chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had immunization appt at 8:45AM. Pt was accompanied by father. Father checked in with secretary, secretary gave Father standard immunizations forms and directed father and pt into room 1. This nurse was sitting at nurses station facing secretary. At no time did father state or produce any additional shot record besides what were already on file. This nurse reviewed pt immunization record to determine what vaccines were needed and gathered VIS sheets for shots needed based on the current vaccine record on file. This nurse took the VIS sheets into room to discuss with father. This nurse informed and discussed needed and optional vaccines (Hep A). Father was educated on Hep A and asked if would like to start the 2 dose series. Father was told them that pt would come back in 6 months for second and final dose then. Father agree to all vaccines and stated he had no questions or concerns. This nurse prepared vaccines and went back into the room. At this point, this nurse provided father with 2 copies of updated shot record. Father was by pt side at time of injections. After receiving vaccines father was informed he could make follow up appt for second Hep A before leaving if desired. When leaving father said good bye and was directed up to cashier's office.  About 10:15AM mom calls in angry stating pt was given duplicate vaccines. Mom states she sent an updated shot with father for today's appt. Mom stated father came home with updated shot record from us. It was then she realized at today's appt pt received vaccines that were on the shot record from the pediatrician's office that father was to bring in. Mom states father told her he gave the shot record to the secretary. This nurse spoke with mom and was given an account of how the visit transpired. This nurse explained that this nurse was sitting at nurses station facing secretary's desk. At no time did pt's father state or produce updated shot record to the secretary or this nurse. At no time before, during, or after vaccines did father state there an additional vaccine record that existed. Nor, voiced a concern that the vaccines this nurse was giving today did not sound right. Mom states she wanted to file a complaint. This nurse notified the supervising nurse. Mother's name name and number were taken and she was informed a supervisor would be calling her back on the steps needed to file a complaint. Mom stated she understood.
With in 36 hours of the injection I started having a ronging in my ears and dizziness. I also had trouble keeping my footing at times. I also seemed to be incoherant and my brain functions seem to be impared. The most serious problem is the constant ringing in my rars. I can not sleep or work normally. This has been a horible experience for me. I have discussed this with a few medical people with no solution. Please cantact me ASAP
Injection area swelling and hardened swelling from R shoulder to midway to R elbow and extended to back side of arm. Causing pain to back shoulder area and neck. She spoke with her doctor on the phone and was advised to ice area and take BENADRYL. Follow up phone call to client on 10-2-08 and swelling/hardness still present but extent has decreased. No radiating pain now.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 05-JUN-2015, the patient was vaccinated with an expired dose (3 months past expiry date) of ZOSTAVAX 0.65 ml, subcutaneously in the left deltoid (lot # J016257, expiration date: 20-FEB-2015) (strength was not reported). No concomitant medications were reported. No adverse experience was reported. The outcome of the event was unknown. The patient did not seek any medical attention. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was reported. Additional information has been requested.
pain at the site of the injection; Body aches; Fever; severe nausea; stomach spasm in increasing intensity; severe pain in the liver; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL RIGIDITY (stomach spasm in increasing intensity), HEPATIC PAIN (severe pain in the liver), VACCINATION SITE PAIN (pain at the site of the injection), MYALGIA (Body aches) and NAUSEA (severe nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ABDOMINAL RIGIDITY (stomach spasm in increasing intensity) and HEPATIC PAIN (severe pain in the liver). 30-Apr-2021, the patient experienced NAUSEA (severe nausea). On 01-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the site of the injection), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Hepatic pain and Abdominal spasm, at an unspecified dose and frequency. On 01-May-2021, HEPATIC PAIN (severe pain in the liver) had resolved. At the time of the report, ABDOMINAL RIGIDITY (stomach spasm in increasing intensity), VACCINATION SITE PAIN (pain at the site of the injection), MYALGIA (Body aches), NAUSEA (severe nausea) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  The action taken with mRNA-1273 in response to the event was not applicable.
Patient was given an expired vaccine. Vaccine that was administered was for the 2020-2021 Flu Season. No adverse reaction occured. Patient has been informed that she will need to be re-vaccinated.
Pt devel vesicles of clear fluid over the trunk area, described as "shingles" approx 1 month p/receiving Influenza vax;
Sore arm on the first night, fever of 100.5, body aches and headache on the 2nd night.
patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 31-OCT-2023, the patient received Kinrix. On 31-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2023 The HCP (health care professional) reported that patient under the age of 4 that was due for both Dtap and IPV was administered the Kinrix, which led to inappropriate age at vaccine administration. No reactions reported. The reporter consented to follow up.
Low-mid grade fever, shivers, sore arm, achy, headache The fever lasted through the night starting around 9:30 pm. The shivers started at the same time but stopped around 2 am before I started sweating.  I took two acetaminophen around 2. Around 3:30 I fell asleep and woke up around 6:30 with a low grade fever.
After receiving the vaccine, patient started having dizzy and nauseous. He also reported tingling arm on the vaccinated one, weak leg, and hearing muffled. He was sitting down for at least 30minutes and felt better afterward. He was fully recovered.
04/21/2021 3:00 pm-vaccine left arm  sore arm at injection site 04/22/2021 7:30 pm-fever 101 (all temps taken in the ear), hot/cold with chills, sore arm, no other issues 04/23/2021 5:00 am-tinnitus for about one and a half hours; 7:30 am-slight temperature 99.4, still sore arm; 11:30 am-lightheadedness, slightly dizzy, no temp. 98.7; 12:30 pm-hot, ashen gray in face, dizzy, sitting outside to cool off;  1:30 pm-lying on cool floor, dizzy, nauseous and unable to move head; 2:30 pm-lying in floor, dizzy, dry heaves; 3:00 pm-dizzy, vomiting; 3:45 pm - dizzy, vomited; 7:13 pm-went to bathroom, dizzy; 8:00 pm-vomited 04/24/2021 all day-lightheaded, achiness in jawline from base of ear to throat (eustachian tube area)
(L) arm swelled 2nd day after vaccine. Seen by Dr 11/29/18 red, swollen and slightly warm to touch measuring 17 x 10 cm firm raised area at injection site 3.5 x 3.5 cm.
lightheaded, hot flashes, gen urticaria; taken to ER 19FEB p/treatment, w/cont urticaria, syncope;claritin, DPH, pred given in ER
feeling tired; This is a spontaneous report received from a contactable consumer (the patient's grandfather). A 20-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday (unspecified date), and he was feeling tired. Tomorrow he needed to run 2 miles, and the patient's grandfather wanted to know should he run. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pain of short duration in lower back shoulder muscle; shingles pain; stabbing pain; Lower back pain; left arm with pain; pain in shoulder / pain of short duration in lower back shoulder muscle; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a month after receiving Shingrix, the patient experienced shoulder pain. On 17th August 2020, the patient experienced pain in arm, muscle pain, shingles, pain and low back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix my left arm with pain in the shoulder for a few days. The patient had short stabbing pain of short duration in the lower back shoulder muscle.  The reporter believes this was shingles pain.
Lght headed, point of injection began to hurt, the next morning entire bicep area was red and hot to the touch, 2nd day after: fatigued and bicep area of arm swollen, 3rd day out-signs of recovery. 9 days out today, area of injection is bruised, no swelling or redness.
Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who on 18-SEP-2006 was vaccinated with a first 2 ml oral dose of Rotateq vaccine (human-bovine) (lot#"B08682H"). Concomitant vaccinations administered on the same day included a first dose of Pediarix, a first dose of Hib conj vaccine and a first dose of Prevnar. On 17-NOV-2006 the patient was vaccinated with a second 2 ml oral dose of Rotateq (human-bovine) (lot#654352/0410F). Concomitant vaccinations administered on that included a second dose of Pediarix, a second dose of Hib conj vaccine and a second dose of Prevnar. The patient presented to the office on 24-JAN-2007 with bloody stools, decreased appetite, and mucus in her stools. A stool analysis was performed, which was positive for rotavirus. The reporter did not know the patient's status at the time of the report. The patient was not hospitalized. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's bloody stool was considered to be an other important medical event. Additional information has been requested.
Patient was given vaccine indicated for people over the age of 18.   We contacted patient's mother to notify of error and mother stated daughter had bruised, sore arm also.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unspecified date in January 2017 (reporter as  "from 01-JAN-04-JAN-2017"), the patients were vaccinated with a dose of improperly stored GARDASIL 9 intramuscularly (batch/lot # reported: L040054 with expiration date: 24-DEC-2017; however, dosage number was not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of maximum 1 C (Centigrade) for a time frame of 18 hours. Data logger was involved and there was no previous temperature excursion reported. Furthermore, there was no product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-SEP-2014 the patient was vaccinated with VARIVAX (Merck) 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Onset of severe ipsilateral arm pain 2 days after immunization.  Pain improving. Exam consistent with bicep tendonitis.  Treating with rest, ice, acetaminophen.
pt recv vax; 5-10 mins later, both legs had huge induration & erythema 20x10cm area; dph given; epi given
I have been feeling not myself since my last vaccination on 5/13/22. I have been tired, nauseous and dizzy most days since approx. one week, maybe two  after vaccination #4.
Left arm (site) swelling, redness with distal paresthesia. Antihistamine, ice, monitoring. Continue naproxen.
This spontaneous report was received from a physician and refers to a currently 62 year old male patient. The patient did not have any pertinent medical history or drugs reactions/allergies and was not taking any concomitant medications. On 27-SEP-2016, the patient was vaccinated with ZOSTAVAX injection, 19400 plaque-forming units, via subcutaneous route, lot # L046900 with expiration date of 27-FEB-2017 (dose was not reported) as Herpes Zoster prevention. The vaccines were reconstituted with sterile diluent. On an unknown date (reported as a few months after the vaccine), the patient complained of itchy nodules on lower legs and lower back. The patient sought medical attention and was referred to a dermatologist on an unspecified date. The patient received treatment for the adverse events. No laboratory diagnostics studies were performed. The reporting physician saw the patient on 27-MAY-2017, and the condition persisted. The physician declined Varicella Zoster Virus Identification Program but requested a lot check of ZOSTAVAX. There was no product quality complaint involved. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and suspect therapies was not reported. Additional information has been requested.
24 hours after vaccination experienced fatigue and headache (8/15/21-8/16/21). Then 2 weeks following vaccination left shoulder/arm pain began (8/28/21). Pain became worse and contacted physician's office on 8/31/21. Said to monitor. Self treated with tylenol, Aleve, Advil, heat and ice. The evening of 9/2/21, the pain was excruciating if I moved. At one point in the night while lying on my back, I could not lift my arm.  Called physican's office first thing in the morning and was seen on 9/3/21, Inflammation in the brachial plexus nerves highly likely from vaccination. Physical Therapy of shoulder may be necessary.
sleepy p/vax hard to wake 5:30 to nurse;seemed limp when sleeping, holding tongue out;1010PM was blue/grey in color;rapid blinking of eyes, took 45 min for color return
Pain under arm after injection; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (Hypo thyroid). The patient had no known allergies. Concomitant medications were not reported. 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 10Apr2021 at 16:00, the patient experienced pain under arm after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain under arm after injection was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of numbness on one side of body in a 50-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The reporting consumer is the subject's boyfriend.  The subject was described as premenopausal.  Concurrent medications included Sertraline hydrochloride (Zoloft).  On 05 April 2007 the subject received the first dose of Twinrix (1 ml, unknown, left arm).  On 6 April 2007, 1 day after vaccination with Twinrix, the subject experienced numbness on the right side of her body, swelling in the lower right extremities, loss of balance, and walking difficulty.  The subject's numbness started in the lower extremities, but moved to the neck as well.  The numbness reportedly occurred on the right side only.  Additionally, she developed headache and blurred vision on an unspecified date.  She reported to a physician's office for unspecified medical attention.  Blood and urine tests and a computed axial tomography scan were reportedly "all negative".  The reporting consumer noted that the swelling of the lower right extremity was "particularly bad" in the subject's toes.  At the time of reporting the events were worse.  The vaccination course with Twinrix was discontinued.
Pain between shoulders in shoulder blades, frequent urination, dizziness/unsteadiness beginning evening 1/26/21 Followed on 1/27/2021 by increased dizziness/unsteadiness, more frequent urination and very frequent diahrea - lasting through the day/evening. On 1/28/2021  - pain between shoulders is slightly subsiding, unsteadiness remains along with frequent urination and  diahrea
Patient stated that immediately started to swell up and turn red around injection site. Patient stated that she received a migraine the next day. She experience Vertigo.  Within 14 days patient has been to the ER 3 times. She experienced delusional spell when she didn't know who any of her family members was. She has been experiencing emotional episodes. She had serve fatigue.
Patient is a 65-year-old male with a medical history that is significant for OSA, atrial flutter, hypertension, HFrEF, along with other medical conditions who presented to the ED on 9/18 due to weakness. Patient been diagnosed with Covid on 9/13/2021. He reported worsening generalized weakness and poor p.o. intake.  Also stated that he had intermittent episodes of diarrhea.  Upon presentation to the ED, his vital signs were stable/was satting well on room air.  Labs were remarkable for hyponatremia, hyperkalemia, and AKI on CKD with a creatinine of 3.52. Chest x-ray was obtained which showed pulmonary venous congestion and increased patchy pulmonary opacities consistent with mild viral pneumonia. BNP was negative. Patient was later noted to have lower blood pressures in the ED at 80s over 50s.  He was asymptomatic during this time.  He received 2 L of IV fluids with improvement in his blood pressure.  He was admitted to general medicine for further evaluation.  Patient was started on IV fluids for hydration, he was not started on dexamethasone as he did not have any oxygen needs. Patient did have a slight temperature elevation to 100.2. Pro-Cal negative, chest x-ray with no signs of infection thus no antibiotics were started.  Patient's temperature has remained within normal limits for the past 24 hours. Creatinine improved to 2.36; fluids were discontinued. He tolerated a general diet well with no episodes of nausea or emesis. Creatinine further improved to 1.73. PT OT evaluated patient and recommendation was discharge home given his current functional status.  Given that patient had improvement in his p.o. intake and creatinine and he remained hemodynamically stable, he was discharged home with close outpatient follow-up and a repeat BMP in 1 week
No additional AE; HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X004814, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #W008704, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported.
Patient complained of feeling faint-like shortly after vaccination, while in observation unit. NP assessed patient. Patient was slightly tachycardic HR 102. O2sat 99%. She was provided water. Once patient was able to relax, heart rate returned to normal and left site without incident. Her father accompanied her (minor).
arm is hurting a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is hurting a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is hurting a little). At the time of the report, VACCINATION SITE PAIN (arm is hurting a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.