chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27 year old male reports "redness and swelling with bumps on my eyes since Sunday".  Referred to vaccine healthcare center for probable autoinoculation following smallpox vaccine.  Also, noted new lesions on his trunk and legs last pm. Received primary smallpox vaccine (3 jabs, left arm) on 01/26/2005.  His smallpox vaccine site has followed typical progression, with reported pruritis of site.  Vaccine site assessed as "major reaction" on 02/02/2005.  Systemic tender, swollen gland in his left axilla on 02/04, which seems to be resolving.  On Sunday, 02/06/2005, patient noted some "bumps", redness, and swelling on his eyelids.  When he awoke on 02/07/2005, the eyelids were worse, and he sought evaluation at site where he received the vaccine .  he was evaluated by the FNP who consulted with the physician.  Patient was referred to Opthamology and was seen that morning, 02/09/2005.  He was also seen by the Dermatologist for evaluation of non-pruritic, acne-like lesions on his trunk and upper legs, which he first noted last night, 02/08/2005. patient denies eye pain, visual photosensitivity, blurred vision, or decreased visual acuity.  He does not wear contacts or glasses.  He denies any recent use of eye drops. Patient had received a general briefing on smallpox vaccine shortly after arriving with a separate specific briefing on small vaccine site care on the day of vaccine receipt.  He received trifold pamphlet on smallpox vaccine.  He denies illness or symptoms on the day of vaccine receipt.  Patient reports practicing frequent hand washing, specifically after touching vaccine site or bandages.  He has been keeping vaccine site covered with a 2x2 band-aid with adhesive on all sides or a standard band-aid.  He has been wearing a short sleeve t-shirt to bed with a standard band-aid over the vaccine site.  He thinks the most likely explanation of mechanism of autoinoculation would be that he scratched the site (under the band-aid) and then rubbed his eyes during his sleep.  His current living arrangements are with 3 other roommates (all recently vaccinated with SPV) in a barracks setting.  He has a tentative deployment date of 02/22.
woke up 3AM on 15OCT97 w/severe pain in arm & chills;took APAP & went back to bed;went to clinic 16OCT97 w/swollen & red arms;17OCT97 came to clinic to see MD & arm much better today;
That evening I was getting numbness in bottoms of my feet, My body was very heavy, had to think of how to move, over weeks, numbness on right side of mouth. Numbness and weakness in all extremities, especially right leg. Peaked 3-4 weeks after. Slow improvement of 6-9 months. No medication, saw a lot of specialists.  Numbness in limbs & mouth continue to flare up every few months.
Black and blue, raised, painful, lump, warm ----pt is going to take aleve
Narrative: Patient with multiple myeloma received first Moderna vaccines 2/3/21, 3/3/21 and final shot on 1/3/2022 (died 1/13/2022). Of note pt spent 6 weeks hospitalized with severe COVID Pneumonia around July/August 2021.
This child has a rash (looks like port wine hemangioma) around the DTaP injection site.
This case was reported by a nurse and described the occurrence of limb swelling in an 18 month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 7/9/03, the patient received Infanrix. On 7/10/03, one day post immunization, the patient experienced a more than usual reaction characterized by a large amount of swelling extending from shoulder to elbow, redness, and warmth. The patient was seen by the physician. The events persisted as of 7/16/03. Comment: The reporter indicated that two or three other patients experienced these events following receipt of Infanrix lot DTPA541E9. However, they are not identifiable.
Swollen leg few hours after vaccine given, black mark, then gave Tylenol, next day swollen right leg tender painful -> resolved in one week.
Twelve hours after the second shot I began to have fever and Intense headache. About sixteen hours in I tried walking around and head was pounding, everything felt heavy, and it worn me out to walk small distance in home. Hot and sweats. Fever got up to 102 F about 24 hours in. Extreme fatigue and slept the whole day. No appetite and drank lots of water. That next night had night sweats and woke up in pile of sweat. Next morning fever went down to 100 and headache was much less. Was able to make breakfast and move around my home again. By  48 hours in fever was gone and just slightly fatigued.  Arm is sore and red around injection site.
MOTHER CALLED 08/14/2019 STATING PATIENT HAD A RAISED RED INJECTION SITE (HALF DOLLAR SIZE) WITH NO OTHER SYMPTOMS.  WAS ADVISED TO DRAW A LINE AROUND INJECTION SITE AND CALL BACK IF IT HAD SPREAD OUTSIDE OF THE LINE THE NEXT DAY.  CALLED BACK 08/15 THE REDNESS HAD GOTTEN WORSE REDNESS HAD SPREAD OUTSIDE OF THE MARKINGS ON HER INJECTION SITE AND WAS RX'D CEPHALEXIN.
Symptoms: Rash and Urticaria Pruritus. Treatment: Diphenhydramine 25 mg PRN, Prednisone 5 mg MG Other.
At approximately 4:50 pm patient complained of feeling lightheaded and "woozy". Vital signs stable; 99% on room air, 123/67, HR 65. Monitored in room for 30 minutes. Symptoms resolved after about 20 minutes, only sore arm remains. Discharged at 5:15 pm.
Moderna COVID-19 Vaccine EAU  Swollen lymph nodes in neck, soreness in underarm, night sweats all occurring within the past 48 hours.
she had TIA  (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor said is ok to get 2nd covid 19 shot.
Mother reported that the patient received her first dose of Prevnar along with IPV (Aventis Pasteur SA), DTaP (manufacturer unknown), and Hib (manufacturer unknown) on 09/06/00 and subsequently developed a fever of 101.8 deg. F. and vomiting. One or two days post-immunization, she developed an ear infection. She was treated with either azithromycin or amoxicillin.
Both shots (my first was lot number ER 8730 also Pfizer) caused me to be covered in hives from head to toe for 4 weeks. I was without hives prior to injections both times. I do not respond to antihistamines which forced me to wait till the vaccine took affect. Then I had to take 2 rounds of medrol dose packs to relieve the hives on top of getting 2 injections of xolair every month (I have to split up the injections because they also caused me problems so I go every other week. I?ve been getting them nonstop for years). I took in total 4 dose packs of steroids to get my hives under control and prior to that it felt like I had chicken pox .  They caused me severe sleep deprivation and everything else that goes along with being covered in extremely itchy rashes. I know they say there aren?t any sulfas in the vaccine but something triggered my allergenic response and it was intolerable and insufferable.
Very sore, red, and swollen injection site approximately 3" by 4"; Sore, achy body joints; Temperature the first 12 hrs after injection 101.8 degrees F.
Patient was administered the monovalent Covid Pfizer vaccine instead of the intended bivalent booster and was discharged home. Upon discovery, the provider called the patient  twice and received voicemail messages. Clinic staff following up to reach live person to discuss.
Extreme fatigue, upset stomach, vomiting several hours after injection. Fatigue lasted 3-4 days, felt week and tired.
Unknown. I communicated with the patient who was a/o x4. Recommended no need to repeat vaccine.
Extremely sore arm started 12 hours after shot and woke her at night due to pain. Fever and flu-like symptoms started 24 hours after shot. Lasted one week.
my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent; my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bypass surgery" (unspecified if ongoing); "stent" (unspecified if ongoing); "pacemaker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), ASTHENIA (non-serious), outcome "unknown" and all described as "my heart has become weaker and to the point that last week; two week from now, I got a pacemaker;  I have had bypass surgery, I had stent". Therapeutic measures were taken as a result of cardiac disorder, asthenia.  Clinical course : Consumer stated, "Just curiosity, more than any kind, we have taken three of the Pfizer COVID-19 shots, very thankful for those to be out, but at the same time in the last couple of years my heart has become weaker and to the point that last week; two week from now, I got a pacemaker now, I have had bypass surgery, I had stent but it seems that in the  last couple of years other things happening related to my heart and I am not trying to do anything other than to wave a little flag and saying this is happening to me and if it is of any help to Pfizer, to know this and to follow up on it with my heart doctor. I would be more than glad to give information." When probed vaccine name: Consumer stated, "It is the COVID-19 shot. I do have my record so." When probed if consumer wants Pfizer to follow up with doctor: Consumer stated, "If that is the best time for you to do. I am trying to make Pfizer aware of this and if it is something that you have seen and heard about  then yes. I would like for you to follow up with my doctor to see if they can help and prove the drug in the future. You know that thing." Consumer was informed about the role of Pfizer Drug Safety and Pfizer medical information department and offered the number.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event. The vaccine administered on 3/30/22 expired on 3/17/22. Moderna tested the stability of the same lot number determined that the dose given was still protective against the Covid-19 virus.
blister; Received expired dose of tenivac; Initial information was received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 77 years old male patient who had blister and received expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2023, the patient received a standard dose (booster) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL total (lot U6922AA, expiry date- 22-Jan-2023) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of blister (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  On 21-Feb-2023 the patient developed a non-serious event of expired dose was received for diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expired product administered) (latency- same day).   It was reported, patient received and expired dose of TENIVAC. The patient had a blister on his finder. The caller is wanting to know if the patient needs to be revaccinated. No further information provided by reporter. Still using product : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (blister).  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Initial report received from a health care professional on 13 May 2010: This patient was vaccinated with MENVEO (batch no: 100003), (dose: unknown) intramuscularly on 29 Apr 2010. The patient was administered MENVEO without being reconstituted with the Men-A lyophilized component. No adverse event had occurred. The outcome of the event was not reported.
Maternal exposure during pregnancy; Arm Soreness; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Aug-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Whole body muscle ache, sweating, chills, fatigue. It feels like the flu.
Patient received immunizations on 1Jul 2020. developed o rash on her foot on 6 Jul. Seen in podiatry on 7 Jul and was given atarax. States the Atarax made her nauseous. 8 Jul she awoke with paresthesia's  bilater lower extremities. Exam demonstrated hypoesthesia bilat lower legs and decreased strength on left.  Concerned for Guillian-Barre Syndrome, she was sent to ER, subsequently admitted. Neuro consult confirmed GBS, and was managed with IV Ig.
arm was swollen, very red and very hard, hot to the touch, the size of their hand and; hey have limited range movement with their arm, and when they try to move it is painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful). At the time of the report, PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Treatment details included none
I have a fever of 101; This case was reported by a consumer via media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 2nd dose of Shingrix. On 7th August 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix today (on the day of reporting) and experienced fever of 101 degree Fahrenheit. Also inquired was this typical
Swelling of throat on left side, difficulty breathing/swallowing, heart rate more than doubled, ulceration of left tonsil, tingling in hand. Began management with antihistamines and NSAIDs ? symptoms persisted for ~36 hours.
COVID-19 like symptoms; Chills; Body aches; Heavy Perspiration; Extremely thirsty; Cannot sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), INSOMNIA (Cannot sleep), THIRST (Extremely thirsty) and COVID-19 (COVID-19 like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 positive). Concomitant products included TESTOSTERONE (ANDROGEL) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INSOMNIA (Cannot sleep). On 27-Mar-2021, the patient experienced PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), THIRST (Extremely thirsty) and CHILLS (Chills). On an unknown date, the patient experienced COVID-19 (COVID-19 like symptoms). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, INSOMNIA (Cannot sleep) had resolved. On 29-Mar-2021, PAIN (Body aches), HYPERHIDROSIS (Heavy Perspiration), THIRST (Extremely thirsty) and CHILLS (Chills) had resolved. At the time of the report, COVID-19 (COVID-19 like symptoms) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test (other-Unknown): had IgM and IgG antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information include androgen Treatment information included Tylenol .
Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022; Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2022 as dose number unknown, single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 01Mar2022 / Treatment of COVID-19 start date: 18Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid for Treatment of COVID-19 and experienced Covid rebound.
patient received undiluted Pfizer Bivalent indicated for 5-11. No adverse reactions noted during post vax observation
2 hours following administration of vaccine started irritability x 2-3 hours followed by 10-15 minutes episode of lethargy and eye rolling followed by complete lethargy then irritability again.
PATIENT STOPPED BY THE PHARMACY AT 3:56PM TO SHOW ME THE ODD SHAPED FOUR PLUS INCH RED RAISED WARM RASH OVER THE VACCINATION SITE. I ADVISED SHE SHOW IT TO HER DOCTOR OR POSSIBLY TRY AN ANTIHISTAMINE
22 month old female received DTap vaccine on 12/12/2006. Mother noticed child developed a large erythematous and indurated area on the left thigh associated with slight reduction in appetite over the past 1-2 days. Symptom: Erythema start: 12/13/02006 Comment: Over the left lateral and anterior thigh. Symptom: Edema at injection site 30-50mm Start: 12/13/2006 Comment: Induration primarily at the left thigh laterally. Symptom: Tenderness Start: 12/13/2006 Comment: At the initial inoculation site to direct palpation.
Patient 11 1/2 yrs old given COVID-19 vaccine for 12 yrs old -> adult. Incorrect dosage of Pfizer vaccine given
Injection was extremely painful.  Injection site was itchy and sore for a few days.  Fever of 101 for about 36 hours starting day after injection.  Round, hard lump (chick pea size) developed at injection site a week or so after injection.  Lump faded over 3-4 weeks.  Left a quarter size indentation about 1/4 inch deep.  My primary physician said there is muscle atrophy and the chemicals in the injection likely killed muscle cells.  Left arm is slightly sore.
Red fine rash over entire face  noticed the day after receiving first dose of vaccination. Presently still have the rash (10/29/2021@3:00pm will completing this form)
HERPES ZOSTER DIAGNOSIS IN TWO DOSE VARICELLA VACCINE RECIPIENT. She is immunocompromised: dermatomyositis. Takes prednisone and mycophenolate. RASH LASTED LESS THAN FOUR WEEKS. LOCATION: ONE DERMATOME. TREATED WITH ACYCLOVIR. Went to ER on 3/18/2014 for severe leg pain- could not walk. Admitted at Hospital from 3/18- 3/22.  No sign of rash- they thought it was Amplified Musculoskeletal Pain Syndrome. 3/20 she developed rash- on 3/26 it worsened and that's when they consulted ID. Positive vaccine strain VZV lab results reported on 4/2/14.
Per patient report, "Immediately upon receiving the vaccine I shrieked because I felt the shot shoot down my arm into my fingertips. I?m not sure if you were at the conference, but I am one of the co-chairs of the conference and I was given my shot when all the attendees were in the conference hall, so there were just the two nurses and a couple of us who were doing registration, etc. out in the lobby. We all laughed and joked about how we don?t usually hurt our own and just kind of went along with our day.     In any event, I am still experiencing extreme upper left arm pain that radiates down my left elbow, forearm and into my fingertips. I have extreme limited range of motion of my shoulder and was diagnosed with frozen shoulder due to vaccine administration. I am being treated for this and have started to see improvement."
Information has been received from a physician concerning a 2-year-old male with no pertinent medical history and no history of drug reactions or allergies, who in November 2006, was vaccinated with Varivax. Subsequently, the patient experienced multiple herpetic lesions in the groin, IGG and IGM titers were elevated. Medical attention was sought, and treatment included DENVIR. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
pt diagnosed positive for COVID @ SNF on 9/8/21, treated with dexamethasone, cefuoxime, and azithromycin; brought to ED with confusion, cough, SOB, abdominal pain, vomiting and diarrhea; placed on 4L O2 in ED; found to be dehydrated and with failure to thrive; renal function and respiratory status declined greatly and pt died in the hospital