chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; Shortness of breath; Flu like symptoms; Nausea; This is a spontaneous report from a contactable nurse, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Sep2021 at 12:00 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Sep2021 at 22:00, the patient experienced chest pain, nausea, shortness of breath and flu like symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain, shortness of breath, flu like symptoms and nausea were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
severe urticaria; This case was reported by a physician via sales rep and described the occurrence of urticaria in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient experienced severe urticaria after a dose of Shingrix. Further information was not reported.
Day 1: Intense arm pain at and around injection site (left arm);Day 1 - current: feeling of heart racing.Day 3 - 25: chest and upper back pain, radiates up to neck; Day 3- 9: feeling of walking on a marble under right foot. Left foot affected days 8-9 but w/ less intensity. Day 5: Right foot, inner side, felt wet and cold for a day.Day 3 current: increased tinnitus in both ears, continues on and off all day, 30-40 times/day. Day 10: Paresthesia/ pins and needles with sharp, painful zaps in both hands, feet and lower legs. More intense after exercise.Day 17: electric zaps now felt in face and head.Day 17 - current: strange sensation on front 1/3 of tongue that progressed to numbness. Day 21 - 25: Both arms and top of hands have a burning sensation.Day 10 current: Body vibrations in core when at rest, more intense at bedtime. Feet feel like they are vibrating.
Hand aching; Fatigue; Headache lasted for 12 hours; Joints and wrists started aching; Heart beat started racing over 90-100 for more than 24 hours; Joints, wrist, and face started itching/itching in same place I was achy, progressively getting worse; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Heart beat started racing over 90-100 for more than 24 hours), PRURITUS (Joints, wrist, and face started itching/itching in same place I was achy, progressively getting worse), PAIN (Hand aching), FATIGUE (Fatigue) and HEADACHE (Headache lasted for 12 hours) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2001, the patient experienced PRURITUS (Joints, wrist, and face started itching/itching in same place I was achy, progressively getting worse). On 05-Jan-2021, the patient experienced PALPITATIONS (Heart beat started racing over 90-100 for more than 24 hours), PAIN (Hand aching), FATIGUE (Fatigue), HEADACHE (Headache lasted for 12 hours) and ARTHRALGIA (Joints and wrists started aching). On 06-Jan-2021, HEADACHE (Headache lasted for 12 hours) had resolved. At the time of the report, PALPITATIONS (Heart beat started racing over 90-100 for more than 24 hours), PRURITUS (Joints, wrist, and face started itching/itching in same place I was achy, progressively getting worse), PAIN (Hand aching), FATIGUE (Fatigue) and ARTHRALGIA (Joints and wrists started aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the treatment antihistamine helped with itching. Treatment for the event included acetaminophen, fexofenadine, famotidine and antihistamine.
10 Minutes following the vaccine I experience G.I (Gastro intestinal) issues, upset stomach. The following day my neck felt as if there was a lump in it, probably from swollen lymph nodes. As days pass I had several sinus attacks, Acid reflux, and being weak in general. Which I dont regularly have. I am still experiencing a lump like feeling in my throat.
This spontaneous report as received from a medical assistant refers to a 11 week old female patient. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 31-MAY-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # M016238 and expiration date: 07-DEC-2017), (dosing regimen and frequency unknown) orally for prophylaxis (product storage error). The ROTATEQ vaccines were stored between 44 Fahrenheit degrees (F) and 77 F for 45 minutes. There was no previous temperature excursion. There was no previous temperature excursion. The medical assistant also stated that a data logger was involved on 23-OCT-2017 that prompted her to call the company. This is one of the many reports from the same source. Sender's Comments:US-009507513-1710USA012197: US-009507513-1805USA007925: US-009507513-1805USA007926: US-009507513-1805USA007927: US-009507513-1805USA007929.
Pt had large localized swelling at the injection site the day after. Then 2 days later he developed hives to upper/lower extremities, buttocks, groin, with mild radiation to face and trunk.  07/15/19 Office Visit.     Suspect likely vaccine reaction. Use prescriptions as directed. Continue to monitor at home and provide comfort. Return for evaluation if current symptoms are not improved in 2-3 days or for any new/concerning symptoms. Hydroxyzine HCl 10 mg/5 mL oral solution - Take 10 mL every 6 hours by oral route as needed.         Prednisolone 15 mg/5 mL oral solution - Take 10 mL twice a day by oral route for 5 days.      .
Patient was given Varivax while on Humira (immunosuppressant). Connect with Pedi ID who recommended VariZig 625 Units less than 1 gram 7/26/19 and Valtrex 1000 mg tid x 21 days started approx. 7/28/19. Patient did NOT develop any clinical varicella lesions.
Blood in urine diagnosed from kidney biopsy as pauci immune glomerulonephritis
Pt arrived for dose #2 Moderna vaccine, vaccine given at approximately 0850.  Moderna Lot #008C21A Exp 13 Oct 21, .5ml given in left deltoid.  At approximately 0855 pt reports difficulty swallowing, no tingling.  Pt ambulated to triage room. Pt placed on gurney, Vital signs obtain BP 130/86, HR 71, O2 sat at 98%, lungs clear, heart  regular rhythm noted.  Notified Dr.  at 0856, continue to monitor patient.  At 0905, pt reports increased difficulty swallowing, tightness in throat , 0 hives, 0 tingling, difficulty breathing.  Epi Pen administered at 0904, Lot 0FM352 Exp Nov 21, administered in right thigh.  0905 vital signs: BP 170/75 HR 85 O2 sat 98%. Additional information for Item 18: History obtained: Pt alert, answered questions appropriately, pt reports 1st dose Moderna on 31 March, no adverse reaction noted.  Pt reports hx anaphylaxis reaction with chilis, shellfish and CT contrast, has used epi pen 3X in past.  Pt reports cardiac hx, ventricular hypertrophy has resolved post gastric bypass Nov 2019, metabolic disorder, HTN.  Vial signs at 0908: BP 173/97 HR 87, pt reports no change in symptoms.  0910 - EMS notified per responder, dispatch unit to facility.  Vital signs at 0912: BP 165/94  HR 77.  0913 EMS arrived, report given to responder. 0915 vital signs: BP 148/97 HR 73. Pt assessment per EMS personnel.  0917 vital signs 153/90 HR71 O2 98%, pt reports easing of tightness in throat. 0920 - pt departs via ambulance to Health Center, notified Dr.
Numbness down right thigh. MRI reveals no nerve damage. Treatment is exercise and stretching, no change. Severe pain in left shoulder. No treatment other than Motrin.
pt recv vax;06may96 devel rash on back & groin area; pt was isolated & recv no tx;by 15may96 rash had resolved;
Pt received pre-deployment vaccine requirements then found confirmation of pregnancy. TYPHOID Vi caps (x1), ANTHRAX (x3), INFLUENZA (x1), SMALLPOX (x2), TDAP (x1)
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date) and product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 054A22A) for COVID-19 immunization. No medical history reported. On Jul 1, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 1, 2022, patient administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date). On an unknown date, patient experienced product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022). At the time of the report, administered expired product (HCP reported dose of Moderna vaccine administered beyond 30-day use-by date) and product storage error (vial initially stored in refrigerator on May 31, 2022, at 4 pm, then administered Jul 1, 2022) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. On May 31, 2022, at 4 pm, vial went from freezer to refrigerator. It did not undergo any temperature excursions. Administered Jul 1, 2022 between 9 am and 12 noon.
shivering; Pyrexia; headache; body aches all over; stomach problems; fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach problems), PYREXIA (fever), CHILLS (shivering), PYREXIA (Pyrexia) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 04-May-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach problems), CHILLS (shivering), PYREXIA (Pyrexia), HEADACHE (headache) and PAIN (body aches all over). On 30-Apr-2021, PYREXIA (fever) had resolved. On 05-May-2021, ABDOMINAL DISCOMFORT (stomach problems), CHILLS (shivering) and PYREXIA (Pyrexia) had resolved. At the time of the report, HEADACHE (headache) and PAIN (body aches all over) had not resolved.            No concomitant medications were reported.  Treatment details included tums.
Information has been received from a physician concerning an approximately 2 month old patient who in approximately November 2006, was vaccinated PO with a 2.0 ml dose of Rotateq. concomitant vaccinations administered on that same day included a dose of DTP, a dose of PedvaxHib, a dose of Polio virus vaccine and a dose of Recombivax HB (manufacturer unknown). The physician reported that in approximately November 2006, 2-4 days after being vaccinated with Rotateq, the patient developed a fever, diarrhea, vomiting and dehydration. Unspecified medical attention was sought and the patient was admitted to the hospital. While hospitalized the patient tested positive for rotavirus. The patient was discharged from the hospital a couple days later. In approximately November 2006, patient recovered. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JUL-2018, the patient was vaccinated with ROTATEQ, one oral dose of 2 ml, lot # N032567, expiration date: 10-MAY-2019 for prophylaxis (also reported as for rotavirus protection). No adverse effects were reported.
Myocarditis...heart inflammation...full cardiac arrest...brought back by CPR On ventilator for 6 days and ECMO...in hospital for 15 DAYS PERMANENT DEFIBRILLATOR INPLANT...ONLY GIVEN 1% CHANCE OF SURVIVAL. VISITING NURSE AND OCCUPATIONAL THERAPY AND JUST FINISHED CARDIAC REHAB 6 MONTHS...DESTROYED MY LIFE!!
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 29-APR-2015 the patient was vaccinated with improperly stored VAQTA (lot # K010579 and expiry date: 12-FEB-2017) (dose, frequency and route were not reported). The patient did nott experience any adverse events. No product quality complaint (PQC) was reported for hepatitis a vaccine, inactivated. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Received 1st shot 4/2/21. Mild symptoms of sore arm, nausea, slight head ache. Symptoms were gone by 4/5/21.  Headaches started again on 4/8/21 until present. Noticed rash at injection site 4/12/21.
INITIALLY DEVELOPED SKIN LESIONS, EVOLVED TO TYPICAL ERYTHEMA MULTIFORME TARGET LESIONS, THEN APPROX 11-4-2023 DEVELOPED ULCERATION OF ORAL MUCOSA, BUCCAL AND SOFT PALATE, WITH INCREASING SKIN LESIONS, CONSISTENT WITH ORAL VARIANT OF ERYTHEMA MULTIFORME OR ERYTHEMA MULTIFORME MAJOR.  INITIALLY TREATED ONLY SYMPTOMATICALLY, ULCERATIONS AND RASH WORSENED, BEGAN PREDNISONE TAPER 11-10-2023.  OUTCOME TO BE DETERMINED.  DOXYCYCLINE 100 MG BID BEGUN 11-6-2023 AFTER ENT DIAGNOSIS OF RECURRENT SINUS INFECTION.  ANTIBIOTIC BEGUN AFTER RASH AND ORAL LESIONS BEGAN, NOT CONSIDERED CAUSATIVE.
SMELL ALTERATION; TASTE ABNORMALITY; headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 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 subject experienced smell alteration, taste abnormality, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from smell alteration, taste abnormality, and headache. This report was non-serious.
pt recvd vax;w/in 1-2 min of adm,devel "blotches" on high forehead & anterior;purple coloration under eyes,purple circumoral palor w/ generalized loss of skin color;rash confinded to head;no resp distress;resp rate=68;fever 20-30 mins later
Significant swelling and pain at injection site with fever over 101.5 degrees F developed within 18 hours of injection and lasted for more than 3 days.
I am a healthy 43-year-old woman with no major medical problems and no history of cardiac disease of any kind. I received the COVID-19 vaccine on December 22, 2020 because I am a healthcare worker. Five days later, I felt palpitations and my fitness Watch recorded at least 30 seconds of an abnormal heart rhythm. I was admitted to the hospital where my treating cardiologists felt that the rhythm was ventricular tachycardia. I received an extensive inpatient evaluation including a CT angio, MRI, and  echocardiogram all of which were normal. I received my second dose of the vaccine on January 11 or 12th of 2021. Two weeks there after, I had a documented episode of ventricular tachycardia on a Ziopatch. I continue to be followed by a cardiologist with an implantable recorder and have  had no episodes of VT since. The etiology of my VT remains unknown but it?s timing in relation to the vaccine has prompted me to submit this report.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (shingrix) for prophylaxis. On 14th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving shingrix, the patient experienced injection site pain and injection site joint pain. On an unknown date, the outcome of the injection site pain and injection site joint pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site joint pain to be related to shingrix. Additional details were reported are as follows: The patient self-reported this case. The patient received 1st dose of shingrix on arm. The patient stated that with the 1st shingrix shot her (injected) arm and shoulder were sore and these events were resolved. The patient did not had the lot number or expiration date recorded. The patient consented to contact her physician; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266332:same reporter.
feels like got run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like got run over by a truck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (feels like got run over by a truck). At the time of the report, FEELING ABNORMAL (feels like got run over by a truck) had resolved.            No concomitant medications were reported. No treatment related information has been reported.   This case was linked to MOD-2021-255982, MOD-2021-255983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Regulatory Authority report received on 14-JUL-2021 : updated patient demographics , AE outcome updated- recovered/resolved
HEADACHE, FEVER, FATIGUE, SORE THROAT TYLENOL WAS GIVEN TO HELP RELIEVE SYMPTOMS THIS MORNING 08/16/2023. TEMPERATURE IS DOWN AND HEADACHE HAS RESOLVED. EMPLOYEE STATED SHE STILL FEELS REALLY FATIGUED AND THROAT CONTINUES TO BE SORE.
pt recv vax 10MAY95 3PM;no rxn noted in 20min post inject waiting period;that afternoon pt noted hives on shoulders & thighs evening of 10MAY95;had recurrent hives off & on past 5 days;responded to DPH;11JUL95 PC to clinic resolving hives
Information has been received from a registered nurse referring to an unspecified number of patient of unknown age and gender. On unspecified dates, doses of GARDASIL (lot number K006124, expiration date 02-FEB-2017 and lot number "K001562", expiration date 08-APR-2017; route unspecified) dates, which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients. No adverse experience had been reported. Lot number K001562 is an invalid lot number for GARDASIL. Additional information has been requested.
Day 1-Chills/Shaking, Body Aches, Dizziness, Itchy Throat, wheezing breathing, difficult walking, extreme fatigue, Abdominal cramping. Day 2-Injection site pain, Nausea, fatigue.Day 3-Nausea,fatigue.Day4-Extreme lower and mid back pain, indigestion, gas, bloating, constipation.Day5-Fatigue lower back pain.Day6-Fatigue,lower back pain.Day7-Fatigue,lower back pain.Day8-Fatigue, Rash appears on torso and back, red bumps and itchy, Fever onset.Day9 Fatigue, Fever, rash itchy red bumps.Day10-Joint pain onset, Knees swollen large, reduced range of motion, hamstrings cramped up. Feet swollen and tingling. Rash over entire torso.Day11-rash abated, knees and legs swollen with limited range.Day12-Cramps hamstrings and knees swollen. Day13-Knees and leg cramps, fatigueDay14-Knees and legs cramped, fatigue.Day15-nausea,fatigue, hives on side and feet.Day16 Migraine onset, severe nausea, high fever, no sleep.Day17- extreme migraine, fatigue, nausea, hives.Day18-migraine,nausea,hivesDay19-Nausea,hives,fatigueDay20patchy hives, fatigue. Fatigue through to April 1, Skipped second dose.
HEADACHE BODYACHES SORENESS  AND SWELLING AT THE INJECTION SITE CHILLS  NAUSEA LIGHT HEADED
rheumatoid symptoms coming back; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program XELSOURCE. A 76-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 11 mg for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced rheumatoid symptoms coming back on an unspecified date with outcome of unknown. Patient's doctor told her to stop taking tofacitinib citrate for 7 days after receiving the COVID vaccine. By the 4th day after stopping tofacitinib citrate she could feel her rheumatoid symptoms coming back. The action taken in response to the event for tofacitinib citrate was post-therapy.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
No adverse event; The patient was inadvertently administered a dose of VAQTA that was expired; This solicited report was received from a medical assistant referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 03-MAY-2019 the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R002487, expiry date 21-APR-2019, strength 25/0.5 (units not provided)) for prophylaxis.    It was reported that the dose was expired (expired vaccine used). No adverse event was reported. The outcome of expired vaccine used was unknown.
She began spitting up more than normal and would not eat like she normally would. She ran no fever though. On the 10th of January she stopped breathing in her sleep. I am not sure that the vaccines were the cause of her death.
Patient described ringing in the ears and had an apparent rash on both arms with swelling in the administration arm. Symptoms appeared 10 minutes after vaccination. We administered 50 mg Diphenhydramine and about 15 minutes after patient stated that symptoms were resolving.
Pt. noticed swelling and redness. It continued to get worse. She walked in to our office to show the Dr. on 10/04/2017. Dr. measured a 6 x 4 cm lump with erythema at the injection site.