chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner (N.P.) and a registered nurse (R.N.) concerning a 9 week old patient with no concurrent conditions, no known drug allergies and no pertinent medical history who on 03-FEB-2012, was vaccinated with a first dose of ROTATEQ, 2 ml, P.O. (lot number 669825/1347AA) which was given as part of the 2 month vaccination series. Concomitant vaccine included PENTACEL. There were no other concomitant medications. It was reported that within a week of getting ROTATEQ, the baby had "coffee ground emesis". The reporter stated that the exact date of adverse experience was unknown. Patient's family called the office on 05-FEB-2012, to report the event. Patient was admitted to hospital at that time. The baby was diagnosed with an upper gastrointestinal bleed. It was unknown if the event was disabling or life threatening. It was reported that the therapy with ROTATEQ was not reintroduced. The nurse practitioner reported, that the baby's stool tested negative for blood but the vomit tested positive for blood. There were also some other unspecified laboratory studies performed. At the time of the report, the baby's outcome was unknown. Additional information has been requested.
Reported to first aid room stating she was "having a reaction, Chest tight, throat tight, difficulty breathing. " Patient had own EPI pen with current date, self- administered at 1024 AM.  911 called and responding to site. 1026 AM  BP:86/56, HR 67. 1030 AM- improving airway open 1032 AM BP: 157/110, HR:112, symptoms resolved. 1035 AM EMS on scene, transported patient to Hospital.
Left upper arm over Tricep with 3x4cm redness with mild swelling, mild warmth shin with redness.
2nd dose given too early, 1st dose 2/27/21, 2nd dose 3/16/21
sudden onset of whole body aches , nausea, vomiting after 3 hours of onset.
I got COVID in July, 2022. I now feel very foggy and out of it, am having memory problems.
Beginning about 30 minutes after the shot, i started to feel pain in my left hand ( same side as the shot). It gradually became worse as the day went in.   a really painful arthritic pain causing me to not use that hand most of the day. I was able to move my fingers if I tried, but it was very painful to do so.  I took ibuprofen and it helped enough to get me through the night.  The pain is minimal as of 24 hrs post vaccination.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients received improperly stored VAQTA dose, route, lot numbers and expiration dates were not reported. This is one of several reports received from the same source. Additional information has been requested.
A few hours after receiving injection start having achiness, sweats, headache, temp 102.1 and nausea with vomiting. Benadryl and Motrin recommended, did feel improvement next day
Onset of frequent (multiple times per day) hot flashes/night sweats that are still ongoing and significantly impair sleep. This could be a coincidence - unclear if tied to Moderna booster except by timing.
she passed away last night; She reported no side effects other than being tired.; This is a spontaneous report from a contactable consumer. A 96-years-old female patient (reporter's mother) received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  Medical history included high blood pressure, heart disease, stent in heart. The patient was not pregnant. There was no known allergy. Concomitant medications included blood pressure and other medications. The patient previously received first dose bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation. Patient received her second Pfizer vaccine on 07May2021. She reported no side effects other than being tired. It may not be related to the vaccine, but she passed away last night. Note that she had heart issues. The adverse events resulted in Emergency room/department or urgent care. Treatment for the adverse events included CPR and other life saving measures. There was no Covid prior vaccination. The patient was not Covid tested post vaccination. Death cause was unknown; may be listed as heart attack (as reported). The outcome of event Tiredness was unknown. The patient died on 09May2021.  An autopsy was not performed.  Information about lot/batch has been requested.; Reported Cause(s) of Death: she passed away last night
5 days after 2nd covid vaccine, I started experiencing severe pain, with pins/needles sensation.  Started in plantar aspect of both feet and traveled upwards to my hands, in a matter of hours.  Extreme pain in lower back and extremities caused me to go to the ER.  Following lumbar puncture and a series of diagnostic tests, I have started on IVIG for Acute Inflammatory Demyelinating Polyneuropathy.  This is a subtype of Guillain Barre syndrome, believed to be precipitated by autoimmune response generated from the 2nd covid vaccine.  I am now on day 4 of my hospitalization.
Breakthrough Case. Presented to ER on 5/8/2022 with cough that has worsened over time. Hx of asthma. Treated with Paxlovid and discharged to home.
In LA w/ZOSTAVAX pt had baseball sized, warm welt, that decreased next day to size of golf ball.
Significant itching and scaly/peeling skin at/around  the injection site (within about two inches).  Duration was approximately 10 days after presenting.  No treatment sought or required for full recovery.
Extreme pain from right shoulder down to right elbow x 7 days, unable to lift arm to shoulder height, pain continued as of this date in mid arm to shoulder as sharp stabbing sensation. Visit to primary physician on 11/14/2018 (dr out of country and then too busy to return communication) who referred to ortho physician. Ortho physician (Dr.) visited on 12/3/2018, x-rays taken of right shoulder, doctor said an MRI needed to be done. MRI done on 12/11/2018. Radiologist report of impression of MRI states: Edema within the inferior aspect of the infraspinatus muscle and the teres minor at the humeral insertion with osseous edema in the posterior aspect of the humeral head. These findings are consistent with changes related to a recent flu injection with penetration of the joint capsule and/or posterior humeral periosteum. The appearance is consistent with SIRVA (Shoulder injury related to vaccine administration).
Patient / under 50 years old had a script from a doctor to receive a / dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   It was unknown if the reporter considered the intercepted drug prescribing error to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not applicable for this report. Pharmacist reported that an unknown patient who was under 50 years old had a script from a doctor to receive a dose of Shingrix over a year ago, which led to intercepted drug prescribing error. Health care professional declined to provide information about it. Health care professional disconnected the call so no follow up was done.
Patient is a new patient to me who presents today for follow up of his medical problems. The patient is c/o insomnia. He was prescribed Xanax by his cardiologist, but he did not get the Rx. He also did not get the lipitor filled. He states that he has used ambien and trazodone without relief. He is also c/o sweating w/ activity. He has had this chronically. He notes that his BP has been running high at home. He does have some occasional pain at his umbilicus. The patient denies other complaints. He does smoke. Labs from 8/28/09 and 12/8/09 were reviewed. History reviewed and updated in epic.
2/22/22 pt with a positive COVID test, treated with Azithromycin and steroids by PCP outpatient; 3/3/22 pt to hospital with increasing SOB, hypoxia, ARF; transferred to ICU; O2 supplementation eventually requiring intubation; CXR showed lung volume diminished and multifocal pulmonary infiltrates, right > left; remdesivir, decadron, albuterol, AKI; condition worsened significantly; pt transitioned to DNR and pt expired in the hospital
pt recvd vax; pt fussy at noc after immun; sleeping quietly 3am; found dead by mom at approx 6:30am;
Constant Tinnitus (Ringing in the ears) began day after the 2nd Pfizer shot High pitch tone Causes headache and difficulty sleeping
lt arm (deltoid area) noticed 17SEP96 arm red, hot, swollen (welts under skin); (area 5 1/2 inches long, 4 inches across);rx DPH & APAP;
Redness, itching, rash, swelling, and sore to the touch  on  02/09/2021 Improved but still present on 02/11/2021
Hot flash, headache, nausea, dry mouth - 3/21, 5pm Headache, stomach pain, tiredness, dry mouth - 3/22, 10am - 3/24, 10am Stomach pain, chills, hot flashes  - 3/21, 9pm Hives breakout - 3/28, 2am Leg tingling - 3/21, 9pm through present day
VAGINAL BLEEDING ABDOMINAL PAIN N17.9 - AKI (acute kidney injury) (CMS/HCC)
Bad shaking like I was freezing for 3 hours super bad headache and still have the headache. One of the worse headaches in my life.
4-5hrs p/receiving DTP, child had high pitched screaming, lasted about 1hr; Mom called ER;
Patient presented to the ED on 2/19/2021. Patient again presented to the ED on 3/19/2021 and was subsequently hospitalized for 4 days.
lower back pain; abdomen pain; leg pain; big muscle on the left side of her back, that won't loosen up/ knots; This is a spontaneous report received from a contactable consumer from medical information team.  An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 07Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "lower back pain"; ABDOMINAL PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "abdomen pain"; PAIN IN EXTREMITY (non-serious) with onset 28Feb2021, outcome "unknown", described as "leg pain"; MUSCLE DISORDER (non-serious) with onset 28Feb2021, outcome "unknown", described as "big muscle on the left side of her back, that won't loosen up/ knots".  Additional information: The reporter stated that her mother (patient) has been bed ridden since 28Feb2021. The patient has been experiencing lower back pain, abdomen pain, and leg pain and it's been hard to get out of bed for the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives on her trunk and head; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Feb2021 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Medical history included diabetes which was also a family history of patient. Concomitant medications included metformin 1000 mg once daily for diabetes mellitus, Januvia 100 mg once daily for diabetes mellitus. The patient previously took iron infusion and got a reaction and had allergic to sulfur. On 13Feb2021, patient woke up with hives on her trunk and head. Patient called her doctor in the morning and asked if she could take the Benadryl, he said she could but that didn't seem to work. Patient went to the MD who gave her a shot of prednisone that did work with unspecified medication and some Prednisone 20 mg tablets to take for 5 days with Zyrtec as a treatment for the event and patients hives went away within hours. Outcome of event recovered.  Call back was done to gather details of Unspecified medications and Product details for Iron infusion. However, it was not successful.
diagnosed with an allergic reaction; left arm started itching at the injection site; left arm was also sore; rash kept growing; "full on rash"; arm became hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (left arm started itching at the injection site), PAIN IN EXTREMITY (left arm was also sore), RASH (rash kept growing), VACCINATION SITE RASH ("full on rash") and VACCINATION SITE WARMTH (arm became hot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (left arm started itching at the injection site), PAIN IN EXTREMITY (left arm was also sore), RASH (rash kept growing), VACCINATION SITE RASH ("full on rash") and VACCINATION SITE WARMTH (arm became hot). On 16-Feb-2021, the patient experienced HYPERSENSITIVITY (diagnosed with an allergic reaction). At the time of the report, VACCINATION SITE PRURITUS (left arm started itching at the injection site), PAIN IN EXTREMITY (left arm was also sore), RASH (rash kept growing), VACCINATION SITE RASH ("full on rash"), VACCINATION SITE WARMTH (arm became hot) and HYPERSENSITIVITY (diagnosed with an allergic reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included triamcinolone acetonide cream USP 0.5 %, and oral methylprednisolone tablets USP 4 mg dose pack and Tylenol.
Client states red rash covering both hands and intense itching (worse at night) approx 24 hours after vaccine with JE Vax and Rabies. Benadryl cream applied itching rash decreased after 2 days. On day 7 client returned for 2 JE Vax states itching less but observed scratching hands. Red dots remains bilaterally approx 10-15. No respiratory involvement.
pt p/receiving vax & waiting 5 minutes became nauseated; pt was pale but skin was warm & dry to touch; pt was evaluated for 30 mins & then released to mom;
On 03/05/2023, I started to feel bad in the evening. On 03/06/2023, I took a COVID-19 test.  My doctor called in Paxlovid for me and I started taking it that day.  A couple of days later, I felt better. I had 102 temperature, and I had aches, weakness and fatigue.
This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-DEC-2010, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent of herpes zoster, also known as shingles and other complications. In 2011, the patient was treated at a hospital (did not specify whether admitted; therefore, considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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 of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt had a 5 minute generalized seizure. Brought to ER with no fever or signs of infection. No focal findings. Given boost of phenobarbital and discharged from ER. Pt known to have seizure disorder and had therapeutic level of phenobarbital (20) on 8/20/2000.
Mother assists with history that patient's throat felt "funny" once they return to their car after post-observation 15 mins observance.  States that this is similar to when she eats certain foods namely cherry which is noted as an allergy in pt chart. Patient given 12.5mg diphenhydramine oral suspension with reported resolution of symptoms ("funny feeling in throat") after additional 15 mins observation.  Patient discharged with mother.
Client was vaccinated and waiting in  the observation area when she stated she was seeing black spots.  Client was taken to the reconstitution area in a wheelchair where her vitals were taken and she was asked to lay in a supine position.  Parent explained that client gets like this or has similar experience if she does blood draw.  Client was asked if she had a meal and she said she ate very little and had done her morning exercise.  Client declined having her sugar done.  Client was hydrating with water then her vitals were taken again while sitting up.  Client parent stated that her BP is usually normal.  Client was asked if she wanted to go to an emergency room.  Client responded that she was feeling better and wanted to leave with her mother.
I started feeling unwell mid-morning. I did a COVID-19 test and tested negative. The next day I tested positive. I made a telehealth appointment and my doctor prescribed Paxlovid.  I felt better after two days of the Paxlovid. I have been tired after it was over.
rph found that we vaccinated expired product by 1 day and so contacted the pfizer and they said it's okay if it's by 1 day and no need to revaccinate
This case was reported by a consumer via patient support programs and described the occurrence of viral infection in a 18-year-old female patient who received Meningococcal B vaccine for prophylaxis. In August 2018, the patient received Meningococcal B vaccine. In August 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired. On an unknown date, the outcome of the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired were unknown. It was unknown if the reporter considered the viral infection, headache, neck pain, palpitation, fever, chest pain, dizziness, nausea, feeling unwell and activities of daily living impaired to be related to Meningococcal B vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The patient received meningitis vaccine and the day she received it, she had headaches, neck pain, palpitations and fever. She had since been missed the school and experienced continuous headaches and pain in her chest with palpitations as well as dizziness and nausea. Initially the mother of the patient brought her to the doctor's office twice. The first few days, the patient was not feeling well and was informed by medical professionals this might be expected after receiving the vaccine. The mother brought the patient again a week later and explained she still had the same symptoms then medical professionals said she might had a viral infection. After the third recent visit to a medical professional, the doctor said the patient might need to see a cardiologist because it might be a side effect from the vaccine. The reporter did not know if there was anyone, who could have a discussion with. The reporter stated, it seemed to get worse rather than better. The patient was an athlete and she could not compete in figure skating anymore. The patient's mother noted her daughter studying overseas and that she had documentation on the vaccination at home. The patient's mother had been investigating the serious side effects that might be caused by the vaccine and got inconsistent feedback from the medical professionals she had spoken with. The reporter agreed to be contacted for follow up.
Puctured vial was left in the refrigerator overnight; Dose administered from a vial that was punctured for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Puctured vial was left in the refrigerator overnight) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Time of administration of vaccine was 1:10-1:15 PM. Vial was initially stored in the refrigerator on 08-JUN-2022. Vial was first punctured on 9-JUN-2022 at 2:32 PM  and 3 doses were administered at that time.Post punctured vial was stored in refrigerator.  Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature (8 to 25 degree Celsius= 46 to 77 degree Fahrenheit) was 15-20 minutes. No treatment information was provided.
c/o sore swollen red hard & hot to touch @ inject site; recvd flu shot on 26OCT93; 29OCT93 site was improved; 3-4" diameter;
4? by 3? rash at injection site but it is still spreading.  Headache  and arm soreness.   Low grade fever 100.1.  Fever controlled by Tylenol.   Headache dulled by Tylenol but still a strong ache.   Still on-going so no results for recovery yet.
Since the previous report, there was evident left leg edema with pitting seen as well as severe, localized left sided chest pain that came and go a few days after the second dose. Some red lesions were seen on the palms of the left and right hand along with black lines on nails bilaterally on both the toes and fingernails (mostly big toe and thumb and index finger). Edema faded after a few days and the intense chest pain subsided slowly. However, since then, there has been a persistent left sided chest pain that comes and goes. It was worsened the past few weeks in intensity and location. Has come to the point it is distracting for daily living on some days. Went to student clinic earlier this year and given basic exam but pain persists along with irregular menstruation, enlarged right post-auricular lymph node, and need to take deep breaths while wearing regular surgical masks.
The day of the shot I started having some pain behing my eyes (8 pm). I went to bed at about 11 pm and could not sleep so I took a sleeping pill (Zolpidem 10 mg) but could not sleep all night feeling very exited and restlees. At about 8 am next day (april 8) I started feeling nausea, headache and an overall sick feeling in my body. The nausea went on until about 2 pm, On april 9 I had head ache again at around 2 pm. On april 10 I had a ligh headache at around 1 pm that continued until night (around midnight).