chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; HCP reported that GARDASIL 9 was not shaken before it was administered to a patient.; This spontaneous report was received from physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis (dose, lot #, expiry date, route of administration and anatomical location were not provided). The vaccine was not shaken before it was administered to a patient (wrong technique in product usage process). No additional adverse event was reported.
Received  #1 Vaccine  Friday  at 1pm Fri evening  about 8-9p My back(kidney area was sore) having  sharp pains throughout  my organs. Woke up Sat am,could not move, my whole body was in so much pain, My back,kidney area, stomach, uterus  area. I was in so much pain, could not get out of bed, felt like insides were ripped out. Right arm I couldn't  move,swollen. As of Tues 4/27 ,back still sore, but getting  around. I supposed to get my 2nd vax May 14, after  going  through this. I do not want to go through  this again.  I've given birth and had several  surgeries,  I could deal with all that more than this pain.
Onset the evening of 1-28-16 with general malaise, T. 100, mild nausea, and occipital headache. Around 11 p.m. noted (? onset) area of redness 4 1/2 in. x 6 in. on lateral aspect of left upper arm distal from injection site at left deltoid. Also noted 2 50 cent size areas of redness posterior from larger reactions. Gen. S/S intermittent through 1-30. Local reaction through 1-31. Treatment: TYLENOL; ice packs locally.
Pt admitted on 3/4 due to acute on chronic lower back pain and chronic debility. The pt was tested for COVID on 3/14 as required for transfer to Hospice and was positive, but asymptomatic.
Within an hour of receiving both vaccines, 1 & 2. I had a level 10 migraine.; Each time I through up at least ten times with such force, projectile vomiting.; lost so much weight; This is a spontaneous report received from a contactable consumer (patient).   A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8727) via an unspecified route of administration at right arm on 24Mar2021 (at the age of 57-year-old) as dose 2, single and received first dose via an unspecified route of administration at left arm on 03Mar2021 19:30 (Lot Number: EN6199) (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Chronic migraines; Mitral valve Prolapse. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL), atorvastatin, lorazepam, sumatriptan succinate (IMITREX). The patient previously took compazine [prochlorperazine edisylate] and experienced allergy, Known allergies: Compazine. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and since vaccination patient has not been tested with COVID-19. The patient experienced events reported as "within an hour of receiving both vaccines, 1 & 2. I had a level 10 migraine, each time I through up at least ten times with such force, projectile vomiting, lost so much weight on 03Mar2021 20:30. Patient reported that within an hour of receiving both vaccines, 1 & 2. She had a level 10 migraine. Each time she through up at least ten times with such force, projectile vomiting. 2 solid days and nights. 3rd day still had a horrible migraine but the vomiting stopped". she lost so much weight that she fell below 100 lbs. Now they are talking about a third vaccine and she was petrified to go through this entire event again. Both times she had to get a telemedicine appointment with her physician because she thought her husband would need to take her to the hospital. She made sure to stay hydrated before the vaccines as well as after the vaccine. The patient underwent lab tests and procedures which included weight: below 100 lbs on 03Mar2021 (I lost so much weight that I fell below 100 lbs). Patient stated that both occasions she received treatment with oral Fiorinal Tablets. Patient visited physician office for the events. Outcome of event vomiting recovered on an unspecified date in 2021 and remaining events was recovering/resolving.   No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Patient was to young to be given quadracel. There are no adverse affects. Patients parents were contacted and informed and will be vaccinated properly. Staff has been retrained regarding vaccines and appropriate ages.
Pt devel a well defined 5" lesion @ inject site ("contact type dermatitis"); Pt otherwise fine; Pt given DTP in opposite leg-no rxn;
This spontaneous report as received from a health care worker refers to a 5 year old female patient. The patients drug allergies and pertinent medical history was not reported. On 03-MAY-2012 the patient was vaccinated with M-M-R II (dose 0.5 ml) (lot # and expiry date was not reported, therapy status was not reported) subcutaneously in an unspecified location. Concomitant medications were not reported. On 03-MAY-2012, the patient was vaccinated with third dose of M-M-R II. No adverse effects were reported. The healthcare worker reported that this error occurred when they were converting their paper records to electronic records. No product quality complaint (PQC) was reported for M-M-R II. This case is linked to case # 1407USA011556 (same reporter link). Additional information is not expected as the reporter do not want to be contacted about the report.
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
Patient was into office for well child check up. Hepatitis A and GARDASIL given. Venipuncture started immediately after vaccines given. While doing 1 vial of blood for venipuncture, patient complained of "lightheadedness" and "dizzy". Withdrew needle and patient immediately fell forward. Laid patient back on exam table. Awoke within 30 seconds. Pallor and low heart rate monitored patient in office for approximately 20 mins after the incident and patient symptoms improved. Repeat venipuncture done at end of visit with no adverse effects.
01/26/2021, Went home, around that evening, I felt fatigue, sleepiness, around 2 am I woke with chills, sweats, headache, body aches, I had no thermometer to take a temperature but I took some advil, could not go back to sleep, next day I was fatigued, chills body aches. By Jan 28th, I started feeling normal again, only thing still felt was arm pain. By 1/29/2021, I was feeling completely normal again.
About 2 weeks after second shot have had cold sores; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 52 years old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 16Jan2021 at 10:30, as a single dose for COVID-19 immunisation. The patient medical history included asthma from unknown date. The patient did not received any other medications within 2 weeks of vaccination. The patient has allergies to medications, food, or other products and  Sulfa was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. About 2 weeks after second shot, The patient experienced cold sores one after the other so far four on 27Feb2021. Therapeutic measures were taken as a result of cold sores and included treatment with oral Famvir. The clinical outcome of the cold sores was recovering.   Information about lot/batch number cannot be obtained. No further information expected.
Severe Chills & Fatigue for over 2 hours during the night.  Also, mind started thinking the "worst" since lost sister to COVID in Dec.  Was crying hysterically.  Then complete exhaustion set in at approx. 11 am and slept for 3 hours.
No reported symptoms at time of injection, the injection was found post-vaccination to be a duplicate vaccine based on patient's history.
Red rash that lasted two weeks and is still slightly red and irritated. Used cortizone cream, which helped somewhat.
Sudden tingling and numbness in hands, I couldn't move my fingers for 2 minutes. My whole body started pouring sweat. My head got foggy and my vision got blurry and for a second. I vomited once and felt nauseous the rest of the night, and also felt like I had a migraine the rest of the night as well.
2 days after the shot there was crustiness on the admin site. The next day he had diarrhea, joint pain and pain in the muscle of the site. 5 days after receiving the shot his skin in the injected arm felt like it was crawling. 4-7 days after shot low grade fever 99.6 deg to 100 deg F (ear probe).
?Covid arm? I have a rash on my upper arm around the injection site, which itches and is sore.
18 hours past vaccination, developed skin mottling, itching, and headache persisted for 3 days. Improved after Prednisone IM, Hydroxyzine and benedryl.
Vaccination Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination Site Pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage, Carpal tunnel syndrome in March 2008, Tiredness, Tenderness, Cyst removal (Ganglion cyst removal) in 2007, Cholecystectomy in 2017, Tubulization nerve repair in 2019 and Abortion. Concurrent medical conditions included Alcohol abuse (Eight glass) since 1994, Tobacco user (Two packs of Cigarette per week.) since 1994, Medical marijuana therapy since 1994 and Latex allergy (Manifested by scratchy throat, swelling and hives.). Concomitant products included MESALAZINE (APRISO) for Crohn's disease.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination Site Pain). At the time of the report, VACCINATION SITE PAIN (Vaccination Site Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-589107, MOD-2022-589105 (Patient Link).
6/10/09 office visit- firm, red, tender, warm area on (L) thigh.
Severe shoulder pain. Inability to rotate shoulder without pain. Upper arm and hand swelling. Numbness from shoulder to fingertips. Extreme pain at site of injection. Night sweats.
Patient was given the monovalent vaccine in error when he should have received the bivalent vaccine.
PATIENT STARTED TO SLUMP OVER AFTER INJECTION, DID NOT PASS OUT BUT DID LAY ON THE GROUND WITH HER FAMILY AROUND HER.  WE GAVE HER WATER AND MOM FANNED PATIENT.  AFTER PATIENT LAYED ON THE FLOOR FOR AWHILE, SHE FELT BETTER.   DID LEARN THAT PATIENT DIDN'T EAT ANYTHING THIS MORNING AND WAS QUITE APPREHENSIVE ABOUT THE VACCINATION.  PATIENT LATER LEFT WITH FAMILY AND WAS FEELING MUCH BETTER
TIA came on approximately  44 hours after the shot. Rushed to urgent care. Taken by Ambilsnce to  Hospital, hospitalized 2 days and released.
One week post first dose: Swelling of left sub clavicular lymph node. Size of large grape. Swollen lymph has continued to be palpable and present since but at the size of a marble.
47 y/o female with history of rheumatoid arthritis who p/w increased sob. The patient notes she began to feel she had some sinus issues about a week ago. Her husband began to feel ill a couple of days later. Symptoms kept worsening and so they got tested on Tuesday for Covid, tested positive. They received monoclonal ab on Wednesday (yesterday). Patient has been very short of breath, not able to get around her home. She called her PCP after her O2 sats dropped from low 90s yesterday to upper 80s today on her home pulse ox, and her PCP told her to come in to be evaluated. Patient is fully vaccinated with moderna, husband with pfizer. She has not yet received her booster. Patient states that she has actually been home from work the last 3 weeks with an RA flare (and has started prednisone and increased the dose), she then got shingles after this. Patient at baseline is on plaquenil and also sulfasalazine. She states she just started a new injection Saturday (after covid symptoms started), but does not know the name (Kevzara by facility).  In the ER, patient with ABG showing 7.44/36/58. She is currently saturating well on 2L. CXR with bilateral infiltrates c/w covid. Admission requested.   Discharge Summary Information  Admit Date: 12/02/21 20:00  Discharge Date: 12/5/2021 14:33:59  Discharge Diagnoses:  1. Pneumonia due to COVID-19 virus, Discharge, 12/02/2021 2. Acute hypoxemic respiratory failure, Discharge, 12/05/2021 3. Acute heart failure with preserved ejection fraction (HFpEF), Discharge, 12/05/2021 4. Rheumatoid arthritis, Discharge, 12/05/2021 5. Hypokalemia, Discharge, 12/05/2021 6. Obstructive sleep apnea, Dischrge, 12/05/2021 Hypoxia, Discharge, 12/02/2021 Secondary Diagnosis and Comorbidities: Hospital Course   This is a 47 year old lady with a PMH of RA who presented to the ED with shortness of breath. Fully vaccinated against COVID, recently started on new injection for her RA. She began to feel poorly about 1 week prior to presentation, 11/28. She began to worsen, she underwent COVID testing with her PCP and was positive on 11/30, received monoclonal Ab infusion on 12/1/21. ABG on presentation 7.44/36/58 on RA, started on 2L NC, started on remdesivir, dexamethasone, and admitted. CXR with cardiomegaly and bilateral airspace disease. She was started on IV lasix. Echo with preserved EF, G1DD, right heart without issues. She improved, she was able to stay off supplemental O2 for 24h, was able to ambulate throughout room on RA without issues. She did have electrolyte abnormalities that were corrected throughout her stay. She will be discharged home today. Complete PO dexamethasone as OP. Started on PO lasix, also PO potassium supplementation. Will need follow up with PCP, will need repeat BMP, potassium as an OP. She will need to follow up with her PCP, possible cardiology referral as an outpatient. She has been given isolation and booster shot recommendations, these are included in her discharge paperwork
numbness and tingling in fingers and feet, dizziness, blurred vision that progressed to shortness of breath, rash, tongue swelling and inability to feel legs
Muscle ache; doesn't feel all that great; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) and FEELING ABNORMAL (doesn't feel all that great) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Apr-2021, the patient experienced MYALGIA (Muscle ache). 01-Apr-2021, the patient experienced FEELING ABNORMAL (doesn't feel all that great). At the time of the report, MYALGIA (Muscle ache) and FEELING ABNORMAL (doesn't feel all that great) had not resolved. Not Provided          This case was linked to MOD-2021-065209, US-MODERNATX, INC.-MOD-2021-065209 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-065209: US-MODERNATX, INC.-MOD-2021-065209:Husband case
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient felt N/V post vaccination. Patient vommited twice. BP: 110/70 HR:  74 O2: 99% After resting, patient was able to leave feeling better accompanied by parent. Clinic staff assisted with the situation.
Initial report was received from a consumer, who was also the patient's husband, on 20 November 2012. A female patient (age and date of birth not reported) had received an intramuscular injection in the left upper arm near shoulder area of FLUZONE HIGH-DOSE, lot number U4498BA, on 21 October 2012. The next day, on 22 October 2012, the patient's left arm and shoulder was very painful and had limited motion resulting from the injection. A physician referred the patient to a rehabilitation group for treatment. The symptoms persisted at the time of the report and the patient continued to receive physical therapy. The outcome was not recovered (also reported as unknown). Documents held by sender: None.
pain/soreness in arm where shot was administered; feeling of pain extending beyond arm to back of shoulder; low grade fever; This is a spontaneous report from a non contactable  consumer. A non pregnant female patient of an unspecified age received the first dose of  bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm  on 21Jan2021 at single dose for covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced pain/soreness in arm where shot was administered  on 21Jan2021 with outcome of recovering , feeling of pain extending beyond arm to back of shoulder  on 21Jan2021 with outcome of recovering , low grade fever  on 21Jan2021 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
16 yo F presents to clinic with possible vaccine reaction or viral illness. Pts mother states pt came in on 6/12 for WCV and was given the 2 meningitis vaccines. Pt states immediately after the vaccine site on upper right arm became swollen, over the rest of the day it became progressively more swollen and irritated. Redness resolved over the next 1-2 days. However, pt states the next day she began experiencing stomach pain, nausea, diarrhea, night sweats and states felt "disoriented." Diarrhea has been loose, not watery and 2-3 times per day.  Pt has still eaten normally with her Weight Watchers  parameters and has not skipped meals or snacks or had abdominal pain.  Pt had gone to amusement park and a concert in the 2 days before her WCV and may have picked up something there.
dizziness; high blood pressure/ at 175/110 when normal BP is at 120/70; swelling of tongue/ tongue swelled but did not close up; felt pretty sick; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient was vaccinated at a clinic. Medical history included Lyme disease, bell's palsy and neurological pain all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient reported that she had her first dose of the PFIZER BIONTECH COVID19 vaccine on 02Mar2021 (reported as a month ago). Also seeking assistance if we had any study as to patients who participated in the clinical trial with co-morbidity specifically to that of the Lyme disease. The patient also reported that she had "bad reaction" towards the vaccine that lead her HCP  to decide that she should no longer take the second dose of the vaccine. The patient said prior to this that she had Lyme disease, bell's palsy and some neurological pain. Also severe adverse events she experienced immediately after taking the first dose (02Mar2021) are dizziness for many hours, high blood pressure taken by paramedic to be at 175/110 when normal BP is at 120/70. Also experienced swelling of tongue after 15-20 mins post vaccination and felt pretty sick after days after. Also she mentioned that she can't have epinephrine for her severe adverse reactions to the vaccine. The patient was recommended not to take the second dose of the vaccine as she had severe adverse reaction during her first dose. The patient is asking assistance if she can be issued a certificate or a form that would state this for the purpose of international travels. The patient also inquires on any studies on the covid-19 vaccine and Lymes disease, as she had Lymes disease several years ago and had bells palsey, states she reacts to vaccines badly, the patient had her first dose of the covid-19 vaccine on 02Mar2021 had immediate dizziness for many hours, blood pressure was elevated, tongue swelled but did not close up, and cannot have epinephrine and was advised not to have the second dose of the vaccine. The patient also needs to travel overseas to visit with her mother and is asking if there is a waiver or something else she will need in order to travel. The outcome of the events was unknown.   Information on Lot/Batch number was not available. No further information is expected.
Moderna COVID 19 vaccine ADR.  Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.
Left axillary lymphadenopathy with tenderness and swelling, headache, malaise