chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "blood clot". The patient date of death was unknown. Reported cause of death: "blood clot". It was not reported if an autopsy was performed. As reported: Her friend that was 44 had 2 kids and she died all of a sudden with a blood clot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: blood clot
No known adverse effects; A patient received a dose of M-M-RII on 29-SEP-2015, on 12-JUL-2018 and on 03-SEP-2019.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 29-SEP-2015, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter stated that the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) on 12-JUL-2018 and another one on 03-SEP-2019 (inappropriate schedule of product administration). No adverse effects were reported.
This spontaneous report as received from a nurse via field representative refers to a male patient of unknown age. A couple of weeks ago, on an unknown date in 2014, the patient was vaccinated with GARDASIL (dosage information unknown). No concomitant medication was reported. The patient fainted after administration of GARDASIL. The patient sought medical attention (in office). The patient was given fluids and monitored in the office and recovered from the event within 1 hour. The causality of the event was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Had subdural hematoma from fall on 5/23/2021 Death certificate: "ACUTE RESPIRATORY FAILURE_INTERSTITIAL LUNG DISEASE_COVID-19" Not LTCF. PCR(+) 5/23/21. On 5/21: Admitted to hospital with subdural hematoma due to fall, diagnosed with Covid PNA. 6/15: Hospitalized again, EMS called for low O2 sats in the 70s, dx of Covid, ARF w/hypoxia, SOA. Fully Vaccinated (Moderna): 3/31/21 and 5/3/21. DC support covid-19.
Patient received PedvaxHIB in the right thigh on 9/21 and about 9 days later developed a right thigh abscess. Parent was offered I&D  on 10/2 but parent opted to do warm compresses and abscess drained on its own on 10/3. Patient was prescribed antibiotics but due to supply chain issues, did not start antibiotics.    Patient previously had a sterile abscess after her 4 month old shots in June of 2022. Wound culture showed no organism. Prescribed clindamycin at that time. She received her 6 month old and 12 month old vaccines without any complications.  Patient has an appointment with Allergy to evaluate for delayed hypersentivity to aluminum on 10/30/23.
Next day (1/18) noticed three small rash spots on inside upper right thigh. Wasn't sure if related. Since then more rash spots have occurred on upper right thigh and across lower back.
Discomfort in legs and hips which has increased in intensity - just recently experiencing around my neck, across my shoulders, down my left shoulder through my bicep
Pt received JEV #2 and Flu Vaccination on 16May05. On morning of the 17th, pt began to feel heat to the back of right deltoid where JEV was given.  When she looked at the site saw that it was raised, itchy with minor burning sensation. No Fever or H/A, just feeling of fatigue. Site was marked 1 1/2 inch in height and diameter. Site looked like allergic reaction to bee sting. Warm to touch, no drainage. Recommended Tylenol and Benadryl. To present in Morning for follow-up.
bruising, peticuli,bleeding. Took to er and he had a platlet count of 2,000. He was admitted and given two rounds of IVIG. He was not responsive and had a bone marrow biopsy and it was neg. 6 days later his platlets rose to 523,000. Being treated by hematologist. Diagnosed with pancytopenia. DOS 10/6-10/10/16 DC DX: pancytopenia resolving, coombs negative anemia, thrombocytopenia, IPT suspected. Cytogenetics prelimary report:no chromosomal abnormalities were identified. Follow-up visit 10/25/06-doing fine since DC, had URI 2 weeks before low platelet count. Assessment: recovered from ITP status post IVIG, most likely after viral infection.
AFTER VACCINATION, DURING 15 MINUTE OBSERVATION PERIOD, PT WAS SITTING AND SUDDENLY SLID OUT OF CHAIR. SHE LOST CONSCIOUSNESS MOMENTARILY.  SHE FELT VERY HOT, AND WAS PALE.  EMT'S WERE CALLED AND CAME. PT DID NOT FEEL THE NEED TO GO WITH THEM.  NO BENADRYL OR EPI PENS WERE ADMINISTERED
Constant Fatigue; progressive weakness from time of vaccination to present. Neurological symptoms, i.e. leg & hand spasms No longer able to walk or stand; requires long term care
Moderna COVID-19 Vaccine EUA  arm swelling, redness, itchiness ... 9 days after the shot! also dizziness.  arm fine before then  had a backache like a pulled muscle for 3-4 days after the shot, but might have been a coincidence - but don't recall doing anything
Fever equal or above 104 F for 1-2 days needing ER visit and admitted to hospital 3 days.
First day after 2nd shot: sore arm, mild fever, achy body, headache. Second day after, sore arm that developed swollen, itchy red spot.  Also developed 3?x4? red rash under right breast.   After first shot, little reaction until 8 days after, then developed red itchy patch at  injection site in left arm
Hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HOT FLUSH (non-serious) with onset 08Oct2023, outcome "unknown", described as "Hot flashes". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
fever, aches, chills 8 hours after injection.  Swollen lymph node under armpit (painful) on side of injection 16 hours after injection (still occuring)
Pt was given the vaccine. Within less than 5 minutes, she said she was feeling light-headed and proceeded to pass out. She fell to the floor, and I went out to assist her. She was able to keep her head from hitting the floor, and I supported her head as she regained consciousness. She tried to sit up but lost consciousness again and appeared to convulse (arms and legs drawn up). She regained consciousness again, and was completely lucid. We called 911 and EMT arrived and continued their usual procedures including checking blood pressure, heart rate, and blood glucose. Her BP was 130/80 laying, and 80/60 sitting. Her pulse was 50. Her blood sugar was 56 before consuming glucose and 71 after. She was given water as well. She declined a ride to the hospital but did have a friend give her a ride home.
Pt returned to HD for reading of TB test on 05/05/05. Pt c/o arm hurting. Left upper arm swollen, hot to touch, red. Father states" it looks better today" Instructed Benadryl children's allergy 12.5mg per directions. Tylenol for pain PRN per package instructions.,
Information has been received from a registered pharmacist concerning a 68 year old female who on approximately 12-SEP-2007 "a week ago" was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL, IM. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced pain in her left hip, at the injection site after immunization with PNEUMOMAX 23. Unspecified medical attention was sought as the patient called the pharmacist. The patient's pain her left hip persisted. No product quality complaint was involved. Additional information has been requested.
I had arm/hand/neck pain pretty quickly Immediately following the injection.   Wednesday it was severe; I couldn?t really lift my arm all day. I started having chills/nausea/pain all over.  Thursday  morning I started sweating profusely and was fatigued.
Approx 3 hours after injection, I began to feel these symptoms:  1. Headache (minor and then progressively worse, lasted for 24 hours) 2. Body chills (lasted for 10 hours) 3. Muscle aches (lasted for 24 hours, off and on)
Patient reported feeling unwell about 5 minutes after receiving vaccine. She fainted on the seat in the waiting room. Her pupils dilated and pulse was racing. She was able to answer questions regarding name and where she was. She was given diphenhydramine 25mg with water.  She was then transferred to wheel chair and brought back to a patient's room. She stood from chair and immediately fainted the second time. Her blood pressure and pulse were taken and when repeated, they were returning  to within normal limits. Upon arrival of the ambulance, they checked blood sugar and vital signs, all were within normal limits. Patient left clinic with her mom to go home.
Patient became lightheaded diaphoretic with complaint of nausea after vaccine at 1053 VS 93/60 O2 sat 97 P 78 Given juice and crackers. 1055 VS 107/67 P 56 O2 sat 99 denies lightheadedness.
On 6-27-07, pt called to report the following reaction: "Tingling feeling (like the kind one feels before getting a fever blister) occurred in the face and scalp area, lasting 2-3 days." All is now resolved.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-APR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 30-NOV-2014, the patient was treated by a nurse practitioner for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Interchange of vaccine products; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        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.   No concomitant medication listed.   No treatment information provided.
urinating a lot and noticed that the urine was cloudy; in bed for 2 days straight; low-grade fever; chills; typical flu-like symptoms; body aches; Pain at injection site; arm hurt so bad she couldn't lay on it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it), INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) and LETHARGY (in bed for 2 days straight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 11-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021 at 2:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), PYREXIA (low-grade fever) and CHILLS (chills). On 14-Mar-2021, the patient experienced URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy). 14-Mar-2021, the patient experienced LETHARGY (in bed for 2 days straight). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it) had resolved. On 14-Mar-2021, INFLUENZA LIKE ILLNESS (typical flu-like symptoms) had resolved. On 15-Mar-2021, PAIN (body aches), PYREXIA (low-grade fever), CHILLS (chills) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) had not resolved and LETHARGY (in bed for 2 days straight) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient would be seeing her health care professional to rule out urinary tract infection.   This case was linked to MOD-2021-111119 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added concomitant drugs, treatment drug and one event. Updated the outcomes of events.
Patient rec'd vaccine 12/17/2015. Experienced blurry vision, headache, fever, body aches, fatigue.
Dx of Guillain-Barre Syndrome, at hospital. No hx illness prior to onset of symptoms. Had imms. 11-9-09. Symptoms muscle weakness, drooping eye lids, difficulty swallowing about 12-18-09. Symptoms progressively worsen. Admit to hospital 12-27-09.
SWELLING IN THE WRIST; EXCRUCIATING PAIN IN THE RIGHT WRIST; COULDN'T HOLD OR DO ANYTHING WITH RIGHT HAND; TIREDNESS; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included levaquin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced not feeling good. On 08-MAR-2021, the subject experienced tiredness. On 27-MAR-2021, the subject experienced swelling in the wrist. On 27-MAR-2021, the subject experienced excruciating pain in the right wrist. On 27-MAR-2021, the subject experienced couldn't hold or do anything with right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling good, and tiredness, and had not recovered from excruciating pain in the right wrist, swelling in the wrist, and couldn't hold or do anything with right hand. This report was non-serious.
Sunday - high temp 104.6. Went to doctor 3 times since vaccines were given. Measly like rash, itchy.
Patient discharged after (4) day inpatient stay. 11/12-11/16/2021.  Patient is a 72 yo with PMH of ulcerative colitis( on sulfasalazine,ursodiol), Dm2, MVP, HTN who was admitted with acute hypoxemic respiratory failure secondary to b/l covid 19 pna( patient has received both dose of covid 19 vaccine). Required 2l via nasal canula in the ED.Given symptoms for more than 10 days patient was not a candidate for remdesivir. Post admission patient continued to be stable on 2l. Follow up inflammatory markers remained stable. Initially patient was to be discharged on 11/14/21 with home covid patient. However patient had acute drops in oxygenation with minimal ambulation and was nervous about discharge home. She was evaluated by Pulm Rehab who confirmed she requires 2L at all times.  Discharging home in improved condition.
I contracted COVID in August 2021. I spent 4 days at the health care receiving treatment. I received the vaccine on a Friday afternoon. Two hours later I began to have fatigue, fear, chills, a temperature over 103 degrees.  By the next day, I had begun to itch tremendously, but continued doses of Benadryl kept that symptom in check. In addition,  my pulse oxygen level was below 87.  I had diarrhea and vomiting and could keep no food or liquid down. These were the same symptoms that I had with COVID. I began to have problems breathing and had to use an Albuterol inhaler several times.  I experienced these symptoms for 3 days. I called my doctor who informed me that I should not get the second dose of the vaccine, because of my bad reaction and my allergy to shellfish.
Information has been received from a physician assistant concerning some patient which were vaccinated with GARDASIL vaccine (yeast). The physician assistant reported that some patients experienced injection-site pain after receiving GARDASIL vaccine (yeast). Follow up information was received from the physician assistant which reported that the patients felt "minimal to mild discomfort" while receiving GARDASIL vaccine (yeast). The physician assistant also reported that the "pain was significantly less than with the tetanus shot". He added that he does not have any patient information to provide since none of the patients returned with a problem. No further information is available.
Information has been received from a physician concerning an approximately 4 month old male who was vaccinated PO with his first and second dose of ROTATEQ (lot# 657661/0973U). Subsequently the patient experienced "wicked diaper rash." The patient did not seek medical attention. The outcome was unknown. The physician reported that the patient's mother decided to finish the series with the third oral dose of ROTATEQ (lot# unavailable), but was not sure if the patient experienced the diaper rash again. There was no product quality complaint. Additional information has been requested.
Vaccine not fully administered, needle not properly on; Vaccine was trickling down the arm; Vaccine was trickling down the arm; This non-serious case was reported by a pharmacist and described the occurrence of incomplete dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7373X, expiry date 18-JUN-2024) for prophylaxis.   On 08-APR-2023, the patient received the 2nd dose of Shingrix. On 08-APR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Vaccine not fully administered, needle not properly on), inadvertent exposure to vaccine (Verbatim: Vaccine was trickling down the arm) and exposure via skin contact (Verbatim: Vaccine was trickling down the arm). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 11-APR-2023 A pharmacist gave the Shingrix vaccine to a patient but the needle was not on properly so the vaccine was not fully administered. Vaccine was trickling down the arm according to the patient. It is unknown how much of the vaccine was actually administered. The reporter was trying to determine should he/she repeat the dose and when. Was it possible that no vaccine might have been injected and it all squirted out. The needle leaked at the time of administration, which made unsure if any dose was administered and trickled down the arm, which led to Inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. The reporter consented to follow up. Case US2023052544 was found to be duplicate of this case, as cases have same patient. Therefore, the case US2023052544 was deleted. All future correspondence would be submitted to case US2023AMR052458 (case of record).
Patient reported numbness in face/cheek. Prednisone was given by doctor and symptoms cleared.
Employee who received immunization states that at approximately 7:00 pm on night of 12/25/20 she began experiencing stomach pain and nausea and vomited twice. Approximately 2 hours later she noticed hives on back of left arm and on neck and started having difficulty breathing and feeling like tongue and back of throat were swelling. She went to local ER approximately 30 min later. In the ER she was given Benadryl, Zofran, Dexamethasone, Toradol, She states shortly after Benadryl was given she was able to breath more easily and symptoms were significantly reduced in 3-4 hours. She states nausea and stomach pain did continue until 12/26/20