chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphonia, Blood test normal, Cardiac failure congestive, Cerebral disorder, Cerebrovascular accident
Clinical narrative: In November 2022 after the 5th dose, I was diagnosed with Rhino Virus. My symptoms were a violent cough and difficulty breathing. The virus lasted for three weeks, and I lost my voice for even longer. I visited the emergency room, and I was prescribed gel pills. March 10th 2023 I felt pressure on my diaphragm for two days. It felt like someone had punched me in my gut. At the end of March, I was having a hard time breathing and went back to the emergency department. They saw fluid in my lung, gave me antibiotics and sent me home. April 7th I was unable to breath and went back to the emergency room. They found that I was in congestive heart failure and was admitted to the hospital. I was assigned a cardiologist and put me on LASIX and food restriction. After walking around the hospital, I woke up and was told that I had had a stroke on March 9th or 10th. I was admitted to ICU. As a result of the stroke, I lost my left peripheral vision. That part of my brain is brain dead, and my vision cannot be restored.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Diaphragmatic disorder, Discomfort, Dyspnoea, Echocardiogram abnormal
Clinical narrative: In November 2022 after the 5th dose, I was diagnosed with Rhino Virus. My symptoms were a violent cough and difficulty breathing. The virus lasted for three weeks, and I lost my voice for even longer. I visited the emergency room, and I was prescribed gel pills. March 10th 2023 I felt pressure on my diaphragm for two days. It felt like someone had punched me in my gut. At the end of March, I was having a hard time breathing and went back to the emergency department. They saw fluid in my lung, gave me antibiotics and sent me home. April 7th I was unable to breath and went back to the emergency room. They found that I was in congestive heart failure and was admitted to the hospital. I was assigned a cardiologist and put me on LASIX and food restriction. After walking around the hospital, I woke up and was told that I had had a stroke on March 9th or 10th. I was admitted to ICU. As a result of the stroke, I lost my left peripheral vision. That part of my brain is brain dead, and my vision cannot be restored.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Gastrointestinal pain, Intensive care, Magnetic resonance imaging head abnormal, Medical diet, Pulmonary oedema
Clinical narrative: In November 2022 after the 5th dose, I was diagnosed with Rhino Virus. My symptoms were a violent cough and difficulty breathing. The virus lasted for three weeks, and I lost my voice for even longer. I visited the emergency room, and I was prescribed gel pills. March 10th 2023 I felt pressure on my diaphragm for two days. It felt like someone had punched me in my gut. At the end of March, I was having a hard time breathing and went back to the emergency department. They saw fluid in my lung, gave me antibiotics and sent me home. April 7th I was unable to breath and went back to the emergency room. They found that I was in congestive heart failure and was admitted to the hospital. I was assigned a cardiologist and put me on LASIX and food restriction. After walking around the hospital, I woke up and was told that I had had a stroke on March 9th or 10th. I was admitted to ICU. As a result of the stroke, I lost my left peripheral vision. That part of my brain is brain dead, and my vision cannot be restored.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinovirus infection, Visual field defect
Clinical narrative: In November 2022 after the 5th dose, I was diagnosed with Rhino Virus. My symptoms were a violent cough and difficulty breathing. The virus lasted for three weeks, and I lost my voice for even longer. I visited the emergency room, and I was prescribed gel pills. March 10th 2023 I felt pressure on my diaphragm for two days. It felt like someone had punched me in my gut. At the end of March, I was having a hard time breathing and went back to the emergency department. They saw fluid in my lung, gave me antibiotics and sent me home. April 7th I was unable to breath and went back to the emergency room. They found that I was in congestive heart failure and was admitted to the hospital. I was assigned a cardiologist and put me on LASIX and food restriction. After walking around the hospital, I woke up and was told that I had had a stroke on March 9th or 10th. I was admitted to ICU. As a result of the stroke, I lost my left peripheral vision. That part of my brain is brain dead, and my vision cannot be restored.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood test normal, Computerised tomogram head normal, Electronystagmogram, Gait inability
Clinical narrative: Chronic Tinnitus and vertigo with inability to ambulate, 2 weeks after the vaccine date with no resolution.  Hospitalization in November 2022 for increased and severe symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Tinnitus, Vertigo
Clinical narrative: Chronic Tinnitus and vertigo with inability to ambulate, 2 weeks after the vaccine date with no resolution.  Hospitalization in November 2022 for increased and severe symptoms.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects but patient was given (Moderna Bivalent Booster 6m-5y Covid-19) - Dark Pink Cap/Yellow Border (dose 0.20) on 4/28/23.  After. having one dose of (Moderna Monovalent Peds 6m-5y Covid-19) - Blue Cap/Magenta Border on 3/22/23. Patient should have received single dose 0.25 mL on 4/28/23.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Arrhythmia, Atrial fibrillation, Chest X-ray abnormal, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: I started having heart arrhythmia, I walked about ten feet, I could not catch my breath. I called the doctor to make an appointment. My doctor ordered that I have and EKG, ECG, chest x-ray, the EKG, ECG showed positive for Atrial Fibrillation and low pulse. Tomorrow I will start wearing a Holter monitor to actual check the rhythm of my heart at this time. On Monday I will be going into to the hospital so they can stop my heart and restart to get it back into rhythm.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Heart rate decreased
Clinical narrative: I started having heart arrhythmia, I walked about ten feet, I could not catch my breath. I called the doctor to make an appointment. My doctor ordered that I have and EKG, ECG, chest x-ray, the EKG, ECG showed positive for Atrial Fibrillation and low pulse. Tomorrow I will start wearing a Holter monitor to actual check the rhythm of my heart at this time. On Monday I will be going into to the hospital so they can stop my heart and restart to get it back into rhythm.
Age: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Rash, Rash papular
Clinical narrative: RASH SEVERAL HOURS AFTER VACCINE.  FULL BODY, DENCE, PAPULAR RASH.NOT ANAPHYLACTIC.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Feeling of body temperature change, Headache, Malaise, Nausea
Clinical narrative: I had hot/cold spells, fever, violent coughing attacks, nausea and a pounding headache for days. I still don't feel great. I spent 3 days in bed already.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: I had hot/cold spells, fever, violent coughing attacks, nausea and a pounding headache for days. I still don't feel great. I spent 3 days in bed already.
Age: 0.83
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash papular
Clinical narrative: RASH SEVERAL HOURS AFTER VACCINE.  FULL BODY, DENCE, PAPULAR RASH.NOT ANAPHYLACTIC.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Marked right upper arm redness, warmth, swelling, itching.  Two episodes of "cold sweats" which woke her from sleep.  Oddly enough the arm symptoms were distal to the injection site.  The site itself appeared normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Marked right upper arm redness, warmth, swelling, itching.  Two episodes of "cold sweats" which woke her from sleep.  Oddly enough the arm symptoms were distal to the injection site.  The site itself appeared normal.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, Respiratory failure
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/5/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/5/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Anisocytosis, C-reactive protein, Computerised tomogram abnormal, Erythema, Fasciotomy
Clinical narrative: After receiving Shingrix vaccine on 05/01/23 pt presented right arm pain, erythema, and swelling the following day, along with 1 episode of nausea and vomiting on the morning of 5/2. Pt was referred to the ED due to concerns of compartment syndrome, upon assessment and CT arm pt had right upper arm fasciotomy on 05/3/2023. As of 05/4/2023 Pt remains admitted for in-patient care with expected release date 05/09/23
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphocyte percentage decreased, Nausea, Neutrophil count increased, Neutrophil percentage increased, Oedema peripheral
Clinical narrative: After receiving Shingrix vaccine on 05/01/23 pt presented right arm pain, erythema, and swelling the following day, along with 1 episode of nausea and vomiting on the morning of 5/2. Pt was referred to the ED due to concerns of compartment syndrome, upon assessment and CT arm pt had right upper arm fasciotomy on 05/3/2023. As of 05/4/2023 Pt remains admitted for in-patient care with expected release date 05/09/23
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Red blood cell anisocytes present, Red blood cell elliptocytes present, Red blood cell microcytes present, Soft tissue swelling
Clinical narrative: After receiving Shingrix vaccine on 05/01/23 pt presented right arm pain, erythema, and swelling the following day, along with 1 episode of nausea and vomiting on the morning of 5/2. Pt was referred to the ED due to concerns of compartment syndrome, upon assessment and CT arm pt had right upper arm fasciotomy on 05/3/2023. As of 05/4/2023 Pt remains admitted for in-patient care with expected release date 05/09/23
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, Vomiting, White blood cell count increased
Clinical narrative: After receiving Shingrix vaccine on 05/01/23 pt presented right arm pain, erythema, and swelling the following day, along with 1 episode of nausea and vomiting on the morning of 5/2. Pt was referred to the ED due to concerns of compartment syndrome, upon assessment and CT arm pt had right upper arm fasciotomy on 05/3/2023. As of 05/4/2023 Pt remains admitted for in-patient care with expected release date 05/09/23
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 5/12/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, Cough, Headache, Malaise, Pain
Clinical narrative: COVID-19 infection symptoms started in med February 2023 probably in the afternoon. I had cough, headaches, post nasal drip, and achy. I did 2 home tests which were positive. I did a telehealth with my doctor who prescribed me with 2 different pills. I am not sure of the name exactly. I also take vitamin D along with the medications. As of now I still have the lingering cough from COVID-19 infection and my throat is more sensitive now.
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Pharyngeal disorder, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: COVID-19 infection symptoms started in med February 2023 probably in the afternoon. I had cough, headaches, post nasal drip, and achy. I did 2 home tests which were positive. I did a telehealth with my doctor who prescribed me with 2 different pills. I am not sure of the name exactly. I also take vitamin D along with the medications. As of now I still have the lingering cough from COVID-19 infection and my throat is more sensitive now.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, Status epilepticus
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  STATUS EPILEPTICUS 6/30/2022 HX OF FALL  STATUS EPILEPTICUS 6/30/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, WO BEHAVIORAL DISTURBANCE
Age: 0.92
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Client was given wrong dose.  Was given 0.3 instead of 0.25
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Diabetic nephropathy, Thrombotic stroke, Type 2 diabetes mellitus
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 11/10/2021 DM 2 W RENAL MANIFESTATION ACUTE STROKE DUE TO THROMBOSIS OF UNSPECIFIED ARTERY 1/24/2022 DM 2 W RENAL MANIFESTATION
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle rigidity, Neck pain
Clinical narrative: Patient reports neck pain and rigidity approximately 24 hours following vaccine administration.  Patient states the issue has not resolved or improved.
Sex: U
Vaccine: HEPAB
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse events reported yet; vaers site says it encourages healthcare professionals to report administration errors - the immunization was given without being shaken
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve stenosis, Atrial fibrillation, Cardiac assistance device user, Cardiac failure acute, Cardiac failure congestive
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------------  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 HX OF MITRAL VALVE REPLACEMENT    SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC  CARDIOGENIC SHOCK 11/18/2021 PRESENCE OF CARDIAC PACEMAKER  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 11/18/2021 SYSTOLIC HEART FAILURE, UNSPECIFIED ACUITY  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 CARDIOGENIC SHOCK
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Left ventricular failure
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -----------------------------------------------------------------------------------------------------------------------------  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 HX OF MITRAL VALVE REPLACEMENT    SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC  CARDIOGENIC SHOCK 11/18/2021 PRESENCE OF CARDIAC PACEMAKER  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 AORTIC VALVE STENOSIS  CARDIOGENIC SHOCK 11/18/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED  CARDIOGENIC SHOCK 11/18/2021 SYSTOLIC HEART FAILURE, UNSPECIFIED ACUITY  CARDIOGENIC SHOCK 11/18/2021 ATRIAL FIBRILLATION, PERSISTENT  CARDIOGENIC SHOCK 11/18/2021 CARDIOGENIC SHOCK
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: I had a mild case of COVID-19, I went to the doctor to get medication. I got over COVID-19, then I suddenly I started having extreme pain in areas of my body where I had, had previous injuries. I had used marijuana cream that gave me no relief. I made an appointment with my doctor who gave me pain medication that did help, but once I was out of the medication the pain returned much worse like I had been hurt by a large truck. I went back to the doctor, I was prescribed Tramadol, Meloxicam, Cymbalta that do help to give me relief. My hands, fingers swell, my arms ache all the way up into my neck. I will be going to the COVID-19 clinic to see if I can find out what is going on and hopefully get some relief.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Arthralgia, Bursitis, Pain in extremity
Clinical narrative: Patient states that she developed severe pain in the shoulder after the vaccination. She didn't notify us back then and she mentioned it today when she came to get a bivalent shot. She went to the MD right after receiving the vaccination as the pain was not going away and the MD said it was Bursitis possibly caused by the vaccination. She tried different things and nothing helped the pain relief. She ended up going to an accupuncturist and after getting several months of accupuncture therapy, took a herbal pill per accupuncturist recommendation. She thinks the pill had helped her after taking for 2 months. She is fine now except she has a slight achy feeling in her arm all the time.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle tightness, Pruritus, Rash
Clinical narrative: Patient c/o feeling itchy, a little rash, and tension in the back of neck. Vital was taken BP:130/88, HR:71, Oxygen:100. Patient reported allergic to penicillin and spicy food. Patient reported she also received Tdap and IPV-Polio today at  clinic. Patient was given 1 Benadryl and observed another 15 mins and retake vital BP: 126/86. Oxygen 100. HR:72. Patient felt better and cleared by nurse. No EMS.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Computerised tomogram, Computerised tomogram head normal, Computerised tomogram neck, Magnetic resonance imaging normal
Clinical narrative: Covid Vax 1  - 3/26/2021.  Lot ER8732 Covid  Vax 2 - 4/16/2021. Lot EW0169 Booster -  12/15/2021. Lot  33130BA  1 month after my booster, I started hearing my pulse in my right ear. This began on January 12, 2022 and HAS NOT STOPPED
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Covid Vax 1  - 3/26/2021.  Lot ER8732 Covid  Vax 2 - 4/16/2021. Lot EW0169 Booster -  12/15/2021. Lot  33130BA  1 month after my booster, I started hearing my pulse in my right ear. This began on January 12, 2022 and HAS NOT STOPPED
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Aneurysm, Computerised tomogram abnormal, Dizziness, Headache, Hypoaesthesia
Clinical narrative: - Same day with numbness, headache, dizziness, fever and 2 days after
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: - Same day with numbness, headache, dizziness, fever and 2 days after
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: intense pruritis accompanied by an urticarial rash and erythema multiforme over the trunk and extremities lasting 4 hours and treated with loratadine 10 mg tid and topical 0.8% lidocaine gel.  Afebrile. Duration of treatment approximately 8 hours. (Photos of rash are available with date and time stamp).
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Patient developed varicella rash 2 weeks post injection
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after BUD
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Gastrooesophageal reflux disease, Incorrect dose administered, Nausea, Rhinorrhoea
Clinical narrative: Administered to both arms (R and L).  Dosage administered was twice standard dosing for this patient (40 mcg instead of 20 mcg).  Patient reports prolonged nausea, increased stomach acid, stomach pain and runny nose.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: USED AFTER BUD
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: administered after BUD
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Dyspnoea, Shock, Skin ulcer
Clinical narrative: ACUTE RESPIRATORY FAILURE 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  ACUTE ON CHRONIC RESPIRATORY FAILURE 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  SHOCK, UNSPECIFIED 5/1/2022 CHRONIC ULCER OF SKIN, UNSPECIFIED SITE AND DEPTH  ACUTE RESPIRATORY FAILURE 5/1/2022 SHORTNESS OF BREATH  ACUTE ON CHRONIC RESPIRATORY FAILURE 5/1/2022 SHORTNESS OF BREATH  SHOCK, UNSPECIFIED 5/1/2022 SHORTNESS OF BREATH
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Bile duct stone, Chronic respiratory failure, Facial paralysis, Hypotension, Hypoxia
Clinical narrative: RIGHT FACIAL PALSY 1/20/2022 CHOLEDOCHOLITHIASIS  HYPOTENSION 2/5/2022 CHOLEDOCHOLITHIASIS  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/7/2022 CHOLEDOCHOLITHIASIS  HYPOXIA 12/28/2021 CHOLEDOCHOLITHIASIS
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: RIGHT FACIAL PALSY 1/20/2022 CHOLEDOCHOLITHIASIS  HYPOTENSION 2/5/2022 CHOLEDOCHOLITHIASIS  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/7/2022 CHOLEDOCHOLITHIASIS  HYPOXIA 12/28/2021 CHOLEDOCHOLITHIASIS
Age: 60.0
Sex: F
Vaccine: COVID19-2, FLU4, HEP, TDAP
Symptoms: Urticaria
Clinical narrative: At approximately 11:15 am, the Patient, as mentioned above, returned to the nurse health assessment room, reporting she was having a reaction to the vaccines she had received. The Patient had received Pfizer Covid-19 bivalent, Tdap by GSK, Hepatitis B by Dynavax, and Influenza vaccine by ID Biomedical. The pt presented with generalized urticaria. Pt denied any SOB, difficulty swallowing, or chest pain. Vitals were immediately taken B/P 146/84 P: 64 Pulse Ox: 100% T: 98.4.   11:18 am Upon assessment from NP, Benadryl 25mg/0.5 ml was given IM. Generalized urticaria noted by NP. No angioedema or wheezing was noted on auscultation. A second set of vitals were taken B/P: 145/80 P: 66 Pulse ox: 100% T: 98.3. No acute distress was noted. 11:23 am Patient continues in observation. No acute distress was noted. Urticaria still noted. 11:35 am Vital retaken B/P: 135/76 P: 63 Pulse ox: 100% T: 98.2. No acute distress noted. Urticaria is subsidizing. 11:45 am Vital retaken B/P: 130/72 P: 60 Pulse ox: 100% T: 98.0. Urticaria localized to face, chest, and abdomen. Pt discharged at this time with discharge instructions and referral to PCP. Pt advised to seek immediate medical attention (911) should she present with any Urticaria, SOB, Chest pain, Angioedema, or difficulty swallowing. Pt verbalized understanding of all discharge instructions given. Pt left in stable condition, accompanied by family member.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Apathy, Asthenia, COVID-19, Pyrexia
Clinical narrative: I had a covid breakthrough. I had no energy. I had a fever- unknown temp, it lasted less than 24 hours. I  lost my sense of smell for 2 days. I did a breathing treatment due to my asthma.  I was very apathetic. I was also prescribed paxlovid.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: I had a covid breakthrough. I had no energy. I had a fever- unknown temp, it lasted less than 24 hours. I  lost my sense of smell for 2 days. I did a breathing treatment due to my asthma.  I was very apathetic. I was also prescribed paxlovid.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; vaccine was administered after temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, 1 dose, lot #W029553, expiration date: 14-MAR-2024, administered for prophylaxis (route of administration was not provided). The vaccine was administered after temperature excursion at 6.9 degrees Fahrenheit (F) for 15 minutes (product storage error). Previous temperature excursions were at 7.1 F for 30 minutes and at 11.6 F for 1 hour. No additional adverse events (AEs) were provided.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; VARIVAX was administered to patient with temperature excursion; This spontaneous report was received from a nurse prescriber and referred to a 13-year-old female patient. Concomitant vaccines on 09-FEB-2023 included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), polio vaccine and meningococcal vaccine a/c/y/w conj (crm197) (MENVEO). The patient had no significant past medical history no illness at time of vaccinnation. Information about drug reactions/allergies was not reported.  On 09-FEB-2023, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 milliliter, lot # w008712, expiration date 14-MAR-2024, administered for prophylaxis; anatomical location, strength and route were not provided) that exposed to a temperature excursion of 15.7 Fahrenheit degree for a time frame of 20 minutes (product storage error).  On 10-MAR-2023, the patient received second dose of varicella virus vaccine live (oka/merck) (VARIVAX). No adverse events related to vaccination.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA001247:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs.; a TE for ROTATEQ, product administered after the excursion.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 05-APR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dosage form, lot #W026136, expiration date: 31-JAN-2024, administered orally for prophylaxis (strength was not provided), after the temperature excursion (product storage error). Suspect vaccine experienced the temperature excursion of 61.7 degree Fahrenheit for 4 hours 39 minutes. There was no previous temperature excursion. No additional adverse event.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired lot of VARIVAX was administered to patient; This spontaneous report was received from a Registered Nurse (RN) regarding a 6-year-old-female patient. Her medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 18-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter once, lot # U012222 and expiry date: 16-APR-2023 (route of administration was not provided) for prophylaxis. No further information provided, no additional adverse events were reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; inadvertently administered ROTATEQ after 15 weeks of age; This spontaneous report was received from an other healthcare professional (HCP) and refers to a 15 weeks and 4 days old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot number: 1938974, expiration date: 30-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) after 15 weeks of age (product administered to patient of inappropriate age). No symptomatic side effects were reported during the time of the call and no additional adverse event details were provided (no adverse event).
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; PEDVAXHIB and VAXNEUVANCE was administered to a patient after being improperly stored.; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient medical history, current conditions and concomitant medications was provided.     On an unknown date the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # W036242 and expiration date 01-OCT-2024 (valid lot number) for prophylaxis (exact dose and route of administration were not provided) and also improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot# W028536 and expiration date 12-MAY-2025 (valid lot number) for prophylaxis (exact dose and route of administration were not provided) (experienced product storage error and no adverse event).
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: dehydration; vomiting; diarrhea; This spontaneous report has been received from a physician via Company representative, concerning a 6-year-old male patient. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient received the "complete series" of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally as prophylaxis (dosage regimen, lot number and expiration date were not provided).   On 30-APR-2023, the patient presented to the ER for dehydration, vomiting and diarrhea. On 01-MAY-2023, the patient was admitted to the hospital. Outcome of the events was not provided.   Causal relationship between Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and the events was not reported.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2305USA000844:
Sex: M
Vaccine: UNK
Symptoms: Antibody test abnormal, Bacteraemia, Blood culture positive, Drug interaction, Streptococcus test positive
Clinical narrative: evaluation of pneumococcal titers, all of which were low; drug interaction;   Information has been received from the authors of a published literature article, titled as stated above, regarding a 27-month-old male patient.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.    On an unknown date the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (route, dosage information and lot number were not provided) for prophylaxis.  On an unknown date, the patient was diagnosed with B-cell acute lymphoblastic leukemia (ALL), CNS 1, neutral cytogenetics and he was randomized to two cycles of blinatumomab (route, dose and frequency were not provided) in addition to standard chemotherapy. He received intravenous immunoglobulin (IVIG) twice for hypogammaglobulinemia.    Approximately 19 months after completion of blinatumomab, during cycle 1 of maintenance, he presented to the emergency department (ED) blood cultures were drawn and S. pneumoniae grew within 12.3 hours.  Ten weeks later, during cycle 2 of maintenance therapy, he again presented to the ED. Blood cultures grew S. pneumoniae at 12.1 hours.  Recurrent S. pneumoniae bacteremia prompted evaluation of pneumococcal titers, all of which were low (antibody test abnormal).  The authors mentioned it was likely that treatments he received for leukemia contributed to his low pneumococcal titers (drug interaction).  He received re-vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Four weeks later, vaccine titers demonstrated a normal humoral response.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Nurse reported that VARIVAX was administered following temperature excursion. Consent to contact obtained. No additional AEs/PQCs reported.  ?    Names of vaccines involved (including lot/exp) VARIVAX  Lot: W031815  Exp: 10/5/2024         ?    Te; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# W031815, expiration date: 05-OCT-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine was exposed for the temperature excursion of 9 degrees Fahrenheit for 2 hours and 6 minutes.  No previous temperature excursion had occurred. There were no additional adverse events reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles breakout now, disconcerting; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient have had shingles before).   On an unknown date, the patient received the 2nd dose of Shingrix. In JUN-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles breakout now, disconcerting). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 27-Apr-2023 The patient has had shingles before. The patient received the Shingrix vaccine last year first dose in June 2020 and second in August or September 2020. The patient has developed a shingles break out now. As we get ready for vacation travel, this was most disconcerting. The patient was asking for advise. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Felt very flu like; Horrible shaking chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient suffered from  shingles two-three months prior to vaccination in his/her scalp.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 10 hrs after receiving Shingles vaccine, the patient experienced chills (Verbatim: Horrible shaking chills), fever (Verbatim: Fever), general body pain (Verbatim: Body aches) and influenza-like symptoms (Verbatim: Felt very flu like). The outcome of the chills was resolved (duration 5 hrs) and the outcome of the fever and general body pain were not reported and the outcome of the influenza-like symptoms was resolved (duration 48 hrs).   It was unknown if the reporter considered the chills, fever, general body pain and influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the chills, fever, general body pain and influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that after the first dose, within 10 hours he/she had horrible shaking chills, fever and body aches. The chills subsided 4 to 5 hours later but still felt very flu like for another 24-48 hours.  The patient also had shingles two-three months prior in scalp.  Fortunately, the patient caught shinles early and was better in a couple of weeks. The patient stated that he/she would rather have the side effects from the shingles vaccine than shingles again, which was told he/she couple get it again, that was why the patient's physician  recommended him/her to get the vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that there was to many vaccines for everything and it hurts but it goes away. The patient stated that we must live like this. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Urticaria
Clinical narrative: hives; pain; burning; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (It had been 3 months since it came out).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hives (Verbatim: hives), pain (Verbatim: pain) and burning sensation (Verbatim: burning). The outcome of the hives, pain and burning sensation were not resolved.   It was unknown if the reporter considered the hives, pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the hives, pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-APR-2023 This case was reported by a patient via interactive digital media. It was reported that it had been three months since it came out. The patient had just received the second dose of the shingles vaccine and still got hives. The patient could not use bras anymore because it was a pain and burning at the same time.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dont remember if I had the 2nd shot; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date years ago).   On an unknown date, the patient did not received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Dont remember if I had the 2nd shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The patient reported that he or she received Shingles vaccine years ago but did not remember if he or she received second dose. The patient wanted to know should he or she receive the second dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Got chills; fever 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2023, the patient received Shingles vaccine. In APR-2023, less than a day after receiving Shingles vaccine, the patient experienced chills (Verbatim: Got chills) and fever (Verbatim: fever 3 days). The outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.     It was unknown if the company considered the chills and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-Apr-2023 The patient got the shingles vaccine two days ago and it gave him/her chills and fever for three days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue; achiness; headache; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), pain (Verbatim: achiness), headache (Verbatim: headache) and fever (Verbatim: fever). The outcome of the fatigue, pain, headache and fever were resolved (duration 2 days).   It was unknown if the reporter considered the fatigue, pain, headache and fever to be related to Shingrix.     It was unknown if the company considered the fatigue, pain, headache and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR061467   Additional Information: GSK receipt date:25-APR-2023 The reporter reported that he received the first Shingrix vaccine and about three hours after he received the first Shingrix vaccine, he experienced fatigue, achiness, headache and fever.  His symptoms resolved two days later. The reporter does not give permission to contact HCP. For tolerance to the 2nd dose refer case US2023AMR061467.; Sender's Comments:  US-GSK-US2023AMR061467:Same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Terrible headache/severe headache; chills with no fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-APR-2023, the patient received the 2nd dose of Shingrix (left arm). On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Terrible headache) and chills (Verbatim: chills with no fever). The outcome of the headache and chills were resolved.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.     It was unknown if the company considered the headache and chills to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 23-APR-2023. The reporter was the husband of the patient.  The reporter stated his wife received Shingrix and she woke up this morning with a terrible headache and chills but no fever.  The reporter did not consent to follow-up. MI phone number provided. Referred to HCP
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: liquid component only given; liquid component only given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 25-APR-2023, the patient received Menveo. On 25-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: liquid component only given) and inappropriate dose of vaccine administered (Verbatim: liquid component only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The nurse reported patient was administered only the liquid component of Menveo (unreconstituted), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number Bg92z, expiry date 04-JUL-2022) for prophylaxis.   On 25-APR-2023, the patient received Engerix B. On 25-APR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose administered). 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 Information: GSK receipt date: 25-APR-2023 The Pharmacy technician reported that an expired dose of Engerix-B was administered on the day of reporting.  The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow up. The patient was administered with expired vaccine which led to Expired vaccine used.