chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented with GI bleed 3 days post vacinnation and became lethergic, mottled, with severe swelling. Pt was taken to the ED on 03/28. He was later found with acute intussusception and bowel was resected. Currently in PICU. 5/15/07 Received medical records from hospital which reveal patient experienced fussiness, bloody stools & massive GI bleed.  Initially seen at outlying ER where patient found to be in shock & transferred to higher level of care.  Admitted from 3/28-5/3/07.  Pulses & perfusion were extremely poor, he was tachycardic, poor urine output & he was cold & mottled.  Surgical consult done, central line placed & patient transfused.  Taken to OR on 4/3/07 where found ischemia & infarction of small bowel.  Resection of jejunum done; leaving only approx 30 cm jejunum.  Proximal jejunostomy created w/ileostomy & mucous fistula performed using approx 15 cm of terminal ileum.  Started on TPN & very slowly built up to 5 mL/TID at d/c oral feeding.  Treated w/multiple antibiotics while hospitalized & developed c. difficile.  Continued on TPN at d/c w/Home Health follow up due to high output jejunostomy.  FINAL DX: ischemia & infarction of small bowel; resection of small bowel w/creation of jejunostomy.
There was no adverse reaction that occured; MMRV was given to a 15 yr old child and should not have been used. There was no adverse reaction that occured; This spontaneous report was received from a registered nurse, referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions and allergies were not reported. Concomitant medications included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), hepatitis a vaccine inact (HAVRIX), polio vaccine inact 3v (vero) (IPOL POLIO VACCINE) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA).  On 23-OCT-2019, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, administered subcutaneously in the right arm, lot number S012533, expiration date was not reported, but upon internal validation was established as 20-OCT-2020 (strength was not reported) as prophylaxis (product administered to patient of inappropriate age). There was no adverse reaction that occurred.  The outcome of product administered to patient of inappropriate age was reported as recovered/resolved.  Follow-up information was received from the nurse on 15-MAR-2022. The nurse reported it was so long time ago that she wouldn't have information. No further information is available.
Patient received blood draw directly after the immunization for a blood work order.  Shortly after that she fainted while making her follow-up appointment.  She was only momentarily out and did not hit her head as she slumped forward (per the person who witnessed it, who was not me).  She remained in the clinic for observation for almost 30 minutes and given Gatorade.  She then left under her own power with no problems.
This spontaneous case reported by a consumer, describes the occurrence of gout (flare-up of gout) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced gout (flare-up of gout). At the time of the report, gout (flare-up of gout) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Fever developed the day after the vaccine along with reflux symptoms. The fever lasted for 2 days but reflux symptoms persisted and worsened for over 3 weeks, requiring prescription medication (ZANTAC).
Information has been received from a physician concerning a female who was vaccinated with her first and third dose of Gardasil vaccine in the upper arm deltoid area. The patient's second dose of Gardasil vaccine was administered in the buttocks and the patient has been experiencing hip problems. Physician reported that they have no update on the patient's status because the patient is currently away at law school. The patient sought unspecified medical attention. Additional information has been requested.
Pt became dizzy, nauseated immediately, post vax. O2 began SC/mask. Pt then complained of chills and hands numb. Benadryl/IM was given. EMS notified and transported to ER.
The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed. No concomitant medications were reported No treatment given to patients.
Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; Terrible pain and swelling in the injection site; my arm pains, my arm at the injection site is so sore; I was not feeling good; I couldn't eat and I was just so cold; Fever / temperature was about 100; I have got chills right now and my body is shaking; Nauseous; couldn't eat; body is shaking; sick; This is a spontaneous report from a contactable consumer. This consumer received the first dose of BNT162B2 (COVID Vaccine, lot number: EL3249), via an unspecified route of administration on an unspecified date in right arm at single dose for COVID-19 immunisation. Medical history included Covid from first week of Mar2020. The concomitant medications were not reported. The consumer previously got flu shots and shingles shot for immunization. The consumer got injected and then sometime in the middle of the night 2 or 3 clock, the consumer had terrible pain and swelling in the injection site so the consumer didn't pay attention to it, so the consumer went out and around 3 o'clock, the consumer was not feeling good, the consumer was feeling low but the consumer was like he/she will go out for and do things and all, so the consumer went to the lunch with a friend and he/she couldn't eat and was just so cold and then came home and the consumer take temperature. Normally my is 97 its never 98 and temperature was about 100, the consumer have got a fever and have got chills and body is shaking. The consumer had Covid in first week of Mar2020 until got the Covid test by the time Apr2020. The consumer already gone through but this is how the symptoms started, the consumer don't want to get it again. The consumer have got flu shots and shingles shot and stuff but nothing like this so sick, the consumer was nauseous, have a fever, have chills, arm pains, arm at the injection site is so sore and it's swollen, whole body is shaking. The consumer need to go to bed, whole body is just shaking terribly. The consumer will wait through the morning if not, he/she will go to the ER, was not going to get sick like he/she get in March, the consumer won't survive if I get sick again. The outcome of the events was unknown.
Myalgia & Fever Narrative:  x3 d fever max was 102, fatigue myalgia, sx resolved
I do not know if this was related to the flu shot but what I will described has never happened to me before.  I became aware of fairly intense discomfort as if my relaxed fit clothes were suddenly extremely tight.  As I walked through the house to change into night clothes in response to this feeling, my upper left arm became intensely itchy.  The shot was administered to my right arm and it showed no reaction throughout this episode.  When I looked at my upper left arm it was very red but there were no hives, just widespread redness.  Then I became aware of itching at the waist, mid and lower back, upper buttocks and the backs of my lower legs.  All these places were quite red and again no hives.  The back of both lower legs had furrows and exhibited edema.  Apparently the legs of my jeans had caused the furrows as the cloth tightened in response to the swelling.  I took a generic Claritin and applied Eucerin Itch Relief cream to all the affected areas.  I took my blood pressure -- it was 148/81, quite high for me, pulse was a normal for me 63.  My temperature was 97.3.  The symptoms gradually resolved over the course of the next hour with the exception of some furrows and edema remaining on the backs of the legs.  My blood pressure returned to normal 118/68.  By morning there were no remaining abnormalities.  I did not seek medical attention.  I have several photos of the skin reaction.  Again I don't know if the vaccine caused this but thought I should report it in case it is of use to anyone.
Patient returned 24 hours after receiving varicella vaccine. Site of administration red, swollen and harden center. Bactrin prescribed given with instructions for care of site. Follow up on 1/5/07 area resolved.
This spontaneous report as received from a physician refers to unspecified patients. It was reported that unspecified patients were vaccinated with improperly stored M-M-R II (lot#, dose, strength and frequency were unknown) subcutaneous. No adverse effects were reported. Additional information has been requested.
Patient received Pfizer COVID vaccine on 4/17/21 (lot EW0164), 5/8/21 (lot EW0182), and 12/16/21 (lot FD0810). From 1/13/22 to 1/15/22, patent was admitted to our inpatient med/surg unit for uncontrolled type 2 diabetes with hyperglycemia and COVID-19 infection with possible superimposed bacterial pneumonia (relatively asymptomatic during this hospitalization). On 1/16/22, patient was re-admitted to the hospital with acute respiratory failure with hypoxia and pneumonia due to COVID-19 virus. As of today (1/17/22), patient is still admitted in the med/surg unit.
Fever, chills, headache, tightness in chest, shortness of breathe, ?swimmy? feeling in head,coughing, head congestion, feeling like throat was closing?. Over 12 hrs? went to ER. IV Steroids and pain injection
Patient was down from the shot for 4-5days in bed. He didn't take any OTC supplements and complained of nausea,extreme fatigue, joint pain, severe headaches and diarhea
Patient experience a 3 seizures following administration of vaccine. Vaccine was administered at 10:35am, seizures started at 10:40am, EMS  arrived at the  10:52am.
Patient had a reddened swollen left deltoid. Pneumonia Vaccine given 12/08/2006.  Patient seen on 12/9/2007.  Redness was beginning to improve when he was seen.
Had MMR, Varivax, and Prevnar vaccine in the morning.  Returned to clinic around 2 pm after having shaking episode of 1.5-2 minutes after waking up from nap.  Temperature at that time 101.5 (rectal).  Temperature upon arrival at clinic 100.7 tympanically.
Incorrect product storage; no adverse event; Medical assistant calls to report AE.  GARDASIL 9 given during a temperature excursion.  No further AE.  No PQC.  GARDASIL 9 was evaluated as supported see TE case.  TEs were on Aug 2, 2023 and Aug 4, 2023.  Called in on 9/6/2023.  AE cases0; This spontaneous report was received from a clinical medical assistant (CMA) regarding a patient of unspecified age or gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported.   On 02-AUG-2023 and 04-AUG-2023, it was evaluated that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Lot #w026152 and expiration date: 29-JAN-2025) underwent temperature excursion (Product temperature excursion issue and Product storage error). Then, on 05-SEP-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) once for prophylaxis (Lot #w026152 and expiration date: 29-JAN-2025) administered for prophylaxis (dose description, and route of administration were not provided). There were no further adverse events regarding this administration.
MILD FEVER, NAUSEA, PROFUSE SWEATING FOR 2 DAYS POST VACCINE.
Information has been received from a health professional concerning a 26 year old female, with no known allergies, who on 16-JUL-2007 was vaccinated with a first dose of Gardasil vaccine. Concomitant therapy included Yasmin. On approximately 23-JUL-2007, the patient developed a rash over her entire body. The rash became worse and was red and warm to the touch. She was seeing a dermatologist and allergist for treatment. Additional information has been requested.
Low grade fever 101 degrees Joint pain  Chills  Nausea  Headache  Injection site became extremely inflamed and raised. Approximately the size of a half dollar.  Day of vaccine patient experienced itching all over her body, day two mostly only in right arm
The patient recieved Zostavax on 6/2/08 and presented to the Emergency Department on 6/4/08 complaining of pain. Upon examination, erythematous vesicular lesions were noticed. She was diagnosed with herpes zoster and discharge with Valtrex and Lidoderm patch. She followed up with her primary care physician, who gave her pain medications. As of 6/23/08, the pain is still present.
Positive for COVID; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL and THYROID for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
mother reported patient had three seizures, last night until this morning, 5 minutes, 3 minutes and 5 minutes
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: pt described felt like heart attack-Severe, Additional Details: vaccine given on sat. felt symptoms on sun. went to ER. EKG and chest xray normal. gave hydroxyzine and nitroglycerin SL. Followed up with pcp and cardiologist. all normal
Developed anterior chest pain 48 hours post vaccination. Went to ER - P.E./Pneumonia ruled out. F/U at PMD 9/6 - Exam c/w costochondritis- pain on palpation anterior chest, pain with deep breathing. No reported rash. Tx with NSAID.
She began to get generalized headache and felt feverish, some nausea.  No photophobia.   Temp 37.7  Headache 7 on 1-10 scale.   Has had headache off and on since then though gradually getting better and do not think major problem.
Patient used Paxlovid as COVID-19 treatment; Patient used Paxlovid as COVID-19 treatment; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Patient used Paxlovid as COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Paxlovid COVID 19 Treatment; (13Jul2022) Negative, notes: tested negative on rapid antigen; (18Jul2022) Positive, notes: 18Jul2022 retest due to new symptoms and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors. Severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Per pt mother he felt warm and she TYLENOL about 1 hour after this mom was feeding him and he had head jerking that lasted 10-15 seconds this was approx 10hrs after 4 mo immunizations.
Information has been received for the Pregnancy Registry for GARDASIL from a nurse practitioner concerning a female (age not reported) who was vaccinated with a first dose of GARDASIL (lot# unknown) injection.  Subsequently the patient received her first dose 8 days post conception.  Medical attention was sought.  No adverse experience was reported.  The date of the last menstrual period and the estimated date of delivery is unknown.  Follow-up information was received from a nurse practitioner.  The female patient was 21 years old with no pertinent medical history and no drug reactions/allergies.  There was no concomitant medication.  The patient's date of last menstrual period was 14-JUL-2007 and on 16-JAN-2008 the patient was 26 weeks gestation.  The patient had a shortened cervix (unknown if this was a condition prior to pregnancy).  On 06-AUG-2007 the patient received a first dose of GARDASIL (unknown if this was the first or second dose) from her primary physician.  On 20-AUG-2007 the patient had a positive pregnancy test.  The nurse mentioned the pregnancy was going well.  The estimated date of delivery is 19-APR-2008.  The patient delivered a female baby on 21-APR-2008.  Additional information is not expected.
helped her fibromyalgia; helped her fibromyalgia/ fibromyalgia symptoms were gone; bad chills; teeth were chattering; temperature of 102 point something; didn't feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2006 (unspecified if ongoing), notes: She states that she has had fibromyalgia since 2006. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot number: EM6202 , Expiry: Jun2021), administration date: 01Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "helped her fibromyalgia"; PRE-EXISTING CONDITION IMPROVED (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "helped her fibromyalgia/ fibromyalgia symptoms were gone"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "bad chills"; CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "teeth were chattering"; PYREXIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "temperature of 102 point something"; MALAISE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "didn't feel good". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, chills, pyrexia, malaise.  Additional information: She confirmed that he chills and fever ended on the following day, either 05Sep2021 or 06Sep2021 and that's also the same day that she noticed that her fibromyalgia symptoms were gone as well. She is still feeling good from not having her fibromyalgia symptoms. She busted her ass the following day which is usually a big mistake with fibromyalgia. Usually you are not going to do as good as you want and will overdo it and have a bad day for possibly weeks afterwards and she felt like shit even thought she had a great day, she felt crappy when she went to bed and then she woke up the next day in the same condition, she was feeling better and she finds that highly unusual with how her fibromyalgia works  No follow-up attempts are possible. No further information is expected.
Chicken pox-vesicular rash (itchy), decreased intake. Had vaccine on 12/9/15.
After the immunizations on Wednesday, the patient stated pain in the right arm where the MCV4 vaccine was administered. On 8/3, patient ate dinner but was feeling sore and tired. By 1 AM on 8/4, she woke up feeling badly. Her temperature was checked by her mom and was 103.7 F. Mom administered 3 tsp. of children's TYLENOL. She also developed swelling of the right axilla. By morning, patient was feeling better but still had a fever of 99.5 to 100 degrees and the swelling continued (mom states she when patient raises her arms, the visible swelling is around 2 to 2.5 inches in diameter). Today (8/4) patient has been home with her father. At around 12:30, her temperature came up to 102.5. Mom had her take an additional TYLENOL dose. Mom is trying to bring her in to seek medical care though there are no appointments available. She was advised by Dr. at the Clinic to go to the ER if mom felt it was necessary. At this time, she will wait with her daughter at home to see if the symptoms improve. The temperature is responding to the TYLENOL and she is drinking and eating well. Mom will keep an eye on her over the weekend and seek care if s/s do not improve or worsen.
Seizure with fever, had one febrile seizure in past, got Zithromax in ER after had seizure (otitis).