chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my neck is all swollen; Diarrhea; my neck is all swollen and it hurts; I have been sick; Fever; Headache; just like been sleeping a lot; my body is achy; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Aug2021 (at the age of 49-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included heart problems. The other medication included baby Tylenol. On an unspecified date in Aug2021, the patient stated that not affecting her heart or giving her an infection or anything because she having every symptom that there was. She had diarrhea, have been sick and had a bad fever, she have a bad headache you know just like been sleeping a lot, body was achy and now even on the fourth day her freaking neck was all swollen and it hurts. The patient did not take treatment for the events. The outcome of events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Vaccine was received  Friday around noon. Friday night i had a headache. By Saturday morning I had muscle aches, chills, and terrible headache. Muscle aches, chills and headache resolved by early Sunday morning. Sunday morning around 9am an itchy rash started on the abdomen. Over the course of 30 minutes it moved from the stomach area to other parts of the body (shoulders, back, head, feed, hands, etc, only the face and neck have avoided seeing rash). It pops up and then dissipates and then moves to another area over the course of 30 minutes to an hour. It has been two weeks since the shot and the rash is still present, coming and going, moving around the body. Allergy medication controls the rash, but when the medication wears off the rash returns.
AFTER THE 2 VACCINES WERE ADMINISTERED, THE PATIENT WAS FINE. MOM, THE PATIENT AND MY SELF WERE WALKING OUT OF THE ROOM. I WAS IN FRONT AND MOM AND PT WERE BEHIND ME. I HEARD MOM SAY HELP. I TURNED AROUND AND SAW PT FALLING TO THE GROUND AND MOM WAS HOLDING HER ON ONE SIDE AND THEN A MEDICAL STUDENT CAME OUT OF THE OFFICE. DR. AND I WERE HOLDING HER ON BOTH SIDES BUT PT STARTED TO PASS OUT BEFORE WE COULD GET HER TO THE EXAM ROOM. WE IMMEDIATLEY LAYED HER DOWN ON THE FLOOR UNTIL WE COULD GET HER SETTLED. DR. CAME OUT OF THE OFFICE, TOO. PT "WAS OUT COLD" FOR AT LEAST 5 MIN. DR. WAS ABLE TO AROUSE HER BUT PT DIDN'T KNOW WHERE SHE WAS OR WHAT HAPPENEND. DR. HAD MOM MOVE IN SIGHT OF PT TO CALM HER. AT THIS TIME PT HR WAS  120s, PALE, NYSTAGMUS, UNABLE TO FOCUS, STARTED TO BECOME NAUSEOUS. WITH HELP, WE WERE ABLE TO MOVE PT INTO THE EXAM ROOM ON THE TABLE. PT WAS COMPLAINING SHE WAS COLD SO WE COVERED HER ON THE TABLE. SHE HAD HER HEAD AT 45 DEGREE ANGLE. SHE BEGAN TO COMPLAIN HER STOMACH HURT AND THEN SAID HAND WERE TINGLING AND SAID SHE COULD MOVE HER HANDS. THEN SHE GOT WARM.  ONLY TJE HANDS BECAME STIFF (DYSTONIC). SHE WAS DIAPHORECTIC AND SHAKING AT THIS TIME BP 79/42 HR 80s. WE HAD INJECTABLE DRUGS (COMPAZINE AND OTHERS) BUT PT WAS GETTING ANXIOUS ABOUT THE NEEDLES SO DR. TOOK A BENEDRYL  25MG CAPSULE AND POKED HOLES IN THE CAPSULE AND MADE HER TAKE IT THAT WAY. IT DID WORK WITHIN SECONDSTO RELEAVE THE DIAPHORECTIC. WE STARTED GIVING HER WATER AND PRETZELS. WE FOUND OUT SHE ONLY ATE WATERMELLON FOR BREAKFAST.SHE CONTINUSED TO RESTFOR ANOTHER 20-30 MIN WITH EATING. FELT BETTER, COLOR WAS COMING BACK TO HER AND FELT STRONGER SO SHE DECIDED TO GET UP AND TOOK 2 STEPS AND WAS CARRIED BACK TO THE TABLE. PT THEN WAS FREEZING AND THEN SHE FELL ASLEEP. DR. ADVISED MOM PT NEEDED TO GO TO THE HOSPITAL. DAD ARRIVED AT THIS TIME AND MOM AND DAD FELT AN AMBULANCE WOULD BE BEST. I CALLED THE AMBULANCE GAVE THEM THE HISTORY AND THEY ARRIVED APPROX. 15MIN LATER. THEY ASSESSED HER- GLUCOSE 130 ON METER, + ORTHOSTATIC HYPOTENSION AND AGREED SHE SHOULD GO TO HOSPITAL ED. THE TOTAL TIME IN THE OFFICE 12:15PM-2:15PM  WE DID CHECK THE VACCINATION AREA AND THERE WAS NO REACTION VISIBLE.
Confusion, Myalgia, NauseaVomiting, anxiety, hot flashes, eye pain Narrative:
I have previously experienced small but manageable asthma attacks after receiving the 2 vaccines. On my 3rd vaccine I was prepared with my inhaler and prednisone was taken before receiving the vaccine. I was at the 30 minute mark and was told that I could go home but I decided to wait a little longer because my chest felt as if started to tighten up. A few minutes later I started to have a very bad asthma attack one as I have never experienced before. I was not able to get the medication that they were injecting me with to help with the attack. I did receive a shot from an EpiPen which seemed to help a lot.
Immediately after the shot was administered, I felt a stinging down my arm to my hand, but didn't think if was a big deal or maybe it was what was supposed to happen, when I got home, my arm was hurting, the next day it hurt more and more and was swollen with red rash.  I took Aleve and alternated between heating pad and ice pack. It never got better, So the Tuesday before my second shot was due, I sent a picture of my arm to my doctor and explained that my arm was still sore and had rash and swollen. She had me come in the next day and confirmed, she has prescribed Diclofenac sodium 1% gel to use 4x daily and Rx of meloxicam 7.5 mg. (I am waiting for this to be filled, so I have not started it This is day 5 of treatment and my arm is STILL sore, the rash marks are still there but no longer red.
Started following morning with mild flu like symptoms which continued to worsen to the point that I could barely walk, chills, dizzy, tempature 100.1, entire body ached especially joints, injection arm turn deep red burning hot to touch lump spread the size of 5 inch diameter. Could not stand to walk more than a few feet for 24 hours. After 24 hours sweating, stomach pain, headache, joint pain for 24 more hours. Third day after vaccine injection started to symptoms began to subside continuing until fourth day felt almost normal, still dizzy at times. Arm is still red and hot but not as much.
she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch; she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "she had an injection site reaction from a Pfizer COVID booster injection/it was "like a spider bite" and that her upper arm was warm to the touch".  Additional information: Patient had an injection site reaction from a Pfizer COVID booster injection. She reported that it was "like a spider bite" and that her upper arm was warm to the touch. No intervention was required.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an RN concerning a patient who on 04-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U. The patient developed a cellulitis-like reaction: redness, swelling, and warmth in the arm from the upper arm to lower arm. As of 05-OCT-2007 the patient's outcome was unknown. The nurse also reported additional patients who had adverse reactions after receiving pneumococcal 23v polysaccharide vaccine, lot #655765/0061U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Patient was given Varicella vaccination on 10/23/08.  Mom states she began acting "fussy" last night and brought her in for scheduled visit today.  Temperature 98.5 orally at visit today. Patient has scattered lesions (30-35) over anterior trunk, groin, and bilateral lower extremities.  Mom did not notice lesions until patient was undressed at OV today.
Severe Headache, Hives, Vomiting, Body Aches, Fever
Sore Throat 4:30 PM. Touble breathing shortly thereafter.  Patient then went to the ER and received treatment.
Sore arm day 1-3, bruising occurred day 2. Mild fever (approximate 99 deg) beginning around 5:30pm-day of injection lasting 12 hours. Body Aches and Mild Headache beginning the evening of day of injection lasting through day 2. Body rash (non-itchy) on trunk, low back, inside of upper arms, upper chest beginning on day 2 post injection lasting until day 3.   Treatment: IBU every 4-6 hours prn.
5 mins. approximately - post injection, while in the waiting room sitting in a chair, patient had syncopal episode which last approximately 2 mins. Cool compresses applied to patient's forehead. She was gently eased to the floor and her legs were elevated. She roused, then was moved - she walked with assistance - to a room. We monitored patient's BP. (she has a low baseline BP). She drank 2 juice boxes and 3 12 oz. glasses of water. She remained supine with her BP's increasing. I then did orthostatic BP's. Dr. reviewed and cleared patient to leave. We obtained a progress report the next day. Dad stated that patient was doing very well.
Vaccine administered was stored greater than thirty days in refrigerated temperatures. A case opened with the vaccine manufacturer demonstrated that the vaccines were still safe and effective but requested that we report to VAERS.?
Nerve pain down left leg; back pain that goes down left leg; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ENG6199) via an unspecified route of administration on 27Mar2021 at 10:00 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included amlodipine besilate (NORVAC), daily multivitamin, "estradiol and prog" from unspecified dates for unspecified indications. The patient previously received dose 1 of BNT162B2 (lot number ENG202) on 06Mar2021 at 10:00 as a single dose for COVID-19 immunization. On 29Mar2021, the patient started with back pain that went down the left leg; "nerve pain down left leg." The patient visited a doctor for the event. The patient underwent lab tests and procedures that included X-rays and "possible MRI." The outcomes of back pain that went down the left leg and nerve pain were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Swollen leg, wheezing, vomiting.  Taken by ambulance to ER.
Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confirmation of cortical venous thrombosis, and spontaneous ventricular tachycardia.
pt began screaming & crying (unconsolable) for 24 hr starting approx 5 hr p/vax 19OCT94; no fever; mom reported to MD 19OCT94; further pertussis vax contraindicated per pediatrician;
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Morbilliform rash 24-36 degrees after immunizations 5X care - tylenol and/or motrin.
severe outbreak of genital herpes; This is a spontaneous report from a contactable consumer (patient). This 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 09Feb2021 at 12:45 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included soy allergy from an unknown date and unknown if ongoing. The patient had not received any other vaccines in four weeks and did not have COVID prior to vaccination. Concomitant medications included lorazepam (ATIVAN) from an unknown date for an unknown indication and fexofenadine hydrochloride (ALLEGRA) from an unknown date for an unknown indication. The patient reported that two days after vaccination, she had a severe outbreak of genital herpes; she did not know if there was a connection. No treatment was provided for the event. The clinical outcome of severe outbreak of genital herpes was recovering. It was also reported the patient had not been COVID tested post-vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of my feet and hands, on my left arm and occasionally on my face.; Burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of my feet and hands, on my left arm and occasionally on my face.; This is a spontaneous report from a contactable other healthcare professional (HCP, patient).  A 60-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in left arm on 11Feb2021 at 13:00 at single dose for covid-19 immunisation.  Medical history included grave's disease, hypertension, high cholesterol, previously Ramsay Hunt Syndrome with bell's palsy, struma ovaria. Patient had no covid prior vaccination and was not covid tested post vaccination. No known allergies.Previously on Jan2021 at 13:00 (at 60 years) patient received the first dose of the vaccine administered in left arm covid-19 immunisation. Concomitant medications included hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ), levothyroxine sodium (LEVOXYL) and colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported.  On 12Feb2021 at 20:00 the patient experienced burning/tingling sensation on tops of hands, and after mostly subsiding, returned in a week on the tops of her feet and hands, on her left arm and occasionally on her face. No treatment given; the final outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Hive started 5 days after vaccines inner thigh / outer thighs, stomach, chest and both upper arms.
This spontaneous report was received from a medical assistant, concerning 26 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-JUN-2018, the patient received a dose of the pediatric/adolescent VAQTA for prophylaxis (strength, route of administration or anatomical location were not provided); which was considered as an inappropriate age at vaccine administration. No adverse effects were reported.
pt recv vax 22JAN97 & 24FEB95 pt devel swollen hands & a gen rash;26FEB97 pt devel swelling, purpura, fever of 104, heart murmur;25FEB97 pt hosp;3MAR97 pt improved & d/c;15MAR97 pt devel pseudomembraneous colitis;
Main adverse effect is heart palpitations, that I experienced 3 days after the first vaccine. This lasted for 2 weeks. After second vaccine I experienced even stronger heart palpitations  started on the day 3 after, and still continues now, which is  over 3 weeks after the second dose of vaccine.
Hypothyroidism; Loss of hearing in my left ear; autoimmune flair up; Injection site pain; muscle ache; Fever; Fatigue; Dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) dose 1 via an unspecified route of administration, administered in arm right on 2021 12:00 PM and dose 2 via an unspecified route of administration, administered in arm left on 2021 (Batch/Lot Number: Er8736) both as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. Patient had no allergies. Patient was not pregnant at the time of vaccination. Patent did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. In 2021, dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021 also. On 21Apr2021 22:00, the patient experienced hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. These events resulted in doctor or other healthcare professional office/clinic visit. SYNTHROID dose was increased, and blood work (date and result: not reported) was performed to treat the adverse events of hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. The outcome of events hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue were recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Hypothyroidism, condition aggravated, Unilateral deafness and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received form a Nurse Practitioner and refers to a 16 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 10-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Pt was given two doses of Pediatric Hep B, same manufacture and lot number, at the same appt in place of giving one adult dose of Hep B. No adverse events or reactions reported.
Diffuse itching on his right arm that began right after the inoculation, over the last few months the itching remains primarily on the back of his right hand in a 3"x 3" square pattern and a similar sized area on his forearm.  The itching was at first diffuse but has coalesced down to these two areas.  No rash and no skin marking indicating another cause of the itching.
It was reported in a published article that an approximately 36 month old male patient in approximately February 1990 at the age of 29 months, was vaccinated with a dose of MMR (second generation). Subsequently, he had no language by 36 months and a diagnosis of autism was later confirmed. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought.
vomited x 1 evening p/vax; temp to 103 & irritability for 3 days following DTP;
Large red itchy welt appeared at injection site, one week later. No treatment.  It's still there 6 days later.
pt admitted to hospital with a positive COVID test on 9/7/21; COVID pneumonia; AHRF; BiPAP dependent; pulls off BiPAP and O2 saturations dip to the 30s%; restraints used to keep from pulling O2 off; sedated; unable to take po; transitioned to comfort care with inpatient hospice; pt expired in the hospital
large, round, red, warm, and itchy at site of injection. (4 in circ?)
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. The patient was allergic to sulfa drugs. On 04-SEP-2014 the patient was vaccinated with ZOSTAVAX 0.65 milliliter, lot # K003599 and expiry date of 13-MAR-2015, subcutaneous. Concomitant medications include blood pressure and cholesterol medicines. On an unknown date in September 2014, the patient experienced itching and redness around the injection site after receiving ZOSTAVAX. On 13-SEP-2014, the patient asked the pharmacist how long injection site reaction usually lasts and complained that she was still experiencing itching and redness around injection site. The patient was treated with BENADRYL. No lab tests were performed. The patient sought medical attention by calling the physician. The outcome of itching and redness around injection site was reported as not recovered/not resolved. Additional information has been requested.
Red, shaky, hot, light headache, felt like going to pass out, tingly all over.
Patient was given FLUZONE-HD at 2:21 PM on 9/28/12, appeared normal after 20 minutes, and was sent home. The patient entered the Emergency Dept. around 7:30 that evening experiencing shortness of breath and subjective bronchospasms. The patient then experienced syncope. EKG and vital signs appeared normal and patient was discharged after a couple of hours.
Pt vaccinated with Recombivax HB developed Bells Palsy R onset 2 wks post vaccine.
At present time, there are no reported adverse event. PENTACEL was inadvertently given to patient instead of the ordered HIB. Guardian was contacted, reported no fever or change in behavior or level of consciousness. Guardian will continue to monitor and report any adverse effect to MD. It has been more than 24 hours since injection and patient is reported to be doing well as per guardian.