chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left upper extremity severe pain from shoulder to elbow, including axilla that limited ability to move arm. Occasional numbness. Slight area of redness at injection site. Pain med, ibuprofen, heat, rest and trial of BENADRYL - no change by day 3 so far.
The night of vaccine administration patient felt very sick (stomach upset, headache), her injection site got red, hot and swollen and remains like that to this day.
Patient started to experience dizziness a couple seconds after the shot.  Provided patient with water and he waited another 30-45 minutes and he started to experience nausea and chest pain that was rated a 3/10.  911 was called and his blood pressure was measured at 210/110 (previous blood pressure was 190's/110.  Nitroglycerin was given but it did not help with his chest pain and he began to have a headache.  He was taken to the hospital.   He stated that he was not feeling good a couple days before today.  He felt better today and received his J&J vaccine.  Fired his cardiologist and was looking for a new one.
Marked swelling, induration, heat, erythema at site of Prevnar Vaccine.
5 minutes after flu shot, patient reported dizziness, increased heart rate, shortness of breath, chest tightness, urticaria on chest-pt self injected with EPIPEN, then taken to hospital by EMT for anaphylaxis.
Diagnose Juvenile Rheumatoid Arthritis-> seen at medical center. Tx Prednisone, Methotrexate, LEUCOVORIN. 1/09 started having back pain, unilateral shoulder, arm pain, followed by progressive knee pain and swelling, limitation of activity.  8/4/09 Rheumatology consult records received DOS 3/5/09 to 5/15/09. Assessment: Polyarticular Juvenile Rheumatoid Arthritis. Patient presented with pain in back, knees, shoulders, ankles, feet, elbows and wrists. Pain started in back and then started involving other joints. Difficulty with range of motion and activities in school. Involves 1 or 2 joints for 2-3 joints then moves on to a different joint. She has noticed swelling in knees and hands. Recent URI, fever, chills, sore throat, and cough. Posterior pharynx has erythema with mucus. Wamth of elbows with synovial boggy tissue. Swollen MCP joints. Right hip decreased ROM and pain. Warm both ankles. Synovitis PIP joints. Swelling of knees. Slight scoliosis. Pes planus. Later refusing to walk. Screams when leg or foot touched. Difficulty with ADLs. Chiropractic treatment. Physical therapy. Nearsighted. Rash on arms. Itchy rash on foot. Anxious, depressed affect. Cervical lymphadenopathy. Uses wheelchair.
Redness, warmth, and swelling around the site of injection that developed into cellulitis.
Information has been received from a pharmacist concerning a 25 year old female patient with a history of fainting when was given shots who on 21-SEP-2010 was vaccinated IM with her first 120 microgram dose of GARDASIL (lot # 662765/0821Y, expiration unspecified). On 21-SEP-2010 the patient received her first GARDASIL shot and 15 minutes after receiving the shot the patient stood up and then felt faint and passed out. Patient hit her head and bruised her knee. Pharmacist gave patient orange juice, called her mother to pick her up, and kept her at the store for an hour before allowing her to leave to make sure she would not faint again. The mother of the patient told the pharmacist that the patient had not eaten breakfast that morning. At the time of reporting, the patient had recovered on 21-SEP-2010. The pharmacist administered the shot. Follow-up information has been received from the pharmacist indicating that he patient received the injection and then remarked that it was not bad that she usually passed out when she got shots. The pharmacist then suggested she stayed seated a while until she felt ok. After approximately 5-10 minutes she said she was ok and then proceeded to the pharmacy counter to check out. As she stood there, she then said she thought she should go back and sit down. Before the pharmacist could get out the door, she was on the floor. She was then helped to a sitting position. She was conscious but dazed. The got her to chair and she stayed there until her mother arrived. The placed a cool towel on her face and forehead and eventually she felt better, the mother came and asked if she had eaten, she stated she had not. They got her some orange juice. Eventually she felt better and walked out on her own. Additional information is not expected.
Woke up at 3:30 am after getting the shot.  Was shaking uncontrollably, freezing, deathly sick at my stomach.  Fever.  For next 24 hours I was deathly sick at my stomach.  Dry heaves.  Fever and chills.  Could barely raise my head.  Couldn't even eat a cracker.  Then my arm started hurting, got big long red knot,hurt down the inside for about a week.  I was sick like this for almost 48 hours.  I was exhausted, so tired.  This lasted for a week.  After the first week, every afternoon I would get exhausted and have to stop and rest.    First shot effected my breathing, causing rapid breathing, like I was anxious.  Had a headache.  My heart beat fast for about 20 hours.  Then all of it stopped.  Several days later I got a round red hot knot that stayed about a week or two and was really sore.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M016193 with expiry date: 24-APR-2018 and lot # L036301 with expiry: 20-DEC-2017 (dose and route were not reported). The vaccines underwent a temperature excursion of 9 degrees Celsius for 1 hour 24 minutes. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
I am peri menopausal, had missed my period for 2 months. The second day after the second dose my period restarted with a very heavy cycle. Two days later I had an occular migraine for the second time in my life.  It only lasted about 15 minutes. Otherwise, there were no other symptoms.
arm sore to touch; swollen/puffed up underneath her arm, thinks is a  swollen lymph node; swollen/puffed up underneath her arm, thinks is a  swollen lymph node; Itchy; restless; seems like she has a rash in her upper chest neck area, neckline; This is a spontaneous report from a contactable consumer (patient) and a contactable physician. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EK9231) via an Intramuscular route of administration on 27Jan2021 at single dose on left arm for covid-19 immunization. The patient medical history included allergies. The patient concomitant medications were not reported. On 27Jan2021, in evening patient was really restless that night because she was itchy. Physician stated that patient has been experiencing some itching, but it seems like she has a rash in her upper chest neck area, neckline. The itching/rash has stayed the same so far. On 28Jan2021, next day morning It was really sore to touch, like when patient was putting deodorant on, its all puffed out underneath her arm that she had the vaccine administer in. It's swollen, but patient thinks its her lymph node. It doesn't feel like its effected any other one, but just that one lymph node. The outcome of the event Itchy, rash was not recovered while outcome of rest all events was unknown.
Pt experienced back ache about 8 hours after receiving the vaccine.  He described the pain as being stabbed in the kidneys.  At 4 am on the day after his vaccine he woke up to a temp of103.  He used a cold bath to reduce his temp and pain.  Pt experienced more back pain latter in the day.  He woke up the next day with more back pain and a temp of 104.  Pt utilized a cold bath again.
Redness, swelling, tightness, bruising not feeling - all to skin around injection site - used ice pack and TYLENOL.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 03-SEP-2013 (lot# H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Patient called stated severe itching redness at injection site that had increased over days non responsive to antihistamine. Hot to touch and slight relief by ice application.  Recommended evaluation by health care provider.
Subsequent to receiving one dose of varicella virus vaccine live in 1996, the pt, in 2000, broke out in a mild case of varicella.
Red, swollen, tender lump at site of DTaP injection.  Also developed mild Varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles that subsequently crusted over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.
pt recvd vax; devel rash approx 30 lesions described as "mosquito bites";severe HA that lasted for 2-3 days;the lesions devel into small blisters lasting several days; at time of rpt pt had recovered
Lliquid dripped down the patient arm; Needle detached from barrel while pulling out the syringe; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had Covid-19, 90 days prior.). Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and CARVEDILOL for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe). On 03-Mar-2021, INCORRECT DOSE ADMINISTERED (Lliquid dripped down the patient arm) and DEVICE CONNECTION ISSUE (Needle detached from barrel while pulling out the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of a 50-year old female patient who experienced liquid dripping down the patient's arm and that the needle detached from the barrel while pulling out the syringe(syringe connection issue and Incomplete dose administered) for mRNA-1273 (Lot number: 011A21A). There were no reported AEs associated with this case of syringe connection issue and Incomplete dose administered.
Information has been received from a health professional concerning a 13 month old male with no medical history and no known allergies who on 9/17/04 at 10:00 AM was vaccinated SC with a second 0.5ml dose in the left thigh of varicella virus vaccine live (lot # 647718/0193P). Concomitant vaccines given at the same time included a fourth IM dose in the left thigh of HIB conjugate, hepatitis B vaccine (lot # 647168/1114N), a second SC dose in the right thigh of MMR, and a fourth IM dose in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 495700). It was noted that there was no illness at the time of vaccination, and that the patient's sibling had no adverse events following prior vaccination. On 9/13/04, the patient experienced chicken pox. It was reported that some of the lesions were starting to crust over already. It was also reported that the patient's mother is pregnant, she did have chicken pox as a child, and that the mother had not contracted varicella so far. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient's chicken pox began on 10/29/04 at12:40 PM. Additional information is not expected.
Tinnitus- constant high pitched sound since last year. Sneezing - daily sneezing.  Seldom. Occurred before vaccination Warm hands-started few weeks after second dose.
Patient was administrated with an expired dose of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number unknown, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided are as follows: The age at vaccination was not reported. Medical assistance reported that, the patient was administered with an expired dose of pediarix on 17th June 2021 which led to expired vaccine used. No adverse event was reported. No patient's identifiers was provided. No LOT number was provided. The reporter did not consented to follow- up.
PATIENT REPORTED 2 DAYS AFTER RECEIVING SHINGRIX VACCINE "FLOATERS" IN HIS EYE. THIS HAD NEVER HAPPENED TO HIM BEFORE. HE DID VISIT HIS EYE DOCTOR WHO SAID THIS IS SOMETIMES AN OCCURRENCE IN AGING, HOWEVER, FELT IT WAS REPORTABLE DUE TO HAVING JUST RECEIVED THE SHINGRIX VACCINE.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On unknown date the patient was vaccinated with a dose of M-M-R II, injection, (lot # J002502, expiration date 28-FEB-2015). There was no concomitant medication reported. The nurse practitioner reported that the vaccine was exposed to a highest temperature of 11.5 degree centigrade for 16.5 hours. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
accidentally received pediatric dose; accidentally received pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included bone marrow transplant.   On an unknown date, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were 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: 17-May-2022 Reporter's comment: Registered pharmacist reported that a patient who recently had a bone marrow transplant accidentally received pediatric dose of Havrix. The reporter asked that how long this patient should wait to get the adult dose. The reporter did not provide any demographic details from patient.  The reporter stated he could not provide them. Lot number and expiration date of pediatric dose were not provided by the reporter since reporter did not had that information. The reporter did not consent to follow-up. Additional Supportive Information: The patient accidentally received pediatric dose of Havrix, which led to accidentally underdose and adult use of a child product. Note: Suspect was coded as per narrative.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who experienced swelling and fever, while he/she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect QUADRACEL lot number not reported via unknown route in unknown administration site. The patient developed a non-serious swelling following the administration of QUADRACEL. The patient developed a non-serious fever (pyrexia) following the administration of QUADRACEL. Patient had emergency room (ER) visit. (Other relevant tests included No lab test.) Final diagnosis was fever and swelling. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling and as Unknown for fever.
Pt. given 3 vaccines today, as she got up to leave room she fainted, braced against the wall. Recovered immediately. Denied injury or feeling ill. BP 100/70 (stable). Rested x 20 minutes. Given juice. Recovered.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 03-NOV-2017, the patient received an improperly stored dose of PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccines was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013918: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
The outbreak of Herpes labialis on the lower lip.  I did not have any outbreaks of Herpes labialis for more than 2 years before that.
Fever after 12 hours, 101 degrees, ending after 36 hours, at 60 hours below injection upper arm red, hot to touch, sore.  Doctor prescribed cephalexin 500 mg, 3x daily.  90 hours tender still, less red and less hot, other than are feeling much better.
(R) shoulder/prox arm pain causing decreased ROM. Vaccine (R) arm at 3:30 9/29/15-sx 7:30 9/29 a lot better 9/30/15.
Administered vaccine from vial which has been punctured for more than 6 hours; A spontaneous report (Un was received from a nurse concerning a 51-year old, female patient who received Moderna's COVID-19 Vaccine and experienced administered vaccine from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of expired product administered.
This spontaneous report was received from a health care professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX (dosing regimen unspecified) (lot M005972, expiry 02-FEB-2018) (dose, route and frequency unspecified) for prophylaxis. Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 5.9 F, Time frame: 2 hours, there was previous temperature excursion:18F for 17 hours, 16F for 3 hours and 15.3F for 2 hours and 3 minutes. It was a call because of a data logger. No adverse effect reported. No further information was provided. Additional information has been requested.
Healthy Patient received Tdap on 5/20/08, 12 hours after receiving the vaccine she developed hearing loss in the same side ear.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 at 13:30 as dose 1, single (Lot number: HH7595) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty original/omicron ba.4-5 (DOSE NUMBER UNKNOWN, SINGLE, lot number: GJ2524, Anatomical location=Left arm, ), administration date: 17Sep2022, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 08Nov2023 to 13Nov2023. Clinical course: Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381467 same patient, different event/ drug;
Injection site swelling and pain - subsided day 2 after vaccine. Severe Exhaustion - in bed day 2 and 3. Loss of apetite , not motivated to eat or drink. Muscle aches, moderate. Full headache, mild dizziness, fever with chills maximum 102.3 recorded.  By day 3 these symptoms mostly went away.
It was reported that an 8 year old male pt received a Fluzone SV '00-'01 vaccination on 1/16/01. Reportedly, the pt experienced a seizure 20 hours, post vax. New onset of seizures; no fever. Pt was evaluated in ER and discharged home. Further information is requested. F/U correspondence rec'd on 4/18/01, additional pt vaccine,resposible physician vaccine administrator and lab data were provided. F/U rec'd on 5/7/01, the following information was provided: vaccine was given in the pt's deltoid. The pt had no history of seizures before the vaccination. The current medical condition of the pt is stable, no seizures.
tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache next morning.
On Monday I had a high fever, highest has been 102 and chills. The fever continues and I have cough, aches and pains. I've taken TYLENOL, SUDAFED, AFRIN, NYQUIL.