chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per ER call to on call physician 8/11. Last night he stopped feeding and then his eyes rolled back and he stopped breathing.  911 called and CPR initiated. Coded for 1-1/2 hours (paramedics and ER) without success.  9/4/07 Received pcp medical records which included vax record which confirmed RO dose & lot #s as reported.  Office note of 8/9 indicates well child visit on day of vax excep for thrush & umbilical hernia.  1/8/08 Reviewed autopsy report which states COD as sudden unexplained infant death syndrome due to dilated cardiomyopathy & primary endocardial fibroelastosis, dilated form.
Alopecia Areata, followed by hair loss from entire scalp. Currently I've lost about 50% of my hair, but it has started accelerating.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 2 doses of improperly stored M-M-R II lot# reported as L043703 with expiration date: 03-NOV-2017 and 1 dose of improperly stored M-M-R II lot# L032182 with expiration date: 25-AUG-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of M-M-R II underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
bit of feeling; Circle of redness spread over 2 in diameter; Swelling in the middle; Extreme itching; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (bit of feeling), ERYTHEMA (Circle of redness spread over 2 in diameter), SWELLING (Swelling in the middle) and PRURITUS (Extreme itching) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (Circle of redness spread over 2 in diameter), SWELLING (Swelling in the middle) and PRURITUS (Extreme itching). On an unknown date, the patient experienced FEELING ABNORMAL (bit of feeling). At the time of the report, FEELING ABNORMAL (bit of feeling), ERYTHEMA (Circle of redness spread over 2 in diameter), SWELLING (Swelling in the middle) and PRURITUS (Extreme itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
After she got her 2nd Moderna shot she noted many issues: her left leg> right swelled (doppler was negative). She had prior DVT in that leg years ago and is hypercoag state and is on ASA.  Associate signs: leg aches later in the day, slight pink color at times, edema of left ankle. Abnormal labs: Homocysteine 10.8 H, hs-CRP 2.1.
Patient reports slight pain in her arm, and she says the area around the injection site is itchy, swollen, hot, and burning. She has not treated the localized reaction, but she was counseled on how to treat such reactions.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient of unknown age who received 5th dose of PENTACEL (lot C5437AA) via unknown route in the left thigh on 18-Jul-2018. On the same day, the patient also received a dose of vaccine HEPATITIS A not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in the right thigh. It was reported that the patient had received her 4th dose of PENTACEL on 17-Jan-2018 at the same practice. The patient's past medical history, medical treatment(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient arrived to ED via ambulance Patient is a 44-year-old male who presents to the emergency department for evaluation of an allergic reaction.  Patient reports that he is in EMS paramedic and that he had received his second dose of the COVID-19 Materna vaccine today at approximately 10 AM.  Since noon he noticed that he felt his ears tingling and that his skin became beet red and he broke out in hives.  He has a history of recurrent allergic reactions and anaphylaxis.  He went back to his EMS facility.  He noted that it was starting to get worse and so he was given IV with Benadryl and a dose of epinephrine and transported to the emergency department.  He still complains of itchiness and redness to his skin but says he feels better.  He denied having any tongue swelling or lip swelling or shortness of breath or wheezing or abdominal pain or diarrhea. In the ED he also received dexamethasone 10mg IV and 1L IV 0.9% sodium chloride
Shortly after receiving Zostavax patient started to feel "strange" and then started to shake and continued for approx 15 minutes.  Pt's blood pressure became elevated to 184/89.  Over the course of 30 min pt's blood pressure decreased to 165/82. Pt states that her systolic BP is 120 or lower.  Developed rt arm soreness, red, swollen, hard and warm area at injection site on 8/20/10.
Swelling with warmth in triceps region. Small 1.5cm X 1.5cm, SC nodule with tenderness.
Patient reports that she went to the local ER after her vaccine on 8/17/21 received at a different clinic site than that of this current reporter. (Per due diligence, pharmacist is reporting this event in case it was not reported during her ER visit earlier in August.) Patient reports "pin and needles" sensation as well as "something wrong with nerves" that spread down her left arm and "down both legs." She reports that the ER diagnosed her with "neuropathia."
Felt dizzy and drunk and blurry within 10 min of receiving vaccine and developed a burning throat on day 1.  Day 2 - dizzy spell, nauseous, and hot.  Day 4 - hot flashes, nausea, dizziness, palpitations and fast racing heart developed, blurry vision, panic attack and difficulty breathing.  Day 5 - nausea, vision blurred, and heart palpitations, which have continued through the present.  Heart jumps and then races fast palpitations throughout whole day.
Dysgeusia - Faint metallic taste experienced within 30 minutes post injection.  I am continuing to experience this (transient) 24 hours later.   Injection site reaction - soreness, bruising 24 hours post injection (pain is 4 out of 10) Diarrhea - have experienced 3 bouts of diarrhea with onset around 12 hours post injection and continuing to 24 hours post injection.
This spontaneous prospective pregnancy report as received from a registered nurse for VARIVAX (merck) a Pregnancy Registry Product, refers to a 33 year old female patient. On 15-MAY-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (merck) (Lot # reported as H018781, expiration date 15-OCT-2014) subcutaneously. The nurse reported that the patient denied pregnancy at time she received VARIVAX (merck). The nurse stated that patient completed a home pregnancy test after she received VARIVAX (merck) and the home pregnancy test was positive on 15-MAY-2013. The patient informed the nurse that she believed she was 4 weeks of gestation. The patient's LMP was on approximately 17-APR-2013 and her EDD would be in 22-JAN-2014. No adverse event was reported. Additional information has been requested.
Cellulitis; blood pressure increased; red spot just a little to the right of where the injection went in/came back bigger and redder/darker; hard lump underneath it; it was sore; also mildly itchy, at times; A spontaneous report was received from Consumer and healthcare professional concerning a 67-yeay-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis and blood pressure increased.  The patient's medical history was not provided. Concomitant products were not provided.  On 28 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number 025A21A) by intramuscular route on left arm for prophylaxis of COVID-19 infection.   Patient reported noticing a red spot just a little to the right of where the injection site. There was a hard lump underneath it, and it was sore. The area was about 3 inch across. It was also mildly itchy, at times. On follow up, she stated she developed cellulitis around the injection site and was on antibiotics to treat the infection. Patient stated, to the right of where she was injected she had a red spot the size of a quarter, sore, it was a lump, and warm. She stated that it began to fade between 2 Mar 2021 and 5 Mar 2021. Then this past weekend, 6 Mar 2021 it came back bigger and redder/darker. She went to a walk in clinic because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter.  Lab tests were included Vitals taken at clinic: Temperature - 99.5 degrees Fahrenheit, Blood Pressure: 203/81 - She stated that her BP is never that high, Pulse Rate: 104, Respiratory Rate: 16 and O2 sat: 98%.  The event of cellulitis was considered as serious with criteria of important medical event.  Treatment was antibiotics, tylenol, ice pack on injection site for her symptoms.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis, and blood pressure increased was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
mom states noticed swelling to rt leg p/pt awakened from nap 230PM; mom states swelling from knee up to upper thigh w/redness noted form inject site extending to leg & foot;
Extreme fatigue, dizziness, nausea, flu like symptoms 12 hours after vaccination lasting 4 days
pt recvd vax & around 9AM 4APR94 later afternoon c/o pain; still swollen almost to knee; redness around immun area; warm to touch; had some fever;
Presented to ER (April 26 th 2008) for fussiness, decreased appt and acting "strange" for several hours.  In ER passed large bloody stool.  BE showed intussusception.  Despite multiple attempts, it could not be reduced. Flown to Hospital.  Arrived early April 27th.  Exploratory Laparotomy after resuscitation ws performed by Dr.  In OR, he had reduction of intussusception with right hemicolectomy and ileostomy.  Total hospital stay was 10 days (D/C was May 7th).  He was re-admitted 2 days later for vomiting and dehydration.  He is now home.  5/29/08 Reviewed hospital medical records for 4/27-5/7/2008. FINAL DX: Intussusception Records reveal patient experienced irritability, reduced oral intake, inconsolable crying, abdominal pain, emesis.  Seen at outlying ER where BE revealed IS & initially reduced it.  Had bloody diarrhea & bilious emesis in ER & transferred to higher level of care.  Attempt to reduce w/air contrast enema unsuccessful & taken to OR.  8/8 Received operative report which reveals patient had exp lap, reduction of IS, right hemicolectomy w/ileostomy & central line placement.
12/17/21 physician's note: "The patient is a 74-year-old F with PMH of COPD, AS (awaiting AVR), OA and PAD who presented to the ER with a c/o feeling tired and SOB. She states that she has been feeling sick for the past 4-5 days. She felt very tired and started having a dry cough. She continued to feel sick and developed SOB and left-sided chest pain yesterday. No fever or chills. She tested positive for COVID in the ER. She was admitted to the floor and started on methylprednisolone for COPD exacerbation. She feels better today. She received her booster COVID vaccine on 12/09/21. Her husband has been coughing a lot for the past 2 weeks and he is going to get tested for COVID tomorrow. She remains saturating well on 2 LPM NC oxygen which is her baseline.  COVID-19 infection: 4-5 days into symptoms. Vaccinated (including Moderna COVID booster on 12/09/21 but possible exposure prior). Oxygenation at her baseline.  CT chest negative for new infiltrates.  D-dimer 1,371 CRP 0.4 Ferritin 86 2. COPD on chronic home O2:On 2 LPM at home. Continues to be on the same amount of oxygen.  3. Severe AS: awaiting AVR.  Plan 1. Pt. Early into symptoms and has multiple risk factors putting her at greater risks of progression. Will proceed with monoclonal ab. Risks/benefits/EUA status discussed with Pt.  2. Steroids for COPD exacerbation per Pulm.  3. D/C abx.  4. Prophylactic anticoagulation. 5. COVID High sens with cycle threshold number. "
Information has been received from a registered nurse concerning a 2 week old patient who on 08-Nov-2007 was vaccinated with a dose of Rotateq.  The patient was not experiencing any known symptoms.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of two reports from the same patient.  Additional information has been requested.
Blood work showed anemia after Shingrix; This case was reported by a consumer via call center representative and described the occurrence of anemia in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th May 2022, 2 days after receiving Shingrix, the patient experienced anemia. On an unknown date, the outcome of the anemia was unknown.   It was unknown if the reporter considered the anemia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for himself. The patient received Shingrix vaccine and then had blood work 2 days later. The reporter stated that his blood work showed he was anemic. The reporter did not have any more information about the vaccine. The reporter consented to follow-up. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022091791:Same reporter
Face and back have prickly feeling. Been 4 days and still itching; Face and back have prickly feeling; This is a spontaneous report from a sponsored program . A female consumer (patient) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (reported as on Tuesday) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got first vaccine on Tuesday. Face and back have prickly feeling. Been 4 days and still itching. The outcome of the event itching was not recovered, unknown for other event.  Information on the lot/batch number has been requested.
HE RECEIVED THE COVID VACCINE AT APPROX 11:00 AM ON 4 OCT 2021.  HE FELT FINE UNTIL HE AWOKE AT APPROX 2:00 AM ON 5 OCT 2021 WITH RIGORS.  HE WENT TO THE ER AT  HOSPITAL AND CHEST X-RAY AND EKG WERE UNREMARKABLE.  LABS WERE NOT COLLECTED.  HE WAS DISCHARGED TO HOME AND RECOMMENDED TO TAKE TYLENOL TO TREAT.  I SPOKE WITH HIM AT 4:00 PM ON 5 OCT 2021 AND THE RIGORS HAVE STOPPED, HE IS OTHERWISE FEELING OKAY.
01May96 pt recv 1 dose vax. 21Jan98 pt presented w/papulovesicular rash on back,neck,trunk,face & abdomen."blister-like varicella lesions". None scabbed.Febrile.
The day I received the shot, I started to feel severe fatigue, headache, light-headed, and started running a fever about 6 hours after the shot was administered.  The next day (4/6) was worse. Severe fatigue, muscle aches, headache, loss of appetite, fever (101.5 was the highest I notice but seemed to be around 101.1-101.3 all day), and general flu like symptoms. However, I also started experiencing abnormal menstrual bleeding. I am on the Depo shot and have been for some time. Due to this, I do not usually experience any menstrual bleeding so I found this to be a little odd. It was not heavy but it was noticeable and contained quite a few clots.   Day 3 (4/7) was about the same except my fever came down and ranged from 99.8-101.1. Abnormal menstrual bleeding continued. New side effect this day included diarrhea.   Day 4 (4/8) I started to see improvement. No fever (that I could tell). Remaining side effects included mild headache, fatigue, diarrhea, and abnormal menstrual bleeding.   Day 5 (4/9), I had one of the worst nose bleeds I've ever had in my life. I apologize for the graphic description but it lasted about 20 minutes and my bathroom looked like a crime scene after. Blood was pouring out of my left nostril and I threw two large clots that were about the size of slug (or slightly larger than a fun size snickers... I wish I had a better way to describe it). I've had some bad nose bleeds, particularly when I was on Accutane, and this was worse! The rest of the day I felt like I was improving. Energy levels were better. No fever. Menstrual bleeding stopped. Only lingering side effect was mild headache and mild diarrhea.   Since then I've continued to feel better and the diarrhea seems like it's improving.  Mild headache persists. Only new  item is an annoying twitch in my left eye that started on Monday (4/12).
Pain and tenderness in left shoulder (triceps) area for 5 days after shot. Pain progressively developed in left outer elbow where the triceps tendon attaches to the left  lateral malleolus.  Sharp pain  associated with extension of left arm . Local swelling and tenderness  in area of malleolus.  Problem continues and is getting worse!
HARD KNOT SIZE OF A PEA/NODULE IN HER LEFT ELBOW CREASE AND ON HER LEFT SHOULDER (AREA WAS SWOLLEN, WARM AND VERY SENSITIVE/PAINFUL; TIRED; DARK PURPLE VEINS IN ELBOW REGION; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dark purple veins in elbow region. On 09-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced hard knot size of a pea/nodule in her left elbow crease and on her left shoulder (area was swollen, warm and very sensitive/painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 10-APR-2021, and was recovering from dark purple veins in elbow region, and the outcome of hard knot size of a pea/nodule in her left elbow crease and on her left shoulder (area was swollen, warm and very sensitive/painful was not reported. This report was non-serious.
About 2-3 minutes after vaccination, patient became pale and lethargic, and proceeded to vomit
Immediately after shot was given I could feel my chest closing, and shortness of breath I also immediately felt nausea and light headed. I had waited for 40 mins prior to leaving to make sure I was okay to drive. I have since had shortness of breath and it has been almost 3 weeks now.   I was 20 weeks pregnant at time of shot, due on 12/18/21.   I am scheduled for my second dose on 8/28 but am now unsure if I will get it.
Patient reported light heade fullu recovereddness and had syncopal episode for few seconds. no  shortness of breath or respiratory symptoms. he was table with heart rate 98 and  oxygen 98%. patient is not taking any medications but did report has ADHD. Patient advised to lay flat with legs elevated after a couple minutes. Water offered. No medications and patient encouraged to hydrate. Patient left premise  once no ADHD. Patient fully recovered.
Pt called on 4/7/18. She received a shingles vaccine on Wednesday 4/4/18. She was told of mild side effects including muscle aches, but she had major achiness "all down left side of body". Pt states it was "extremely painful" was nauseated and vomited 4-5 times on the Friday and felt flushed and sweaty at times. When she went online to check out concerns because they were so severe, at that time she found there was a "class action lawsuit" so she thought it would be best for her to call in and report her symptoms. She does admit that no vomiting today, and feeling better. On 4/8/18, pt called at 4 am with new onset of rash or hives. She states about 25 whelps "like a horror show" itchy. No swelling of lips or tongue, no change in breathing. Nurse instructed to take BENADRYL and monitor. If hives worsen or other changes to call back and can be seen in urgent care. On 4/9/18 pt called back and stated rash is resolving, states is now dry and scaly, asking if SHINGRIX #2 is recommended.
Given both PNEUMOVAX and flu shot in right arm - within 48 hours developed fever to 103 with right arm redness and swelling. Seen in ER.
Within 15 minutes after H1N1 administration, skin on (L) arm looked like "goose flesh" and (L) arm had ice like feeling internally from wrist to shoulder. Lasted about 16 hrs. and was warm to touch/no numbness. Resolved completely.