chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleepy Unable to hold self up, very limp Unable to walk (previously able) Only sit for majority of the day Puking bright yellow
The patient had severe pain in the right arm about three hours after an injection. On 12/22/00 the patient fainted in the store. Arlington EMS was called they checked the patient out and then the patient went home, and notified her doctor that the pain continued.  By 10 PM on 12/22/00 the patient arm from elbow almost to the shoulder, was so swollen, difficult to get shirt off. Arm also had become very warm and purple color. Swelling worse the next day. Swelling and soreness finally over on 12/27/000.
Vaccine-induced immune thrombotic thrombocytopenia; Literature Article:   Information has been received from the authors of a published literature article, titled as stated above, regarding a 25-year-old female patient without a history of heparin exposure. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, route, lot #, expiry date, and anatomical location of administration were not provided).  On an unknown date, 10 days after vaccination, the patient developed vaccine-induced immune thrombotic thrombocytopenia (VITT), thrombosis sites included the right internal iliac vein and bilateral pulmonary emboli.   On an unknown date, she underwent several laboratory tests including D-dimer which levels were elevated, the reactivity of patient's sample to activated platelet factor 4 (PF4)polyanion complexes evaluated in a heparin-induced thrombocytopenia (HIT) enzyme-linked immunosorbent assay (ELISA) showed that patient 's antibodies strongly recognized polyanion-complexed PF4 and assay's positive cutoff was 0.4 optical density (OD). Additionally, patient's serum in the un-complexed PF4 ELISA (which was considered a vaccine-induced immune thrombotic thrombocytopenia (VITT) specific assay) showed that her antibodies strongly recognized un-complexed PF4 and assay's positive cutoff was 1.0 optical density.    The patient was treated with intravenous immunoglobulin G (IVIg), to which she responded promptly. Subsequently, her levels of immunoglobulin G (IgG) were quantified and showed 7.88 mg/mL.   Then, on an unknown date, 12 months after acute presentation, a sample was obtained and continued to test strongly positive (greater than >1.0 OD) in both PF4polyanion and un-complexed PF4 ELISAs.   At the time of follow-up, the patient's platelet count sampling was 246000/micro-L considered as normal and she was clinically stable with no thrombosis/thrombocytopenia (recovered).   The author considered vaccine-induced immune thrombotic thrombocytopenia to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was specified that this vaccine is based on virus-like particle technology and does not utilize adenoviral vectors where patient antibodies strongly recognized uncomplexed PF4.    Upon internal review, the event vaccine-induced immune thrombotic thrombocytopenia was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
After the 4th dose, I discovered that it became very difficult for me to breathe, especially after going outside. I also experienced fatigue and difficulty walking because it became harder to breathe. My doctor gave me an albuterol inhaler around June 2022. After taking the 5th dose, the problems continued. I went to a cardiologist to check if I was having heart problems.
04/05/05- While at school, student c/o double vision on 04/05. Parent was called and stated the pt had itching and hives of right arm on 04/04/05. Mother gave Benadryl and Tylenol. She was instructed to contact DR and make appt. but did not keep appt. States pt ok 04/07/2005.
Date of vaccine nausea, fatigue, headache, then on 10/20/2016 onset of bell's palsy.
Mom called reporting patient w/cough and hives. Denied wheezing or vomiting. Mom took to an urgent care facility near by. Per mom given Benadryl and prescription for prednisone. Spoke to mom frequently after episode reports sx have resolved.
Patient arrived to clinic with 2 small clusters of pink papular rash, 1 cluster on her abdomen, and one on her back. Rash was in a dermatomal pattern. She described the rash as "painful and burning." She was given Valtrex 1 gm BID for 7 days and a topical analgesic was suggested to the patient.
A hot large rash around my injection site; Large rash around my injectionsite and pain in that area; swollen at injection site; Shortness of breath; tingly mouth; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 16Mar2021 at 1715 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma. The patient had soy and sulfa allergy. Concomitant medications included singulair (MANUFACTURER UNKNOWN), zyrtec (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for unknown indications received on unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the right arm on 23Feb2021 at 1900, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 1800, the patient experienced typical allergic reaction which was vaccination swelling, shortness of breath and tingly mouth. On 19Mar2021, the patient noticed a hot large rash and pain around her injection site. Therapeutic measure taken as a result of the events vaccination swelling, shortness of breath and tingly mouth included benadryl (MANUFACTURER UNKNOWN) and it relieved most symptoms. The clinical outcome of the events  vaccination site swelling, shortness of breath, tingling mouth, hot large rash and pain around her injection site were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2PM started getting nauseated & arm began to get sore & larger, extended down the arm to 3" above the elbow; arm throbs-is red; warm to touch; has been using ice packs; very uncomfortable w/movements, aches or feels a little like asleep;
RAPID HEART PALPITATIONS (PRE VENTRICULAR PALPITATIONS); This spontaneous report received from a health care professional via a company representative concerned a 70 year old male. 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: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 08-MAR-2021, the subject experienced rapid heart palpitations (pre ventricular palpitations). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart palpitations (pre ventricular palpitations) on 08-MAR-2021. This report was non-serious.
Patient is a 78-year-old female with a history of atrial fibrillation on Eliquis who presents to the emergency department via EMS from local nursing facility for elevated heart rate and shortness of breath.  She tested positive for COVID yesterday.  Patient denies any chest pain.  No nausea or vomiting.  Cough has been nonproductive.  No measured fevers. Associated Symptoms: cough, fatigue, palpitations, shortness of breath, URI symptoms, weakness
from 10 pm until 10 am, chills, body aches, headache, exhaustion, sleeplessness
The symptoms began with a rash on my back and hips, and developed into a rash all over my body that was raised and very painful. Main sites would be arms/armpits, hips, tailbone, skull, breasts, and legs. A day or two later, my joints began to swell ? wrists, ankles, feet ? starting with my left hand, then quickly gained onto my right hand and both legs. I was very limited by this; walking was difficult and very painful so I had limited mobility, simply pressing on faucets to wash my hands was difficult, etc. The rash persisted. We went to see a doctor, who prescribed me Prednisone (40 mg for three days, 30 mg for two days, 20 mg for two days, 1 mg for three days) for the swelling. I tested negative for COVID-19.  This treatment alleviated the swelling and tasks like walking and using my hands became easier and less painful; within a few days, the swelling was gone but the rash persisted for longer. I began to develop chest pains during this time which occurred most days. I went to the hospital, where I got many tests done and an x-ray conducted. I didn't receive any conclusive results. The rash became alleviated towards the second half/end of taking Prednisone, and the joint swelling subsided. At the end of the Prednisone, I met with my physician again and am now taking Celebrex twice a day with food. The rash is now merely irritating but not severe (if anything, a small hive that disappears after a bit without much irritation). I don't have much swelling in the previous areas, but still experience chest pain every couple of days.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza, feeling down and headache. On an unknown date, the outcome of the influenza, feeling down and headache were unknown. It was unknown if the reporter considered the influenza, feeling down and headache to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that, he was not sure if he had flu after administration with the first dose of SHINGRIX. The healthcare professional additional reported that, after receiving the first dose, he could not work for the next day after receiving the vaccine and he also stated that the vaccine knocked him so low. The events were updated after call review. This case was linked with case US2018129628, reported by the same reporter for the same patient.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 19-JAN-2017 at 16:22, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck)(VARIVAX) injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Pt vaccinated with DTP/OPV developed painful red raised lump at inject site. Advised to use ice at site & Tylenol.
Myalgia, Nausea without vomiting.  Treated with aspirin and cold pack.
I got a really sweet 8 inch diameter hive on the injected arm. It is hot and very itchy. It's not where the injection was actually at, which is weird.
Pt rec'd first dose on 24SEP90; Had onset of yellow tongue ("Top & bottom") on 26SEP90. no treatment was given. Outcome is unknown;
Stomach shocks in left abdomen started about 34 hours after 2nd vaccine. I contacted my gastroenterologist about going to ER. He recommended MiraLax.  Found out about 2 other people that experienced same symptoms after their 1st or 2nd vaccination. I forgot to tell the gastroenterologist about  vaccination.  People recommended Pepto Bismol and/or Tylenol. Pharmacists confirmed Tylenol and Pepto Bismol ok after MiraLax. Said I could take both. I took Pepto Bismol and it got worse.  I figured because empty stomach and did chicken  broth which helped a lot. I also placed heating pad on my stomach. I felt a stomach shock as I'm typing this.
Hives on whole body - including scalp. Chills. Pt treated with BENADRYL and topical hydrocortisone.
felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal).  The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy.  Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids.   On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy.  On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more.  The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours.  The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately.  At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray.  All test results were normal.  The patient's COVID-19 test was negative.  Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction."  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.
Vaccine administered at about 9.05am and temp maxed at 101.5 degrees by 7 PM. Vomiting started at 5pm, ended by 6pm. All symptoms passed by next day except for redness around injection site and sore arm.
Breakthrough case admission after 2 vaccines Pfizer 2/26/21 Lot# EN6202;  Pfizer 3/19/21 Lot# EN6204
101.5 fever for 3 days; nausea; debilitating aches and pains over entire body; excessive sweating and chills; excessive sweating and chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 15Jul2021 at 17:45 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN); both for unspecified indication from unknown dates, unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 09:00, the patient experienced 101.5 fever for 3 days, nausea, debilitating aches and pains over entire body, excessive sweating and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 101.5 fever was recovered on 18Jul2021, which lasted for 3 days. The clinical outcome of the events nausea, debilitating aches and pains over entire body, excessive sweating and chills was recovering at the time of the report.
Pt had a local reaction with redness and itching 1 day after vaccine administration, 3 days after administration, pt broke out in a severe rash all over body with itching/pain at vaccine site (L) arm.
Pt c/o nausea 1-2 days post vax. She then noticed increased left shoulder pain on 8/25/01. On 8/26/01 her left shoulder was swollen. She saw MD on 8/27/01 and was diagnosed with cellulitis and placed on the oral antibiotic Tequin. She was also given antibiotic injections in the office. She was off work x 2 days. She will follow-up with MD on 8/28/01.
I?m a healthcare worker who has worked in Neurology and Behavioral Health for 10 years. I have never had an abnormal EEG due to my history of migraines.   I was in bed when I felt severe lightheadedness and an urgent needed to defacate. My husband lowered the bed to help with the lightheadedness however the need to defacate remained and I went into the bathroom had LOC, hit my head on the door jam, fell to the floor. No tonic/clinic movement was noted by husband. No bowel or bladder incontinence. The LOC remained for 15 seconds. I regained consciousness and was aware of my surroundings but was not clear headed. I crawled to the toilet but was not able to hoist myself onto the toilet. I leaned over the bathtub (Still on my knees) and nearly had another LOC. My husband helped me onto the toilet and I was able to relieve myself and a couple of minutes later while still lightheaded I was able to get back to the bed on my own while holding onto the wall. I texted Dr and made him aware of this incident. He advised me to schedule EEG, carotid ultrasound and CT head on the upcoming Monday. Carotid ultrasound was within normal limits.
At approx  8:30pm on the 13th  I started to have stomach/intestinal pain and I thought I was having a bout of Diverticulitis.  It was very severe, and included nausea and frequent trips to the bathroom.   I was up all night in pain,  which finally seemed to be getting better after 8 am.     At approximately 10am on the 14th I realized I was coming down with a fever......my temperature was 100.2    I had a temperature of 100.2 until at least midnight.   I woke up at 6 am on the 15th  with a normal temperature.  I am feeling better now, but I put myself on a clear liquid diet.  I have no energy and I plan to take it easy for a couple of days.
R-arm has light pain in morning Tiredness Shortness of breath Slower thinking Light indication of head ache All above still occurring daily since 04/18/21
Hives to face, neck, groin, hands, feet, torso, facial and ear flushing that came on 1 1/2 weeks later
My mild tinnitus on the right increased greatly for about six days, now back to its usual level.  Just htought this might be helpful to researchers.
This spontaneous report as received from a pharmacist refers to a 27 year old male patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route, indication not reported), which was outside the recommended age range of 9 to 26 years old. Additional information has been requested.
Patient was fully vaccinated and boosted on 1/24/21, 2/21/21, and 11/19/21. Patient admitted with COVID 19 on 1/8/22. Symptoms of weakness, congestion, cough, hypoxic.
throwing up; lethargy; Terrible headache; Sleep for; could not eat or function; This is a spontaneous report from a contactable consumer, reporting for herself.  A 35-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: ER8737), via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 at a single dose for covid-19 immunisation. There was no medical history. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); topiramate (MANUFACTURER UNKNOWN); methylprednisolone (MANUFACTURER UNKNOWN); and drospirenone/ethinylestradiol (GIANVI). The patient previously received the first dose (Lot Number: ER8737) of the bnt162b2 on 06Mar2021 at 11:15 at 35 years of age at a single dose for covid-19 immunization. No other vaccinations given 4 weeks prior to the immunization. In Mar2021 (reported as 01Mar2021), the patient was throwing up, lethargy, terrible headache, sleep, and could not eat or function. Therapeutic measures were taken as a result of terrible headache (headache). There was no treatment given in response to the other events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.