chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gum swelling for a week; left arm has been numb; This is a spontaneous report from a non-contactable healthcare professional. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Jan2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced gum swelling for a week after receiving the shot and the left arm has been numb since receiving the shot. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events gum swelling was resolved on 31Jan2021 while that of left arm numbness was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
When the pt. was seen for her 1 year checkup on 2/1/12 she did not receive her 12 month vaccinations. The mother of the patient reported concerns regarding intermittent fevers, intermittent diarrhea and an abdominal "lesion" (which was later diagnosed as 2 epigastric hernias and an umbilical hernia). A review of the EMR indicates several notations of intermittent fevers, diarrhea and various rashes prior to the 1 year checkup. The pt. was seen again on 4/5/12 for a red, papular rash on her arms and face, a cough and congestion. She was diagnosed with eczema and an URI. The pt. received her MMR, HepA and Varicella vaccinations on 4/18/12. At her 15 month checkup on 5/1/12 it was noted that the pt. had macular blanching lesions scattered on her entire body and papular lesions scattered on her body with some in the scalp and an isolated dime sized brown/orange lesion on her forearm with a positive Darier sign (the Mother of the pt. confirms that this solitary brownish lesion was first noted when the child was 6 months of age). She was diagnosed with a viral exanthema most likely related to the MMR, referred to Allergy/Immunology for the history of intermittent fevers and Dermatology. The HIB #4 and PREVNAR #4 vaccinations were deferred. Labs for Hgb, Lead and Pediatric Airborne Allergy Panel were wnl. On 5/2/12 the Mother of the pt. reported that the infant's rash had changed and now was purple spots that looked like bruising. Upon questioning dark lesions were noted on the oral mucosa. According to the EMR the infant was seen at a ER and her platelets were noted to be 4. Peds Hematology-Oncology was consulted and the infant was transferred to hospital for admission. Labs were: ESR 25, CRP wnl, PT 13.2, INR 1.01L, and CBC with diff wnl except: HCT 31.7. Platelets NT, Neutrophils 1.3L and Monocytes 1.3H. The infant received IVIG without adverse event and was discharged at the Mothers request on 5/3/12.Repeat platelet count on 5/10/12 was 422 and on 5/17/12 was 289. No further episodes of ITP have been noted.
16 year old white male with history of spina bifida; shunt and latex allergy.  No shot records, came in for update.  Given Td, Hep B2, varicella #1, MMR2, IPV2.  Approximately given 9:45am. School called approximately 11:15 stating itching; hives, shortness of breath, called 911.
Felt nauseous at 17:00, progressed to chills, fever, temp not taken, general malaise, muscle aches, headache. Pt had to retire to bed at 20:00. Woke next morning feeling slightly ill, all symptoms resolved by 11:00. Pt took Advil.
Dose administered during active Shingles case/the second dose on; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (recurrent case of Shingles for the last 6 months).   On 01-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Dose administered during active Shingles case/the second dose on). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date 13 Jul 2023 A pharmacy intern called in to request information about the validity, guidance and recommendations for Shingrix in a patient whom has had a recurrent case of Shingles for the last 6 months, received the first dose 3 months ago during an active flare and the second dose on 12th of July 2023, batch number: y77xy, expiry date 21 August 2024 whilst dealing with another active flare. Information about the vaccine, patient and event was provided. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
I developed pain and swelling in my left leg. Increasing over 5 days. Went to Urgent Care on 11/18/2021. Had ultrasound of my leg that showed extensive DVT or thrombus in the left leg extending from mid thigh to mid calf. Diagnosis was unprovoked DVT. Started Lovenox injections as a blood thinner. Then, switched to oral Xarelto that I continue at this time.
evening of 10/4/99 pt could not move arms w/o pain by morning arm was red, pain down arms radiating to fingers & hives noticed by pt inj site;lt arm warm to touch;arm still sore but more mobile redness down & hives still present;
pt recv vax & 1-2 days later devel a huge area or redness & swelling @ the inj site;
Bad chills, light fever, light headed then after chills went away I passed out and became disoriented.
Per Pt report: Rash to upper neck reigon, insidious onset; spreading to chest, back, and R AC.  No pain at or near injection site to R deltoid.  No treatment proivded due to delayed reporting.
While laying down to sleep, I started feeling my heart was like   I was having an arrhythmia but it was continuous.  The arrhythmia I normally feel last only seconds.  So after fifteen minutes of having my heart like jumping all over,  I took my blood pressure five times in a row and all the readings were different from one another and high.  So I went to the emergency room and after they make several tests they admitted me into the hospital.  They treated me and about 5:00PM on the 29th of May, they finally had the atrial fibrillation under control and I was sent home.
Localized soreness immediately after shot. Within 48 hours exhibited soreness in joints and fatigue not related to any other possible causes.
Beginning on Thurs. 3/18 I have had daily migraine headaches. Very intense involving half the head. there is the main headache from the base of the skull up over forehead accompanied by shooting lines of pain. The headaches last for hours at a time, with very sore suboccipital muscles and neck stiffening. I have a slight warning that the headache is coming with flashes of head pain one to two hours beforehand, then the headache develops fully, usually when I'm sleeping and wakes me up at about 1 to 2 am. Because this is a brand new phenomenon, I have been treating with ice, lying on tennis balls placed at the base of the skull. To date I have not tried Zomig medication as I'm still trying to understand how these headaches work as they are so different from cluster headaches.
Arm red/swollen that evening (9/27/05). Rash appeared on legs following day (9/28/05). Full body rash appeared (9/29/05). ER clinic ran blood tests that doctor ordered chest x-ray, Benadryl.
04/02/2005 c/o rash on face, neck, legs, arms x 3 days. DX: chicken pox.
Migraines (aura, sensitivity to light and sound, confusion, extreme tiredness, nausea) resembling seizures every two weeks starting April 19th. 5 days after first dose.
Patient has a history of fainting after receiving injections.   Patient was seated at a bench and complained of feeling dizzy immediately after receiving the injection. Patient had her head lowered and I noticed that her arm had dropped. The patient passed out and was out for approximately 30 seconds. Pt regained consciousness on her own after 30 seconds and was very clammy feeling.  Her blood pressure was 102/68 and her temp was 96.6. I gave her an ice pack and she remained seated with her head lowered for about 15 minutes.  She recovered on her own after 15 minutes and was able to walk out of the store.  Her sister was with her during this and drover her home.
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female patient who on 26-FEB-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ORTHO-CYCLEN. On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to reports previously submitted on 3/14/2007. Initial and follow up information has been received from a license practial nurse (L.P.N.) concerning a 18 year old female stundent who on 26-FEB-2007 was vaccinated IM in left upper quardant gluteus with her first dose of GARDASIL lot #654389/0961F. Concomitant therapy included ORTHO-CYCLEN On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. In follow up it was reported that the lesion started 2 days after the injection. The patient's feet were painful night before. On 12-MAR-2007 complete blood count was done and the laboratory result of red blood cell count was 3.65. Hemoglobin 11.7. Neutrophils 64.4 and lymphocytes was 22.0. the patient was recovered. Additional information is not expected.
the DTaP-IPV diluent portion of the Pentacel kit was given by itself in the left vastus laterus, the ActHIB lyophilized portion was not given; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 11 months old female patient who received (second dose) DTaP-IPV diluent portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: ActHIB portion- UJ095AA, Dtap-IPV diluent portion- UJ108AA, Outer carton- UJ095AA, expiry date: 20-Jul-2024) via unknown route in the left vastus laterus, the ActHib lyophilized portion was not given.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if any adverse event occurred or not.  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 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.
Approximately two weeks after second dose she woke up one evening with swelling, stiffness and pain in joints. Took NSAID's and Tylenol. Went to see a Rheumatologist who did blood work and x-rays.
12/15/2021: Symptoms of COVID started on 12/08. Pt began decadron 6mg x 10 days. Start albuterol inhaler and pulmicort  12/16-12/17: Hypoxic on 3L. Began on IV remdesivir. Continuing IV decadron 12/18/2021-: Pt doing better. Supplemental oxygen currently at 2L. continuing medications 12/20/2021: Finished course of remdesivir  12/22/2021: Pt discharged. Continue dexamethasone
This case was reported by a healthcare professional and described the occurrence of passed out in a 9-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline).  On 25 February 2011 at 16:02 the subject received 1st dose of HAVRIX (.5 ml, unknown, left arm).  On 25 February 2011, less than one hour after vaccination with HAVRIX, the subject experienced passed out, fainting, sweating, fell off the exam table which caused head swelling.  The healthcare professional reported the subject did not eat well that morning so the physician did not know if this may have also resulted in what occurred.  This case was assessed as medically serious by GSK.  On 25 February 2011, the passed out, fainting, sweating, fell and head swelling were resolved.
Soreness at injection site; This is a spontaneous report from a contactable consumer. A 73 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on an unspecified date as single dose for covid-19 immunisation.  Medical history included high blood pressure. The patient was on high blood pressure medication but is not sure what the name of it was.  The patient experienced soreness at injection site on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
she is hard of hearing; not so well today; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 72 years old at single dose for covid-19 immunisation.  The patient medical history was not reportable and concomitant medications included pregabalin (LYRICA). The patient stated she is hard of hearing and not so well today(09Apr2021). Patient she was back and forth on getting vaccine not easy decision due to she is 72yrs old. Outcome for events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hives developed on L side of cheek 1 inch x 1.5 inches and R side of cheek- 0.25inch x 0.25 inch about 15 minutes after vaccine administration. other parts of skin: no rash, no anaphylaxis, angioedema, or acute distress. No difficulty breathing. Patient monitored for another 30 minutes and left the center in stable condition. Patient mother advised to bring patient to medical team if worsening or not improving. Also discussed red flags that warrant EMS/ED. VIS form given to the mother and educated on sign and symptoms and side effect of vaccine. treatment: hydrocortisone 1% topical cream.  patient was seen by different provider. during that time, patient has Urticaria with erythema noted to bilateral sides of face and upper back. PE-WNL, no other significant findings. treatment: Benadryl allergy 12.5mg/5ml oral liquid- administered 1ml by oral route. vitals were stable and patient was not in acute distress. patient was transported to ER via EMS for further evaluation.
Patient is beyond the recommended window for the second dose and still has not got it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it) outcome was unknown.        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.   No information regarding concomitant medication was provided.   No information regarding treatment was provided.
mom advises pt had constant screaming since 1/2hr p/shots, & shaking all over;taken to ER;t99R;MD advises cause d/t adverse effect of immunization;pt cont w/constant & persistent crying more than 3hrs;
Patient came in for 2 year WCC. MA looked at record and misread what patient was due for. Patient is due for 4 year vaccines on 7/22/19, MA gave them. Patient would have been due for KINRIX, MMR, and Varicella. Patient was given PEDIARIX, MMR and Varicella. Patient did not have any symptoms from vaccines. MA was called into office and asked if she could point out what was wrong with the record. MA noticed the date and the age of the patient. MA was informed that she would need to contact mother and let her know. MA gave verbal understanding. Manager is also notified.
Severe tailbone pain. It was hard to get back up and severe lower left quadrant pain (almost like I had a bad ovulation). I have only one ovary left - everything else has been removed but it was not on that side. It was like my whole back was separating and tearing apart. I've seen 14 doctors. 2 ER visits. Admitted once. MRIs - seven and two CT scans. I have had two ultrasound guided steroid injections. I have had a cyst respiration also via Interventional radiology. Pelvic organ prolapse - I found out I have it. I have Ischiofemoral Impingement and also Gluteal tendinopathy. And Hamstring tendinopathy. Iliopsoas bursitis.  I have had 2 steroid injections into my ischium; I have had: a cyst respiration - I have been going to Pelvic floor physical therapy and I have been going to regular physical therapy; I have been out on disability since June 3rd. I have not been able to sit down or stand up for any length of time.  My immune system may have just gone crazy and attacked connective tissue. I saw a doctor for the first time on Feb. 9th and had a physical done that day - an established care visit. He did all kinds of tests for me and everything came back normal. That was the day before my vaccine. I did not have anything happening like this before the vaccine.
Pt states that about 3 weeks after the vaccine, pt experienced pain in his right calf where he did not feel like he can put any weight on it. Pt states going to the doctor to check on the leg, ran tests, and also did an xray. Pt states the Dr did not find a clot and mentioned that perhaps it was a sprain/strain. The pt did not agree that it was a sprain and wanted the pharmacy to report this adverse event. No other side effects were reported. Recommended that pt goes back to doctor to get leg checked out some more.
SHOULDER ACHING, THOUGHT HE HAD INJURED IT.  STARTED TRAVELING DOWN ARM AND INTO FINGERS. CONTINUES TO ACHE 2 1/2 WEEKS LATER.  HURTS TO MOVE ARM OR GRAB ANYTHING. PAIN IS INTERMITTENT.  TOUCHING IT OR LAYING ON THAT SIDE AT NIGHT HURTS.
Papular rash to neck and torso 5 days post vaccine. Fever present 8 days post vaccine Fever resolved with 2 days.
Transient Ischemic Attack (TIA).   Treated at Hospital. Symptoms: inability to stand, loss of balance, slurred speech, extreme tiredness.  Stroke protocol with warfarin injection.  Observed overnight and released next day when symptoms subsided.  Placed on apixaban 5mg.
ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/22/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Highe fever of 101.5 within 12 hrs. Then URI and severe productive cough.  Lasted three weeks.  Visited urgent care on day 8.
Pt had Pneumovax and influenza vaccines at 10/16/2001 then had rash, pain and itching. Pt later had Steven Johnson Syndrome. The discharge summary states headahce, coagulopathy and hepatitis C.
Diarrhea Profuse sweating Chills (tempertures: 95, 94, 91, 95, 97.9) Fatigue Muscle or body aches Headache
COVID?19 Vaccine EUA- Patient was light headed and blacked out twice the day after the vaccine. No history prior to this incidence.
Pt developed a whole body, maculo-papular rash. No fever or real blisters.
My heart was beating too fast and i had chest pain , it was like something was ?? walking??? between my back ,my shoulders , my arms and my chest because i was feeling pain in my chest after a while the pain was kind of moving to go to my back  and after my  shoulder and my arms like i said it was like a ?? walking pain??.
around 9:45 p.m., sudden onset of forgetfulness, could not remember getting COVID booster earlier in the day. called 911 tranported to Hospital, given many test to include: CT stroke alert panel, echo cardiogram, PHVC cardiology consult, lab  Events occurred in peri-vaccination period for second mrna covid booster administration. Conclusion : a reactions to the 2nd moderna booster shot
First Covid Vac 06/15/2021  Second Covid Vac 03/07/2021, Third (1st Booster) Covid Vac 11/30/2021.   March 1, 2022  TIA Stroke, affected eyesight in left eye per doctors no known reason, perfect bill of health sent home with eye doctor follow-up appointments. Fourth (2nd booster) May 1 2022.    June 6, 2022 Multiple Strokes in each lobe of the brain, both frontal and back; affecting his ability to see, walk, talk, or take care of himself in any way.    October 8, 2022 TIA Stroke, affected speech  Patient has since tested positive for Covid in late 2022 since living at the nursing facility he is home bound to.
This initial spontaneous report was received from a 48 year old male consumer reporting on himself. The patient's concurrent conditions included psoriatic arthritis. History or drug allergies/drug reactions and medical history were not provided. On 17-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # K005402 with expiration date 07-NOV-2015; dose and route were not provided) as he would soon be on medication that could compromise his immune system. Concomitant therapies included meloxicam (manufacturer unknown). After the PNEUMOVAX23 injection, an unspecified pharmacist who administered the injection noticed that it was expired on 07-NOV-2015. The patient also reported on 17-NOV-2015 tenderness at the injection site (injection site pain). The patient sought medical attention (called the physician). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of injection site pain was unknown. The relatedness between the vent to PNEUMOVAX23 was not reported. Additional information has been requested.
Intense pain at time of shot, shooting pain down to elbow. Could not move arm for months (due to extreme pain). Pain eventually/slowly subsided. Immunization given in extreme upper deltoid per pt.