chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer vaccine with no issues.  Walked to observation area and sat in chair.  Observer noticed patient stiffen in chair.   RNs helped patient to the floor.  Alert but slightly confused.  Patient said he felt "weird", was sweaty and pale.  EMS was called who came onsite and evaluated the patient.  Patient went to the Emergency Dept. for evaluation.
Severe back and leg pain began after doing daily stretches on 3/26.  MRI determined that the minor herniation had ruptured and caused an extrusion.  A surgical microdiscectomy was necessary to remove the extrusion.
approx 15min p/vax pt broke out in hives on face & of chest/back;pt weighed 44lb epi given; clear of hives in approx 10min p/epi;
the patient, was given the vaccine at roughly 10:15am. At about 10:30am, after waiting 15 minutes after the shot, the patient stood up from his chair in the waiting area. He staggered over to the pharmacy drop off window and stated that he felt like he was going to pass out. His eyes rolled back and he collapsed. Another patient was approaching the counter at the same exact time and was able to catch him on his way down. By the time I ran from behind the pharmacy counter, he was awake, breathing heavy and confused. One of the pharmacy technicians called 911 immediately and started the emergency response. he was able to regain his composure and move himself back the chair. The EMTs arrived and took his vitals, and discussed what happened. They eventually determined that he was ok and was free to go. The patient did not go to the hospital.
1st dose 3/31/21.  As of mid April, started having severe nose bleeds.  Went to ER on 4/27 as I was unable to stop bleeding that day.  My nose was cauterized.  Had my 2nd vaccine dose on 4/28.  The nose bleeds lasted about 6 weeks.  I had an appointment with an ENT on 5/26, and my nose was cauterized a 2nd time.  Also during this period, started developing painful headaches at right rear base of head, experiencing eye pain with swelling/drooping, and started having dental pain.  All on the right side of my head.  I started bleeding and bruising easy, and I felt like my veins were inflamed.  The nose bleeds stopped after about 6 weeks.  I've had a brain MRI, and now being referred to a neurologist to try to diagnose the various head pain.  Initial diagnosis was Trigeminal Neuralgia.  Most all these symptoms developed after the first vaccination.
Pt had a seizure Friday 2-22-08 Temp taken by EMS 100.3 rectal. Pt transported to ER and admitted. LP and CT scan done results not available at this time. Follow up by Dr on 2-25-08 with normal exam. Suggested neurology follow-up, EEG if appropriate.  3/19/08 Reviewed hospital medical records of 2/22-2/23/2008. FINAL DX: Complex febrile consulsions, viral syndrome, right serous otitis media. Records reveal patient experienced fever.  Found to be jerking, posturing, foaming at mouth, unresponsive & w/eyes deviated to the right during nap, lasting approx 8-10 min.  Exam in ER revealed lethargy, eyes glazed over, irritable when awake.  Pulse ox in ER was 90% & temp 100.3.  Older sibling w/URI.  Peds neuro consult done.  Improved w/no further seizure activity noted.  D/C to home on oral antibiotics & to f/u w/peds neuro for EEG.
Patients outside of 2-6 month window; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Sept-2022 Reporter's comment: The reporter submitted the report to Medical Information as an inquiry from a physician. The reporter asked that what was the protocol around the patients who had received a first dose of Shingrix and had been well past the 2-6 window. How long could a patients go between doses.  The possible duplicate was adverse event.  As reported that, medical information did not speak with the physician at any point.  The reporter consent for follow-up from safety was not provided.  Additional Supportive Information: Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2022130646, reported by the same reporter.; Sender's Comments:  US-GSK-US2022130646:Same reporter
Swelling on collarbone size of baseball, hot to touch, phone call to doctor's office after two days with swelling, told to take Advil, took for 3 days regularly, and it resolved.
At the time of the second vaccination in the series, I was  17 weeks pregnant with an estimated date of delivery of 6/21/21. I have had an uncomplicated pregnancy. About 12 hours after vaccination, I woke up in the middle of the night around 2:30am with chills and body aches and had a temperature of 100.7.  I also had a headache, soreness at the site of injection, and a mild stomach ache. I took Tylenol every 6 hours starting 1 hour prior to vaccination and throughout the next day but continued to have temperatures ranging from 100.4 to 101.3 associated with chills, body aches, headache, and severe fatigue.  I continued to have these symptoms until about 9pm that night. Once the fever broke, the majority of symptoms subsided, but I did continue to have a daily headache for about one week after the vaccine.
Patient stated had pain, aches, and a rash that started on truck and expanded to extremities.
W/in 45min started w/ h/a, became severe w/pain behind eyes; Shivering, nausea & vomiting w/in 3-4hrs; Seen by MD-thinks probably acquired flu (intestional virus) & gave her suppository for nausea, t99.2;
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The vial was initially stored in the refrigerator on 31 Aug 2021. The vial did not undergo any temperature excursions. Upon follow up, the reporter clarified that information provided by email was from new patients different than previous patients reported by her colleague on 31-Mar-2022 and that some of these new patients belongs to different clinics, but all of them pertained to the same community clinic. No treatment medication were provided. This case was linked to MOD-2022-534284 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Significant Follow up - Narrative updated.
Pleurisy type pain on week 2 after first dose, then back pain, and new event of nerve pain that began all over and now has localized to the trunk (back, chest and abdomen) Feels like a bad sunburn- nerve pain began on 9/10 after my second dose was given on 9/9 and has been worsening.
Redness and swelling of arm into axilla. Arm is painful and achy x 4 days with irritability x 4 days. Redness 23cm with swelling. According to mom, pt is better as of 3/29/2000. Pt had Tetramune at 2 months, 4 months, 6 months and 15 month of age.
1st dose 03Jun2022, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 03rd June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date :14 DEC 2022 Reporters comment: Reporter is the HCP who stated that it had been more than 6 months since a patient received his first dose of Shingrix. The patient had not yet received his second dose. Did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
no adverse effect; administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 27-JAN-2020 the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # S024364, expiration date 06-AUG-2021 (exact dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between -14 to -10 Celsius degrees (-12.6 Celsius degrees) for 9 hours an 53 minutes. There was previous temperature excursion between -14 to -10 Celsius degrees (-13.00 Celsius degrees) for 14 hours and 22 minutes. Data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001459: US-009507513-2002USA001358: US-009507513-2002USA001517: US-009507513-2002USA001486:
I had a quite severe response to the shingle vaccine taken last Tuesday (Aug 11).    I had sore shoulders (from the two vaccines) the first night, which I suppose is to be expected. The next day (Wednesday) I had a bit of a tired feeling--not too bad--which often occurs after a vaccine. Wednesday evening I began to have significant stomach discomfort which fairly quickly became quite painful, and which by bedtime caused me to want to vomit. I spent the night vomiting on the order of 6 times, but without significantly relieving the pain (at least not for more than a few minutes).  I tried Alkeselzer (sp?) at the start of this, but it was no help.   Thurday, I slept all day, partly from not sleeping much over night, and partly because I was still in "moaning mode" with stomach discomfort/pain.  By evening, I was feeling a bit better. I took another Alkeselzer, which this time seemed to help.   I managed to get some work done on Friday and through the weekend, but still felt like I was recovering from a significant illness (more or less like a flu or stomach virus).    I felt well enough to go on a brisk "hill walk" on Sunday, but not well enough to run.  Indeed I  still feel a bit of stomach tenderness today (Tuesday) a week after the shot.
Hives at day 3 (with large local reaction desquamation of both thumbs and continues large local Rxn (R) thigh at 2 wks).
ARM HURT; MILDLY FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced arm hurt, and mildly fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mildly fatigued and arm hurt was not reported. This report was non-serious.
Diagnosed - Guillain-Barre Syndrome.  9/14/07 Reviewed hospital medical records which reveal patient experienced progressive  weakness, leg & arm numbness, difficulty walking & difficulty climbing stairs x approx 1 week prior to admit.  Had received vax for travel to Africa.   Admitted 8/27-8/30/2007.  Tx w/IVIG x 5 doses & had notable improvement in strength but no change in numbness.  Had HTN while hospitlized which normalized by d/c.  Received final IVIG as outpatient. FINAL DX: Guillain-Barre syndrome. 9/18/07 Received EMG/NCS report which reveals abnormal study with delayed distal latencies, decreased conduction velocities, mild temporal dispersion, decreased amplitude but no signs of denervation c/w acute inflammatory demyelinating polyneuropathic process affecting the LEs more than the UEs. Follow up: The patient proceeded with his trip out of country although required re-hospitalization upon his return. Regaining strength and return to work as of 11/15/07.
Upon receiving the shot:  pain and burning under skin from shot area to distal extremity.  Followed by numbness and heaviness immediately after.  This lasted approximately 6-8 hours (shot administered 12:30, Thursday).  Friday, localized pain and (muscular) soreness at site with no reddness.  Noticed canker sores found in mouth.  "Pimple (chicken pox like) or "bug bike like" on my scalp and nose.  Saturday,  more of these found on my scalp, abdomnial area, and back.  Sunday, more found on my torso and proximal extremities.  Appearing more like blisters/lesions.  Monday, more found on my face, torso, buttock and proximal extremities.  Some itch and some burning sensation.  Sore throat.  Went to ER, lesions were found on the back of my throat.  Went to Dermatologist that day, biopsy done.  Given prednisone 30 mg once a day. Tuesday, more new "blisters" with pus filled.  Wednesday, saw Dermatologist- one was scaped for culture I believe.  Dermatologist instructed me to stop taking the prednisone.  Wednesday evening - phone call from dermatologist to confirm PLEVA(pityriasis lichenoides et varioliformis acuta/mucha haberman disease).  Treatment:  minocycline 100mg BID.
Fatigue causing 2-3 hour naps for 2 days; Very cold hands/ ice cold feet; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 28May2021 at 16:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 16:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021 at 09:00, the patient experienced fatigue causing 2-3 hour naps for 2 days following plus 1-2 hrs resting after awakening. 1 day after, patient had very cold hands. After napping, had ice cold feet despite wearing sweatpants and being covered with a blanket while asleep. Therapeutic measures were taken as a result of the adverse events and included measures like napping for 3 hours, resting  1-2 hours and earlier bedtime. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue causing 2-3 hour naps for 2 days and very cold hands/ ice cold feet were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Injection site cellulitis. Patient notice hard mass at injection site, presented with Wednesday morning, by afternoon of 8/1/12, fever of 101 degrees F, went to walk in care, diagnosed with cellulitis.
This spontaneous report received from a nurse referred to unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that doses of improperly stored vaccines ROTATEQ (lot M029251 expiry date: 14-MAR-2018, lot M005732 expiry date: 19-OCT-2017) were administered to unspecified patients. No adverse effects were reported. The vaccines was stored at 47.49 F for 1 hour. The vaccines had a previous excursion of 47.03 F for 1 hour. The call was because of a data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007382.
Felt okay after shot, but started to feel more tired than usual after a few hours; took a warm shower and before getting out started coughing from deep in chest. Since I have never smoked, this is unusual for me. Experiencing chest congestion and intermittent coughing since then (for the last hour).
Patient received HPV at 4:30 p.m., given juice, observed for 15 minutes, left clinic without incident. Later that night, at softball practice, blacked out, slurred speech, couldn't remember incident. Taken to ER and CT, xray, labs done per mom. Referred to neurologist for possible seizure.
had a breakthrough COVID-19 infection despite full vaccination.  Mild-to-moderate disease right now and she is doing well on room air, although she does have significant comorbidities that put her at risk for severe disease.  Will treat her with remdesivir
I was given the wrong vaccine by a nurse. I verified with the front desk beforehand that I was supposed to get my 2nd Moderna, not Pfizer. The nurse failed to check my record, or my vaccination card, and gave me the Pfizer vaccine instead.
pt was perfectly healthy @ 6 mo when recvd 3rd DTP 25MAR87; 6 days later suffered 1st sz; sz have cont virtually unchecked despite all med; brain damage has robbed pt of future pt will require care rest of life;
Patient states she is feeling warm after vaccine. Denies any other S/S or adverse reactions to previous vaccinations. Symptoms improved after a couple of minutes. Total Observation period was 30 minutes. Patient signed transport refusal.
less than 48 hours post vaccine, patient experienced chest pain and arm numbness. She contacted her PCP, who directed her to a nearby Urgent Care. Once at the Urgent Care, she was sent home and advised to follow up with her PCP.  She was then directed to a cardiologist but could not get in for several months. Her symptoms slowly improved over the course of 3-4 months but unknown cause. She is a healthy, 35-year old female with no chronic or known health conditions and on no medication except famotidine for stomach issues. All medical physicians refused to notify VAERS. By the time patient was able to have visit with cardiologist, symptoms had dissipated, cardiologist did stress test.  Patient was unaware of any clinical findings and believes it was a result of vaccination.
Potential ring around injection site noted 5 days after injection with erythematous patch 10cm x 5 cm and mild pruritus.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and CHILLS in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA and CHILLS. At the time of the report, PYREXIA and CHILLS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.
Patient presents with 2 days of rash around the site of injection on the right thigh. Patient had received chicken pox vaccine on 12/28/2018. Two days ago, mother noted erythema to the site along with clusters of vesicles. Patient does not seem to be bothered by the rash. Family has kept it covered. There are no other associated symptoms. Review of systems otherwise negative. Varicella vaccine marked as an allergy in patient's chart.
Information has been received from a consumer concerning his/her 77 year old mother. The patient did not have any medical history nor drug reactions/allergies. Her concurrent conditions and concomitant medications were not provided. On an unknown date in 2006, the patient was vaccinated with one dose of ZOSTAVAX (strength, dose number, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prevention of shingles. On 11-MAR-2017 (reported as over the weekend 11-MAR-2017-12-MAR-2017), the patient presented with the following symptoms: pain over the body and chest pain. On 12-MAR-2017, the patient went to an emergency room. She was then diagnosed with shingles (vaccination failure). Unspecified treatment was given for the adverse events and unspecified laboratory diagnostics tests were performed. The patient's outcome was reported as not recovered. The causality assessment between ZOSTAVAX and the adverse events was not provided. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
7pm tactile fever, 9:30pm arching head backwards, did not seem to engage eyes when spoken to, constant inconsolable cry.
Injection site is red, swollen, itching tingling sensation down arm when arm is raised above head. Site has been red and swollen since the afternoon of 03/17/2015 tingling sensation began in evening of 03/18/2015.
Mom states approximately 1 1/2 hours after immunization, pt got a "red rash on face", hands and face got swollen, and got "very hot". Temperature not taken. Went to ER, was examined and mom told symptoms were an allergic reaction to immunizations. Pt asymptomatic by next day (today). Meet mom to sign release of info to receive ER records.
Mother calls Health Department to inform us that the patient had a reaction to her 2nd Men B vaccination and had to be taken to the emergency room. Mother relates that she had a temp of 102, and that she felt like she was going to pass out. Mother states this occurred 30 minutes after leaving Health Department after vaccination.
Pt has a significant knot in her arm which is slightly warm to the touch and around 4  inches in diameter. She has slight itching at the time of vaccination, but swelling came up approximately 4 hours after injection.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild
Left thigh developed cellulitis from injections site. Parents report small bump, which progressed into infection. Unclear if introduced by patient scratching, inadequate cleaning, or actual injection. Treating with cephalexin currently, today is day one. On 10/27, developed significant right leg swelling/welt (localized reaction). Patient seen for this on 10/27, which has resolved as of today
pt recv vax 14JUL98 & 30sec later screaming badly-leg changing color-mottled look;1135AM pt observed gurgling to swallow, sl cyanotic mottled diaphoretic;1136AM pale yet legs cyanotic;1140AM pale, mottled;