chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking); fainted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jun2021 13:00 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Vaccine Administration Time: 01:00 PM), administration date: 24May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset 15Jun2021 09:00, outcome "recovered", described as "The morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking)"; SYNCOPE (medically significant) with onset 15Jun2021 09:00, outcome "recovered", described as "fainted". The events "the morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking)" and "fainted" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative. Therapeutic measures were taken as a result of seizure, syncope.  Additional information: The patient had no other vaccine in four weeks. It was not reported that patient took Other medications in two weeks. The patient had covid prior vaccination and tested yes as covid post vaccination.Known allergies: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MEDI-0005739 is a serious (Important Medical Event), spontaneous case from a 44-year-old male consumer involving atrial flutter. The patient indicated that he had been in excellent physical condition prior to developing atrial flutter. He denied having any relevant cardiac disorders in the past and denied having any family history of heart conditions. The patient indicated that he had been on Warfarin. it was unclear whether the above medication was started prior to developing atrial flutter or as a treatment of atrial flutter. The patient stated that he received FluMist either on 22-Oct-2006 or on 29-Oct-2006. Five days after receiving FluMist, the patient experienced atrial flutter which lasted for nearly ten hours. On the following day, the patient felt ill and developed a mild flu which lasted for the subsequent three weeks. During that time, the patient continued to experience intermittent atrial flutter. In early November 2006, the patient was seen by an internist for his symptom. An electrocardiogram revealed that the patient had the flutter. The patient was referred to a cardiologist. Stress test, echocardiogram and heart scan test results were all negative. The atrial flutter subsided and the patient did not experience any further problems. However, on 12-Mar-2007, the patient developed a stomach virus. And on 24-Mar-2007, the patient had another 10 to 12 hour episode of atrial flutter. The patient indicated that the above symptom still persisted and that the symptom had been occurring nearly on a daily basis. The patient provided no causality assessment for the event of atrial flutter. Per 60 day follow up: Spoke with reporter via phone-states atrial flutter still ongoing-occurrs "rarely"-had only one episode since July 2007-last episode "few weeks ago" lasting "only a few minutes-exercise induced-no other associated sxs-not currently on any cardiac meds-no other medical complaints.
The patient stated that her arm was red, swollen, and hot to the touch. She stated the reaction started the evening after she received the vaccine and worsened overnight.
Right after I got my shot, my tongue started swelling but that eased up a couple hours later. About two weeks after the shot, about 20 bruises of different color and severity appeared on my legs and then I broke out in a full body rash with hives and intense itch. The rash was all down my legs, under my arms, on my stomach and the back of my neck mostly. I felt a little short of breath for the few days I had the rash. My injection site also burned and itched through this reaction.
On 10-3-07 resident received Pneumonia and flu vaccine thru the same injection. No adverse reaction
patient had a swollen arm all the way down to his wrist, injection site was also warm to the touch
1/25/2021- fever, sore arm, and overall fatigue Moderna COVID-19 Vaccine EUA
A non-serious spontaneous report of accidental exposure while administering drug and asthma attack has been received from a nurse concerning a 31-year-old female, subsequent to administering FLUMIST to patients in a physician's office.  Neither relevant medical history nor concomitant medications have been reported for this patient.  The patient administered FLUMIST to two patients in a physicians office.  Immediately after administering FLUMIST to the two patients, the patient (a health care worker) experienced an asthma attack.  The patient self-administered a nebulizer treatment and experienced relief.
Began with lymphadenopathy and fever, then progressed to a rash under immunized arm with surrounding upper chest, back and both arms.
1/11/08 patient states started having low grade fever the night of 1/8/08.  1/9/08 temp of 101.8.  Arm red at site about size of quarter and swelling on 1/10/08.  Redness increased to about 8" in size.  Arm warm to touch and painful.  The fatigue and restless increased from 1/8/08.  States had been taking Ibuprofen and took Benadryl.  States has called into MD.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient received first, second and third doses of vaccination with either GARDASIL or GARDASIL 9 (dose, route, lot # and expiry date unknown) for prophylaxis. On an unknown date, the patient had inadvertently received vaccination with fourth dose of either GARDASIL or GARDASIL 9 (dose, route, lot # and expiry date unknown) for prophylaxis (extra dose administered). No adverse effects were reported. The patient's father reported to the pharmacist that his son received the fourth dose in the physician's office however he could not specify which one of the above vaccines the patient was administered. No product quality complaint was involved.
POSITIVE COVID TEST AFTER VACCINE; SORE ARM; DRY THROAT; WARMTH WENT UP NECK; VERY THIRSTY; WATERY EYES; FEELING A LITTLE NASALLY; This spontaneous report received from a consumer concerned a 50 year old female. 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 and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling a little nasally. On APR-2021, the subject experienced watery eyes. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced dry throat. On 09-APR-2021, the subject experienced warmth went up neck. On 09-APR-2021, the subject experienced very thirsty. On 18-APR-2021, the subject experienced positive covid test after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive covid test after vaccine on 25-APR-2021, and the outcome of sore arm, feeling a little nasally, dry throat, warmth went up neck, very thirsty and watery eyes was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Site was swollen and tender temp 100.8 degrees F at office - 9/30/2009 couldn't walk on it. 10/1/2009 - no fever - redness and swelling spread and hot to the touch could walk on it 7x7cm.
3/21/07 Patinet from a foreign country.  Child seen for initial refugee physical.  Noted rt. knee pain on and off since 2006, diastolic heart murmur.X-ray rt. knee and cardio referral ordered.  3/23/07 translator called for mother stating child couln't walk due to pain in legs; sent to ER.  X-rays and labs done, diagnosed with acute exacerbation of Rheumatic Fever.  Dishcarged on Pen VF TID x10days, ASA 650 mg.q 6hrs x 5weeks, Bicillin IM q 4weeks.  Follow up with cardiologist. 4/20/07  Symptoms are now resolved. 05/01/07-records received from reporter. visit notes on 3/21/07 document c/o right knee pain which has occurred off and on since 2006. HX of TB exposurePE revealed heart murmer. HX of rheumatic fever.
Patient said about 15 min after vaccination she felt tingling in the left side of the face. It subsided after a few minutes. The next day she experienced major swelling at the site of the injection. She says her arm was the size of a softball. It is now 2 days post injection and patient says her arm swelling is not worse but remains about the same. She has spoken with her doctor over the phone but has not gone into the office for treatment.
From initial information received on 6/30/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 30 year old female patient received her first dose of pre-exposure series IMOVAX RABIES administered on 2/24/04, a second dose of IMOVAX RABIES administered on 3/2/04, and a third dose of IMOVAX RABIES, administered on 3/16/04. Lot numbers as well as routes and sites of administration were not reported. The patient returned to the health department for her post-exposure series and received IMMUNOGLOBULIN HUMAN ANTIRABIES, administered in the left deltoid, as well as her fourth dose of IMOVAX RABIES, administered in the right deltoid on 4/20/04. She received four more doses of IMOVAX RABIES, all administered in the right deltoid, with the fifth dose administered on 4/22/04, the sixth dose administered on 4/27/04, a seventh dose administered on 5/5/04, and an eight dose administered on 5/18/04. Lot numbers as well as routes of administration for all vaccines listed above were not reported. Since the receipt of the initial dose of IMOVAX RABIES on 2/24/04, the patient experienced muscle contrcations in her right deltoid and biceps. Also, during and after receipt of the series, the patient experienced soreness in her right arm. Per the patient, the health department has filed a report and referred the patient to a family physician. She was scheduled for a visit on 6/10/04 and was diagnosed with deltoid tendonitis. Results from an MRI completed on 6/29/04 are pending. The patient is to follow up with the physician. Her recovery status was not reported. From additional information received on 7/12/04 through an internal e-mail, it was reported that this case involves a medical error. Reportedly, the patient received IMMUNOGLOBULIN HUMAN ANTIRABIES and five doses of IMOVAX RABIES as follow up treatment after receipt of a recalled IMOVAX RABIES dose during their pre-exposure series. This regimen does not conform to the detailed guidance document issued during the recall. From additional information received on 11/9/04 from the responsible physician, the patient's date of birth was provided. Per the reporter, no relevant laboratory data was obtained. The patient's symptoms were treated with physical therapy. The reporter also stated that he does not have the lot number information or the routes and sites of administration for the suspect products, as the patient was vaccinated by her employer. At the time of this report, the patietnt has not recovered and continues to experience low-level pain at the site of injection. From additional information received on 12/15/04 from the responsible physician, it was reported that the patient is making slow progress, but has still not fully recovered from these events. It was also reported that the patient is not on any medications at this time. From additional information received on 3/3/05 from the responsible physician, it was reported that the patient still experiences a pain, diagnosed as tendonitis, in her right arm, at the site of injection. No further information is anticipated, this case is considered closed.
Could feel vaccine travel to my shoulder, along the top on my trapezius muscle into the side of my neck muscle. From there it continued to move upwards into the left side of my face causing a numb type of swelling sensation. I massaged my face in downward strokes to try to move it out of my facial muscles. It slowly spread downward into the area of my lymph nodes and into my throat and windpipe. This was the same type of numb swollen sensation. This process probably took about a half hour up to this point. my face continued to feel odd, and my throat remained painful and sore especially in the area of my adams apple, for about 3 to 4 days. I did not experience closing of the trachea. I did not seek medical attention for this reason. My facial muscles and the side of my neck still feel slightly odd at this time. The feeling is a slight numbness and discomfort. I had no other apparent reaction to the shot.
12/03/2021   12 year present in clinic for 2nd Pfizer vaccine.  RN administered Pfizer Pediatric dose 0.2cc to left deltoid. bandage applied. pt tolerated well.  12/06/2021:  RN notified grandmother/guardian that the 12 year old received the pediatric dose of 0.2cc instead of 0.3cc Pfizer Adult for 12 year old and up. grandmother stated that 12 year old is fine, done good the whole weekend, hadnt complained of nothing, just been playing around as usual. " he is fine".  RN stated just wanted to make you aware of the incident
On 10/17/18, one day after vaccination, hives were noticed on child's back. Parents contacted child's primary care provider who advised them to give child BENADRYL. They did this and hives improved. Every day since child broke out in hives at different times and on different parts of body. Each time they gave Benadryl and hives improved. On 10/19/18, child was seen at clinic where they did a strep test with negative results. A dose of steroids was given as well as BENADRYL. Hives continued over weekend. Parents continued to treat with BENADRYL, Aveeno baths and cool packs as needed. Parent called here on 10/22 and was advised to contact PCP again.
This spontaneous report was received from a physician via a company representative and refers to a 25 year old female patient. The patient's medical history and drug reactions/allergies were not reported. On 14-OCT-2015, the patient was vaccinated with the first dose of GARDASIL in the left arm (dose, route, lot # and expiration dates were not reported). No concomitant medications were reported. On 15-OCT-2015 (reported as the first day after injection), the patient experienced nausea, vomiting and headache. Two to three more days later in October 2015, the patient experienced full body hives that lasted two weeks. At the time of the report, the outcome of nausea, vomiting, headache and urticaria was unknown. The relatedness between the events and the GARDASIL vaccine was not provided. No product quality complaint was involved. Additional information has been requested.
Headache, Body aches, fever of 99.5 (normally 97.x)
Client received the 1st dose of Pfizer Covid vaccine (Lot #ER 2613, Exp. 7/2021). Client was sitting on post-vaccine waiting area  approximately 10 minutes and alerted EMT at 1408 of numb sensation on tongue. PHN joined EMT to further assess client. Client alert and oriented, stated numb sensation at mid top of tongue. Sensation not radiating anywhere else. Vitals at 1411: Pulse 87, blood pressure 176/108, oxygen 99, respirations 22. Minor headache per client on left side. Client denied tingling sensation, dizziness, shortness of breath, chest pain. PHN assessed for swelling around face and inside mouth. 1417 PHN reassessed blood pressure and obtained 172/102, pulse 80. Client stated history of brain aneurysm 2yrs ago, brain tumor, diabetes, and hypertension. No history of allergies. Per client takes metoprolol in the evenings and yesterday's last reading 113/67. Per client blood pressure has been controlled and follows up with provider. Medication she currently takes: metformin, multivitamins, and metroprolol. PHN informed client due to medical history and high blood pressure it was recommended to be further assessed at the hospital. Client agreed, PHN called 911 at 1423. Client's daughter waiting in car, client called her to update her. Paramedics assumed care at 1426. Client transported to Hospital.
After receiving the vaccine, around 6 minutes later the patient stated she noticed that her left arm below her elbow was puffy/swolen.  I continued to observe the patient for 30 minutes.   It never got any bigger, wasn't warm to the touch.  I asked the patient if she had any difficulty breathing, or tinging, no swelling of lips or tongue.  I informed the patient to take benadryl. pt left with her husband
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-NOV-2015 at time- 15:12, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Received Dtap, influenza, Prevnar on 11/8/04. Called triage on 11/10/04 complained of slight rash and redness of area, no swelling T 99 degrees (R).
Given too early, dose one was given  12/21/22 and second dose given 1/11/23.  Requires 28 days between doses
Peripheral Nueropathy - Pins and needles, burning, feeling like adverse/limited circulation to extremeties Blood pressure increased  - 30+ Sys / 10+ Dia
No menstrual cycle for 6 months; No menstrual cycle for 6 months; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for Covid-19 immunization. The following information was reported: AMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "No menstrual cycle for 6 months". Therapeutic measures were not taken as a result of amenorrhoea, menstrual disorder.  Additional information: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Other medical history: None. Not Covid tested post vaccination. No known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered with sequelae", described as "headaches". The event "headaches" was evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Prior to vaccination, whether the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 were unknown.
The patient reports: 2 hours after vaccination, she started to experience pain in the shoulder/joint and radiated to the elbow.  This pain slowly worsened over the next 24 hours.  At the worst point the pain radiated to the patient's back and she could not lift her arm without assistance.  Patient reports no injection site reaction or redness.  This occurred on the right arm that she received the Pneumovax 23.  The same day the patient also received Fluad in the left arm but experienced no ill effects from this vaccination.  2 days after vaccination, the patient reported running a low grade fever of 99.1, she reports a usual temp for her is around 97.5.  By the evening of Oct 24th, 3 days after vaccination, the pain started to subside.  As of today, Oct 26th, the patient reported no pain and feels she is back to normal.
Symptoms:  hives, chest tightness, felt dizzy  Blood pressure taken at 2:05 p.m.- 150/110, 50 mg Benadryl administered  BP recheck at 2:10p.m.- 140/90 Symptom improvement at 2:20p.m. Patient remaining in observation for about 30 additional minutes, symptoms subsided, had boyfriend drive her home
swollen Lymph nodes; lingering headache; feeling unwell; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes, lingering headache and feeling unwell on an unspecified date. She has been experiencing side effects for 5 days and wanted to knowif these symptoms were normal to last this long. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax & exp 4-5cm swollen rash @ inj site & a mild fever;
BATHROOM FREQUENCY/WENT TO BATHROOM ABOUT FOUR TIMES; URINE WAS LIKE A LIGHT PINK COLOR; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 03-MAY-2021, the subject experienced bathroom frequency/went to bathroom about four times. On 03-MAY-2021, the subject experienced urine was like a light pink color. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The outcome of the bathroom frequency/went to bathroom about four times and urine was like a light pink color was not reported. This report was non-serious.