her arms were rigid and she was shaking and drooling with her eyes fixed up and to the left. I removed her from her crib and laid her on her right side. The shaking lasted at least 3 minutes and during that time I called 911 and they were on the way. After the shaking, she still stayed laying on her right side with her eyes fixed up and to the left and she kept smacking her lips together and after 10 minutes she let out a cry and then continued to smack her lips. When the paramedics arrived she started crying and began yelling out baby (the word she knows how to say best) and mamamama (she never said the mmmm sounds) her arms were still slightly rigid and her eyes weren?t focused on anyone but still looking off to the left. We took the ambulance to our nearest hospital. Upon arrival, her temperature was101.7.  While in the care of the emergency room she finally snapped out of it and recognized me (this took almost 1 hour from the start of her seizure to her focusing on me and acting normal). They wanted to run tests to find the cause of the fever. They wanted to use a catheter to get a urine sample, blood draw from her arm, and an x ray. I declined all tests because she didn?t show any signs of a cold prior and I felt the cause of fever was from the MMR vaccine that she received 10 days prior to this incident. I told the doctor that the disease control says that a febrile seizure can happen 5-12 days after the first vaccine of the MMR but he refused to admit that could be the cause. By this time, they gave her some children?s tylenol (at 3:47 PM) and she was sleeping peacefully. We signed the needed paperwork to be discharged and went home. The next day, she was fever free and was back to her old self. She did not have any more seizures. She had a follow up appointment with her regular doctor and I filled him in with what happened. He agreed she had a febrile seizure but said it wasn?t because of the MMR vaccine because it was too far out from when she received it. I showed him what the disease control said about the 5-12 days after administration that a febrile seizure could happen and he finally said it was possible. He said usually when a child has one febrile seizure they could have another so now whenever she has a fever I am supposed to give her Tylenol to keep her temperature down.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient's left deltoid and surrounding area of injection site appears erythematous even after 1 month after injection. Patient had no reaction to the first dose back in March 2022.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria noted on trunk less than 24 hours after vaccine resolved with use of Benadryl.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Decreased appetite, Malaise, Nasal congestion
Clinical narrative: I began developing symptom on 22-Jun-2022 which began with general malaise and lack of appetite. The symptoms progressed to somnolence, cough, nasal congestion and fever the following day. I tested positive for COVID with a home nasal swab test on 24-Jun-2022. As of 6/30/2022, I was free of symptoms. I had the 2 vaccine series as well as the booster dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Somnolence
Clinical narrative: I began developing symptom on 22-Jun-2022 which began with general malaise and lack of appetite. The symptoms progressed to somnolence, cough, nasal congestion and fever the following day. I tested positive for COVID with a home nasal swab test on 24-Jun-2022. As of 6/30/2022, I was free of symptoms. I had the 2 vaccine series as well as the booster dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Pfizer COVID-19 vaccine (gray cap) booster dose administered to patient.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Malaise, Nausea, Pain in extremity, Pallor
Clinical narrative: Patient reports feeling ill, nausea, pain in left arm and pale, 5 minutes after receiving vaccination.  Remained under observation until 12:27, patient reports feeling better, doesn't report nausea or pale skin. Patient stable, walking and leaving the facility with legal guardian.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Patient was spiked with a fever of 100.8; felt crappy for 4 days with body aches & malaise.; felt crappy for 4 days with body aches & malaise.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 046C21A and 028L20A) for COVID-19 vaccination.     Patient had not had COVID as far as she knows.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8). At the time of the report, MALAISE (felt crappy for 4 days with body aches & malaise.) and PAIN (felt crappy for 4 days with body aches & malaise.) had resolved and PYREXIA (Patient was spiked with a fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8.         No concomitant medication were reported. It was reported that patient had very, very strong reactions to these vaccines. No treatment medication were reported.   This case was linked to MOD-2022-600690, MOD-2022-600693.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Malaise, Pain, Pyrexia
Clinical narrative: Patient was spiked with a fever of 100.8; felt crappy for 4 days with body aches & malaise.; felt crappy for 4 days with body aches & malaise.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001J21-2A, 046C21A and 028L20A) for COVID-19 vaccination.     Patient had not had COVID as far as she knows.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt crappy for 4 days with body aches & malaise.), PAIN (felt crappy for 4 days with body aches & malaise.) and PYREXIA (Patient was spiked with a fever of 100.8). At the time of the report, MALAISE (felt crappy for 4 days with body aches & malaise.) and PAIN (felt crappy for 4 days with body aches & malaise.) had resolved and PYREXIA (Patient was spiked with a fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8.         No concomitant medication were reported. It was reported that patient had very, very strong reactions to these vaccines. No treatment medication were reported.   This case was linked to MOD-2022-600690, MOD-2022-600693.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Immediate burning pain at injection site at the time of I received the vaccine. A couple of hours after getting the vaccine I started getting muscle cramps all over. Whole body felt like it was smoldering on fire. Airway constriction was felt. I could not breath without coughing and had to force it out. Inhaling was difficult, but I could exhale. This happened for 5-10 minutes. Symptoms in my airway subsided some after that, but lasted about an hour. All of my body felt like it was on fire while this was happening. This left me exhausted and I slept. The next day, I had a great deal of body pain, though it was lessor than previously. I also had body inflammation for about a week afterward.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Inflammation, Injection site pain, Muscle spasms, Pain
Clinical narrative: Immediate burning pain at injection site at the time of I received the vaccine. A couple of hours after getting the vaccine I started getting muscle cramps all over. Whole body felt like it was smoldering on fire. Airway constriction was felt. I could not breath without coughing and had to force it out. Inhaling was difficult, but I could exhale. This happened for 5-10 minutes. Symptoms in my airway subsided some after that, but lasted about an hour. All of my body felt like it was on fire while this was happening. This left me exhausted and I slept. The next day, I had a great deal of body pain, though it was lessor than previously. I also had body inflammation for about a week afterward.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Chest discomfort, Death, Dyspnoea
Clinical narrative: 8/24/21 pt had a positive COVID test and was given doxycycline and ivermectin by PCP (name not in medical records); 8/27/21 Regeneron infusion given; 8/28/21 pt to ED with worsening SOB and chest tightness; O2 sat on RA 88%; O2 supplementation given; pt had fever in ED; admitted; given Remdesivir, ABX, Methylprednisolone; O2 requirement increased; pt went into A Fib with Ventricular response of 150-170 bpm; intubated; was later able to come off of ventilator; continued to have poor respiratory status; condition worsened with severe hypoxia; comfort care measures and pt expired in the hospital
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, General physical health deterioration, Hypoxia, Mechanical ventilation, Pyrexia
Clinical narrative: 8/24/21 pt had a positive COVID test and was given doxycycline and ivermectin by PCP (name not in medical records); 8/27/21 Regeneron infusion given; 8/28/21 pt to ED with worsening SOB and chest tightness; O2 sat on RA 88%; O2 supplementation given; pt had fever in ED; admitted; given Remdesivir, ABX, Methylprednisolone; O2 requirement increased; pt went into A Fib with Ventricular response of 150-170 bpm; intubated; was later able to come off of ventilator; continued to have poor respiratory status; condition worsened with severe hypoxia; comfort care measures and pt expired in the hospital
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, SARS-CoV-2 test positive
Clinical narrative: 8/24/21 pt had a positive COVID test and was given doxycycline and ivermectin by PCP (name not in medical records); 8/27/21 Regeneron infusion given; 8/28/21 pt to ED with worsening SOB and chest tightness; O2 sat on RA 88%; O2 supplementation given; pt had fever in ED; admitted; given Remdesivir, ABX, Methylprednisolone; O2 requirement increased; pt went into A Fib with Ventricular response of 150-170 bpm; intubated; was later able to come off of ventilator; continued to have poor respiratory status; condition worsened with severe hypoxia; comfort care measures and pt expired in the hospital
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amegakaryocytic thrombocytopenia, Biopsy bone marrow abnormal
Clinical narrative: Under care for the treatment of myelodysplastic syndrome since 03/23/2022. I have been admitted twice for severe thrombocytopenia and anemia and required weekly platelet transfusions. Unfortunately I  am now platelet refractory due to HLA antibodies and there is now more concern for bleeding. I am now pending infectious disease evaluation for CMV viremia.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Myelodysplastic syndrome, Platelet transfusion, Refractoriness to platelet transfusion, Thrombocytopenia
Clinical narrative: Under care for the treatment of myelodysplastic syndrome since 03/23/2022. I have been admitted twice for severe thrombocytopenia and anemia and required weekly platelet transfusions. Unfortunately I  am now platelet refractory due to HLA antibodies and there is now more concern for bleeding. I am now pending infectious disease evaluation for CMV viremia.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: meningitis; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Is the patient a smoker/former smoker: No" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LIPITOR; LOSARTAN; GABAPENTIN. Vaccination history included: BNT162b2 (Dose 1), administration date: 11Feb2021, for COVID-19 immunisation, reaction(s): "COVID-19"; BNT162b2 (Dose 2), administration date: 05Mar2021, for COVID-19 immunisation, reaction(s): "COVID-19"; BNT162b2 (Dose 3), administration date: 08Oct2021, for COVID-19 immunisation, reaction(s): "COVID-19".   The following information was reported: MENINGITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive; (30May2022) Negative.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Meningitis, SARS-CoV-2 test
Clinical narrative: meningitis; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Is the patient a smoker/former smoker: No" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; LIPITOR; LOSARTAN; GABAPENTIN. Vaccination history included: BNT162b2 (Dose 1), administration date: 11Feb2021, for COVID-19 immunisation, reaction(s): "COVID-19"; BNT162b2 (Dose 2), administration date: 05Mar2021, for COVID-19 immunisation, reaction(s): "COVID-19"; BNT162b2 (Dose 3), administration date: 08Oct2021, for COVID-19 immunisation, reaction(s): "COVID-19".   The following information was reported: MENINGITIS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive; (30May2022) Negative.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Computerised tomogram, Fibrin D dimer increased, Positive airway pressure therapy
Clinical narrative: Patient had a positive COVID at-home test on 6/10. He was seen at an outside ED on 6/10 with shortness of breath and persistent cough. He was noted to be significantly hypoxic where he required BiPAP and was transferred to Hospital on 6/11 as a direct admit. Patient discharged on 6/13. This meets criteria for vaccine breakthrough case review.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient had a positive COVID at-home test on 6/10. He was seen at an outside ED on 6/10 with shortness of breath and persistent cough. He was noted to be significantly hypoxic where he required BiPAP and was transferred to Hospital on 6/11 as a direct admit. Patient discharged on 6/13. This meets criteria for vaccine breakthrough case review.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Hypoxia, Positive airway pressure therapy
Clinical narrative: Patient had a positive COVID at-home test on 6/10. He was seen at an outside ED on 6/10 with shortness of breath and persistent cough. He was noted to be significantly hypoxic where he required BiPAP and was transferred to Hospital on 6/11 as a direct admit. Patient discharged on 6/13. This meets criteria for vaccine breakthrough case review.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient had a positive COVID at-home test on 6/10. He was seen at an outside ED on 6/10 with shortness of breath and persistent cough. He was noted to be significantly hypoxic where he required BiPAP and was transferred to Hospital on 6/11 as a direct admit. Patient discharged on 6/13. This meets criteria for vaccine breakthrough case review.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Dysarthria, Feeling hot, Mouth swelling, Oral mucosal blistering
Clinical narrative: pt states he started developing scabs on his scalp that would bleed and then got painful blisters and cankers soars in his mouth.  He went to Hospital ER for treatment. He was given ointment for the scabs but no medication for his mouth.  A few days later he got dizzy and lightheaded and fell down.  He fell on his right wrist which he broke in 3 places. He went to Urgent Care.  He was referred to a doctor which took XRAYS.  He will send him to see surgeon on July 21, 2022.  Scabs and sores in mouth have subsided.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphthous ulcer, Dizziness, Fall, Haemorrhage, Oral mucosal blistering
Clinical narrative: pt states he started developing scabs on his scalp that would bleed and then got painful blisters and cankers soars in his mouth.  He went to Hospital ER for treatment. He was given ointment for the scabs but no medication for his mouth.  A few days later he got dizzy and lightheaded and fell down.  He fell on his right wrist which he broke in 3 places. He went to Urgent Care.  He was referred to a doctor which took XRAYS.  He will send him to see surgeon on July 21, 2022.  Scabs and sores in mouth have subsided.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scab, Wrist fracture, X-ray limb abnormal
Clinical narrative: pt states he started developing scabs on his scalp that would bleed and then got painful blisters and cankers soars in his mouth.  He went to Hospital ER for treatment. He was given ointment for the scabs but no medication for his mouth.  A few days later he got dizzy and lightheaded and fell down.  He fell on his right wrist which he broke in 3 places. He went to Urgent Care.  He was referred to a doctor which took XRAYS.  He will send him to see surgeon on July 21, 2022.  Scabs and sores in mouth have subsided.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Incorrect template was used to document vaccine.  Pfizer Covid Booster dose administered on 4/25/22.  On 6/27/22, at next appt. vaccine forecast showed pt was due for booster vaccine.  Pfizer Covid Booster dose administered on 6/27/22.  The time between both doses was two months and not the recommended 4 months.    No adverse symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Incorrect template was used to document vaccine.  Pfizer Covid Booster dose administered on 4/25/22.  On 6/27/22, at next appt. vaccine forecast showed pt was due for booster vaccine.  Pfizer Covid Booster dose administered on 6/27/22.  The time between both doses was two months and not the recommended 4 months.    No adverse symptoms.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Hypertension, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: I just got over the COVID. I was fully vaccinated; I just got over the COVID. I was fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rhuematoid arthritis" (unspecified if ongoing), notes: I have rhuematoid arthritis which is in remission. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "I just got over the COVID. I was fully vaccinated". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: My BP & O2 level bottomed out on me; Oxygen saturation: low, notes: My BP & O2 level bottomed out on me. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now  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) : 202200931807 same patient, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: I just got over the COVID. I was fully vaccinated; I just got over the COVID. I was fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rhuematoid arthritis" (unspecified if ongoing), notes: I have rhuematoid arthritis which is in remission. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "I just got over the COVID. I was fully vaccinated". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: My BP & O2 level bottomed out on me; Oxygen saturation: low, notes: My BP & O2 level bottomed out on me. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now  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) : 202200931807 same patient, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Drug ineffective, Oxygen saturation, Suspected COVID-19
Clinical narrative: I just got over the COVID. I was fully vaccinated; I just got over the COVID. I was fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rhuematoid arthritis" (unspecified if ongoing), notes: I have rhuematoid arthritis which is in remission. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "I just got over the COVID. I was fully vaccinated". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Low, notes: My BP & O2 level bottomed out on me; Oxygen saturation: low, notes: My BP & O2 level bottomed out on me. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The reporter reported that, patient will be 70 in November. Patient just got over the covid. Patient was fully vaccinated & continued to wear my mask & etc. The patient was very thankful for the vaccines & the antiviral made by Pfizer and doing fine now  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) : 202200931807 same patient, different dose/event;
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Burning sensation, Musculoskeletal stiffness, SARS-CoV-2 test, Urticaria
Clinical narrative: mild case of Pneumonia; Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 vaccine; Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1 , single (Lot number: EW0150, Expiration Date: 31Jul2021) and on 06May2021 as dose 2, single (Lot number: ER8736, Expiration Date: 31Jul2021) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Left Lumpectomy" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Hives" (unspecified if ongoing), notes: States she has had hives from bug bites. There were no concomitant medications. Vaccination history included: Flu (Caller states she has taken flu and other vaccines and never had a reaction). The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022), described as "Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 Vaccine"; VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "recovered" (2022), described as "Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 vaccine"; PNEUMONIA (medically significant), outcome "unknown", described as "mild case of Pneumonia". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Normal, notes: Date: Not Provided; Result: Normal; Unit: Not Provided; SARS-CoV-2 test: (Jan2022) Positive, notes: got Covid in after receiving the 2 doses. Therapeutic measures were taken as a result of pneumonia.  Clinical Information: Patient states she got Covid in Jan2022 after receiving the 2 doses of the Pfizer Covid Vaccine. States she went to the ER in January for a mild case of Pneumonia with the Covid and was put on 2 weeks of antibiotics. Patient states on an unrelated note she was prescribed Eucrisa. Caller states she has had no adverse events, but when she tries to refill it, the pharmacist says they stopped making it, caller asking does Pfizer still make Eucrisa.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, COVID-19, Pneumonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild case of Pneumonia; Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 vaccine; Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1 , single (Lot number: EW0150, Expiration Date: 31Jul2021) and on 06May2021 as dose 2, single (Lot number: ER8736, Expiration Date: 31Jul2021) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Left Lumpectomy" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Hives" (unspecified if ongoing), notes: States she has had hives from bug bites. There were no concomitant medications. Vaccination history included: Flu (Caller states she has taken flu and other vaccines and never had a reaction). The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022), described as "Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 Vaccine"; VACCINATION FAILURE (medically significant) with onset Jan2022, outcome "recovered" (2022), described as "Tested Positive for Covid 19 in Jan2022 after received 2 Doses of the Pfizer Covid 19 vaccine"; PNEUMONIA (medically significant), outcome "unknown", described as "mild case of Pneumonia". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Normal, notes: Date: Not Provided; Result: Normal; Unit: Not Provided; SARS-CoV-2 test: (Jan2022) Positive, notes: got Covid in after receiving the 2 doses. Therapeutic measures were taken as a result of pneumonia.  Clinical Information: Patient states she got Covid in Jan2022 after receiving the 2 doses of the Pfizer Covid Vaccine. States she went to the ER in January for a mild case of Pneumonia with the Covid and was put on 2 weeks of antibiotics. Patient states on an unrelated note she was prescribed Eucrisa. Caller states she has had no adverse events, but when she tries to refill it, the pharmacist says they stopped making it, caller asking does Pfizer still make Eucrisa.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: My Breaststfed child was positive for COVID within the following day of me receiving the vaccine. He was running a high fever of 102.5 and severely dehydrated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Vaccine admin after manufacturer exp date
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event. Vaccine given after manufacturer exp date
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Vaccine given after manufacturer exp date
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event. Vaccine admin after manufacturer exp date.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Vaccine admin after manufacturer exp date
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event.  Vaccine admin after manufacturer exp date
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event. Vaccine given after manufacturer exp date
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Vaccine given after manufacturer exp date
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event. Vaccine given after manufacturer exp date
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event. Vaccine admin after manufacturer exp date