chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced a pulmonary embolism about four weeks after getting the injection I've been doing tests and they found nothing wrong with me so it was definitely the injection that cost me to have a Clo; blood clot in my lungs; Sweating; Passed out; almost died; This serious case was reported by a consumer and described the occurrence of pulmonary embolism in a 55-year-old male patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   Concomitant products included apixaban (Eliquis).   On 06-DEC-2022, the patient received the 2nd dose of Zoster vaccine. On 31-DEC-2022, 25 days after receiving Zoster vaccine, the patient experienced pulmonary embolism (Verbatim: I experienced a pulmonary embolism about four weeks after getting the injection I've been doing tests and they found nothing wrong with me so it was definitely the injection that cost me to have a Clo) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), pulmonary thrombosis (Verbatim: blood clot in my lungs) (serious criteria hospitalization and GSK medically significant), sweating (Verbatim: Sweating) (serious criteria hospitalization), passed out (Verbatim: Passed out) (serious criteria hospitalization and GSK medically significant) and near death experience (Verbatim: almost died) (serious criteria hospitalization and GSK medically significant). The outcome of the pulmonary embolism and passed out were resolved and the outcome of the pulmonary thrombosis, sweating and near death experience were not reported.   The reporter considered the pulmonary embolism and pulmonary thrombosis to be related to Zoster vaccine. It was unknown if the reporter considered the sweating, passed out and near death experience to be related to Zoster vaccine.     The company considered the pulmonary embolism and pulmonary thrombosis to be related to Zoster vaccine. It was unknown if the company considered the sweating, passed out and near death experience to be related to Zoster vaccine.   Additional Information: GSK Receipt date: 09-AUG-2023 The reporter reported about himself, he passed out and he came to all his vitals were fine. Just sweating profusely took him to the hospital could not from that out of you. Nothing was wrong with him. Then he needed to get some kind of answer after CAT (Computerised tomogram) scans ultrasound they found that he had a blood clot in his lungs, so he had a pulmonary embolism.  He experienced a pulmonary embolism about four weeks after getting the injection he had been doing tests and they found nothing wrong with him, so it was definitely the injection that cost him. it was December 31 of 2022 that this took place he almost died he had gone through months and months of testing.  They found nothing wrong with him that caused him to get this clot.  The only conclusion was he had the injection done the beginning of December and now because they could not get a determined answer, he had to be on the rest of his life. The reporter consented to follow up.
assessed patient, auscultated normal lung sounds, chest tightness described from patient. Cough observed which was not normal for patient then 911 was called. paramedics arrived on scene, further assessed patient. Patient taken on stretcher by paramedics
This case was reported by a pharmacist and described the occurrence of Bell's palsy in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included TWINRIX; GlaxoSmithKline given on an unspecified date. On an unspecified date the subject received 2nd dose of TWINRIX (unknown). One day after vaccination with TWINRIX, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved.
About 7:30-8:00 pm, my left arm REALLY hurt and it was hard to lift. I because shaking for almost 2 hours. I was dehydrated, and I felt like I had "the flu". I also felt nauseous. I did not have any side effect with the first shingles shot on Sept. 18 in my doctor's office.
This spontaneous report was received from a health professional and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX (lot numbers L013066, L016125, L024256, temperature: 18 degree Fahrenheit for 65 hours) and (lot # L028276, temperature: 22 degree Fahrenheit for 13 hours) which were improperly stored. No adverse effects were reported. No PQC involved. Additional information is not expected as the reporter did not provide consent for further follow up.
immediate onset -severe pain and burning to arm and spread from injection site to fingers  ~ 20 mins later vertigo, dizziness, coughing/throat discomfort, benadryl received  ~ 4-5 hours discharge from ED ~1 week after inflamed lymph nodes/sever pain to side of body for injection   ~5 - 6 weeks to fully resolve
This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that on an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of PROQUAD (albumin status: recombinant human albumin, rHA; lot # M031942 with expiration date at 27-DEC-2017 and lot # M031566 with expiration date at 24-DEC-2017) (lot # reported as M0299598 with expiration date at 10-DEC-2017 and unknown albumin status) (dose and route of administration were not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature over 14 degrees Fahrenheit (F) and below 46 degrees Fahrenheit (F) for 1 hour and 40 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004067: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA000822: US-009507513-1702USA004066: US-009507513-1702USA004068.
Bruising noted 10/11. Went to ER for burn 10/17 Dr noted bruising and did labs - Sent to hosp 1017-10/20 - Via ambulance.  Acute ITP.
First reported near syncope, bilateral hand tingling, "severe" arm pain. "Severe" confusion lasting over an hour, then intermittent, confusion, lack of coordination,  when first called consulting nurse.  Seen in ED on 04/07/2022 with the following note from provider:   MD - 04/07/2022   Formatting of this note might be different from the original. You were seen in the emergency department with bilateral neck discomfort and tingling in your hands. Your blood work your was normal. You had 2 EKGs and troponin tests that were normal with no evidence of stress on your heart. We also did a CT scan of your head and neck which did not show any evidence of tearing in the blood vessels, or any other emergent problem. We recommend that you rest and drink plenty of fluids. Follow-up closely with your primary care doctor to ensure you are feeling back to normal. You should return to the emergency department in case you develop stroke symptoms such as slurred speech, facial droop, or numbness/weakness in 1 part of your body, or if you develop any chest pain or trouble breathing.   Follow up with clinic nurse, pt informed,  "He states he still has upper left arm weakness. States the throbbing has resolved. "
No additional AE reported.; Customer called and reported that a dose of PNEUMOVAX 23 expired on 2/28/2022 and was administered on 5/10/2022. No additional AE reported. No PQC reported. No additional information provided.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 10-MAY-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #T016159, expiration date: 28-FEB-2022, administered for prophylaxis (strength, and route of administration were not provided)(expired dose administered). No additional adverse event reported. No additional information provided.
Seven days after receiving the vaccination, I started having severe headaches culminating in a deafening ringing in my right ear at which time I went to the Emergency Room at hospital. It was determined that I developed a Dural Venous Sinus Thrombosis in my right transverse and sigmoid sinuses. I have no history of blot clots.
PATIENT COMPLAINED OF  HIGH FEVER/ TREMORS AND LOCAL INJECTION SITE WARTH AND ERYTHEMA.
I am 4 months pregnant due on July 9.  I am achy everywhere, general exhaustion, headache, low appetite, and my left arm really hurts.
Swine Flu shot that resulted in type I diabetes - Autoimmune disease in 1976-77 when diagnosed.  12/21/09 MR received for multiple service dates 03/20/86. DX Pt followed up on diabetes. Pt did not have any complaints with no signs of motor or sensory deficits. Pt insulin dependent diabetes.  MR for DOS 08/15/88-16/16/88. Pt admitted to r/o diabetes insipidus. Pt had 12 L urine output. DX studies: BUN and creatinine.  MR for DOS 11/01/97. DX: peripheral neuropathy and sz disorder. Pt c/o peripheral neuropathy and sz. Pt had a seizure due to hypoglycemia. Pt reported several episodes of sz in 96 and 97. Neurological exam: decreased sensation.  MR for DOS Pt occasional poliuria. Neurological exam: decreased pin prick. Peripheral neuropathy.
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, multiple unspecified patients received doses of GARDASIL 9 (lot # L016429, expiration date: 09-AUG-2017, dose, route of administration and injection site were not reported). Administered doses of  GARDASIL 9 underwent temperature excursions at 32.7 Fahrenheit degrees for 9 hours. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Patient filled out the consent form and checked that he had never had a covid vaccine of any kind before. I verbally double checked and asked him if this was his first covid vaccine to be received.  He responded yes. He said he had never had a covid vaccine before now. After the patient left and I was logging him the system, I discovered that he had previously received a Johnson and Johnson vaccine at another pharmacy on 03/07/21. Therefore, since he was already fully vaccinated, he should not have received a dose of Pfizer vaccine.
Patient was hospitalized for severe left chest pain on 5/5/21, diagnosed with mild pericarditis / myocarditis.  This occurred 5 days after 2nd COVID vaccine shot.  Was treated with colchicine. Had complete recovery.
This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 41 year old patient (gender unknown). On 30-Sep-2015, the nurse had re-used the syringe for multiple patients at an employee influenza vaccination clinic. The nurse brought three multiple dose vials of the vaccine that were intended for another event and were stored in her personal fridge without temperature monitoring. The nurse reported using two syringes she found in her supplies to administer vaccine to 67 patients. She reported wiping the syringes with alcohol and using a new needle for each patient. Only 2 multiple dose vials of vaccines (10 doses/vial) were used for 67 adult patients. This patient (one of the 67 patients) was administered intramuscular AFLURIA injection (batch number: 11049221A) in the arm. The patient was offered blood pathogen testing (hep B, hep C, HIV), hepatitis B vaccine and flu vaccine. On 05-Oct-2015, the patient underwent laboratory tests which showed positive results for Hepatitis B surface antibody and was negative for hepatitis B core antibody, hepatitis B surface antigen, HIV antibody, HIV antigen and hepatitis C antibody. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious.
Information has been received from a health professional, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who in September 2008, was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported).  Subsequently the patient was pregnant.  The LMP was 22-AUG-2008.  On 13-NOV-2008, at the 12 weeks of pregnancy, ultrasound showed fetal demise.  The outcome of the patient's experience was unknown.  Upon internal review, fetal demise was considered to be an other important medical event.  Additional information has been requested.
Unable to work the two days following the second injection.    Random, extreme piercing pain in left rear hemisphere of the brain began two weeks following the second injection.  There is no regular time that this occurs.  Episodes may be close together and then not occur for days.  There is no regular time of day or night.  Patient has expressed a fear of not waking when these episodes occur near bed time.  Pain has brought patient to tears on occasion.  First visit to regular physician on June 1, 2021.  Follow-up visit to be scheduled.  Symptoms continue.
shoulder is a little sore; vaccine it stung really bad; swollen; vaccination site swelling; A spontaneous report was received from a consumer, concerning a female patient of 57 age, who received Moderna's COVID-19 vaccine and experienced Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03-JAN-2021, the patient received her first dose of the Moderna vaccine mRNA-1273 in the left arm. (lot number 012L20A) via unknown route for COVID-19 infection prophylaxis.  On an 13-JAN-2021, the patient experienced Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad. She has taken Ibuprofen(Advil) as a treatment medication. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events, Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad was considered to be not resolved at the time of this report.
Difficulty breathing, swollen neck glands, sore throat.   Progressed to swollen eyes, body aches, pale/cold, and weak.   No dizziness nor fast heart beat.  Went to bathroom, came out in panick needed to lie down, and refused my attempts to take her to hospital, or call her Dr., said to wait until morning.  She is currently sleeping (11:45pm on 10/13/2020).
high pitch scream for 10hr/t102 w/APAP whinned in sleep, irritable for month after;momth later cough/month p/that dx pertussis & pneumonia;
Received MMR, DTaP, Varicella, IPV 2d later red 2x2 area with induration (R) upper arm and 1x1" erythema area with 1/4" dia induration below
Patient c/o "flu-like" symptoms. Aches, fatigue, sore throat, headache. Additionally erythema at the injection site of the left arm that radiates downward toward axilla.
a few min p/vax & finger prick child started to feel dizzy, fell to the floor, hit head then started to shake body extremities (for <1min) w/eyes rolled back;
This spontaneous report as received from a registered nurse refers to a 5 month old male patient. The patient's medical history included prematurity. The patient's concurrent conditions and concomitant medication were not reported. On 15-JAN-2016 at 15:28, the patient was vaccinated with the first dose of GARDASIL intramuscularly in right thigh, lot number reported as L030869 (strength, dose and expiration date were not reported), which was improperly stored. Lot number L030869 has been verified to be an invalid lot number for GARDASIL. On an unknown date in approximately 2016, the patient was not reaching expected milestones even after adjusting for prematurity. The outcome of this event and the relatedness between this event and GARDASIL were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills  Hive (3 inch long 1 inch wide) on right arm at injection site Diarrhea
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date the patient experienced shingles. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of shingles was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Anthrax shot 4 received 26Oct03. Had joint pain in elbow and shoulder for 2 to 3 months. Had knot in left arm for 2 weeks. Anthrax shot 5 received 2May04. Have had joint pain in elbow and shoulder since the shot. Had knot in left arm for 2 months.
Patient complained of redness and swelling at site extending to elbow. Patient received injection in right arm. Pt stated he can hardly bend his arm and it is painful. Symptoms began the same evening of receiving the injection. Instructed pt when he reported symptoms on 12/14/2001 to apply warm compresses to arm and take Tylenol or Motrin for pain.
This spontaneous report as received from a medical assistant refers to an identifiable patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dose and frequency were unknown by reporter) from lot N022979 expiry date 23-AUG-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MRK) (lot/expiry date unknown by reporter). No adverse effects were reported. Temperature was reported as 15 degree Fahrenheit to 46 degree Fahrenheit (32 degree Fahrenheit). Time frame was reported as 7 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the three reports linked via same reporter link. Sender's Comments: US-009507513-1803USA012517: US-009507513-1803USA012518.
Fever over 100, headache, took Tylenol and rest for 24 hours
The patient's mother brought him to the clinic on 12-20-01 and he had full body rash and a temperature of 101. Clinic called the supervisor who referred child to MD. called family 12-24-01 N/A 12/26/01 No. Talked with family 12-31-01. Patient seen by MD who treated with Benadryl and advised mother no further doses of Prevnar. Rash remained 5 days post vaccine. Baby fine on 12-31-01.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
The patient developed a rash on both arms that was splotchy, but did not itch. The patient was observed for an additional 30 minutes with no other complaints. She was given benadryl but did not want to take it until she got home. The patient was called later that day and said that she was fine.
Constant headache, and I never get headaches.  Flu-like symptoms, general weakness, fatigue and feeling sleepy all day.
Pt with approx 2.5" circle of induration and erythema on L thigh at site of injection. No rash/fever. Ice and age appropriate IBU suggested.
On 11APR21, patient noticed a red, tender area on her left arm that was warm to the touch.  Injection site was the left deltoid.
Itchy eyes.  Resolved with 25 mg benadryl. Sore arm for three days. Chilly off and on for three days.  Still some tired on third day. Does not know if this is related, but an old boil site started bleeding off and on and has not stopped.
Swelling Rt deltoid area 5 cm x 5 cm, itching with erythema no induration.
Information was received from a 50 year old male patient, with an allergy to codeine. The patient's medical history included: broke left leg in 4 places in motorcycle accident. On 06-OCT-2013, while he was a patient in the hospital being treated for cellulitis of the left leg, the patient was vaccinated with PNEUMOVAX 23 injection (lot #J00786, expiration date 25-SEP-2014) in the left arm. Concomitant medications included unspecified antibiotics. The PNEUMOVAX 23 vaccine was administered to him on either the first or second day of his 4 day hospitalization. Immediately after receiving the vaccine, the patient developed a stiffness in his left arm from the shoulder to the elbow. That part of his arm hardened like "granite." Since then, the patient has lost range of motion in that arm, cannot carry anything with it, lean on it, or use it to put on clothing. The pain feels like "an ice pick going into it." He also developed red sores on his face, hairline, arms, legs, and buttocks. The sores itched and hurt but were never diagnosed. They were, however, treated with a topical steroid, fluocinolone (manufacturer unknown). The patient sought medical attention at a doctor visit. His present status was reported as not recovered. His hospitalization was not prolonged due to the events. Additional information was received from the 50 year old male patient. He reported that on 06-OCT-2013, as soon as he received the PNEUMOVAX 23, his left arm turned granite hard/rock hard from the shoulder to his elbow. Since that time, he reported that his arm is not hard like that any longer, but he has lost full range of motion in the arm. He gets ongoing and sharp shooting pain in the arm. The patient reports it is hard for him to do simple tasks like put on his coat, use his arm to support himself getting out of bed. "All of this happened as soon as I received the shot and it hasn't subsided." He also reports open sores on his face, legs, arms, buttock, and head in his hairline. The patient stated: "This also occurred when I received the vaccine and the doctor's just stood there and looked at me as if I was a lab rat. As if I was contagious and they didn't want to get near me." Lot # J00786 is an invalid lot number for PNEUMOVAX 23. Additional information has been requested.