chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Product preparation error
Clinical narrative: patient was given the Dtap/IPOL portion of the vaccine without HIB component with no reported adverse event; failing to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was given the dtap/ipol portion of the vaccine without hib component with no reported adverse event and failed to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event after receiving Diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Dec-2022, the patient received a (Series-4)dose of suspect Diphtheria/tetanus/5 hybrid ac Pertussis/ipv(vero)/hib(prp/t) vaccine(Dose-0.5mL)(Frequency- Total)( Strength = standard)(Formulation: Suspension for injection)( Drug Treatment Duration: NA)( Lot # UJ682AA, U7331AA) via intramuscular route in the left thigh (Left thigh Dtap-ipv, right thigh) for Immunization.  On 30-Dec-2022 the patient developed a non-serious events patient was given the dtap/ipol portion of the vaccine without hib component with no reported adverse event (incorrect product formulation administered), failing to mix both components of the vaccine and was administered as 2 separate injections with no reported adverse event (product preparation error)  following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.(Latency-same day)  It was reported HIB PORTION o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25 mL. Indications = Immunization or TB skin test. Strength = standard except for Fluzone High Dose Quadrivalent. Nurse states that she gave the patient the HIB vaccine in the other leg.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: used Vaxelis to vaccinate a patient at two months of age, Physician used Pentacel to vaccinate the same patient at 4 months of age with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received via call center from a physician.  This case involves a 2 months old and unknown gender patient who experienced used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and VAXELIS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and VAXELIS.  Action taken with PENTACEL and VAXELIS was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: used Vaxelis to vaccinate a patient at two months of age, Physician used Pentacel to vaccinate the same patient at 4 months of age with no reported adverse event; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received via call center from a physician.  This case involves a 2 months old and unknown gender patient who experienced used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and VAXELIS.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect VAXELIS not produced by Sanofi Pasteur (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient used vaxelis to vaccinate a patient at two months of age, physician used pentacel to vaccinate the same patient at 4 months of age with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and VAXELIS.  Action taken with PENTACEL and VAXELIS was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Fatigue, Foreign travel
Clinical narrative: Contracted COVID-19 in December following return trip from trip.  Returned December 7, 2022.  FIrst "apparent" symptoms December 9, 2022.  But PCR test on December 9th reflected negative results to COVID-19, and Flu. Spouse PCR test on Dcember 10-with results received December 12, 2022, diagnosed positve with COVID-19.        Symptoms included fatigue, muscle aches and pains, chest pressure, congestion, coughing.  I viewed the symptoms mild, similar to those I experienced following COVID vaccine doses.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Influenza virus test negative, Malaise, Myalgia, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Contracted COVID-19 in December following return trip from trip.  Returned December 7, 2022.  FIrst "apparent" symptoms December 9, 2022.  But PCR test on December 9th reflected negative results to COVID-19, and Flu. Spouse PCR test on Dcember 10-with results received December 12, 2022, diagnosed positve with COVID-19.        Symptoms included fatigue, muscle aches and pains, chest pressure, congestion, coughing.  I viewed the symptoms mild, similar to those I experienced following COVID vaccine doses.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Contracted COVID-19 in December following return trip from trip.  Returned December 7, 2022.  FIrst "apparent" symptoms December 9, 2022.  But PCR test on December 9th reflected negative results to COVID-19, and Flu. Spouse PCR test on Dcember 10-with results received December 12, 2022, diagnosed positve with COVID-19.        Symptoms included fatigue, muscle aches and pains, chest pressure, congestion, coughing.  I viewed the symptoms mild, similar to those I experienced following COVID vaccine doses.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Electrocardiogram abnormal, Sinus tachycardia, Tachycardia, Urticaria
Clinical narrative: Patient developed hives within 5 hours of administration on bilateral arms and chest and then developed a feeling of shortness of breath and tachycardia rate of 108.  Patient was given 40 mg Solumedrol IM in the office. Given 0.3 mg IM epinephrine by EMS and taken to the ED for further evaluation, where she was given oral Benadryl and Pepcid for full anaphylaxis prevention treatment and monitored for approximately 2 hours and then discharged to home in stable and improved condition.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Epistaxis, Gingival bleeding, Immune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: Had Covid 2 months ago, took Plaxovid. Then took flu vaccine. Dec. 12 ,2022 developed bleeding gums, nose bleed, mouth blood spots, petechiae on face and covering legs, bruising on arms and legs was admitted urgently to hospital with sudden ITP. Had a platelet count of 1, (with value range of 150-300). Given high dose steroids, IVIG treatments over 4 days. Platelets at 40 as of 12/21/22. Follow up with hematologist for weekly checks and possible long term treatments!!
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Mucosal haemorrhage, Petechiae, Platelet count decreased
Clinical narrative: Had Covid 2 months ago, took Plaxovid. Then took flu vaccine. Dec. 12 ,2022 developed bleeding gums, nose bleed, mouth blood spots, petechiae on face and covering legs, bruising on arms and legs was admitted urgently to hospital with sudden ITP. Had a platelet count of 1, (with value range of 150-300). Given high dose steroids, IVIG treatments over 4 days. Platelets at 40 as of 12/21/22. Follow up with hematologist for weekly checks and possible long term treatments!!
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Condition aggravated, Headache, Intensive care, International normalised ratio increased
Clinical narrative: PAXLOVID use for COVID-19 under Emergency Use Authorization (EUA): The patient presented to the his PCP on 12/16/2022 for severe headache. The headache had been mild for multiple weeks prior, and then became acutely worse after receiving his COVID-19 booster on 12/12/2022. He also had COVID-19 about six weeks prior and was treated with Paxlovid, which he took 10/24/2022 - 10/28/2022. He described the worst headache of his life (bandlike and frontal) with accompanying nausea. He was sent for a head CT which ultimately revealed bilateral subdural hematomas (right > left) with acute and subacute blood products. He was then referred to the ED and subsequently admitted to the ICU.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Subdural haematoma
Clinical narrative: PAXLOVID use for COVID-19 under Emergency Use Authorization (EUA): The patient presented to the his PCP on 12/16/2022 for severe headache. The headache had been mild for multiple weeks prior, and then became acutely worse after receiving his COVID-19 booster on 12/12/2022. He also had COVID-19 about six weeks prior and was treated with Paxlovid, which he took 10/24/2022 - 10/28/2022. He described the worst headache of his life (bandlike and frontal) with accompanying nausea. He was sent for a head CT which ultimately revealed bilateral subdural hematomas (right > left) with acute and subacute blood products. He was then referred to the ED and subsequently admitted to the ICU.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Dyspnoea, Fibrin D dimer increased, Laboratory test abnormal
Clinical narrative: 3 weeks after getting the Johnson and Johnson covid19 vaccine I started having problems breathing. It continued to worsen and then my doctor ordered a d-dimer test which showed I had blood clots. Sent to the emergency room and they found multiple blood clots in my lungs. Was kept overnight and started on blood thinners.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, Thrombosis, Ventilation/perfusion scan abnormal
Clinical narrative: 3 weeks after getting the Johnson and Johnson covid19 vaccine I started having problems breathing. It continued to worsen and then my doctor ordered a d-dimer test which showed I had blood clots. Sent to the emergency room and they found multiple blood clots in my lungs. Was kept overnight and started on blood thinners.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arteriogram coronary normal, Atrial fibrillation, Blood pressure increased, Cardiac disorder
Clinical narrative: I'm 63 years old with no prior history of heart issues or circulatory problems nor a family history of heart issues. I Received the 2nd mandated Pfizer Covid 19 vaccination (FA1485) from Pharmacy on 08/06/2021. I Started feeling heart palpitations & fluttering during my cardio workouts and road bicycling during mid November 2021.My heart rate monitor, which I use on every bicycle ride was reading 206 BPM... I was constantly struggling to catch my breath. I was in constant fatigue with headaches and always felt nauseated. I initially thought this would be a temporary condition. In May of 2022, i fainted on 2 occasions after a somewhat easy ride & workout. I was able to make an appointment with my General Practitioner June of 2022. Upon my examination, he was shocked that my Resting Heart Rate was 161 BPM and that I was in a condition called AFIB. He immediately sent me to a cardiac specialist for further diagnosis that day. After an initial EKG, The cardiologist agreed I was in AFIB, my HR was still 160+ & my blood pressure was an alarming 180/120. The cardiologist told me I needed immediate cardiac attention. I was sent to the adjacent hospital ER due to this serious medical emergency. I was administered IV drugs to bring the HP & BP down to a manageable level. Since this cardiac episode, I've been hospitalized 3 times, had 2 CardioVersions, shocking my heart into a normal rhythm (unsuccessful) and had an Angiogram to determine if I had a circulatory blockage. I did not. I had a Sonogram taken and it was determined my left heart atrium was 5 centimeters enlarged and Mitral valve problems. I'm currently on 4 different cardiac medications to control electrical activity to my heart, medication to keep my heart rate down, medication to keep my BP in a safe, but still high, range & a blood thinner to keep my blood from clotting, causing a potential stroke, heart attack or any other cardiac related emergency. I'm a very (was) active cyclist and did cardiovascular training daily. My family has no history of genetic heart issues and my doctor conducts a thorough, complete physical with a non problematic EKG annually. He would always tell me that I was in "great shape" for my age and whatever I was doing, keep it up. Up until the past few  months, while data comes forth, I believed that Pfizer, Moderna, J&J vaccines were safe, tested, would keep me safe from Covid spread from unvaccinated persons. Because this "mandated" vaccination was a requirement forced upon my 100 plus employee employer, the only choice I had was to Vaccinate or be terminated... Even after 33 years with the same employer at the same job. I believe the FDA needs to leave no stone, unturned to find out why citizens are developing severe cardiac problems  resulting in short term, long term and even death from cardiac related injury. I'm sure this 'heartfelt' diatribe will fall upon deaf ears, but as a citizen, husband, father, grandfather and taxpayer, I felt it was my duty to tell my story.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardioversion, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: I'm 63 years old with no prior history of heart issues or circulatory problems nor a family history of heart issues. I Received the 2nd mandated Pfizer Covid 19 vaccination (FA1485) from Pharmacy on 08/06/2021. I Started feeling heart palpitations & fluttering during my cardio workouts and road bicycling during mid November 2021.My heart rate monitor, which I use on every bicycle ride was reading 206 BPM... I was constantly struggling to catch my breath. I was in constant fatigue with headaches and always felt nauseated. I initially thought this would be a temporary condition. In May of 2022, i fainted on 2 occasions after a somewhat easy ride & workout. I was able to make an appointment with my General Practitioner June of 2022. Upon my examination, he was shocked that my Resting Heart Rate was 161 BPM and that I was in a condition called AFIB. He immediately sent me to a cardiac specialist for further diagnosis that day. After an initial EKG, The cardiologist agreed I was in AFIB, my HR was still 160+ & my blood pressure was an alarming 180/120. The cardiologist told me I needed immediate cardiac attention. I was sent to the adjacent hospital ER due to this serious medical emergency. I was administered IV drugs to bring the HP & BP down to a manageable level. Since this cardiac episode, I've been hospitalized 3 times, had 2 CardioVersions, shocking my heart into a normal rhythm (unsuccessful) and had an Angiogram to determine if I had a circulatory blockage. I did not. I had a Sonogram taken and it was determined my left heart atrium was 5 centimeters enlarged and Mitral valve problems. I'm currently on 4 different cardiac medications to control electrical activity to my heart, medication to keep my heart rate down, medication to keep my BP in a safe, but still high, range & a blood thinner to keep my blood from clotting, causing a potential stroke, heart attack or any other cardiac related emergency. I'm a very (was) active cyclist and did cardiovascular training daily. My family has no history of genetic heart issues and my doctor conducts a thorough, complete physical with a non problematic EKG annually. He would always tell me that I was in "great shape" for my age and whatever I was doing, keep it up. Up until the past few  months, while data comes forth, I believed that Pfizer, Moderna, J&J vaccines were safe, tested, would keep me safe from Covid spread from unvaccinated persons. Because this "mandated" vaccination was a requirement forced upon my 100 plus employee employer, the only choice I had was to Vaccinate or be terminated... Even after 33 years with the same employer at the same job. I believe the FDA needs to leave no stone, unturned to find out why citizens are developing severe cardiac problems  resulting in short term, long term and even death from cardiac related injury. I'm sure this 'heartfelt' diatribe will fall upon deaf ears, but as a citizen, husband, father, grandfather and taxpayer, I felt it was my duty to tell my story.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Left atrial enlargement, Mitral valve disease, Nausea, Palpitations
Clinical narrative: I'm 63 years old with no prior history of heart issues or circulatory problems nor a family history of heart issues. I Received the 2nd mandated Pfizer Covid 19 vaccination (FA1485) from Pharmacy on 08/06/2021. I Started feeling heart palpitations & fluttering during my cardio workouts and road bicycling during mid November 2021.My heart rate monitor, which I use on every bicycle ride was reading 206 BPM... I was constantly struggling to catch my breath. I was in constant fatigue with headaches and always felt nauseated. I initially thought this would be a temporary condition. In May of 2022, i fainted on 2 occasions after a somewhat easy ride & workout. I was able to make an appointment with my General Practitioner June of 2022. Upon my examination, he was shocked that my Resting Heart Rate was 161 BPM and that I was in a condition called AFIB. He immediately sent me to a cardiac specialist for further diagnosis that day. After an initial EKG, The cardiologist agreed I was in AFIB, my HR was still 160+ & my blood pressure was an alarming 180/120. The cardiologist told me I needed immediate cardiac attention. I was sent to the adjacent hospital ER due to this serious medical emergency. I was administered IV drugs to bring the HP & BP down to a manageable level. Since this cardiac episode, I've been hospitalized 3 times, had 2 CardioVersions, shocking my heart into a normal rhythm (unsuccessful) and had an Angiogram to determine if I had a circulatory blockage. I did not. I had a Sonogram taken and it was determined my left heart atrium was 5 centimeters enlarged and Mitral valve problems. I'm currently on 4 different cardiac medications to control electrical activity to my heart, medication to keep my heart rate down, medication to keep my BP in a safe, but still high, range & a blood thinner to keep my blood from clotting, causing a potential stroke, heart attack or any other cardiac related emergency. I'm a very (was) active cyclist and did cardiovascular training daily. My family has no history of genetic heart issues and my doctor conducts a thorough, complete physical with a non problematic EKG annually. He would always tell me that I was in "great shape" for my age and whatever I was doing, keep it up. Up until the past few  months, while data comes forth, I believed that Pfizer, Moderna, J&J vaccines were safe, tested, would keep me safe from Covid spread from unvaccinated persons. Because this "mandated" vaccination was a requirement forced upon my 100 plus employee employer, the only choice I had was to Vaccinate or be terminated... Even after 33 years with the same employer at the same job. I believe the FDA needs to leave no stone, unturned to find out why citizens are developing severe cardiac problems  resulting in short term, long term and even death from cardiac related injury. I'm sure this 'heartfelt' diatribe will fall upon deaf ears, but as a citizen, husband, father, grandfather and taxpayer, I felt it was my duty to tell my story.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Ultrasound scan abnormal
Clinical narrative: I'm 63 years old with no prior history of heart issues or circulatory problems nor a family history of heart issues. I Received the 2nd mandated Pfizer Covid 19 vaccination (FA1485) from Pharmacy on 08/06/2021. I Started feeling heart palpitations & fluttering during my cardio workouts and road bicycling during mid November 2021.My heart rate monitor, which I use on every bicycle ride was reading 206 BPM... I was constantly struggling to catch my breath. I was in constant fatigue with headaches and always felt nauseated. I initially thought this would be a temporary condition. In May of 2022, i fainted on 2 occasions after a somewhat easy ride & workout. I was able to make an appointment with my General Practitioner June of 2022. Upon my examination, he was shocked that my Resting Heart Rate was 161 BPM and that I was in a condition called AFIB. He immediately sent me to a cardiac specialist for further diagnosis that day. After an initial EKG, The cardiologist agreed I was in AFIB, my HR was still 160+ & my blood pressure was an alarming 180/120. The cardiologist told me I needed immediate cardiac attention. I was sent to the adjacent hospital ER due to this serious medical emergency. I was administered IV drugs to bring the HP & BP down to a manageable level. Since this cardiac episode, I've been hospitalized 3 times, had 2 CardioVersions, shocking my heart into a normal rhythm (unsuccessful) and had an Angiogram to determine if I had a circulatory blockage. I did not. I had a Sonogram taken and it was determined my left heart atrium was 5 centimeters enlarged and Mitral valve problems. I'm currently on 4 different cardiac medications to control electrical activity to my heart, medication to keep my heart rate down, medication to keep my BP in a safe, but still high, range & a blood thinner to keep my blood from clotting, causing a potential stroke, heart attack or any other cardiac related emergency. I'm a very (was) active cyclist and did cardiovascular training daily. My family has no history of genetic heart issues and my doctor conducts a thorough, complete physical with a non problematic EKG annually. He would always tell me that I was in "great shape" for my age and whatever I was doing, keep it up. Up until the past few  months, while data comes forth, I believed that Pfizer, Moderna, J&J vaccines were safe, tested, would keep me safe from Covid spread from unvaccinated persons. Because this "mandated" vaccination was a requirement forced upon my 100 plus employee employer, the only choice I had was to Vaccinate or be terminated... Even after 33 years with the same employer at the same job. I believe the FDA needs to leave no stone, unturned to find out why citizens are developing severe cardiac problems  resulting in short term, long term and even death from cardiac related injury. I'm sure this 'heartfelt' diatribe will fall upon deaf ears, but as a citizen, husband, father, grandfather and taxpayer, I felt it was my duty to tell my story.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pruritus, Skin induration, Skin mass
Clinical narrative: 12/23/2022 I received my first dose of Shingrix lot #74FB9 at the Pharmacy. On day 1 I experienced flu like symptoms. Day 2 flu like symptoms subsided. I had a indurateed sub q mass. Day 3 mass had increased in size. Day 4 ( today ) mass is 13cm in length by 12cm in width. Mass is hot to touch. Skin is red. Minor itching. No other illness presented so far. Watching carefully to see if it spreads. I have drawn the current margins. My husband is a doctor and we are keeping a close eye on it. Will seek emergency care if increase in size or other symptoms arise.
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 12/23/2022 I received my first dose of Shingrix lot #74FB9 at the Pharmacy. On day 1 I experienced flu like symptoms. Day 2 flu like symptoms subsided. I had a indurateed sub q mass. Day 3 mass had increased in size. Day 4 ( today ) mass is 13cm in length by 12cm in width. Mass is hot to touch. Skin is red. Minor itching. No other illness presented so far. Watching carefully to see if it spreads. I have drawn the current margins. My husband is a doctor and we are keeping a close eye on it. Will seek emergency care if increase in size or other symptoms arise.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Pneumonia, SARS-CoV-2 test, Syncope
Clinical narrative: Pt's wife reported that pt's last dose of OPSUMIT was yesterday (12/22/2022). pt did not order on time. right now pt is in the hospital. he was unwell on monday, went to complete covid test, and he was vaccinated for covid on monday (12/19/2022). unknown if covid positive. 2 days later (12/21/2022) he didn't fell well again and when he stood up from the bed he collapsed and couldn't breathe. right now pt admitted to the hospital for pneumonia since wednesday(12/21/2022). unknown if hospital can provide opsumit. no other information provided.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Deep vein thrombosis, Echocardiogram abnormal, Presyncope
Clinical narrative: 67yo male without significant medical comorbidities presented with near syncope on 12/20/2022 with subsequent assessment by CT imaging demonstrating a submissive bilateral pulmonary embolus with right heart strain and US of the extremities demonstrating a previously unknown LLE DVT. Patient underwent initial thrombolytic therapy with dissolution of the right sided PE, but the left sided PE required suction catheter thrombectomy. Patient recovered and post-treatment echocardiogram demonstrated mostly resolution of the right heart strain (mild to moderate RV dilation with normal LV and RV function). Patient will be on (at least 6 months) apixaban therapy. Of note, the patient received teh Pfizer booster vaccination on 10-14-2022 (previously received primary and initial booster vaccinations). Bo prior history of DVT/clotting disorders. History of Gilbert's, GERD. No history of cardiovascular, pulmonary, liver, GI, renal or other diseases. No history of diabetes, hypertension, clotting disorders. No change in exercise status, work activity or travel (vacation trip by plane in November, but this has been the routine for the past 12 years). Medications included: omeprazole (40mg qd), Metamucil. No family history of DVT/PE or clotting disorders. Being reported as a possible serious adverse event related to the Pfizer COVID booster vaccination.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism, Right ventricular dilatation, Right ventricular dysfunction, Thrombectomy, Thrombolysis
Clinical narrative: 67yo male without significant medical comorbidities presented with near syncope on 12/20/2022 with subsequent assessment by CT imaging demonstrating a submissive bilateral pulmonary embolus with right heart strain and US of the extremities demonstrating a previously unknown LLE DVT. Patient underwent initial thrombolytic therapy with dissolution of the right sided PE, but the left sided PE required suction catheter thrombectomy. Patient recovered and post-treatment echocardiogram demonstrated mostly resolution of the right heart strain (mild to moderate RV dilation with normal LV and RV function). Patient will be on (at least 6 months) apixaban therapy. Of note, the patient received teh Pfizer booster vaccination on 10-14-2022 (previously received primary and initial booster vaccinations). Bo prior history of DVT/clotting disorders. History of Gilbert's, GERD. No history of cardiovascular, pulmonary, liver, GI, renal or other diseases. No history of diabetes, hypertension, clotting disorders. No change in exercise status, work activity or travel (vacation trip by plane in November, but this has been the routine for the past 12 years). Medications included: omeprazole (40mg qd), Metamucil. No family history of DVT/PE or clotting disorders. Being reported as a possible serious adverse event related to the Pfizer COVID booster vaccination.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: 67yo male without significant medical comorbidities presented with near syncope on 12/20/2022 with subsequent assessment by CT imaging demonstrating a submissive bilateral pulmonary embolus with right heart strain and US of the extremities demonstrating a previously unknown LLE DVT. Patient underwent initial thrombolytic therapy with dissolution of the right sided PE, but the left sided PE required suction catheter thrombectomy. Patient recovered and post-treatment echocardiogram demonstrated mostly resolution of the right heart strain (mild to moderate RV dilation with normal LV and RV function). Patient will be on (at least 6 months) apixaban therapy. Of note, the patient received teh Pfizer booster vaccination on 10-14-2022 (previously received primary and initial booster vaccinations). Bo prior history of DVT/clotting disorders. History of Gilbert's, GERD. No history of cardiovascular, pulmonary, liver, GI, renal or other diseases. No history of diabetes, hypertension, clotting disorders. No change in exercise status, work activity or travel (vacation trip by plane in November, but this has been the routine for the past 12 years). Medications included: omeprazole (40mg qd), Metamucil. No family history of DVT/PE or clotting disorders. Being reported as a possible serious adverse event related to the Pfizer COVID booster vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL.  No adverse events were noted at the time of the administration.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization: 12/28/2022 - 12/31/2022 (3 days) Presentation to the ED: generalized weakness COVID + date: 12/28/2022 Treatment: Remdesivir & oxygen therapy.  Discharge to: home.   006B21A 3/26/2021 039B21A 4/23/2021 037F21A 11/29/2021
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear infection, Erythema, Fatigue, Nasopharyngitis
Clinical narrative: On 11/16/22, he had a light cold with a runny nose, rash, and a cough. He was a little more snuggly than normal, but that is it. He had super red cheeks and that traveled down to his chest. Then, on 12/24/22, he has lots of congestion, runny nose, fatigue, and a terrible cough. This developed into an ear infection. We contacted his doctor and was prescribed dexamethasone. I also gave him ibuprofen and ZYRTEC. He is feeling much better now.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: On 11/16/22, he had a light cold with a runny nose, rash, and a cough. He was a little more snuggly than normal, but that is it. He had super red cheeks and that traveled down to his chest. Then, on 12/24/22, he has lots of congestion, runny nose, fatigue, and a terrible cough. This developed into an ear infection. We contacted his doctor and was prescribed dexamethasone. I also gave him ibuprofen and ZYRTEC. He is feeling much better now.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Dysarthria, Hypoglycaemia, SARS-CoV-2 test positive
Clinical narrative: Hospitalization: 12/27/2022 - 12/28/2022 (31 hours) Presentation to the ED: slurred speech and hypoglycemia.  COVID + date: 12/27/2022 Treatment: no indication for medical treatment at this time.  Discharge to: home.   Moderna 012M20A 1/29/2021 Moderna 011A21A 2/26/2021 Moderna 033H21A 1/5/2022
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Chills, Diarrhoea, Dizziness
Clinical narrative: Became ill  2 month later  after vaccination developed chills nausea dizzy and short of breath next day diarrhea . Out of work for 3 days.  Blood pressure elevated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Illness, Impaired work ability, Nausea
Clinical narrative: Became ill  2 month later  after vaccination developed chills nausea dizzy and short of breath next day diarrhea . Out of work for 3 days.  Blood pressure elevated.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Back pain, Blood disorder, Blood test abnormal, Dyspnoea
Clinical narrative: I had my first Pfizer dose on 4/11/21 and my second dose on May 2, 2021.  On June 14, 2021, I went to the ER because I was having trouble breathing, back pain, and side pain. After being admitted they performed a scan of my chest cavity and determined I had a pulmonary embolism resulting from a blood clot. They immediately put me on a blood thinner and I was discharged on June 16, 2021 and continued taking blood thinners for six months. The insurance company refused to pay for any more of the blood thinners and my doctor had me stop taking them.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: I had my first Pfizer dose on 4/11/21 and my second dose on May 2, 2021.  On June 14, 2021, I went to the ER because I was having trouble breathing, back pain, and side pain. After being admitted they performed a scan of my chest cavity and determined I had a pulmonary embolism resulting from a blood clot. They immediately put me on a blood thinner and I was discharged on June 16, 2021 and continued taking blood thinners for six months. The insurance company refused to pay for any more of the blood thinners and my doctor had me stop taking them.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: COVID-related death, breakthrough case
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Fatigue, Migraine, Peripheral swelling
Clinical narrative: I had assumed that because I was not as active and getting older that I was getting tired more easily. Although I am more active for my age than some people my age as I live on the third floor, I go up and down the stairs four or five times a day. I am finding myself getting a bit more tired than I used to. I do feel that my migraines are starting to get more frequent as well. I am not sure why my migraines may be coming more frequently I have scheduled an appointment with my doctor. I am experiencing swelling in the fleshy part of my arms right inside of the elbow region.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Asthenia, COVID-19, Exposure to SARS-CoV-2, Eye pain
Clinical narrative: My granddaughter told me she tested positive last Thursday. I went to work, but on Monday my breathing wasn't right, I felt weak; I work on a place that I can't sit I couldn't stand straight, but I couldn't work anymore, I went to the bathroom for 10 minutes to rest, I had to do this three times; I took apple juice and energy drink. At 5:00PM I couldn't make it to the car to drive back home. Yesterday, when woke up I couldn't breathe, my eyes hurt, I had nausea, I had head and body ache, my joints hurt. I felt so sick I called to the doctor and took the COVID-19 test at the pharmacy (yesterday at 4:30PM) and it was positive. I have to quarantine for 5 days. I spoke to the doctor today and called the pharmacy for a prescription. I will start taking it today.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Impaired work ability, Malaise, Nausea, Pain
Clinical narrative: My granddaughter told me she tested positive last Thursday. I went to work, but on Monday my breathing wasn't right, I felt weak; I work on a place that I can't sit I couldn't stand straight, but I couldn't work anymore, I went to the bathroom for 10 minutes to rest, I had to do this three times; I took apple juice and energy drink. At 5:00PM I couldn't make it to the car to drive back home. Yesterday, when woke up I couldn't breathe, my eyes hurt, I had nausea, I had head and body ache, my joints hurt. I felt so sick I called to the doctor and took the COVID-19 test at the pharmacy (yesterday at 4:30PM) and it was positive. I have to quarantine for 5 days. I spoke to the doctor today and called the pharmacy for a prescription. I will start taking it today.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiration abnormal, SARS-CoV-2 test positive
Clinical narrative: My granddaughter told me she tested positive last Thursday. I went to work, but on Monday my breathing wasn't right, I felt weak; I work on a place that I can't sit I couldn't stand straight, but I couldn't work anymore, I went to the bathroom for 10 minutes to rest, I had to do this three times; I took apple juice and energy drink. At 5:00PM I couldn't make it to the car to drive back home. Yesterday, when woke up I couldn't breathe, my eyes hurt, I had nausea, I had head and body ache, my joints hurt. I felt so sick I called to the doctor and took the COVID-19 test at the pharmacy (yesterday at 4:30PM) and it was positive. I have to quarantine for 5 days. I spoke to the doctor today and called the pharmacy for a prescription. I will start taking it today.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: I developed symptoms Wednesday night like symptoms of a cold, runny nose, sore throat, sneezing. The next day it got worse, congested sinuses and I started coughing. On Friday the symptoms continued to get worse and I ran a fever of 99.3, whereas my normal temperature is 97. The next morning I went and took the COVID-19 at home test and it was positive. Because I had been around my three granddaughters, who all had runny noses, so I was surprised it wasn't just a cold. I went to the health care facility to confirm with a PCR test which did confirm the positive test. Because of my age and I am an asthmatic they prescribed PAXLOVID. On Sunday, Monday, Tuesday I was up and about but I have probably blown my nose more than 496 times, because of how many boxes of tissues I have gone through, and just coughing, coughing, coughing. The mucus had turned greenish brown and very thick. I called the health care facility on 1/2/23 to ask about a sinus infection on top of the COVID-19 because I have a history of sinus infections, and they sort of gave me the run around. I went to the HCF on 1/3/23 early, they listened to my lungs and said I was clear and that she was 100% sure it was just COVID-19 and the color of the mucus didn't mean it was a sinus infection. She told me to take MUCINEX to loosen the mucus and a saline rinse. I've been trying to use the NETI POT every night. This morning I am finally starting to feel like a human being again and I finally slept okay for the first time in five nights. I tested negative this morning as well, 1/4/23.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Secretion discharge, Sick relative, Sinus congestion
Clinical narrative: I developed symptoms Wednesday night like symptoms of a cold, runny nose, sore throat, sneezing. The next day it got worse, congested sinuses and I started coughing. On Friday the symptoms continued to get worse and I ran a fever of 99.3, whereas my normal temperature is 97. The next morning I went and took the COVID-19 at home test and it was positive. Because I had been around my three granddaughters, who all had runny noses, so I was surprised it wasn't just a cold. I went to the health care facility to confirm with a PCR test which did confirm the positive test. Because of my age and I am an asthmatic they prescribed PAXLOVID. On Sunday, Monday, Tuesday I was up and about but I have probably blown my nose more than 496 times, because of how many boxes of tissues I have gone through, and just coughing, coughing, coughing. The mucus had turned greenish brown and very thick. I called the health care facility on 1/2/23 to ask about a sinus infection on top of the COVID-19 because I have a history of sinus infections, and they sort of gave me the run around. I went to the HCF on 1/3/23 early, they listened to my lungs and said I was clear and that she was 100% sure it was just COVID-19 and the color of the mucus didn't mean it was a sinus infection. She told me to take MUCINEX to loosen the mucus and a saline rinse. I've been trying to use the NETI POT every night. This morning I am finally starting to feel like a human being again and I finally slept okay for the first time in five nights. I tested negative this morning as well, 1/4/23.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Sleep disorder, Sneezing
Clinical narrative: I developed symptoms Wednesday night like symptoms of a cold, runny nose, sore throat, sneezing. The next day it got worse, congested sinuses and I started coughing. On Friday the symptoms continued to get worse and I ran a fever of 99.3, whereas my normal temperature is 97. The next morning I went and took the COVID-19 at home test and it was positive. Because I had been around my three granddaughters, who all had runny noses, so I was surprised it wasn't just a cold. I went to the health care facility to confirm with a PCR test which did confirm the positive test. Because of my age and I am an asthmatic they prescribed PAXLOVID. On Sunday, Monday, Tuesday I was up and about but I have probably blown my nose more than 496 times, because of how many boxes of tissues I have gone through, and just coughing, coughing, coughing. The mucus had turned greenish brown and very thick. I called the health care facility on 1/2/23 to ask about a sinus infection on top of the COVID-19 because I have a history of sinus infections, and they sort of gave me the run around. I went to the HCF on 1/3/23 early, they listened to my lungs and said I was clear and that she was 100% sure it was just COVID-19 and the color of the mucus didn't mean it was a sinus infection. She told me to take MUCINEX to loosen the mucus and a saline rinse. I've been trying to use the NETI POT every night. This morning I am finally starting to feel like a human being again and I finally slept okay for the first time in five nights. I tested negative this morning as well, 1/4/23.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL. No adverse events were noted at the time of the administration.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Inadvertently given Pfizer Bivalent instead of Pfizer monovalent as 1st shot in primary series. Advised to complete the series with monovalent in 21 days to complete the series.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospitalization: 12/26/2022 - 12/30/2022 (4 days) Presentation to the ED: SOB w/ LLL pneumonia. COVID + date: 12/27/2022 Treatment: Remdesivir, Decadron, Levofloxacin Discharge to: home.   FD7 12/24/2021 FJ1614 2/5/2022
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, COVID-19, Cough, Headache
Clinical narrative: I had a really sore throat, headache, low grade temperature, joint pain, mild cough. I got PAXLOVID on 12/30/22. I'm still testing positive today and still with sore throat.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had a really sore throat, headache, low grade temperature, joint pain, mild cough. I got PAXLOVID on 12/30/22. I'm still testing positive today and still with sore throat.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac ablation, Cardiac flutter, Chest X-ray, Chest pain, Diarrhoea
Clinical narrative: I experienced headache, nausea, diarrhea, fatigue, with first shot on 7/15/2021. After the second shot I experienced headache, nausea, diarrhea, fatigue, chest pain with fast beating, fluttering heartbeat and shortness of breath and developed acute diverticulitis without cause.  The chest pain got worse and was rushed by ambulance from urgent care to local Hospital and  referred to a cardiologist. After multiple EKG's, labs, Echocardiogram, and Holter monitor, the results show I  have significant PVCs (22.6%) Ventricular bigeminy, which did not begin until after the shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Diverticulitis, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: I experienced headache, nausea, diarrhea, fatigue, with first shot on 7/15/2021. After the second shot I experienced headache, nausea, diarrhea, fatigue, chest pain with fast beating, fluttering heartbeat and shortness of breath and developed acute diverticulitis without cause.  The chest pain got worse and was rushed by ambulance from urgent care to local Hospital and  referred to a cardiologist. After multiple EKG's, labs, Echocardiogram, and Holter monitor, the results show I  have significant PVCs (22.6%) Ventricular bigeminy, which did not begin until after the shot.