chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: This is a 55y.o. male with PMH significant for CAD s/p DES x 1, T2DM, COPD, Hx DVT/PE, Factor V leidin, OSA, and obesity who presented to the hospital for heart racing and chest pain. Patient states that he was visiting a friend and on his drive back home he developed sudden substernal chest pain with radiation to his shoulder. Admits to taking nitroglycerin without relief. States that this pain is similar to his previous episodes of chest pain. On further chart review, patient presented for similar presentation to Facility with concerns for chest pain and nonsustained V tach 10/22/2021 where he had a LHC without obstructive CAD and patent stent. He was also evaluated by Facility in 01/2022 for similar presentation. At that time he had his loop recorder interrogated which did not show ventricular tachycardia. It was deemed his tachyarrhythmia was artifact and that he had chronic angina. His imdur and lopressor were both increased. While in the ED patient noted to have tachycardia and chest pain with concern that he was going into V tach. He was started on amiodarone gtt with break through arrhythmia. On further review of EKG, v tach deemed to be artifactual and underlying rhythm sinus. -Patient presents with chest pain and shortness of breath. Has a history of COPD and tobacco dependence. History of pulmonary embolism, currently on Eliquis, history of factor V Leiden. He has a negative troponins with no new EKG changes. Echocardiogram reviewed and appropriate. Patient had cardiac catheterization in October 2021 which was negative for significant stenosis at the University. He also has a loop recorder. Multiple hospitalizations secondary to chest pain with multiple cardiac catheterizations and stress testing. He is testing positive for Covid but also tested positive for weeks ago. No respiratory complaints or Covid symptoms otherwise. He has been seen by cardiology and stress test was planned. Patient's symptoms had resolved and he left AGAINST MEDICAL ADVICE before further testing could be completed.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pain, Palpitations
Clinical narrative: This is a 55y.o. male with PMH significant for CAD s/p DES x 1, T2DM, COPD, Hx DVT/PE, Factor V leidin, OSA, and obesity who presented to the hospital for heart racing and chest pain. Patient states that he was visiting a friend and on his drive back home he developed sudden substernal chest pain with radiation to his shoulder. Admits to taking nitroglycerin without relief. States that this pain is similar to his previous episodes of chest pain. On further chart review, patient presented for similar presentation to Facility with concerns for chest pain and nonsustained V tach 10/22/2021 where he had a LHC without obstructive CAD and patent stent. He was also evaluated by Facility in 01/2022 for similar presentation. At that time he had his loop recorder interrogated which did not show ventricular tachycardia. It was deemed his tachyarrhythmia was artifact and that he had chronic angina. His imdur and lopressor were both increased. While in the ED patient noted to have tachycardia and chest pain with concern that he was going into V tach. He was started on amiodarone gtt with break through arrhythmia. On further review of EKG, v tach deemed to be artifactual and underlying rhythm sinus. -Patient presents with chest pain and shortness of breath. Has a history of COPD and tobacco dependence. History of pulmonary embolism, currently on Eliquis, history of factor V Leiden. He has a negative troponins with no new EKG changes. Echocardiogram reviewed and appropriate. Patient had cardiac catheterization in October 2021 which was negative for significant stenosis at the University. He also has a loop recorder. Multiple hospitalizations secondary to chest pain with multiple cardiac catheterizations and stress testing. He is testing positive for Covid but also tested positive for weeks ago. No respiratory complaints or Covid symptoms otherwise. He has been seen by cardiology and stress test was planned. Patient's symptoms had resolved and he left AGAINST MEDICAL ADVICE before further testing could be completed.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Tachycardia, Troponin normal, Ventricular tachycardia
Clinical narrative: This is a 55y.o. male with PMH significant for CAD s/p DES x 1, T2DM, COPD, Hx DVT/PE, Factor V leidin, OSA, and obesity who presented to the hospital for heart racing and chest pain. Patient states that he was visiting a friend and on his drive back home he developed sudden substernal chest pain with radiation to his shoulder. Admits to taking nitroglycerin without relief. States that this pain is similar to his previous episodes of chest pain. On further chart review, patient presented for similar presentation to Facility with concerns for chest pain and nonsustained V tach 10/22/2021 where he had a LHC without obstructive CAD and patent stent. He was also evaluated by Facility in 01/2022 for similar presentation. At that time he had his loop recorder interrogated which did not show ventricular tachycardia. It was deemed his tachyarrhythmia was artifact and that he had chronic angina. His imdur and lopressor were both increased. While in the ED patient noted to have tachycardia and chest pain with concern that he was going into V tach. He was started on amiodarone gtt with break through arrhythmia. On further review of EKG, v tach deemed to be artifactual and underlying rhythm sinus. -Patient presents with chest pain and shortness of breath. Has a history of COPD and tobacco dependence. History of pulmonary embolism, currently on Eliquis, history of factor V Leiden. He has a negative troponins with no new EKG changes. Echocardiogram reviewed and appropriate. Patient had cardiac catheterization in October 2021 which was negative for significant stenosis at the University. He also has a loop recorder. Multiple hospitalizations secondary to chest pain with multiple cardiac catheterizations and stress testing. He is testing positive for Covid but also tested positive for weeks ago. No respiratory complaints or Covid symptoms otherwise. He has been seen by cardiology and stress test was planned. Patient's symptoms had resolved and he left AGAINST MEDICAL ADVICE before further testing could be completed.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anhidrosis, Biopsy skin abnormal, Heart rate, Hyperacusis, Hypoaesthesia
Clinical narrative: Severe twitching all over the body. Diagnosed with small fiber neuropathy from head to feet. Pain, sensitivity to noise, nausea, loss of 20 Ibs, bedridden for 3 months. Inability to sweat. Heart pulse 150. Insomnia. Numbness of fingers. Terrible pain from neuropathy that interrupts daily life, stabbing pain, and needle-like sensation all over the body. Ringing in the ear.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Mobility decreased
Clinical narrative: Severe twitching all over the body. Diagnosed with small fiber neuropathy from head to feet. Pain, sensitivity to noise, nausea, loss of 20 Ibs, bedridden for 3 months. Inability to sweat. Heart pulse 150. Insomnia. Numbness of fingers. Terrible pain from neuropathy that interrupts daily life, stabbing pain, and needle-like sensation all over the body. Ringing in the ear.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Nausea, Neuralgia, Pain, Paraesthesia
Clinical narrative: Severe twitching all over the body. Diagnosed with small fiber neuropathy from head to feet. Pain, sensitivity to noise, nausea, loss of 20 Ibs, bedridden for 3 months. Inability to sweat. Heart pulse 150. Insomnia. Numbness of fingers. Terrible pain from neuropathy that interrupts daily life, stabbing pain, and needle-like sensation all over the body. Ringing in the ear.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Small fibre neuropathy, Tinnitus, Weight decreased
Clinical narrative: Severe twitching all over the body. Diagnosed with small fiber neuropathy from head to feet. Pain, sensitivity to noise, nausea, loss of 20 Ibs, bedridden for 3 months. Inability to sweat. Heart pulse 150. Insomnia. Numbness of fingers. Terrible pain from neuropathy that interrupts daily life, stabbing pain, and needle-like sensation all over the body. Ringing in the ear.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Erythema, Lip swelling, Nasal congestion, Swelling face
Clinical narrative: After receiving her first Covid-19 vaccine, she experienced swelling around her right eye.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: After receiving her first Covid-19 vaccine, she experienced swelling around her right eye.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Antinuclear antibody, Arrhythmia, Blood test, Blood thyroid stimulating hormone
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Borrelia test, C-reactive protein, Cardiac stress test, Chest X-ray, Computerised tomogram
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Liver function test, Pulmonary function test, Red blood cell sedimentation rate
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Thyroid function test, Vitamin B12, Vitamin D
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Dyspnoea exertional, Exercise tolerance decreased, Pulmonary embolism, Pulmonary hypertension
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Right ventricular dilatation, Right ventricular dysfunction, Ventilation/perfusion scan abnormal
Clinical narrative: Roughly 1-2 weeks after receiving his 2nd dose of the vaccination, the patient notice increasing dyspnea on exertion and exercise intolerance.  After several months of evaluation, it appears the patient has chronic thromboembolic pulmonary hypertension.  By clinical history, this appears to have happened  roughly 2 weeks after receiving the 2nd dose of the vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received a second Moderna booster (0.25 mL) but had already received the full two dose series plus his Moderna booster on 12/16/21.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired vaccine used; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 23-FEB-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter live recombinant human albumin (rHA) (Lot# T001215 and expiration date 12-JAN-2022), reconstituted with sterile diluent (Lot# T031063 and expiration date 27-DEC-2022) as prophylaxis (expired product administered). There was no previous temperature excursion. No additional adverse event reported, no further information provided.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of Rotateq was administered; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 25-JAN-2022, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, oral (Lot# U007860 and expiration date 14-JAN-2022) (frequency were not reported) as prophylaxis. (expired product administered). No additional adverse event reported, no further information provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was vaccinated with improperly stored Rotateq; No adverse event; This spontaneous report was received from a other health care professional referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were not reported.   On 23-FEB-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# 1742462 and expiration date 19-SEP-2022) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion 49 degree Celsius for 72 hours. No previous temperature excursion. No additional adverse event reported, no further information provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria all over body comes and goes through out the day. I have never had anything like this or any allergies prior to getting the Moderna booster
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dysarthria, Headache, Nausea
Clinical narrative: Chills, aching, fever, tight throat, vomiting, nausea, diarrhea, headache, slurred speech, syncope
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Syncope, Throat tightness, Vomiting
Clinical narrative: Chills, aching, fever, tight throat, vomiting, nausea, diarrhea, headache, slurred speech, syncope
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: pericarditis. 1/13 chest pain, fatigued. 1/14 pain worsened, short of breath, bp elevated. 1/15 mild pain at night. 1/16 mild pain. 1/18 went to the ER convinced that it was pleural effusion, x-ray didn't show any fluid. 1/19 saw cardiologist for echo, she thought it might be pericarditis. pain still there a week later, started on colchicine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pericarditis, X-ray normal
Clinical narrative: pericarditis. 1/13 chest pain, fatigued. 1/14 pain worsened, short of breath, bp elevated. 1/15 mild pain at night. 1/16 mild pain. 1/18 went to the ER convinced that it was pleural effusion, x-ray didn't show any fluid. 1/19 saw cardiologist for echo, she thought it might be pericarditis. pain still there a week later, started on colchicine.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Echocardiogram, Electrocardiogram ambulatory
Clinical narrative: Sudden onset of rapid heart rate (up to 175 bpm), nausea, dizziness, cold sweat, and weakness.  Tachycardia lasted more than 2 hours. Treated in the Emergency Room at Hospital.  Given an intravenous push of adenosine to reset heart rate.  Diagnosis: Supraventricular tachycardia, nonsustained Prescribed: Metprolol tartrate (lopressor) 25 mg for recurrance
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Nausea, Supraventricular tachycardia, Tachycardia, Ultrasound Doppler
Clinical narrative: Sudden onset of rapid heart rate (up to 175 bpm), nausea, dizziness, cold sweat, and weakness.  Tachycardia lasted more than 2 hours. Treated in the Emergency Room at Hospital.  Given an intravenous push of adenosine to reset heart rate.  Diagnosis: Supraventricular tachycardia, nonsustained Prescribed: Metprolol tartrate (lopressor) 25 mg for recurrance
Age: 25.0
Sex: F
Vaccine: FLU4, MMR, TDAP
Symptoms: Blood pressure increased, Dizziness, Fear of injection, Pallor, Syncope
Clinical narrative: The patient started to feel light headed and her face became pale and slowly collapsed about 5 minutes after vaccination. She was seated on a chair and I was by her side, so she did not hit anywhere on her body. Her body was laid flat on the floor and her legs elevated and she started to be able to answer questions. Her BP was 90/48 at the time of syncope and was seen by a doctor. She was monitored on a reclining chair and her BP rose up to 102/54 after 15 minutes of being monitored. She stated that she has never had syncope but admitted that she was scared of needles and has never had more than 3 shots at the same time, and she did not eat anything in the morning so she was already a little light headed when she came to the clinic. She was monitored for additional 15 more minutes on a chair with her husband and she stated that she felt much better.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Breast disorder, Cardiac flutter, Ear haemorrhage
Clinical narrative: This spontaneous report received from a patient via social media from a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer survivor. On an unspecified date, the patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1), (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for prophylactic vaccination. No adverse events reported following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1).   The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported administered 1 in total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 04-MAR-2022, the patient experienced ear bleeding (dose number in series 2). On an unspecified date, the patient experienced heart flutters, hair falling out, skin like its sunburn feeling, inside of mouth always feels sore, skin thickening, both breasts have issues, legs hurt, headaches, and weaker (dose number in series 2). It was reported that "I wish I was as fortunate. No problems with the regular shot, however, with booster my hairs falling out, my skins like its sunburn feeling and thickening, inside mouth now always feels sore, heart flutters, and legs hurt. Yesterday one ear was bleeding, now left ears bleeding not a little blood comes out of my ear so Monday it begins again I am off to Dr. again. Also I am a breast cancer survivor and both breast have issues now as well as headaches many other things. I am trying to get thru but each day I get weaker". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears bleeding on 05-MAR-2022, had not recovered from inside of mouth always feels sore, both breasts have issues, and weaker, and the outcome of hair falling out, skin like its sunburn feeling, heart flutters, legs hurt, headaches and skin thickening was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220313818-Covid-19 vaccine ad26.cov2.s-heart flutters. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral pain, Pain in extremity, Skin burning sensation, Skin hypertrophy
Clinical narrative: This spontaneous report received from a patient via social media from a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer survivor. On an unspecified date, the patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1), (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for prophylactic vaccination. No adverse events reported following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1).   The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported administered 1 in total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 04-MAR-2022, the patient experienced ear bleeding (dose number in series 2). On an unspecified date, the patient experienced heart flutters, hair falling out, skin like its sunburn feeling, inside of mouth always feels sore, skin thickening, both breasts have issues, legs hurt, headaches, and weaker (dose number in series 2). It was reported that "I wish I was as fortunate. No problems with the regular shot, however, with booster my hairs falling out, my skins like its sunburn feeling and thickening, inside mouth now always feels sore, heart flutters, and legs hurt. Yesterday one ear was bleeding, now left ears bleeding not a little blood comes out of my ear so Monday it begins again I am off to Dr. again. Also I am a breast cancer survivor and both breast have issues now as well as headaches many other things. I am trying to get thru but each day I get weaker". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears bleeding on 05-MAR-2022, had not recovered from inside of mouth always feels sore, both breasts have issues, and weaker, and the outcome of hair falling out, skin like its sunburn feeling, heart flutters, legs hurt, headaches and skin thickening was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220313818-Covid-19 vaccine ad26.cov2.s-heart flutters. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via company representative via social media, concerned multiple patients(two male patients under 30 years old) of unspecified race and ethnicity. No past medical histories or concurrent conditions were reported. The patient's pre-existing medical conditions included: patients were healthy under 30 years old. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the multiple patients died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated, "Two friends died within several days after the vaccine. Both were healthy males under 30 years old I would rather be shamed for not getting the vaccine by shameful people than play the perverbial game of roulette". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220322018-COVID-19 VACCINE AD26.COV2.S-died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered expired Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that the patient was administered an expired dose of Twinrix, which led to expired vaccine used. No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210907568.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Administration site pain, Asthenia, Muscle atrophy, Pain
Clinical narrative: WHOLE BODY ACHINESS (UPPER AND LOWER BODY, WORSE ON THE RIGHT LEG AND WHOLE UPPER BODY); LOSS OF MUSCLE; LOSS OF STRENGTH (RIGHT SIDE IS DETERIORATED AND HIS STRENGTH IS GOING DOWN); FEELING ACHINESS IN RIGHT ARM AT ADMINISTRATION SITE; This spontaneous report received from a patient concerned a 70 year old white male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient felt (body and joint soreness and achiness) soreness throughout his body and joints when started to get active and went outside. The patient stated it was a continuous aching and had made working and activities difficult for him. The patient stated whenever he walked or did something it was painful he described the event was not debilitating but something was not right. The patient stated the achiness went on all summer long and subsided in OCT-2021. At first he thought it might be lyme disease but never got tested for lyme disease. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-DEC-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 17-DEC-2021 two days after taking booster, the patient experienced feeling achiness in right arm at administration site which lasted for more than a month. Patient stated that the achiness traveled throughout whole body, upper and lower body and he feel it daily. He stated that he has some good days and sometime it hurts to move. Patient described that it was worse on the right leg and whole upper body. His shoulder, elbows and arms were achy and felt like workout soreness. Patient noticed loss of muscle and strength as if his right side was deteriorated and his strength was going down (dose number in series 2). Patient has not discussed his symptoms with his doctor yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling achiness in right arm at administration site, and had not recovered from loss of muscle, loss of strength (right side is deteriorated and his strength is going down), and whole body achiness (upper and lower body, worse on the right leg and whole upper body). This report was non-serious. This case, involving the same patient is linked to 20220306407 (Dose number in series 1).
Sex: M
Vaccine: COVID19
Symptoms: Renal infarct, Thrombosis
Clinical narrative: This spontaneous report received from a consumer via social media (via public comment to the J&J Corporate account) via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated that "Our son threw blood clots and suffered multiple bilateral kidney infarcts after his J and J vaccine. I pray that we don't see catastrophic events in the years to come from all of them." On an unspecified date, the patient experienced throwing blood clots, and suffered multiple bilateral kidney infarcts. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the threw blood clots and multiple bilateral kidney infarcts was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220323641-Covid-19 vaccine ad26.cov2.s- Threw blood clots, multiple bilateral kidney infarcts. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Neck pain
Clinical narrative: NECK PAIN; PAIN IN LEGS, PAIN IN ARMS; MUSCLE WEAKNESS; PAIN IN KNEES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced neck pain, pain in legs, pain in arms, muscle weakness, pain in knees, tiredness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, pain in knees, pain in legs, pain in arms, neck pain, tiredness, and muscle weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: NECK PAIN; PAIN IN LEGS, PAIN IN ARMS; MUSCLE WEAKNESS; PAIN IN KNEES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced neck pain, pain in legs, pain in arms, muscle weakness, pain in knees, tiredness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, pain in knees, pain in legs, pain in arms, neck pain, tiredness, and muscle weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN ARM; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220325124-COVID-19 VACCINE AD26.COV2.S- blood clot in arm. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed Covid Tylenol, Remdesivir Inpatient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after vaccination. Patient was diagnosed with Covid Tylenol Inpatient
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash vesicular, Urticaria
Clinical narrative: Rash starting on stomach and spreading over days to chest, upper and lower back, upper arms, thighs. Rash started as hives then changed to red bumps resembling chicken pocks. Very itchy. Some relief from itching with pseudoephedrine.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Event occurred after 2nd dose. Patient was diagnosed with Covid Remdesivir Discharged home
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient stated injection site is swollen and numb and she is having issues moving her arm around and doesn't know how shes going to work
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient stated injection site is swollen and numb and she is having issues moving her arm around and doesn't know how shes going to work
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Migraine
Clinical narrative: Migraine, beginning the night of vaccine and continuing for one month so far. Ongoing.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac murmur, Cardiac operation, Mitral valve prolapse
Clinical narrative: 12/30/2021 Heart murmur/ Atrial Flutter. Mitral Valve Prolapse and AFib. Open heart surgery 01/26/2021 Repaired still in AFib awaiting conversion.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Moderna 2/3/21  038K20A dose 2 Moderna 3/3/21  030A21A
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Patient complaining of menorrhagia and dysmenorrhea since receiving COVID vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "COVID-19 resulting in inpatient hospitalization" of a vaccinated patient
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Soreness in arm,, shivering, headache
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Respiratory failure
Clinical narrative: resp failure COVID ,  expired
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Influenza A virus test negative, Influenza B virus test
Clinical narrative: This is a 73y.o. female   Patient has a past medical history of CHF CAD diabetes hypertension myocardial infarction PE seizures and DVT which the patient comes in secondary shortness of breath 4 days in duration the patient called EMS the patient had a pulse ox 93% the patient was placed on non-rebreather at that time the patient was transferred to the hospital the patient is found to have COVID-19 viral pneumonia the patient was tachypneic tachycardic the patient presented with sepsis on admission the patient was placed on high-flow nasal cannula CT protocol ruled out a PE
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test positive, Sepsis, Tachycardia, Tachypnoea
Clinical narrative: This is a 73y.o. female   Patient has a past medical history of CHF CAD diabetes hypertension myocardial infarction PE seizures and DVT which the patient comes in secondary shortness of breath 4 days in duration the patient called EMS the patient had a pulse ox 93% the patient was placed on non-rebreather at that time the patient was transferred to the hospital the patient is found to have COVID-19 viral pneumonia the patient was tachypneic tachycardic the patient presented with sepsis on admission the patient was placed on high-flow nasal cannula CT protocol ruled out a PE
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia of chronic disease, Breath sounds absent, COVID-19 pneumonia, Carotid pulse abnormal
Clinical narrative: Date of Admission  01/18/2022   Date of Discharge  01/21/2022   Reason for Hospitalization   PER EMS, FAMILY REPORTED PT BEING LETHARGIC AND INCREASED SOB; MILD FEVER.  Hospital Course   Patient is a 85 y/o female with dementia, dysphagia, previous hospice patient admitted for acute hypoxic respiratory failure secondary to COVID-10 pneumonia and suspected aspiration pneumonia.  Grandson is primary decision maker.  Per hospice agency, hospice status was revoked so patient could come to hospital for medical treatment.  Grandson wanted to continue with medical management except for intubation or CPR. She was treated with with dexamethasone, remdesivir, and antibiotics for aspiration pneumonia concerns. Her oxygen requirements were increased on high-flow nasal cannula during hospitalization. Initially she was able to have oxygen requirements decreased to 3L NC.   We had goals of care discussion with family regarding nutrition as patient had been NPO throughout admission. (please refer to addendum on progress note from 1/20/2022). After discussion family wanted to trial patient tube feeds. However, overnight on 1/21 patient had teams called x 2 due to increased work of breathing, oxygen requirement and decreased mentation. After discussion with family patient was transitioned to comfort care.  Discharge Diagnoses      #Acute hypoxic respiratory failure secondary to COVID-19 pneumonia #Suspected aspiration pneumonia #Advanced Dementia  #High anion gap metabolic acidosis #Dehydration  #Underweight  #Hypernatremia  #Pancytopenia  #Anemia of chronic disease     Other Diagnoses   Ongoing  No chronic problems  Historical  No qualifying data        Discharge Disposition  Unable To Determine    Medications  New, Changed, or Refilled Medications  None    Medications to be Continued  acetaminophen (acetaminophen 650 mg rectal suppository) 650 mg, 1 Supp, Rectal, q4h, PRN: fever>100      Discontinued Medications  None  Physical Exam at Discharge       No reaction to verbal or tactile stimulation.  No pupillary light reflex noted, pupils fixed and dilated  Breathing and other lung sounds were absent.  No carotid pulse or heart sound can be heard               Addendum by MD on January 24, 2022 15:02:08 (Verified)    Attestation by MD on January 24, 2022 15:02 I personally saw and evaluated the patient on the result date found in the header of this document.  I independently performed the critical/key portions of the Evaluation and Management service and discussed the management with the author of this document.  I agree with everything documented above.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dementia, Dysphagia, Dyspnoea, Heart sounds abnormal
Clinical narrative: Date of Admission  01/18/2022   Date of Discharge  01/21/2022   Reason for Hospitalization   PER EMS, FAMILY REPORTED PT BEING LETHARGIC AND INCREASED SOB; MILD FEVER.  Hospital Course   Patient is a 85 y/o female with dementia, dysphagia, previous hospice patient admitted for acute hypoxic respiratory failure secondary to COVID-10 pneumonia and suspected aspiration pneumonia.  Grandson is primary decision maker.  Per hospice agency, hospice status was revoked so patient could come to hospital for medical treatment.  Grandson wanted to continue with medical management except for intubation or CPR. She was treated with with dexamethasone, remdesivir, and antibiotics for aspiration pneumonia concerns. Her oxygen requirements were increased on high-flow nasal cannula during hospitalization. Initially she was able to have oxygen requirements decreased to 3L NC.   We had goals of care discussion with family regarding nutrition as patient had been NPO throughout admission. (please refer to addendum on progress note from 1/20/2022). After discussion family wanted to trial patient tube feeds. However, overnight on 1/21 patient had teams called x 2 due to increased work of breathing, oxygen requirement and decreased mentation. After discussion with family patient was transitioned to comfort care.  Discharge Diagnoses      #Acute hypoxic respiratory failure secondary to COVID-19 pneumonia #Suspected aspiration pneumonia #Advanced Dementia  #High anion gap metabolic acidosis #Dehydration  #Underweight  #Hypernatremia  #Pancytopenia  #Anemia of chronic disease     Other Diagnoses   Ongoing  No chronic problems  Historical  No qualifying data        Discharge Disposition  Unable To Determine    Medications  New, Changed, or Refilled Medications  None    Medications to be Continued  acetaminophen (acetaminophen 650 mg rectal suppository) 650 mg, 1 Supp, Rectal, q4h, PRN: fever>100      Discontinued Medications  None  Physical Exam at Discharge       No reaction to verbal or tactile stimulation.  No pupillary light reflex noted, pupils fixed and dilated  Breathing and other lung sounds were absent.  No carotid pulse or heart sound can be heard               Addendum by MD on January 24, 2022 15:02:08 (Verified)    Attestation by MD on January 24, 2022 15:02 I personally saw and evaluated the patient on the result date found in the header of this document.  I independently performed the critical/key portions of the Evaluation and Management service and discussed the management with the author of this document.  I agree with everything documented above.