chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 49 year old female consumer reported that she received an injection of influenza virus vaccine on an unspecified date sometime during 2002 and developed an "allergic reaction." The reporter indicated that she has experienced an allergic reaction to the "flu shot" for the past several years. She stated that she experienced a different reaction every year, and that the reactions became progressively worse. Initially, she developed an injection site reaction characterized by a red welt. In subsequent years, she developed swelling of the injected arm, a rash from the top to the bottom of her body, swelling of her body and an injection site reaction characterized by a painful, itchy, red welt. On an unspecified date during 2002, her physician administered an unspecified injection at the same time she received the "flu shot." The reporter indicated that the allergic reaction "cleared pretty quickly once the other shot was given." This event was considered medically important (OMIC). No additional info was available at the time of this report.
Received vaccination around 0930am, states started feeling dizzy and nauseated around 1030am - states started feeling worse as day went on - c/o chest pressure, shortness of breath, fatigue, N/V, dizziness. States she had not taken AM med and ate little breakfast - seen by EMS. Skin cool and clammy to touch 1245. Dextrose stick-67 - V/S - 162/104 - 72 - 18 - /EMS V/S - 160/87 - 81 - 18. Refused to go go ER.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-JAN-2017, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Child received 6 shots on 1/15/08.  Thursday, 1/17/08 child complained of pain in left arm, and areas that were numb. Mom also stated left upper arm was purple with a white center.  Mom took child to the ER 1/17/08.
The client complained of redness and swelling on 11/01/01 which got bigger than at the time of the injection. The client was seen by a physician and was prescribed an antibiotic for cellulitis. On 1/8/02, the cellulitis was completely resolved.
A week after the vaccination, 10/14/2021, I woke up with a slight fever and my whole body hurt.  I was really congested,  my head was pounding and one nostril was running and the other was stuffed up. I had a really sore throat, it felt like I was swallowing glass.  My symptoms  just let up today, 10, 19, 2021, I just finished my z-pack that my doctor called in on 10/14/2021.   Also on 10/14/2021- I did a hospital COVID-19 test through the  hospital drive thru  and the results were negative.
After given TDaP, IPV and HAV boosters while sitting on the exam table, patient got off the table, walked over to his Dad and was redressing himself; about this time he began to list to his left, fell against the base cabinet and then fell to the floor, striking his head on both surfaces; Dad then lifted him onto his lap, noted he was shaking a bit and that his eyes were rolled back; he gradually returned back to his nl self in about 5 minutes. I saw him shortly after his Dad picked him up, he was awake, moving a bit but quiet. Several minutes later he appeared to be acting normal and exam of HEENT, heart, lungs, and neuro (incl. cerebellar function) was normal. Intend to report incident to VAERS and try to determine what type of reaction he might have had, which of the vaccine components might have been responsible for it and how to proceed with future immunizations.
After receiving the vaccine, injection site was sore for 4 days. On 4th day, it was hot and red. On 5th day, redness was larger. Patient consulted the emergency room and received a 5 day course of cefuroxime 500mg. It resolved after treatment.
Redness and swelling developed, increasing until seen in clinic 02/10/2014.
Pt had a positive COVID test on 8/31/21 and was hospitalized, treated and dc'd; 9/26/21 Pt was brought back to ED from for low BP and increased pulse; presumptive dx of sepsis; given ABX; found to have a low Hgb and HCT; transfused with packed RBCs;  pleural effusion; thoracentesis; acute renal failure; did not want dialysis; on 10/3/21 his respiratory status deteriorated; transferred to ICU and was intubated; MRSA infection; status changed to comfort measures and he passed away in the hospital on 10/5/21.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was 1 month.  On 03-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  The patient was given doses from a vial that were stored in an ultracold freezer which was colder than they should have been.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
The following information is directly transferred from the office visit note 7/12/19- Provider:, PA HPI HPI Details: Patient is a 16-year-old female presenting today for concern about her right shoulder hurting.  Last Wednesday 7/3/19 she got her meningitis shot in the right arm and another in the left.  She admits to having shot anxiety and was tensed when she got injection.  The day after she had more pain.  Ibuprofen helped and applied ice.  It stopped hurting Monday 7/8/19.  No sports until she had gymnastics yesterday with floor routine and tearful because it hurt so much.  Ibuprofen and ice again helped.  Today is better but feels tight.  No swelling or redness at injection site.  She can't specifically locate the exact location that injection was  at.  She has not had any symptoms consistent with allergic reaction.  Mother is concerned because she is still having discomfort and has had a bad experience with another child that she thought could have possibly been related to immunizations.  Plan Plan: At this time hard to determine if pain is still in relation to the injection or not.  She had a pain free period after immunization only for it to start hurting again once doing gymnastics.  May simply need some more time to recover and after discussion on continuing conservative approach or more aggressive treatment with PT or even sports medicine referral they opted to continue with ice and ibuprofen prn.  She will not participate in cheer or gymnastics again until Sunday and recommended that she not do bars.  Could be unusual shoulder injury related to vaccine administration with concern about immune response causing inflammation in the bursa or joint or given into the bursa or joint itself especially if she did flinch or move related to her fear of infections.  They will call clinic on Monday for update to see how she is doing and proceed from there.  They stated understanding and agreement.
The night of vaccine, started to have nausea, lightheadedness, muscle aches. Progressed to neck pain and headache, and later to shortness of breath , chest tightness, and diaphoresis.
I had a slightly enlarged lymph gland in my left breast become tender.  It  had become larger, and so I got a mammogram, got called back for an ultrasound. The finding was enlarged lymph not.  I had gotten swollen glands following my 2nd. dose in my left armpit for a long time - as in over a month.  I have no idea if this is related. I think the mammo was in June; my online records are apparently down as I write.  The swollen gland is still there.
pt recv vax;approx 4 hr later, devel shakiness, thirst & malaise; T 103 & v; 5may95 PAR called; T 100; still malaise; not eating;
pt recv vax (MFR unk) in 1985 & devel hives;no further information is available;
Information has been received from a consumer concerning her 8 week old daughter who on 11-DEC-2007 was vaccinated with a dose of COMVAX (Lot # not mentioned).  The reporter reported that  after her daughter had her injection the injection site had a red welt at the injection site.  Her daughter was irritable, sleeping more and had upset stomach.  A telephone call was made to get more information.  No other information was available at the time of this report.  Unspecified medical attention was sought.  The patient had not recovered.  Additional information has been requested.
Swollen site on the opposite side of arm (opposite to deltoid where injection was given), warm to touch, pain in left arm and difficulty moving fingers. Spoke to the pt next day - sx seem to be subsiding. He took 2 TYLENOLS the day of and the morning after vaccination.
Swelling at site of injection 3 inches x 3 inches. Swollen lymph nodes under arm. Area of swelling hot to touch. Sore and tender in area of swelling. Subject seen at clinic 8/3/04 for second dose of AVA. All previous adverse event symptoms from dose # have resolved as of 7/31/04 per subject.
dies suddenly and unexpectedly; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 37 years old adult and unknown gender patient who died suddenly and unexpectedly while receiving vaccine Influenza Vaccine.  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 influenza vaccine (strength, dose, frequency and formulation: unknown) produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  The consumer commented that the list went on and on, and on and it was happening everywhere and was not normal. On an unknown date the patient died suddenly and unexpectedly (sudden death) (unknown latency) following the administration of Influenza Vaccine. This event was assessed as medically significant and was leading to death. It is unknown if an autopsy was done. The cause of death was reported as Sudden death NOS.  Final diagnosis was (fatal) dies suddenly and unexpectedly.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (dies suddenly and unexpectedly).  At time of reporting, the outcome was Fatal for the event dies suddenly and unexpectedly.; Sender's Comments: Sanofi company comment dated 04-Feb-2022: This case concerns a 37 years old adult and unknown gender patient who died suddenly and unexpectedly, after vaccination with vaccine Influenza Vaccine. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, medical history, concomitant medication, autopsy findings would be needed to rule out the alternative etiology. Based on the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: suddenly and unexpectedly
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement.  - Pt is being admitted for further monitoring
Information has been received from a nurse concerning a 13 year old female patient who on 03-SEP-2010 was vaccinated SQ with a 0.5 ml dose of VARIVAX (Merck) (Lot# 667240/0675Z) (Expiration date: 05-MAY-2012). The nurse reported that in approximately 03-SEP-2010, the patient experienced localized injection site pain of soreness, and redness of the left arm. On 06-SEP-2010, the patient could not move any extremities. The patient was sent to the emergency room, which resulted in a diagnosis of cellulites of the left arm. The patient was admitted on 06-SEP-2010, and discharged on 08-SEP-2010. At the time of the report, the patient was recovering. Patient could not move any extremities and cellulites were considered to be an other important medical events by the reporter. The patient's sibling experienced an Adverse Event with VARIVAX (Merck) (WAES# 1010USA01077). Additional information has been requested.
Patient had 4 episodes of diarrhea on Wednesday and nausea, still continuing with diarrhea today 10/20/2016, patient normally is constipated so this is very abnormal for her, just concerned.
20 minutes after vaccine- tightness under collarbone and halfway up neck, light headed Took Claritin resolved issue, 12/19 arm significantly sore at injection site and went away that night. Morning of 12/20/2020 -12/26/2020  Severe flare-up of fibromyalgia, fever Temp 101.9F, body aches, head aches,  overall exhausted Excedrin, Oxycodone, rest
pt recvd vax;same day at 12pm, exp urticaria on feet & ankles,body itching;dph started;on 13aug93 hives & body itching "pretty much gone";
About 3 hours after vaccination, intense headache began. My head felt like it was being pounded with a hammer, and the pain was so intense it traveled down from my forehead to my jaw bone. At around 3:00 pm on April 8, I began to develop a fever which first started at 100 degrees Fahrenheit. By around 5:00 pm, the fever had progressed to 102 degrees Fahrenheit, and the 700mg of Tylenol I had taken was not breaking the fever. I started to get body chills, muscle pain, joint soreness, and cold sweats. Again, Tylenol was not helping. I had no appetite and was having trouble keeping fluids down. Around 11:00 pm on April 8, I took more Tylenol and the fever began to break but did not fully break until 36 hours after the vaccination. It is now April 10 and I am starting to feel like myself again, but for a full 36 hours the pain was so intense that even a light sheet covering my body was painful.
Patient came in pharmacy to report that the night after she got her ZOSTAVAX vaccine (vaccine administered at 2:10 pm) her injection site has swollen up a little and it got larger the following day and also the soreness. However, she said it gets better today.
It began with extreme chills that turned into uncontrollable shivering, even with heat up and covered in comforters & down blankets (about 2 hours). Then the muscle aches began which were intensified by the shivering ( very painful for 2+ hours, then lessened overbite but still present today).  Joint soreness and pain (especially knees & wrists). Temp of 101.1 for at least 1+ hour by the time we checked prior to bed. A few very strong waves of nausea during fever spell, but that has gone away this morning.
Sore arm at injection site following injecting. Developed fever (school nurse stated 102.3) with nausea within a few hrs of 24 hrs. Very tired and emotional. Checked heart rate and was 178 resting. Call to pediatrician sent us to urgent care.  They treated with additional fluids and Motrin while observing.  Returned home same evening, continued to treat with alternating Tylenol & Motrin.  No additional nausea, fever and heart rate came down to normal within the next 24 hrs.
Contracted Covid, confirmed by PCR test. Symptoms: extreme fatigue for 2-3 days, then improvement, then recurring several times. Slight cough.
product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; ON Day 10 became sick again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 08Nov2021 at 12:00 as dose 3 (booster),single (Lot number: FH8028) at the age of 64 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "irritable bowel and diverticulosis" (unspecified if ongoing); "irritable bowel and diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: LINZESS, start date: 01Dec2021 (also reported as other medication in 2weeks). The following information was reported: ILLNESS (non-serious) with onset Apr2022, outcome "recovering", described as "ON Day 10 became sick again"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Tested Positive for Covid treated with paxlovid; (Apr2022) Positive, notes: tested positive on days 11 and 12; (Apr2022) Positive, notes: Positive on Day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid started on 15Apr2022 and Stopped on 24Apr2022. Therapeutic measures were not taken as a result of illness. Clinical course was reported Tested Positive for Covid treated with paxlovid. Severe symptoms Improved quickly and all symptoms were gone by Day 7. tested negative on Days 7-8-9. On Day 10 became sick again (much less severe) and tested positive on days 11 and 12.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
beginning 2 days after shot, woke up w/ puffy eyes, became to become more swollen including bridge of nose, cheeks.
red/painful at the injection sights.  Within 24 hours, her body from head to toe broke out in a measles like rash and she started having a fever of 103.  I took her to the hospital and she was given an iv with .9 saline.  Discharged home.  The next day, I took her to the doctor office.  Dr said it looked like hives and sent her to the emergency room.  ER gave her an antihistamine and more IV fluids.  Sent her home.  The day following, I took her back to the doctor's office.  They sent her to the ER again.  This time, they gave her steroids and fluids IV.  They couldn't determine if it was measles or not, so they sent her to another hospital via ambulance.   She was admitted to the pediatric unit and put in quarantine.  They wanted an infectious control doctor to rule out measles.   She received a lot of steroids and was on an IV for days.  They documented that she did not have an outbreak of measles but that she had a "virus" prior to receiving the MMR and it caused a rash resembling measles.  Staff still continued to gown up to enter the room she was in.
Individual developed urticaria on bilateral upper extremities, chest and face. Mild shortness of breath reported. ER provider documented no angioedema.
Pt developed swelling, warmth and erythema at injection site, 24 hours, post vax, extending from deltoid to elbow and left anterior chest. No fever. Started on steroids, antihistamines and some antibiotics.
About 25 min after receiving 1st dose, migraine headache, the right side of my body felt heavy and the muscles in my leg, lower back and neck hurt, I also had a lump on my right arm at the injection site.  Within 6 hours the heaviness and the pain in my leg and back were gone.   As of 12/26, the pain in the neck has decreased but it is still there, the lump in the arm still there and the migraine is still continual
Information has been received from a physician and medical assistant concerning a 14 month old male patient with no drug reactions or allergies who was vaccinated with the first, the second and the third dose of ROTATEQ, orally, (dose not reported) on 24-MAR-2011 (lot number 669073/1525Z), 03-MAY-2011 (lot number 668899/1075Z), and 19-JUL-2011 (lot number 669565/0064AA), respectively. Concomitant therapy included FLAGYL. Physician reported that the patient experienced "bowel perforation" and was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date) during which "he underwent bowel resection". Medical assistant reported that on 05-FEB-2012 (a week prior to the 12-FEB-2012, also reported as hospital admission date), the patient experienced a fever (only a symptom) and on 12-FEB-2012, the patient's symptoms included pain, distress, lethargy and vomiting. It was reported that on approximately 12-FEB-2012, an abdominal x-ray followed by CT scan (computed axial tomography) confirmed the bowel perforation. Physician stated that on 06-MAR-2012, the patient was readmitted to the hospital with a "bowel obstruction" and at the time of report was still on hospital. Medical assistant reported that starting on 07-MAR-2012, the patient was getting his colon flushed every 12 hours. The patient's outcome was not recovered at the time of report. Therapy treatment included "many meds given during hospitalization". The patient's outcome was not recovered at the time of report. "Bowel perforation", an indication for "underwent bowel resection" was considered to be other important medical event by physician (intervention to prevent serious criteria). "Bowel perforation" / "underwent bowel resection" and "bowel obstruction" were considered to be life-threatening and disabling by physician. A priority LOT check has been initiated. Additional information has been requested. The patient was hospitalized from 12-FEB-2012 through 21-FEB-2012 / 23-FEB-2012 (physician was unsure of the exact discharge date). Subsequently, on 06-MAR-2012, the patient was readmitted to another Hospital, and "was still confined to hospital" at the time of report.