chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching all over her body; swelling, redness, and hives about two inches around the injection site; swelling, redness, and hives about two inches around the injection site.; swelling, redness, and hives about two inches around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over her body), INJECTION SITE SWELLING (swelling, redness, and hives about two inches around the injection site), INJECTION SITE ERYTHEMA (swelling, redness, and hives about two inches around the injection site.) and INJECTION SITE URTICARIA (swelling, redness, and hives about two inches around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Runny nose, excessive cough that lasted for a few weeks, sneezing, soreness, headache, fatigue. Basically I felt like I had a flu but it only lasted for two days. The cough maintained for the next few weeks, almost a month.
Normal AEs -chills, fever, fatigue, and pain at injection site for first 24 hours. Then developed severe SOB and blue hands.
patient started feeling ill, vomited, sweating, lightheaded, continued to vomit and then stated it was panic attack
Pt had a varicella type rash. Will do home care of Tylenol/Advil and Benadryl as needed for itching.
severe tinnitus that started a few hours after the vaccine and lasted for 2 weeks after.  The tinnitus has persisted and is intermittent but occurs daily for long periods.  I also have experienced a noticeable hearing loss.  I have difficulty hearing  what people are saying and all sounds are muffled.  I did not have this problem or the tinnitus prior to receiving the vaccine.
My left arm under axilla became very swollen for weeks I could not put my arm down and is was the size of a softball, very painful, and warm to the touch with all both vaccines and booster given.
vertigo; hearing and vision issues; hearing and vision issues; significant headaches; This has affected my ability to work from the often; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown"; AUDITORY DISORDER (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "hearing and vision issues"; HEADACHE (non-serious), outcome "unknown", described as "significant headaches"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "This has affected my ability to work from the often".  Additional information: Patient received the first and second Pfizer vaccines for COVID and have been having vertigo, hearing and vision issues as well as significant headaches over the past several months. This has affected my ability to work from the often and I would like to know if others have reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
screamed, cried w/short breaks where would drift off to sleep-only to waken & start over-low grade temp x 2 days;pt slept quit a bit;next day screamed again then stayed up all noc;
After reviewing the first injection of Moderna covid vaccine I  begin to feeling itching and discomfort at the injection site but didn't get bothered much by it and considered as normal injection site symptom. A couple of days later, l noticed a red/ purplish in color circular itchy patch on the side of my breast then, more appeared in the chest area, then one on my right upper arm then another on the left side of my neck then two spots in the middle of my back. These spots had rapidly multiplied during the course of 2-3 weeks but mainly in the previous mentioned areas (chest back arms & neck. The second dose on 8/31 made them erupt more in the stomach and lower back area.
No adverse effects were reported; 3 PATIENTS WERE ADMINSTERED THE VACCINE ON MARCH 3, 2023; This spontaneous report was received from a healthcare professional (HCP) referring to a 76-year-old patient with unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The HCP reported a temperature excursion (TE) with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F temp on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023. Worst case scenario of 46.7F was used for the full 72 hours of the weekend per direction of the HCP.  The patient was vaccinated the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # W027449, expiration date 25-SEP-2024; strength and route were not reported) for prophylaxis on 03-MAR-2023 at the beginning of the excursion (product storage error). No adverse effects were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002750: US-009507513-2304USA002694: US-009507513-2304USA002746: US-009507513-2304USA002667: US-009507513-2304USA002696: US-009507513-2304USA002675: US-009507513-2304USA002696: US-009507513-2304USA002776: US-009507513-2304USA002932: US-009507513-2304USA002696: US-009507513-2304USA002840:
Maculopapular rash on trunk and upper extremities with pruritis. Took approximately 10-14 days to resolve.  I have never experienced such a rash or reaction to a vaccine or medicine.
Rash, itching/swelling around the site of administration. Wheal larger than a silver dollar, no leaking. Given BENADRYL at E.R.
Patient reported to reporter that she has been experiencing significant arm pain and reported that the vaccinator gave the vaccine high in arm (thinks it was jabbed into the shoulder). She has been experiencing this arm pain since the vaccine and will be following up with her provider because of it. She states it has been going on since the vaccine, which has been about 3 weeks ago.
Redness, swelling, left arm. Dx of cellulitis. Tx AUGMENTIN 875-125 1 tab 2x daily.
ANGIO EDEMA; SEVERE URTICARIA; This spontaneous report received from a physician concerned a 64 year old patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, rosacea, and shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 15-APR-2021, one month post vaccination, patient experienced severe urticaria. On 02-SEP-2021, patient experienced angio-edema and was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe urticaria and angio-edema was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210908058-covid-19 vaccine ad26.cov2.s- Angio-edema. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210908058-covid-19 vaccine ad26.cov2.s- Severe urticaria. This event(s) is labeled per RSI and is therefore considered potentially related.
49 Y M with a Hx of IDDM, HLD, who was admitted on 7/27 for SOB, found to have COVID PNA (s/p 1 dose of Pfizer 4/21), hospital course c/b worsening respiratory failure with O2 needs increasing requiring 40L HFNC 100%, was transferred to ICU care for iNO. Pt was given high dose steroids, Tocilizumab x 1 (7/28), remdesivir (7/30-8/1), and eventually weaned to 3L NC and transferred out of the ICU and continued on O2 weaning and steroid taper.    CORONAVIRUS COVID-19 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE Date of sx onset: 7/21/21, Date of positive test: 7/24/21. Patient tested positive 7/24/21, of note wife also tested positive and was admitted. Whole family was tested positive.  Pt was COVID positive on admission 7/27. No leukocytosis, afebrile, Cr 1.3 at baseline, but elevated inflammatory markers Ferritin, LDH, CRP, D-Dimer. CXR with diffuse patchy opacities. CT with extensive ground glass opacities. Found with COVID PNA, treated with Remdesivir (7/28-8/1), high dose steroids, tocilizumab x 1 (7/28, second dose was not given at the time due to patient being an ECMO candidate if needed and a desire to prevent further immunosuppression). He had worsening respiratory status requiring increase from 40LPM HFNC ->100% and was transferred to the ICU for iNO. He was started on Ceftriaxone (7/31-8/5) and Azithromycin (7/31-8/1), sputum cultures with staph. Inflammatory markers followed started to downtrend and were discontinued. Weaned to 30LPM and 30% FiO2, then weaned to 3L NC with >90% saturation. Transferred out of the ICU, with improving respiratory status. Steroids were weaned from methylpred 250 mg q12 (7/28-7/30), methylpred 125 mg q12 (7/31 - 8/2), dexamethasone IV 20mg (8/3), dexamethasone 10mg (8/4-8/6). Pt eventually requiring no supplemental oxygen, able to walk with >92% spO2, no SOB. Given steroid taper on discharge.    DM2  H/o IDDM, takes Lantus 45u and Metformin 1000mg BID at home. Pt was started on sliding scale insulin, continued to be hyperglycemic with BG in 200-300s given high dose steroids. Lantus was increased to 60 and then 70 units daily with high intensity sliding scale for better control. Patient able to tolerate PO as normal, home Lantus increased to 60 units while on steroid taper at discharge.
THE PATIENT SAID THAT SHE WAS FEELING LIGHTHEADED, ABOUT 5 MINUTES LATER SHE PASSED OUT. IT LOOKED AS IF SHE WAS HAVING A SEIZURE. SHE LOST CONSCIOUSNESS FOR ABOUT 2 MINUTES(?). SHE REGAINED CONSCIOUSNESS QUICKLY AND WAS SLIGHTLY CONFUSED, BUT QUICKLY SAID SHE WAS OKAY. SHE ADMITTED THAT SHE HAD NOT EATEN SINCE BREAKFAST. SHE SAT UP IN THE CHAIR AND FELT FINE ABOUT 2 MINUTES AFTER PASSING OUT. THERE WAS SLIGHT BLEEDING AT THE INJECTION SITE. THE PATIENT STAYED IN THE STORE FOR ABOUT AN HOUR. SHE CALLED WHEN SHE ARRIVED HOME TO TELL US SHE MADE IT SAFELY. SHE ALSO SAID HER LEFT HAND WAS TINGLY AND HER LITTLE FINGER WAS NUMB.
sore muscle around inj site & up into neck;small whelps formed on lower neck;disappeared in 48hrs;
pt recv vax & the next day devel an inj site rxn w/swelling, warmth & redness;by 30OCT rxn had extended to hand;dx as an allerg rxn;pt recovered;
I administered the Pfizer 5-11 Covid 19 vaccine (LOT FK5127, EXP 1/31/22) to patient intramuscularly on her left arm on 12/17/21 at 5:26pm. The patient appeared calm and did not show any signs of nervousness while giving the immunization. I gave her a fruit snack as a treat after the immunization. The patient's father, mentioned that they were having a normal conversation together and approximately 5 minutes after the immunization he noticed that she was pale in color and lips were blue. Patient then leaned into her father and fainted into his arms. He mentioned that she did not fall, he laid her on the ground, and called us for help. I immediately left the pharmacy with our immunization cart and supplies to assess the situation and help the patient. The patient appeared to be experiencing syncope. She was pale and mentioned that she was feeling dizziness, nausea, and weakness. While the patient was lying down, I applied cold compresses to her neck, face, and wrist. Patients father, called his wife at 5:38pm and she arrived within 15 minutes. We comforted her and continued to apply cold compresses while she was lying down. Roughly every 15 minutes after lying down, she attempted to sit up but still felt dizziness so she immediately lied back down to feel better. We attempted to get a proper blood pressure reading, but she was unable to sit up. This continued until about 6:45pm. Once patient felt better, Sophie's parents thanked us and dad carried her to the car to go home. I called them at 7:26pm to follow up on patient, they had mentioned that she was feeling a lot better and the color of her skin and lips were back to normal.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015 18:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I feel very tired all I want to do is sleep. Mild headaches. Cough. Body soreness.
Approximately 1 week after the injection and while suffering from constant heavy headache and extreme fatigue, excruciating shooting pain began in my head. They were random and severe. They did not subside until 3 days prior to my 2nd dose appointment on April 12th. Neither the headaches or shooting pain would subside with Tylenol or other pain relievers taken! Because I could not be guaranteed that these debilitating shooting pains would not return or be constant with the 2nd Covid dose, I chose to skip the 2nd dose and cancelled my 4/12 appointment.
rapid heartbeat; she has been having insomnia ever since she went to the hospital; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in the right arm in a hospital facility on 10Mar2021 at 12:30 PM (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks and had no additional vaccination administered on same date of the Pfizer suspect. The patient had no medical history (including any illness at time of vaccination. The patient had no family history. Ongoing concomitant medications included amlodipine besylate from 2019, vitamin D3 taken for general health, calcium taken for bone density, and fish oil taken for heart health. On 12Mar2021, the patient experienced rapid heartbeat. The patient continues to have rapid heartbeat "on and off." The patient asked if it was considered a severe allergic reaction. The patient added that she went to the ER and was admitted to the hospital on 12Mar2021 and discharged on 14Mar2021 due to rapid heartbeat. While hospitalized they did an electrocardiogram (EKG); and Echocardiogram and a computerized tomogram (CT) of the heart and chest and all showed no heart disease and no pulmonary embolism. Adds whenever she gets up and does some slight activity, her heart goes for about 30 seconds. Sometimes it goes from 70 to 115 and then goes back. also added that she was going to see her primary care doctor on 29Mar2021 about it. She was scheduled to get the next dose but she was asking if she should get the next dose. She also added that she has been having insomnia on 12Mar2021 ever since she went to the hospital and it was still happening because she was so anxious about this. The events did require emergency room visit but did not required physician office visit. Therapeutic measures were taken as a result of rapid heartbeat which includes amlodipine and metoprolol. The patient had not yet recovered from rapid heartbeat and insomnia.
Body & joint pain, shivering chills, some numbness on right arm and slight discomfort urinating. This progressed gradually from approximately 18 hrs. after I received the 2nd dose.At about 22hrs.-26hrs. I experienced the most severe of the aforementioned symptoms.After I awoke the next at morning at 5:00am  I still was feeling a little achy. By 10:00am I wasn't experiencing any symptoms.
Tightness on left side of throat Dizziness, vertigo, headache/migraine High fever (101-102.3), chills, sweats Severe body aches (stabbing pain in joints and lower back) Pain and tingling in left arm
light vaginal bleeding/spotting comparable to a light period; This is a spontaneous report from a contactable physician (patient). A 39-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 06Apr2021 at 17:30 (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included asthma and covid-19. The concomitant medications of the patient included mometasone furoate (FLONASE [MOMETASONE FUROATE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), vitamin d3 (VITAMIN D3) and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: UNKNOWN) on ana unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 09Apr2021, the patient experienced light vaginal bleeding/spotting comparable to a light period. Therapeutic measures were not taken as a result of event. The patient recovered from the event on ana unspecified date in 2021.  Follow-up attempts are completed. No further information is expected. Information about lot/batch number cannot be obtained.
Nausea; light headed; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3246, via unspecified route of administration in the right arm on 16Jan2021 13:45 at single dose for COVID-19 immunization. Patient medical history included allergy to dairy (milk allergy) and wheat. Concomitant medications were not reported.  Patient is not pregnant at the time of vaccination. On 16Jan2021 at 14:30, the patient experienced nausea and light headed.  No treatment received for the events. Outcome of the events was recovering.
I started getting pain from left to right hand (back of my hand, neck) and all through my arm, and shoulder joint pain. On my left hand I experienced pain all through my arm. I went to my PCP. They referred me to get an injection in my shoulder and recommended a muscle relaxer for extreme pain. I have had 5-6 appts for 4 months for Physical Therapy. My health insurance stopped the physical therapy after 20 sessions. The pain is still there some days worse than others. There's no day that I don't have pain. I'm not able to lift my hands. I require assistance putting my clothes on. This has caused me to not be able to do my normal activities.
Right thigh indurated, lateral aspect.  Hot to touch, erythematous, painful.
Vaccines given approx noon 11/07/2005 by that evening left arm became red, hot to touch, itching. Treated with hydrocortisone cream with partial improvement but still itchy. Exam showed urticarial rash, no swelling. Treated with oral Benadryl. Hydrocortisone cream with good results.
A physician reported the occurrence of Lyme disease in a 71 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis as part of a clinical trial. The reporting physician submitted this report directly to VAERS.  The subject's medical history, concurrent conditions, and concurrent medications were not reported.  In approximately 1997, the subject received his first and second injections of Lymerix during a clinical trial.  on 04/03/03, the subject was exposed to ticks and developed erythema at the site of a tick bite.  There were no systemic symptoms.  A Lyme IgG Western Blot performed on 04/07/03 was positive.  The reporting physician stated that Lymerix "did not confer immunity"; however, the subject had not received the recommended booster dose.  The subject was treated for Lyme disease.  As of 06/03/03, the outcome of the Lyme disease was unknown.
ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Severe migraine headaches, consistent, severe fatigue, consistent, every day since injection and still as of 10/31.
Fever, Syncope at 1215. Fever stayed until 0300 on 08/25/2012.  Rash and raised area 1cm by 3 cm long at injection site.
This spontaneous report was received from a physician via a company representative, and refers to a 15-year-old female patient. The patient had no medical history, concurrent conditions, concomitant therapies, drugs reactions or allergies. On an unknown date (reported as a couple of months ago), the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date not provided) for prophylaxis. On an unknown date (reported 3 days later), the patient's mother called to report that the patient experienced rash at the injection site. There were no lab diagnostics performed. The patient sought medical attention and was advised to take oral BENADRYL (also reported as no treatment was given for the event). On an unknown date, the patient recovered. The relatedness between the GARDASIL 9 and injection site rash was not reported.
Received Heplisav-B as 1st Dose and Engerix as 2nd Dose; Initial Report Received on 21-Jul-2021 and 22-Jul-2021  A registered nurse reported that a 22 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported.   No relevant concomitant medications were reported.   On 21-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 933624 and NDC # 43528-003-05; expiration date and serial # were not reported) in the left deltoid at a doctor's office.  On 20-Jul-2021, the patient received the second dose with Engerix (Lot # and expiration date were not reported). No adverse effects of the injection were reported.  At the time of reporting, no other information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.