chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Febrile seizure occurred on 12/28/2016. Bed shaking for 5 minutes. Fever of over 105.5 when ambulance arrived. Took over 20 minutes for her eyes to be able to focus on me. Oxygen initially low. Taken to ER. Started regressing in February 2017, with screaming, visual stimming in March as well as smearing feces. Started getting sick a lot. Seemed to do a little better by August of 2017. Another vaccine given in November 2017, which is reported separately for reaction to flu vaccine.
Booster dose provided outside specifications of EUA (last updated September 22, 2021)  Page 2  Booster Dose: A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered intramuscularly at least 6 months after completing the primary series to individuals: ? 65 years of age and older ? 18 through 64 years of age at high risk of severe COVID-19 ? 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19  First two doses 4/12/2021, 05/03/2021
He received Pfier (5-11year) and lost conscience and his face hit the ground. Called 911 immediately. 2 mins later he went back to normal and there is bruise on the right side of his face. Parents Ok to cancel 911 and take the child to ER directly themselves.
dizzy; muscle pain/elt like she was beat up; bad headache; This spontaneous case was reported by a physician and describes the occurrence of   in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported.   This case was linked to MOD-2021-283990 (Patient Link).
From PCP note: He has had some chills and fever. He has a rash over leg and into groin. He had a PNEUMOVAX on the right side, and it is fine.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored ROTATEQ (lot# R003111, expiration date: 12-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis. The vaccines had temperature excursion of 32 F to 35 F (34.9) for 1 hour 10 minutes and 47 F to 77 F (51.6F) for 1 hour 5 minutes Previous temperature excursion was 32 degree F up to 35 degree F for 3 hours 12 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
Itchy, red, raised rash 1-2 inches below injection site approximately 2-3 inches across at time of observation and at time of reporting.
UtI symptoms:  Intense pelvic pain and burning and lower back pain started 24hrs after shot.
On 2/9/2021 @ 9:16am client c/o a dry/itchy mouth after receiving her 2nd dose of covid 19 vaccination brand moderna Lot 024M20A. Injection site Left deltoid. Upon assessment, no swelling warmth or redness noted at the site of injection site. Vitals Temp 98.2 Bp 166/104  Hr 120 RR 18 pain 0/10, O2 97. Client provided water and advised to sit from additional 30 mins for further observation. Client verbalized she has a history of HTN, anxiety, and obesity. Client instructed to continue  resting and taking a few slow deep breaths and to finish as much of the water as she could. reassessed @ 9:40am T98.4 P91 Bp 140/92 Pain 0/10 O2 98. Injection site continues to be free of swelling , warmth, or redness. Client no longer c/o dry/itching mouth. Bc of previous diagnosis of HTN client is satisfied with current vitals and states she feels fine. Client Awake AO to x3(person, place, time) upon leaving  clinic via personal transportation.
Patient reported whole neck and upper thigh area broke out in hives.  Patient only complained of itching and reported taking Benadryl, which was alleviating her symptoms.
Information has been received from a 76 year old female with a rapid heart beat and allergic reaction to erythromycin and tetracycline who on 04-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # was not available). Concomitant therapy included a dose of influenza virus vaccine (unspecified), SYNTHROID and TOPROL XL TABLETS. Two hours later of the post-vaccination, the patient developed swelling on the injection site. The patient sought medical attention. As of 10-NOV-2008, the patient was recovering. No further information is available.
Redness, Sore and warm to touch for 3 days. Treated with Antibiotics.
HEADACHES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headaches was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 06Aug2022 as dose 4 (booster), single (Lot number: fp7137) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: I tested Covid positive after 3 continuous Covid test negative; Negative, notes: I tested Covid positive after 3 continuous Covid test negative; Negative, notes: Tested Covid positive after 3 continuous Covid test negative; Negative, notes: Tested Covid positive after 3 continuous Covid test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Mar2023 to 13Mar2023.
This case was reported by a nurse and described a 33 year old male subject who did not respond to immunization to the hepatitis B vaccine recombinant immunization series.  There were no concurrent medications.   On 02/08/2005 the subject received the 1st dose of Engerix-B.  On 03/17/2005 the subject received the 2nd dose of Engerix-B.  On 08/09/2005, the subject received the 3rd dose of Engerix-B.  On 09/16/2005, a hepatitis B surface antibody titer was less than 2 mIU/ml.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2016, the patient received expired dose of RECOMBIVAX HB second dose, lot # J012520, expiration date: 30-JAN-2016 (exact dose, interval, route of administration and anatomical location were not reported). There were no concomitant medications provided. There was no adverse effect reported. Additional information has been requested.
hives all over back, torso and neck; terrible migraines; This case was reported by a nurse via call center representative and described the occurrence of hives in a female patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   Previously administered products included Hepatitis b (the patient finished series many years ago). Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 14th October 2021, the patient received the 2nd dose of Engerix B. On 15th October 2021, 1 days after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced hives and migraine. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives and migraine were recovered/resolved.   It was unknown if the reporter considered the hives and migraine to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Engerix on 15th September 2021. The patient experienced terrible migraines and hives all over back, torso and neck. The patient did not have any trouble breathing but took 4 doses of Benadryl, then everything was down. The reporter inquired for Engerix, any information available with this type of reaction and how to proceed with third dose. The reporter consented to follow up.
Patient noticed twitching at injection site, lips, eyes, eyebrows and thigh. This began the night of vaccination. She also experienced minor chest pain in both sides of chest. SX lasted for 2 days then subsided on the 3rd and have completely resolved. She also had a mild fever (99.8) on the morning after vaccination.
Grandma yells out from lobby "She just had her covid shot and she almost passed out". This nurse and calls for other triage nurses and immediately goes to assess the situation. Instructed front staff to call 911 and  had MA notify a provider. Pt was then sitting in chair in lobby per grandma's instruction. Other triage nurse enters lobby with vital sign equipment. Pt then starts to jerk and becomes rigid for 5-6 seconds and then comes to again. When asked pt states her" head hurts" At this time there were providers involved. Pt was carefully lowered to the floor and instructed to lay back, in which she did with assistance. Vital signs were obtained per MA and WNL. Pt then denies headache and any further symptoms. Squad arrived at this time and took over pt care. Grandma was present through all.
he looks sick; really weak; right arm became sore at the injection site; right arm became swollen and is worsening; top part of his right arm was sore initially but now it is not sore like it was; dizziness; he can't straighten his right arm out; wore out since the shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), JOINT STIFFNESS (he can't straighten his right arm out) and ILLNESS (he looks sick) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01119121) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat cancer and Radiation therapy on 02-Dec-2020. Concurrent medical conditions included High cholesterol (and "complex nerve symptoms") and Drug allergy (certain "pain pills"). Concomitant products included PREGABALIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (wore out since the shot). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was) and JOINT STIFFNESS (he can't straighten his right arm out). On 01-Feb-2021, the patient experienced ILLNESS (he looks sick) and ASTHENIA (really weak). On 23-Jan-2021, JOINT STIFFNESS (he can't straighten his right arm out) had resolved. At the time of the report, INJECTION SITE PAIN (right arm became sore at the injection site) and INJECTION SITE SWELLING (right arm became swollen and is worsening) had not resolved and PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), ILLNESS (he looks sick), ASTHENIA (really weak) and FATIGUE (wore out since the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.
Swelling of my face, mainly around my eyes. So swollen I could hardly open them. As well as flu/fever like symptoms throughout the night.
High fever, chills, body aches, headache, stomach ache, nausea. Was not able to work. So far, it has lasted 1 day. Took Aleve to break the fever which helped.
A couple hours after the shot, I began to experience some local area soreness. After seven hours, I began experiencing body aches, and before I went to bed around 9PM I was experiencing chills. Throughout the night I had a fever. When I woke up at 9:30AM the next day, I had a headache and slight body aches. I took some Tylenol and felt better at about 12PM that same day.
R09.02 HYPOXIA 6/29/2021 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 6/29/2021 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 6/29/2021 BPH (BENIGN PROSTATIC HYPERPLASIA) R09.02 HYPOXIA 6/29/2021 ATHEROSCLEROSIS OF AORTA
Fever, rigors, chills lasting 12 hours managed with Tylenol, arthalgias and myalgias lasting 36 hours
I had really mild cold symptoms I had a lot of sneezing and a very stuffy head. No fever, cold symptoms lasted about 5 days 2 weeks after had about a 5 days of week of heart palpitations. It wouldn't stop for 5 days. When I walk my heat would get up to a certain number of beats. When I would do cardio exercises I would get heart palpitations. I didn't have any coughing or lung involvement issues. My primary care said I should get an infusion monoclonal antibody doctor recommended but would did get it setup for me and I should set it up. I was not able to get it because were saying it wasn't necessary. 1/5/2022 I had a consultation with my PCP.
After the shot patient experienced itchy face and back and had some whelps come on her back. She had flu shots in previous years without this experience before.  She took BENADRYL and it made itching better.
On Sunday night 22JAN2023 I started to feel stuffy followed by a headache the next morning with continued symptoms I took a home COVID-19 test which was positive later in the day I called my family physician, he told me he would prescribe PAXLOVID because of my age and condition. I started PAXLOVID symptoms continued for several days but within one week I was well and symptoms were never worse than a typical head cold. Being the generous I gave it to my wife and she followed with the same symptoms a week later.
Approximated 12-13 minutes after receiving the shot; my respiration increased, heart rate, and my vision became blurred.  I reported the blurred vision to the Pharmacist and she said they have not heard reports forth this symptom.  Based upon events following the injection relative to my blood pressure; it is likely that my blood pressure became elevated following the injection, resulting in blurred vision.  My blurred vision   resolved several minutes later.  However, my heart rate increased later that evening to the point I slept upright in my recliner that evening.  During sleep, I awoke from my sleep gasping because my heart felt like it was beating too slowly.  It has not been several weeks since receiving the injection, and during this time period, my Blood Pressure (BP) has been fluctuating from "very high" to normal.  Yesterday, I presented to the ER due to High Blood Pressure (145/100), by the recommendation of a NP.   I have NEVER had any history of high BP prior to the injection.
On 09/02/2022  I had headaches, congestions, extremely tired. The same day we did COVID-19 home test and was positive. I went to urgent care they prescribed us Paxlovid for 5 days. They told me to take  acetaminophen  as needed.  After 5 days I had a rebound. They prescription of Paxlovid again for 5 days. After that we had conference with my doctor on 09/20/2022. She said she will give me Paxlovid again but we didn't go that route.  I had to let it fight it by it's own.  On 09/25/2022 we tested negative for COVID-19. I stated recovering.
Pt in clinic for wic & immunization services. approximately 1 hr after receiving varicella and hepatitis A vaccines pt developed red blotchy rash initially on arms which progressed to lower back, and legs. Vital signs bp 100/50, pulse 110, R 30 T 98.8.  9.5ml diphenhydramine given po no wheezing or respiratory distress noted. after 15-20 minutes no visible improvement of rash noted and pt was observed scratching.  Pt referred to facility.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 003B21 and 003B21) for COVID-19 vaccination.     The patient's past medical history included Vitamin D deficiency, Tinea cruris, Hypoxemia, Iron deficiency, Gastric volvulus, Mastalgia, Vitamin B12 deficiency, Anemia, Fibromyalgia and Hernia repair. Previously administered products included for Product used for unknown indication: INFLUENZA (SERIES-1) on 18-Sep-2020, INFLUENZA (SERIES-2) on 15-Sep-2021 and Influenza vaccine. Past adverse reactions to the above products included No adverse event with INFLUENZA, INFLUENZA and Influenza vaccine. Concurrent medical conditions included Paroxysmal tachycardia (supraventricular), Postural orthostatic tachycardia syndrome, Urinary tract infection, Rheumatoid arthritis, Hypothyroidism, Hypertension, Depression, Back pain, Anxiety, GERD, Drug allergy (BUPRENORPHINE PTWK ( CRITICAL)) and Allergy to antibiotic (SULFAMETHOXAZOLE-TRIMETHOPRIM TABS (MODERATE0). Concomitant products included OMEPRAZOLE, SODIUM BICARBONATE (OMEPRAZOLE 20MG/SODIUM BICARBONATE 1100MG) for Acid reflux (esophageal), LORAZEPAM for Anxiety, BUPROPION HYDROCHLORIDE and BUPROPION HCL for Anxiety depression, HYDROXYZINE HCL for Dizziness, TRAZODONE HYDROCHLORIDE for Insomnia, SACCHARATED IRON OXIDE (VENOFER) for Iron deficiency, METHOCARBAMOL (ROBAXIN-750) for Muscle spasm, PROMETHAZINE HYDROCHLORIDE for Nausea, CYANOCOBALAMIN for Pernicious anemia, BETAMETHASONE, CLOTRIMAZOLE (CLOTRIMAZOLE AND BETAMETHASONE) for Rash, MIRTAZAPINE (MIRTAZEPINE TEVA) for Sleepy, GABAPENTIN, LEVOTHYROXINE SODIUM, VERAPAMIL HCL, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), CERTOLIZUMAB PEGOL and VITAMIN D3 for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter. Patient allergies medical history include hiatal hernia and observation and evaluation for suspected exposure to other biological agent. Concomitant medication include portable oxygen concentrator 1LMP per nasal cannula, hypoxemia. patient services due include HEMOCCULT or SIGMOID, TD BOOSTER BP DIASTOLIC, BP SYSTOLIC, PAP SMEAR,MAMMOGRAM, BREAST EXAM.
Fever began 8MAR94, ranged 102-103 through 10MAR94; cough & congestion; fever 104.9 R 11MAR93 w/90 sec febrile sz; nl CBC; fever, irritable 12MAR93 to 13MAR93 w/twitching muscles with high temp; pharyngitis 13MAR93 treated w/Cefixime;
Recurrent episodes of swelling, redness, soreness & warmth at site since 03/14/2003.
Information has been received from a nurse midwife concerning a 22 year old female who on unspecified dates was vaccinated intramuscularly with the three 0.5 mL doses of GARDASIL (LOT# not reported).  The patient had an annual exam and completed series of GARDASIL.  No additional information was provided for individual doses.  Later on the patient experienced genital warts.  The Pap smear was performed.  Unspecified medical attention was sought.  The genital warts were improved; but at the time of reporting, the patient's outcome was unknown.  Additional information has been requested.
received Boostrix, received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 9th November 2021, the patient received Boostrix .5 ml. On an unknown date, the patient started Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse stated that, the child received Boostrix vaccine instead of Flu vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered The reporter transferred to medical information team for guidance The reporter consented to follow up. This is 1 of the 4 linked cases, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER
Fever within 12 hours of vaccine. Fever 102.4 3 days rash 2 days after vaccine. Has some shakiness as well.
after vaccine pt started having diarrhea, myalgias, fevers, fatigue. All symptoms improving except persistent fevers
Right shoulder swollen with redness and warmth, needing close monitoring, Motrin around the clock, ice as able for 15-25 minutes
pt recvd vax; rt cellulitis p/ vax; adm to hosp for 2 days;
myalgias, fever (to 104), weakness was dehydrated,azotemic on presentation w/creatinine of 4.0;
mom states swelling & pain to lt arm 3DEC96;hot packs & APAP started Friday;6DEC96 talked to mom 1DEC96;instructed to cont hot packs, antiinflammatory med & elevate site to see MD;mom states arm much better 9DEC96;arm sore & red 12DEC96;
The shot at first just made me tired and a little dizzy a few times.  About a week later I noticed a rash and hives after showering all over my body.  I went to the doctor and he gave me prednisone.  I have finished the prednisone which didn't help.  I am wondering wether it is safe to get the second shot.
22FEB97 fever climax 105.5-ER MD found no signs of infect-assumed viral infect-sent home;26FEB97 sz (focal point) 11AM following morning of irritability, irrational behavior for babysitter;26FEB-1MAR97 total of 8 sz episodes-MRI nl;EEG abn;