chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received FLUMIST on 08/25/2008. On 9/21/2008 was admitted to CMH with diagnosis ITP. Was told by specialists ITP caused by virus; per mom, only known before ITP was live FLUMIST.  11/12/08-records received for DOS 9/21-9/23/08-DC DX: ITP. Presented with petechial rash on shins bilaterally. Rash non=pruritic. Bruising later same day. Evening of admission developed raised erythematous lesion on tongue and corners of mouth. Treated with IVIG. Follow-up: As of 1/7/09 was to followup in hospital hematology clinic in 2-3 months. If counts normal then, would discharge from hematology as resolved. If counts still abnormal followup CBC's in office / clinic until resolved. Last platelets 153K (NL 150 - 450).
Left sided brachial neuritis. Can not raise her (L) arm-continuous to date- Neurologist states it is a flu vaccine reaction. Still in physical therapy.
herpes encephalitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around July 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes encephalitis. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered not recovered/not resolved. The event was related to zoster vaccine live (ZOSTAVAX).   Upon internal review, herpes encephalitis was considered to be medically significant. The lawyer considered herpes encephalitis to be disability.
Numbness and paresthesias in arm and leg on same side of site of injection.12/2/2009 PCP note from 9/4/2009 patint c/o's numbness and tingling in LUE and LLE. no tx noted. Neuro exam did show decreased senastion in these areas. Sx starting to resolve 9/23/2009.
Shoulder and arm pain for weeks with limited range and numbing of the lower arm going to the fingers. Pain through mid upper arm.  treated with ice and heat plus  treatment with PredniSONE tablets, USP 5mg (12 day package). Condition still persists with mainly pain when raising the arm above the shoulder.
pt devel urticarial rash on both arms & both cheeks; 3-4 minutes p/vax; Epi given immediately; no resp sx; mild episode hives the following day;
11:30pm on 11/10/2005 child quit breathing while at home. Intubated at ER. Mom reports coded. Helicoptered to Hospital. Received IV antibiotics through Sunday. Removed tube AM of 11/12/2005. Discharged 11/13/2005. Mom reports doctors ac Hospital told her they did not know why this happened. Also reports child appears to her to be fully recovered.
Symptoms: Light headedness, slight queeziness in stomach, raised blood pressure, tightening of throat, some difficulty breathing. Treatment: 30 minute retention in observation area, lying in cot in EMS area for 20 minutes, water to drink Duration; Lightheadedness and tightening in throat lasted about 3 hours in total though symptoms did decrease over time.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, myalgia and shivering. On an unknown date, the outcome of the fever, myalgia and shivering were unknown. It was unknown if the reporter considered the fever, myalgia and shivering to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, myalgia, and shivering after the second dose of SHINGRIX. He did not receive the vaccine at the reported pharmacy.
His psoriasis has been more pronounced/ increase in the psoriasis in his legs/seems to have continued; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (His psoriasis has been more pronounced/ increase in the psoriasis in his legs/seems to have continued) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ALLOPURINOL for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (His psoriasis has been more pronounced/ increase in the psoriasis in his legs/seems to have continued). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) for Psoriasis aggravated, at a dose of 0.05 percent. At the time of the report, PSORIASIS (His psoriasis has been more pronounced/ increase in the psoriasis in his legs/seems to have continued) outcome was unknown.
No additional AE reported; Tem excursion of 47.9 F for 47 min on Dec. 1st 2022/ VAQTA administered after a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W023937 verified as valid, expiration date reported and upon internal review established as 06-DEC-2023, administered intramuscularly in the left thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degree for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:MSD
I had pain at the injection site for 36 hours or so, I had a low grade fever 4 days or so, swollen glands for 2-3 days
Red, hot, tender and itchy area approximately 3.5"x1.5" at site of injection. Lasted 3-4 days.
Patient received Zostavax on 5/7/08. Late Friday(5/9/08) she noticed a large red sore itchy area at the injection site.She also had chilling, headache and nausea. This lasted approximately 24 hrs. Today (5/12/08) the redness is decreasing in size and she does not have any other symptoms.
Suspected Vaccination failure; every year I get the flu; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine every year and experienced flu every year. The reporter did not have any other information. This case was considered as suspected vaccination failure as details regarding Time to onset for the event was unknown at the time of reporting.
Sleeplessness, severe headache and body aches, pain at the site of injection, fatigue/lethargy, muscle soreness, sweats/chills
Onset of coughing 2 hrs post injection lasted 45 minutes, report build up of spectrum used inhaler 2 times with relief. Reports previous response with allergy shots. 11/22 completely better.
Next morning: red blister/rash 1" long rt shldr. Next 5 days: burning, very red at injection site (injection site was back of left arm) 2" diameter welt at inject. site.
pt revd vax & exp inject site reaction @ the pne-imune site which began w/in 24 hrs p/vax; reaction was localized; red & hot to the touch- lasted a few days; not seen by MD;
This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that patient was vaccinated with first dose of GARDASIL (dose strength, route unspecified) approximately on an unknown date in 2012 (reported as 3 years ago). Approximately on 13-APR-2015 (reported as 3 weeks ago) the patient was vaccinated with GARDASIL (dose strength, route unspecified) dose 2. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Syringe leaked and only part of the first dose was administered; Syringe leaked; A spontaneous report was received from a consumer concerning a male patient of unknown age who was participating in the mRNA-1273 Emergency Use Program who received only part of the first dose due to the syringe leaking.     The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot 021L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The consumer reported that during administration, product leaked from the syringe and sprayed on his arm. He estimates that he only received 0.25 mL of the dose.   Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event was resolved.; Reporter's Comments: This report refers to a male patient of unknown age who received only part of the first dose due to the syringe leaking for product mRNA-1273 (Lot 021L20A). There were no reported AEs associated with this case of only part of the first dose due to the syringe leaking.
Blood pressure shot up, I felt faint, shaky body, pain in joints. Fast heartbeat. Dry mouth. Need to drink lots of water. Numbness in hands. When I got home I laid down with head up. I could not interact or walk for over an hour. After an hour I recovered enough to have my blood pressure taken. It was 159/89. Normally it is 140/79 I think.
Swollen lymph node on collarbone lasting longer than a week with 6/10 pain. Low grade  fever lasting one day.
Pt received DTaP at about 9:15 am on 9/5/12 & later the same afternoon developed hives on lower back, buttocks & behind one knee - mom gave BENADRYL & called office 9/16 to report.
No further AE; MMR II expired vaccine given to a patient; This spontaneous report has been received from an administrator regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 21-AUG-2023, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-RVAXPRO) injection, one time (valid lot number U024229 [expiration date 04-AUG-2023]) (dose, dose number, frequency, vaccination scheme, route of administration, and anatomical location were not provided) (expired product administered). No side effects.   No further adverse event (AE).
woke up at 1:00 a.m with fever 101 and body aches from neck to feet.  difficulty ambulating, developed wet cough.  took motrin and Advil throughout the 26th.  Woke last night with swollen right arm, right and tender to touch and numbness in right 4th and 5th fingers.    I've been awake and numbness has not subsided. This is probably all normal side effects but after Covid Vaccine, and original Shingrix, I was just sore for a day and didn't feel this  bad.
Per Safety Officer to this RN: was in post observation at the top of the bleachers with her sister post her 2nd Moderna vaccination. Pt states she was feeling dizzy and lightheaded and notified post vaccination nursing staff. EMS contacted. Pt states she has hx of anxiety in large crowds. Pt given water and released from EMS care to be driven home by sister. VS 1140 BP 118/palp HR 100 O2 Sat 99% on RA BG 99
Incredible pain, and my shoulder swelled up within a day. Muscle and fat under injection site sunk down and now has a permanent divot/depression which is painful to the touch. Over the month of April to May the doctors wanted to wait and see, and then after disagreement between the two primary doctors over sonogram/ultrasound vs MRI+Xray, in the middle of may I was finally diagnosed with Bursitis. By then the swelling was down, and even though I was still in extreme pain every day and couldn't move my arm as I should be able to (and the dip is still present), the doctor decided not to refer me to an orthopedic specialist.  5 months after the injection I'm going back tomorrow to ask again for a referral to a specialist under my insurance, because I'm still in pain and it's affection my job.
Widespread erythema, vesicles <50 DX chicken pox post vaccination, TX Acyclovir, Vaccine given 4/17/1997, DX 2/27/2006.
Patient received vaccination and waited the allotted 15 minutes for observation. At the end of her time period, she stood up and walked toward the bathroom and vomited. The patient stated she had someone else present to drive her home. She was instructed to contact physician if necessary but stated she felt much better at the time of leaving.
Left arm warm to touch, red, swollen. Visited doctor-given oral antibiotic.
Patient states about 5 days later developed rash starting from opposite side vaccine received (right side of upper torso). Small bumpy rash causing itch started spreading from right upper torso across chest to other side of body (left upper torso).
Woke up at 9:45 AM to patient having a full body seizure. He vomited, and was gasping for air.  He turned blue, was not breathing, and was unconscious, so we called 911.  He remained unconscious for about 40 minutes.  They took him to Hospital where he was given ibuprofen for 101 degree fever.  He was observed there for a few hours and released.
Significant fatigue, myalgias, nausea, headache, sore throat, arm soreness
Onset of paresthesia from the knees down - bilaterally.  Onset 24 hours after receiving the Covid-19 vaccine.  The paresthesia lasted for 2 weeks.  I did not experience any weakness in the lower legs - only paresthesia.  The paresthesia then resolved after 2 weeks and has not recurred.  No other symptoms; only the paresthesia.
unable to walk; cant talk; dizziness; double vision; shakiness; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced dizziness, double vision, shakiness. On an unspecified date, unable to walk, can't talk. It was reported that patient had dizziness inability to talk inability to walk double vision inability to walk shakiness double vision shaky extremities can't talk couldn't walk done. The outcome of all events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
DRUG EXPOSURE DURING PREGNANCY; This case was reported by a healthcare professional and described the occurrence of drug exposure during pregnancy in a 18-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis while pregnant.  Concurrent vaccination included hepatitis B vaccine recombinant (Merck) given intramuscularly on 10 October 2007. Concurrent medications included Prenatal vitamins.   On 10 October 2007 at 16:25 the pregnant subject received a dose of Boostrix, intramuscularly, at 0.5 ml in the right arm.  This was considered a case of drug exposure during pregnancy.  No events were reported.  The subject is reportedly due to deliver in December 2007.  At the time of reporting the outcome of the event was unspecified.  Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
a patient in their office today was given an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 06-AUG-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot # R030929, expiration date 23-JUL-2020 (dose number, vaccination site and route of administration were not provided) for prophylaxis.
achy knee joints; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 24th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2021, 1 days after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reporter this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix  in left arm and experienced achy knees 1 day after vaccination. The patient also received steroid injections for pre-existing Rheumatoid Arthritis. The patient contacted her doctor and no medications have worked to clear this up. The patient also reported that her achy knee joints seem to be getting worse. The reporter did not consent to follow up.
patient got sick for the night; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who got sick for the night, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's sister is 95, has cancer, low in weight and fragile.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious got sick for the night (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient described it as having a bad night.  (Other relevant tests included no lab data.)  Final diagnosis was patient got sick for the night.  It was not reported if the patient received a corrective treatment.  The patient was Recovering from sickness.  There will be no information available on the batch number for this case.
Two days after, flumist was administrated pt developed fever, nasal congestion, cough and wheezing. Symptoms lasted for 4 days. Pt then came to office to be seen. Pt had cbc which was normal. Albtuerol neb x 2 where given. Pt continued to wheeze. Was sent home on albtuerol and pulmicort.
Bruise appeared on shoulder where flu vaccine was administered and a spot/bump appeared on the back of the arm where the shingles vaccine was administered.
administered Boostrix that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 6th August 2022, unknown after receiving Boostrix and Boostrix 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 Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The patient received expired vaccine. No reactions reported. The reporter consented to follow up via postal. Additional Supportive Information: The patient received Boostrix which was already expired, which led to expired vaccine used.
PM of 6JAN94 got hives on buttocks & swelling in eyes; treated w/Atarax w/little or no relief; sx much worse; 7JAN94 w/addition of abdo pain; 10JAN94 had inc t102.4 & swelling everywhere; started on Pred for 7 days;
Received second dose of COVID Pfiser vaccine at 0900. Upon injection I felt the needle hit something hard. I then got a shooting pain down to my elbow. Injection was given very close to shoulder joint. Can no longer lift arm above waist level.
Rash on entire body, nonstop headache and I mean it's always there! Hip pain
after patient received vaccines , the patient giggled and when my picked the baby up he went limp and was not breathing.  Patients pediatrician was sent in to evaluate patient started breathing on his own . Pulse ox was 99
7/23/08 Received MENACTRA , Hep A and ADACEL. That day developed N/V and abd pain. TO ED 7/23, 7/24 and 7/25. Admit 7/25-7/27/08 inpatient. CT abd (-), Blood cx (-), WBC ct 2.8 with NL diff and Platelets 90,000, no bleeding.8/12/08-records received for DOS 7/25-7/27/08-DC DX: Fever. Abdominal Pain. Mildly low white blood count. Thrombocytopenia. Seen in ED with C/O abdominal pain, vomiting on Fevers continued and returned to ED on 7/24 and 7/25/08.On 7/27/08 nose bleed. Left deltoid warm and tender at site of Adacel vaccine.
Measles caught from MMR vaccine; full body rash, fever, head congestion, cough, runny nose, swollen nodes in the back of his head, and ear infections. He had the fever for 24 hours on 3/19/08 and the rash began then too. The rash covered his body by 3/26/08. Other symptoms followed.  4/25/2008 MR received from PCP for OVs 3/13-4/10/2008. Pt returned to office  1 week s/p vax with DX: Otitis media with c/o fever. TMs inflamed and bulging. Returned 1 week after that with rash all over and fever. DX; Otitis media and Rash due to MMR. 1 Chicken Pox noted at injection site. Rashes resolved by 4/10/08.