chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Both nipples on my chest, they hurt. I would say they are sore.; Area on the right leg itches; Does not feel well; This is a spontaneous report from a contactable consumer (patient's wife) and a non-contactable consumer (patient). A 96-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: 5L3248, expiry date: not reported), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunization. Medical history included thyroid (disorder) and triple bypass a number of years ago. Concomitant medications included apixaban (ELIQUIS), dutasteride (DUTASTERIDE), famotidine (PEPCID), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), furosemide (FUROSEMIDE), nebivolol hydrochloride (BYSTOLIC), simvastatin (CRESTOR), and he also takes cholesterol and thyroid medicine. The patient previously received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL0142, expiry date: not reported), on 12Jan2021 for COVID-19 immunization (at the age of 96-year-old). The patient reported that both of his nipples hurt and his right leg itches on 07Feb2021. He further clarified, "My wife just told you that the symptoms that I am experiencing are, both nipples that would be the both nipples on my chest, they hurt. I would say that they are sore, and I have a area on the right leg itches and that just started. All these symptoms just started. Otherwise, I am okay." The patient's wife also reported that the patient does not feel well at the time of the report. The patient did not receive any treatment for the reported adverse events. Outcome of the events was unknown.
Pt contacted our officeat approx 12:30PM on 5/10/21 stating that she thought she was having a reaction to the second vaccine.  We received a call from the Deputy Sheriff at approx 4:50 PM to inform us that this pt has passed away apox. 4 hours prior. COD: pending.  We have not other information at this stime
Pregnancy; Initial Report Received on 18-Nov-2022 (Safety received 14-Mar-2023)   A patient reported to the Registry that her sister (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site was not provided.   The reporter was provided with the Dynavax medical information number and declined to provide their contact information. The reporter was requested to provide the Registry number to her sister so she may contact the registry for potential enrollment.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Moderna COVID-19 Vaccine EUA  Found patient with scribbled out age making her old enough for vaccine, patient documented that she was not younger than 18.  Called and verified that patient is, in fact, 14 - birthdate in 2006.   Patient's 2nd dose - unable to find 1st dose under patient's name.  Found patient under name of, birthdate 5/30/2003 - prior VAERS entry for that patient.   No adverse events reported
The day after getting the vaccine 12/21, I noticed my blood pressure was high so I went to urgent care. My blood pressure was 190/something. Urgent care gave me Lisinopril for one month. After that it went back to normal. It has come back up again recently but that could be due to an infection in my body.
pt recv vax & upper part of arm (near shoulder) & next morning area very hot & hard as day progressed entire upper arm became hard, hot & red; 2nd day went to ER as red area was reaching bend in arm; couldn't raise arm & arm itched;
Arm was sore; Had a site reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Comirnaty (Dose 1, single), for COVID-19 immunization; Comirnaty (Dose 2, single. Patient contracted covid-19 after initial Comirnaty vaccine series.), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm was sore"; VACCINATION SITE REACTION (non-serious), outcome "recovered", described as "Had a site reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 6 year old twin female who on 04/02/1997 was vaccinated with the first dose of varicella vaccine. Concomitant vaccinations on 04/02/1997 included the fourth dose of diphtheria toxoid pertussis vaccine tetanus toxoid IM and the fourth dose of oral poliovirus vaccine. There was no noted adverse events following prior vaccinations. On 11/24/2001, the pt experienced a fever times one day, felt lethargic and had a cough. On 11/29/2001, the pt presented to her doctor's office with approximately 8-12 lesions that were varicella like in appearance. At the time of this report, the outcome of the events were unknown. No further info is available.
hearing loss; Information has been received from a lawyer and an a patient (pt) of unknown age and ender regarding a case in litigation. Information about the pt's concurrent conditions, medical history and concomitant medication was not reported. In or around October 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine (Date not reported), the pt suffered hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt sustained serious, severe, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; the pt symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX), the pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the condition. The outcome of the event was not recovered. The causality assessment was considered as related. The event was considered as disabling.  Upon internal review, the pt's hearing loss was determined to be a medically significant event.
Vaccine was administered to patient in his room at 12:50pm.  After the patient finished his lunch in his room he was wheeled out to the nursing station for observation.  at 1:30pm the nurse wheeled patient into our working/set up area and stated that patient is having a vaccine reaction.  I observed that his lips were noticeably swollen.  I asked patient to stick out his tongue, it also was noticeably swollen.  Only the tip of his tongue extended about 1/2 inch past his lips.  I administered 0.3mg of Epinephrine via and epi-pen into his right thigh and instructed the nursing staff to call 911.  Patient improved markedly over the next 10 minutes when Fire Department EMT's arrived.  Nursing staff monitored his  blood pressure, heart rate and pulse  and oxygen sat.  heart rate was elevated somewhat likely due to epi , BP was 121/73, pulse steady and ox sat good.  Fire Department transported patient to a nearby ER for further evaluation and treatment if necessary.
Patient said he experienced a "bitter taste" on tongue and constipation the day after his first dose. These lasted three to four days. However, patient does report chronic constipation.
Patient complained that the site of injections remain painful months after the event.  Pain is on and off , usually during cold weather.   No other symptoms reported.
No adverse event, administration error. Patient requested Moderna booster after her Pfizer series but is not old enough to get Moderna. Administering pharmacist did not catch she was too young until after the shot was administered.
Information was received from a registered nurse concerning a male patient of unknown age. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on 06-JUL-2017 during vaccination of RECOMBIVAX HB into the patient, 5 mcg/0.5 ml per prefilled syringe (lot # M001578, expiration date 21-NOV-2018), the "plunger rod fell out" of the prefilled syringe. A second separate vaccination of RECOMBIVAX HB was used successfully (lot number not provided). No adverse effects reported. Product quality complaint was filed. Additional information has been requested.
I was unable to work, around day 3 I got vertigo and I had this for about four weeks.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills, rhinitis Narrative: Employee received 1st dose of Pfizer COVID vaccine on March 26, 2021 and received the 2nd dose on April 6, 2021. The second dose was administered fewer than 17 days. The employee went home from work on 4/6 since she could no longer work due to the diarrhea and headache. She return to work on 4/7 and had continue headache, diarrhea decreased, +myalgias. She was advised to use tylenol and fluids as needed, seek emergency care if symptoms worsen or persist.
pt recvd 2nd Recombivax on 17MAR92 & exp n,v, & d 20MAR92 & escalated on 23MAR92 began projectile vomitting & explosive diarrhea, severe h/a; pt was hospitalized;
Left deltoid red 6x7 cm area. Shot given 7-1-15. Seen 7-6-15.
Failed to dilute Pfizer pediatric vaccine. No known reaction at this time. Called patient numerous times. Patient has not returned our calls.
Chest Wall upper back painful with movement, 6x4.5cm induration at site of vaccine administration. 6x10cm overlying erythema, pain right deltoid. No fluctuance.
This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 44-year-old female patient who received FLAURIX QUADRIVALENT (batch number JC9E9, expiry date 30th June 2018). In October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after FLUARIX QUADRIVALENT, the patient experienced fatigue, welts and leg pain. On an unknown date, the outcome of the fatigue, welts and leg pain were unknown. It was unknown if the reporter considered the fatigue, welts and leg pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient who was also an employee at the facility received a dose of FLUARIX TETRA on last Thursday and developed fatigue, stomach welts and aching legs. The patient visited to physician the following day, however the physician did not believe symptoms were related by the vaccine. No further information was reported regarding this event. This case has been linked with case US2017159873, reported by the same reporter for same events.
itchy arm and leg and turned red. Then bumps with blister centers. Upper legs and arms and abdomen. Then shingles occurred at the site of the biopsy. The bumps occurred for a few weeks and are now all gone. All that remains is shingles at site of biopsy.
red inflamed vasculitic rash confluent over lt upper, anterior thigh & vasculitic hives over both legs, gluteus, arms, face & ears;trunk & diaper area relatively spared
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M028546 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of improperly stored M-M-R II lot number K024038, expiry date 26-NOV-2016 (dose and route were not reported). There was no concomitant medication provided. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning at least three people (ages and gender not reported) who died after being vaccinated (dates not specified) with MMR II (lot numbers not reported). No further information is available. there was no product quality complaint involved.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No medical history was reported. On 16-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry not reported) 0.65 ml, subcutaneously. No concomitant medications were reported. On 27-MAY-2013, the patient developed a chickenpox bump under an unspecified eye and went to see the pharmacist on 31-MAY-2013 due to his eye beginning to itch. The pharmacist instructed the patient to take BENADRYL. Patient sought medical attention-saw the pharmacist. No laboratory tests were performed. The outcome of eye beginning to itch and chickenpox bump was unknown. Additional information has been requested.
07/15/2021 Headaches for two months 09/27/2021, I had issue with getting a referral from my new primary to see a neurologist and it two months from phone referral, Medical Center Neurologist, Doctor. 8 vials of Blood work 12/22/2022 then in that evening I also received my Booster after given blood. Took a relative to the ER and 12/27/202l I was feeling unwell and think had a exposure to COVID, sinus, phlegm in chest and cough and extreme fatigue. 10/2021 Memory lost, Hearing issues - tinking in ear and an ocean noise, bend over seems like the brain is trying to come out of brain head when I roll over in bed. Dose 3: Pfizer-BioNTech 12/28/2021, started having problems after august 2021 and booster in 12/28/2021 neurologist of what is Neurologist saw a neurologist 8 vials of blood and 4 days later and COVID. 03/31/2022 Pulmonary doctor for sleep study for reim study.
Developed Shingles- Multiple blister eruptions on left torso (mid back, under breast and side).
Client developed soreness in vaccinated arm and body aches the day following vaccination. The soreness to the arm did not subside, getting gradually worse. Reddness  around injection site began to spread like an infection- down arm, up neck. Client went to HCP on Jan. 12th and was put on antibiotics(keflex) for cellulitis.
Patient had adverse reaction to Moderna COVID-19 vaccine. Pt. was advised by PCP to take J&J. Given today = similar reaction, needed epi transported to local ER via EMS.
Initial symptom were fever 99.6 lasted two days, Cough is on 3 days that did not start with the other symptoms. Body aches that was 2 days. Congestion is 5 days. Sneezing that's 2 days and most recent that didn't start on the onset. Pressure and difficulty hearing that's been 3 days from today. They have me on an antiviral molnupiravir 200mg.
Little bit of swelling on arms; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received the first dose meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in arm on 06Jan2020 at a single dose to prevent Meningitis B,  received in the doctor's office. The patient has no medical history and there were no concomitant medications. On 06Jan2020, patient experienced a little bit of swelling on her arms and it went on for about 2-3 days. No treatment was received for the event. The event recovered in Jan2020.  Information on the batch number has been requested.
Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Non-stop menstruation for 4 months. I had to take blood clotting meds and need a hysterectomy.
Extra dose provided prior to the 21 days, first dose of Pfizer SARS -COV- 2  was given on 4/2/2021. No adverse reactions was reported at this time.
He got his vaccine, the first few days it was sore at the location, sorer than the last shot and put ice on it.  After that the pain radiated up to his shoulder and was very noticeable, and literally at the shoulder where the arm meets the shoulder.  It then moved into the whole shoulder area, and at one time if was more on top of the shoulder, and now imbedded into the shoulder joint.   He cannot reach for his phone with his left hand as the pain is so severe that he cannot pick it up.  It is painful every single day and has now settled into the entire shoulder joint.  He went to his Sports medicine Doctor, Dr. for his knee and he injected the shoulder due to his pain.  He did two injections into the shoulder.  Today he is in no better condition, and is very scared of what may be going on and wonders if this may be a permanent situation.    He did have 2 x-rays of his shoulder, and is scheduled to go back in 3 weeks to see if this is helping.   It is painful all the time, sometimes it is worse than others, but a constant pain.    He did not have any reactions to any of the other vaccines other than the normal usual reactions.
NDC - 58160-0823-11 Sometime in late Aug-Sept. started having rash on left side of back. grew and started spreading to front, Itchiy little bumps. Bumps started growing and spread from knee up to neck. including scalp. 2 d Oct 9. Tele confer 10/16. gave cream and pill. Derm last Friday. Told me reaction to shingles.Prescibed Allegrea for a while. Cream/oil given as well. Will see derm in 3 wks. I asked the pharmacist when getting 2 d about the rash and ghe said he never heard of it. If I get stressed or hot I get more itchy.
pt vaxed 9SEP92 following day exp inject site react of erythema, induration & tenderness- 1 1/2" in diameter; treated w/ATB for poss cellulitis; no cultures performed;
Pt recvd Engerix-B series (3 doses deltoid region) for prevention of Hep B infect; Pt reported as being a "nonresponder"; plan to administer additional doses;
THE FIRST DOSE WAS GIVEN ON 08/19/21 AND THE SECOND DOSE WAS GIVEN EARLIER THAN RECOMMENDED RANGE BY MISCALCULATION. NO OTHER ADVERSE REACTION SO FAR.
Employee received FLU vaccine on 09/29/2021, on 10/2/2021 she woke up with numbness on right side of face and tongue and right side of body.  She also had a severe headache.
Error between State system and clinic system mirroring information.  State system only listed one PCV13 vaccine.  When reconciled, clinic system showed two additional pneumonia vaccines (after administration).  Patient should not have received pneumonia dose today.  Patient was up to date previously.  Patient was called and she is doing well.  She states she feels fine.  Patient was told if she started to feel unwell in any capacity to please return to clinic, go to the nearest hospital, or dial EMS.  VAERS report will be submitted.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-FEB-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) 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 strain of herpes zoster, also known as shingles and other complications. On or about 02-DEC-2014, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Patient became short of breath and felt flushed within 5 minutes after dose administration. Pulse ox recorded at 92 and pulse of 99. Blood pressure 160/110. EMS was called and vitals had stabilized to pulse ox of 98-99 and systolic BP of 140s. Patient remained short of breath, has a cardiac history but as baseline status was unknown and husband was a poor historian we sent her to the ER for workup. Did not endorse symptoms of anaphylaxis. Unknown h/o COPD or other chronic lung conditions.
Left upper additional pain and left shoulder pain. Palpable mass under left anterior ribs. Tiredness.