chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recieved Inactivated Influenza Vaccine at ~9:30 am, ~1 hour later client reports developed a swelling in her throat and quesy stomach, as she was driving. She stop and took a Benadryl and proceeded. She return to clinic site at around ~2:45-3:00pm to bring her teenage son for his vaccine. She came in to nurse's station and said I think I might be having a reaction to flu vaccine. I asked what were her symptoms she stated mainly queaziness and generalize "dont feel well". At this time she was not in any acute distress, no difficulty breathing, no rashes, no flushing, no swelling in face or throat, no difficulty conversing, no swelling or pain at injection site. I asked her if she had eaten she said yes; soup prior to vaccine and had also had food for lunch. She had good color and she denied any other medical condition or taking of any regular medication. She denied previous reactions to vaccines in the past. No known allergies. I asked her to sit awhile and put her head down see if she felt better since her coloring was good no evidence of distress. She sat in lobby as I continued to give vaccinations. She came in station shortly after and asked to use restroom, she went in and I could hear her vomiting. She came into my area again, I called her Mom (who had been with her all day). Client at this time was pale and I gave her an ice pack and had her put her head at her knee level. Coloring returned quickly and I told them they should go to Doctor or ER and tell them she had recieved a flu shot. They felt like sitting awhile would be best. They moved to an office and sat for awhile. The clerk sat with them and they left to go home to rest, although they were advised to go get medical attention. We called at about 4:00pm to check on her spoke to mother she said she was doing much better and she did not believe her daughter was having a reaction to flu shot. She said her daughter had had a very stressful morning and day, not related to flu vaccine. 10/25/2011 ~7:30pm local immunization aide called mom of client and she said client was doing well and they felt she might be coming down with flu, although no fever present just upset stomach. Aide did again advised them to seek medical attention.
lt arm became painful next morning,got progressively worse until 2NOV94 PM when pain became excruciating & inability to lift arm started; seen by MD 3NOV94; MD felt tendon was infiltrated w/vax;began to move arm 6nov94;
Patient complained of sore arm for 1 week after receiving the shot. Site of injection was sore and tender.
This spontaneous report was received from a nurse Practitioner refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2014, the patient was vaccinated with first in the series of GARDASIL (dose, frequency, and route of administration not provided). On 15-AUG-2015, the second dose in the series was GARDASIL 9 administered. On 20-OCT-2015 (today), the third in the series dose was GARDASIL 9 (lot # L004014, expiry date 04-MAR-2017) administered. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Patient had received a J&J vaccine on 3/7/2021. Patient had self scheduled in the vaccine clinic on 7/1/2021.. Patient informed staff this was his first vaccine. Moderna vaccine given to patient. When entering information on system, we noted the Janssen vaccine under patient name with same birth date and same address.
his arm was sore; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was sore. The outcome of event was unknown. He had his Pfizer vaccine and his arm was sore but he did not get a lump or have redness.  Information about lot/batch number has been requested.
THE SYRINGE WAS DEFECTIVE, THE VACCINE DID NOT GO INTO THE PATIENT'S ARM, IT LEAKED BACK OUT OF THE SYRINGE WHERE THE HUB MEETS THE SYRINGE
Immediately after vaccine administered injection site became visibly swollen. Patient was in no distress and stated that it didn't hurt or itch, patient given two diphenhydramine 25 mg tablets by mouth. Pharmacist had patient to wait in store, viewed the site before patient left and it appeared to have decreased in size. Pharmacist followed up with patient at home hours later- patient was fine.
Dyspnea Onset date: 9/27/2023 Subject enrolled in the Janssen study received study medication (Janssen ad26.CoV2. vaccine) 0n 10/17/2022 HOSPITAL COURSE: 9/27/2023-9/28/2023 study patient went to the hospital instead of his dialysis appointment due to shortness of breath at rest on 9/27/2023. In the ED, he had elevated, but flat troponins (141, 134, 127). CT scan showed loculated pleural effusion in the left long, worse than previous in June( has ongoing AE of Plural. Nephrology was consulted, and dialysis was performed on 9/27/23. He was given twice his normal dose of Lasix and thoracentesis was performed on 9/28/2023. He was discharged on 9/28/2023 with improvement of symptoms. Study Principal Investigator has assessed the causality as not study related.
Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.
STORAGE IN REFRIGERATOR (2°C-8°C) UP TO 30 DAYS. ( VACCINE USED AFTER 10/16/2021 )
received two vials of / diluent without reconstitution; received two vials of / diluent without reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAVA418A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that a patient received two vials of Menveo diluent without reconstitution with the MenA lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional only agreed to follow up via email.
Patient visited  clinic on 01SEP2021 experiencing chest discomfort, shortness of breath and elevated blood pressure; 134/86.  No previous history of high blood pressure; previous annual examinations recorded blood pressure well below 120/80; average of last three readings was 112/68.  Patient began recording blood pressure readings with home monitor following initial visit to clinic.   Patient returned to clinic on 09SEP2021 with worsening symptoms of chest pain, shortness of breath and elevated blood pressure; 145/94.  Patient additionally reported difficulties sleeping and loss of control of bodily functions (urination) while sleeping.   clinic recommended emergency room admission at  hospital,  , for testing.  Differential diagnosis from emergency room: Myocardial infarction, unstable angina.  Sinus Bradycardia observed but patient has history of low pulse and high athletic activity.  Upon completion of tests and lab work, patient was released from emergency room same day with instructions to follow up with primary care doctor. Due to COVID protocols at  clinic, a follow-up appointment was not available until 04OCT2021 and conducted via telephone.  Primary care doctor was unable to access emergency room records and therefore unable to provide analysis or treatment plan.  Emergency room records must be hand carried and appointment rescheduled. Patient continues to self-monitor blood pressure; highest reading recorded at 139/100.  Chest pain and shortness of breath began improving on 17SEP2021.  Blood pressure readings have improved but still fluctuate; average systolic pressure is high 120's, average diastolic pressure is in mid-80's.  Patient is consistently pre-hypertension and sometimes Stage 1 hypertension.  Patient has still not returned to previous blood pressure levels prior to Covid-19 vaccination.
headache, red raised area at injection site, 100.6 fever, fatigue, muscle aches
Diarrhea; nauseated; fever over 101; body aches; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot Number: EL0140, Expire Date: 31Mar2021, via intramuscular route of administration at the right deltoid, from 18Dec2020 14:26 at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 18Dec2020 and then two days later, within 48 hours (20Dec2020), she had fever over 101 (unit not reported), body aches, and GI symptoms. For the GI symptoms, she further stated being nauseated and having diarrhea. She stated she was still nauseated yesterday. The outcome of fever, body aches and diarrhea was recovered on 21Dec2020 whereas she recovered from being nauseated on 22Dec2020. The events did not required visit to ER or physician.  Follow-up attempts are completed. The information on the batch/lot number was obtained.
Menstrual period change; Sore arm; This is a spontaneous report from a non-contactable consumer (the patient).   A 43-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8727 and expiry date: not reported), via an unspecified route of administration, administered in arm left, on 20Mar2021 at 14:15 as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at time of vaccination. Concomitant medications included bupropion for unknown indication, start and stop date were not reported, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for unknown indication, start and stop date were not reported and multivitamin [vitamins nos] for unknown indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On An unspecified date in 2021, The patient experienced menstrual period change and sore arm. Menstrual period change arrived day after vaccines (both with 1st and 2nd doses). The adverse event did not result in emergency room or physician office. The patient did not receive any other treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Headaches and deep fatigue for hours. Starting at 3 PM, about 24 hours after my first shot.
Vaccine is approved for 18 years and older. Patient was 17 at the time of vaccination.
painful on administration and then within a few hours developed large red, warm, painful "welt".  On exam we see: 9CM X 3 CM ERYTHEMATOUS, WARM, SLIGHTLY RAISED DEMARCATED AREA ON THE POSTERIOR UPPER ARM No fevers, nausea, vomiting, diarrhea, increased achiness. No other areas of redness, swelling, hives.
mild headache, chills, insomnia and scratchy throat now.  she developed chills, dizziness, headache, and sinus symptoms 24 hrs after second vaccine.
Information has been received from a registered nurse concerning her 12 month year old nephew who was vaccinated with a dose of MMR II. The day after received the vaccine he spiked a fever of 105F and was hospitalized for several days. Approximately 1 week after recovered from the fever he completely regressed. Before MMR II he was reported to be a happy healthy toddler, walking and talking like a normal 1 year old. he has been diagnosed with autism and his interactions are described now at age 10 years that of a 6 month old. The patient had not recovered. The patient sought medical attention through a hospital visit. Fever was considered to be life-threatening. Autism was considered to be disabling. Additional information has been requested.
pt recv vax 13OCT93 230PM & 14OCT93 3AM pt began to exp sz activity;pt was taken by amb to hosp;pt cont to exp sz & take depokote
Case previously recorded as MA2009-5221. Initial case report received from a physician via MedCom on 19 OCT 2009. A 23 month-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 102124P1) i.m. on 13 OCT 2009. No adverse events were reported. MedCom reference no.: NA09-008308.
Shooting pain/tingling in right arm where shot was given. Trouble breathing. Went to ER and given breathing treatment.
The patient came in on 10/23 and reported that following her vaccination on 10/02/19, she began to have swelling on her arm from shoulder to elbow with a clear white line separating the swollen skin from non-swollen, which she reports being significant and painful. Patient reports that she didn't have any problem breathing. The swelling resolved on its own prior to the time the patient reported the incident to pharmacy staff on 10/23/19.
rash enlarged. It reaches down my waist and up to where my bra goes; itchy; rash in my back, at my waist; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash enlarged. It reaches down my waist and up to where my bra goes), PRURITUS (itchy) and RASH (rash in my back, at my waist) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma. Concurrent medical conditions included Cancer and Heart Condition. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMLODIPINE, LOSARTAN, ATORVASTATIN, LEVOTHYROXINE and METOPROLOL for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (rash enlarged. It reaches down my waist and up to where my bra goes), PRURITUS (itchy) and RASH (rash in my back, at my waist). The patient was treated with CORTISONE at an unspecified dose and frequency; CALAMINE at an unspecified dose and frequency; PREDNISONE at a dose of 7 20 mg tablets. and TRIAMCINOLONE ACETONIDE at a dose of 0.1 %. At the time of the report, URTICARIA (rash enlarged. It reaches down my waist and up to where my bra goes), PRURITUS (itchy) and RASH (rash in my back, at my waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       two eye drops for glaucoma- Unknown medicinal product.   This case was linked to MOD-2021-261762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non Significant information.
Received a call from the pharmacy that the dose I received had not been diluted. I was given 6 doses.
Information has been received from a physician concerning a 16 month old male patient with no known drug allergies and no pertinent medical history who on 18-OCT-2007 was vaccinated with a first dose of MMR II (Dose, route and Lot# not reported). There was no concomitant medication. The physician stated that on 18-OCT-2007 the patient became lethargic and nonreactive for 2 weeks after MMR II was administered. The physician also stated that the patient did not speak or walk for 2 weeks. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient sought unspecified medical attention. At the time of the report the patient had recovered. Additional information has been requested.
Per FNP: "33 yrs old female here with c/o full body allergic reaction after getting the Pfizer COVID vaccine at 1:00pm today at pharmacy.  Patient states a few hours after the vaccine she began to have a rash throughout her body, trouble breathing and palpitations.  Denies a history of vaccine reactions in the past.  States she is allergic to avocados." Benadryl 50mg po given at 7:05pm.  Epinephrine 0.3mg/0.3ml IM given to Right thigh at 7:07 pm.  Patient transferred via EMS to medical facility.
Received the expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the expired vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included METOPROLOL SUCCINATE for an unknown indication.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up  received on 8 Oct 2021 , Medical history, Vaccine facility information added and patient race, ethnicity, patient route of administration and anatomical location  updated, current condition added. Concomitant medication added.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, (reported as "some time ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, strength, anatomical location, lot#, and expiry dates were not reported) to prevent shingles. On an unknown date, (reported as "very short time, a couple of days of being administered ZOSTAVAX"), the patient developed symptoms of Bell's Palsy, without the rash. She did not experience shingles. The patient sought medical attention by seeing the physician. On an unknown date, the patient totally recovered. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of facial paralysis was considered to be medically significant. Additional information has been requested.
Client was vaccinated with the Covid 19 vaccine at around 4:20 pm with Pfizer (lot#EW0173,. and at about 4:30 the client became anxious, sweaty, dizzy and hot. she said she felt like she was about to pass out. Immediately myself and another nurse position our to maintain the clients safety, which at no point doing the event was comprised. her breathing remained regular and unlabored. Vitals was taken: b/p 120/60, p73, O2 99% on room air, T96.8, R20,  I then applied an ice pack to the rear of her neck and forehead and started to fan her. she asked for a drink of water so I re-assessed her breathing(lungs were clear to auscultation bilaterally) and  there was still no difficulty breathing. So I gave her a sip and and she swallowed it  with incident> I then allowed her to take small sips. after about 10 minutes she said that she felt much better and I keot her another 20 minutes to monitor. I then had her stand and no dizziness presented. I then discharged the client and she self ambulated with her family to the car. I also instructed the client to call 911 if she had any difficulty breathing and consult her health care provider before getting her final dose of Pfizer. I called the client a hour and a half later and she stated she felt *okay.
This spontaneous report was received from a consumer regarding her daughter of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (Unspecified HPV Vaccine) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (Unspecified HPV Vaccine) for prophylaxis. The patient had problems with her legs since the shot she gets cluster headaches and may be infertile.  Outcome and causality of the events were not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
BREAKTHROUGH COVID: FULLY VACCINATED WITH HISTORY OF COVID 19. Monitor off Rocephin, Zithromax --stable, No treatment indicated for COVID-19 at this time as she is on room air. PT TESTED POSITIVE 2 WEEKS EARLIER, CONTINUED TO TEST POSITIVE.  PT ADMITTED FOR Chest Pain, COVID19, Pleurisy, Diarrhea,Arthralgia, Hypertension, Hypothyroidism, Fibromyalgia, Myxedema, rectal bleeding and vaginal bleeding.
Arm swelled from the wrist to the shoulder. Left arm had a red rash over most of the arm with pain and itching and tightness in chest.
Day of injection. No pain at first, then more painful starting 8 hours after shot. 2 days after injection, swollen lymph nodes in left armpit. Continued to get worse. Pain at vaccination site. Day 8- still pain at injection site and lymph node pain still present. ?Covid arm? rash developed (noticed around 4pm). Very swollen but not painful to touch.   Have taken Tylenol and ibuprofen intermittently for pain
Flu like symptoms. low fever, whole body aches, sweating hot cold, chills, in BED for 3 days. Only thing worse that I have had was the pneumonia No way I will get the third shot
This spontaneous report as received from a registered nurse refers to a 6 month old patient of an unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M006112 with expiry date: 16-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014706:
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
No additional AE; Expired dose of M-M-R II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were not reported.  On 31-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at a dose of  0.5 milligram subcutaneously (SQ) as prophylaxis (vaccination scheme frequency, anatomical location; lot number S039316 was verified to be a valid lot number, expiration date reported as 04-DEC-2021) (expired product administered). No adverse event was reported.
Sx started on the evening of 2/6/21. Redness, swelling, irritation, and blistering to the face