chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1) Vomiting 10-1-07 and  10-2-07 - IV hydration 2) Mucousy bloody stools 3) Intussusception of the ileocolic was then reduced on 10-3-07 by gastrographing enema.  10/26/07 Reviewed hospital medical records which reveal patient experienced vomiting.  Seen in outlying ER for viral enteritis & rehydration.  Continued vomiting & then developed mucusy-bloody stools.  Suspected IS & transferred to higher level of care.  Admitted 10/3-10/4/2007 s/p reduction for observation.  Progressed well & d/c to home. FINAL DX: Intussusception, ileocolic, enema reduced.  12/14/07 Linked report from provider which included the vax dose & lot #'s.  1/8/08 Received vax record from provider which confirms report.
Increase in blood pressure, irregular heart beat, confusion, light headedness, upset stomach, lethargy, dizziness
Patient came to the pharmacy on Saturday 9/30/2023 and reported he had been experiencing left shoulder pain since April.  He received Shingrix on 4/7/2023 and Prevnar on 4/21/2023.   He thinks it started after 4/21/2023.  Pain is worse when raising his arm.  He has not tried any OTC medications.
Patient called and said that she has dizziness, vomits, muscular weakness and soreness, unbalance and she felt weak. she also said that she was in bed for a least 2 days. In second day, she goes to the doctor and he told her that she had a cellulitis in the arm and she was dehydrate.  He put  normal saline iv and give a prescription for antibiotics, anti-inflammatory and anti-emetic.  Until todays date she still felt weak, with unbalance and pain.
1. Immediate itchiness in the throat (similar to allergy reaction to kiwi), which I did not recognize at side effect at first.  After leaving the site,  in about1 hour,  it escalated to stronger itchiness and clear allergy sypmtoms. Used 2 pills of Benadryl and it became better. Over the next few days allergy came back in the evenings (different form: red spot on throat).  2. Also, over next few days after the vaccine I experienced fogginess in brain, slight fever, and elevated blood pressure (which is usually low).  Not yet fully recovered
Information has been received from a physician assistant and a nurse referring to an 28 year old male patient. Patient had a history of a reaction of nausea and vomiting to VICODIN. On 29-JAN-2015 the patient was vaccinated with his first dose of M-M-R II injection, 0.5ml, lot # J008534, expiration date 12-JUL-2015, subcutaneously in the right deltoid. This was the patient's first vaccine in entire life. Concomitant therapies included RITALIN. The physician assistant reported that on 11-FEB-2015, the patient experienced a rash which began on his face described as little, red areas which were individual fine papules and small lesions, looked more like a vial rash and discoloration of skin. And the rash did not itch and rash was also on the patient's torso, front, back and upper arms and very slightly on legs on this day. The patient had a sore throat for a couple of weeks since an unspecified date and a fever for 24 hours since an unspecified date before the rash appeared. The patient was treating himself with ibuprofen for his fever. The patient sought medical attention at student health center on 11-FEB-2015. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
Pt began with fever following immunizations. Fever increased 104.4 degrees. Mother states pt had no other symptoms.
Narrative: Patient presented to urgent care 4/9/21 with peripheral edema and falling after starting gabapentin on 3/22/2021, and was admitted for 1 night. Of note, patient received a COVID vaccination 3/25/2021 which may have contributed to adverse event. Symptoms: , 1. ATAXIA; EDEMA Treatment Drugs Used: 1 - FUROSEMIDE (FUROSEMIDE 40MG/4ML SOLN,4ML) Dose: 40 Units: MG Freq: ONCE Route: IV 2 - FUROSEMIDE (FUROSEMIDE 40MG/4ML SOLN,4ML) Dose: 40 Units: MG Freq: ONCE Route: IV
headache; blurred vision; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced headache and blurred vision. On an unknown date, the outcome of the headache and blurred vision were unknown.   It was unknown if the reporter considered the headache and blurred vision to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received Flu vaccine (brand name not provided) and experienced headache and blurred vision. This case has been linked with case US2019184323 reported by the same reporter.
A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a patient (unspecified age and gender) for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
After receiving all of the above vaccines, client became dizzy and lightheaded upon standing and collapsed to the floor.  Able to return client to a chair, complained of ringing in his ears, he was also pale and diaphoretic.  Vitals - BP 90/68, temp. 96/1, pulse 60.  Client given some water to drink and a cold compress given for face and neck.  Client allowed to rest for about 20 mins and stated that he was fine and was able to walk out on his own.
weakness down one side of her body; Fell; This non-serious case was reported by a physician via sales rep and described the occurrence of weakness in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy, COVID 19 VACCINE and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy, the patient experienced weakness (Verbatim: weakness down one side of her body) and fall (Verbatim: Fell). The outcome of the weakness and fall were not reported.   It was unknown if the reporter considered the weakness and fall to be related to Arexvy.     It was unknown if the company considered the weakness and fall to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient was in her 80s. The patient was vaccinated at pharmacy with covid, flu and Arexvy at the same time. The patient reported weakness down one side of her body and she fell. Doctor was wondering if the combination of these 3 vaccines (covid, flu and Arexvy) caused the side effect. It was unknown if the reporter considered the weakness and fall to be related to Covid vaccine and Flu vaccine.    The reporter consented to follow up. This case was linked with US2023AMR147038, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR147038:Same reporter
fatigue, high fever, sore throat, rash consistent w/measles, Koplik's spots;
pale, tachycardia/palpitations, hives in the right neck, right chest and abdomen nausea, numbness of right arm (at injection site) and lips All symptoms occurred simultaneously within 5 minutes of receiving injection
Patient hospitalized 7 days after developing symptoms of COVID-19 - tested positive prior to admission.
I had a headache for about a month. I had a CT scan 8/31/2021, I was diagnosed with ground class and advised to contact my primary care doctor. I had another CT scan in 1/2022 to see if the ground glass was still there. It was still there but it changed, some of it was gone and there were new parts. My current lung capacity is at 72 percent. Its supposed to be between 80-100 percent. The doctors aren't super concerned, it's not looking like cancer but I do have a cough that has persisted for about 5-6 months and runny nose and mucus.
3.5" reddened circle around area of inject swollen & tender; H/a for five days; This rxn was called to the office by the pt; She was not seen again;
Given DTaP/IPV on 8/12/03 - Mom noticed late in day on 8/13/03 grapefruit size redness and swelling on left upper arm-hot to touch. No temp, pt given Motrin every 6 hours PRN, Benadryl every 6 hours PRN, ice to area.
On the 15th, the pt received 3 immunizations- DTAP, IPV and MMR. Mom noticed right arm swollen, red and warm that night. Presently (04/16/2004), the upper right arm has increased warmth, swollen and erythematous with almost 1/3 increase in diameter of arm. It is slightly tender, but pt had full range of motion. Good circulation and no lymph nodes involved and afebrile.
Moderna COVID-19 Vaccine EUA  -  In the night I wokeup feeling like all my muscles were being torn from my bones.  Never had such pain.  I took 2 tylonia around 3am.   I finally after hours took 2 Aleve and by dinner time I did feel better.  Layed around the rest of Saturday.  Got a slow start on Sunday but felt okay.  No fever, or headache
Severe local reaction w/ erythematous blanchable rash 10cm x 15cm around injection site. No systemic symptoms.
Began having SEVERE itching all over my body, flushing, and feeling as if I were running a fever, severe head and body aches, and nausea. After a couple of days everything went away except the headache, muscle aches and general feeling of being "run down", and then I began experiencing severe muscle pain and burning in my right upper back and shoulder blade area. This continued and got progressively worse until I was nearly bedridden from the pain on October 5th, and then a painful, burning rash developed overnight. I went to the doctor and was immediately diagnosed with shingles, and am currently being treated with Acyclovir 800mg five times per day, a Medrol dosepack, and Hydrocodone for the pain. I am 41 years old and have never had shingles or the shingles vaccine, but did have chickenpox at the age of 15. I have learned over the last couple of days that many people have reported developing shingles within several days of getting the flu vaccine, and decided that my situation should be documented as well.
Patient was given a vaccine on 11/6/ 21 that expired on 11/5/21.
had the first shingles vaccination, still got the disease; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details reported were as follows: The age at vaccination was not reported. The patient received 1st Shingles vaccine and still got shingles. The patient advised others to take vaccination if not received yet. Follow up would not be possible no contact details provided.
pt recvd vax 19JUN92 in AM by 3PM started running temp, vomiting; pt given Pedialyte which did not work; t104 ax; took to ER 9PM that noc was lifeless acting, vomiting; given APAP supp/Phenegan supp; next day fine;
Dizzy, real weak, Head ache, Fever, Vomiting, couldn't walk with out help
Tingling in left arm; swelling at injection site, red and tender to touch. Treated with Benadryl, Medrol Dose Pak, and heating pad.
PC from patient's grandmother stating the day after the patient received the flu vaccine she started running a fever of 102.2, grandmother states the fever was brought down with liquid Tylenol. Grandmother states she ran a fever of low grade temp of 100 degrees yesterday and states she has not run a fever in 24 hours.  Grandmother asked RN if a fever was a side effect of the flu shot.  RN counseled grandmother that the influenza vaccine was a inactivated virus and should not cause a fever.  Grandmother reports no other symptoms that the fever.
Basically I was running a fever for two days after the next day after the shot. The symptoms were getting worse so I went in for a check up and they did a COVID test. That came back positive. I was out for about a month and a half.
Cellulitis developed 36 hours after vaccines given. She was placed on keflex for treatment.
Patient was in observation area after admistration of covid vaccine.  At 15 Minute mark patient stated throat felt tight and like it was closing up.  Assesment of patient showed tongue PWD, vital signs as follows.  97.6, 118/72, 66 pulse and 100% pulse oxygenation.  Observed patient for 15 minutes more, gave patient water and monitored for full 30 minutes.  Breathing normal at this time.  States feeling better. Discharged  and advised to monitor throughout night and if worse go to emergency room.  Patient agreed and stated understanding.
On the way home I observed purple lines on the top of my fingers  of my right hand. Most of the coloring dissipated over the next 2 hours
Patient described onset the following morning of incoherence and confusion witnessed by his spouse, inability to get out of bed secondary to weakness and confusion, fevers, chills, body aches, hyperesthesia.
Writer immunized patient with 8 vaccines. Upon exciting office patient appeared pale. Writer asked admin to translate in Spanish if he was dizzy, Patient replied :Yes. Writer escorted mother and patient back to office. Staff made aware , vital signs taken. PAtint observed for 20 minutes.  15:00 vital signs BP:102/57, HR 57, RR 16
p/vax pt c/o numbness lt arm & lt side of face; ringing in both ears, primarily lt ear; feeling of lethargy & recently devel bump @ inj site;
Patient did not report an adverse reaction to the COVID-19 vaccine number 3. Vaccine administered was 15 days out of storage guidelines from Pfizer. Reviewed with Pfizer and Department of Health whose recommendation was to revaccinate the patient. Patient declined revaccination. Department of Health recommended reporting.
Pt states she developed a headache aproximatley 15-20 minutes after receiving the vaccine at 12:15. Pt states her headache has not gone away and would like to have her vitals taken. Pt's vitals are stable. Pt requested to sit with the crew and monitor her vitals. At 13:10 Pt states her headache is gone. Pt refused transport to hospital.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: WELLBUTRIN XL, start date: Jun2008; LIPITOR, start date: Feb2009; AMLODIPINE, start date: Dec2009. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose 1 administered on 12/28/2020 Fatigue and body aches on 12/29/2020 morning, resolved by afternoon Tender left axillary lymphadenopathy 01/03/2021-present Swelling, warmth, itchiness, soreness at injection site on 01/04/2021-01/06/2021
Enlarged nymph node under left armpit Swollen left arm with pain along the inner left arm
Case number PHEH2014US021091, is an initial spontaneous report from a physician on 17 OCT 2014. This report refers to a 2 year old male patient. Physician reported that this patient had received an intramuscular dose of FLUVIRIN 2014/2015 (batch number: unknown) on 17 OCT 2014. No adverse reaction was reported. No further information was provided.
Consumer reports that her husband received injection in rt arm and three days later area surrounding the injection site turned black with subsequent swelling and paralysis of rt arm. Pain persisted for 2 wks. Being treated by neurologist.
Anxiety; lump in throat feeling. AOx3; no resp distress; able to swallow; no SOB. Pt appears anxious; VS stable (110/74; HR 100; RR 18; O2 sat 100%). Provider called to consult. Pt stable & released w/father in stable condition
Large red area around vaccination site, no swelling or heat reported. No other signs or symptoms. Resolved in three days (05/26/2014).
Patient is 17 years 3 months old and was accidentally given the Covid-19 vaccine which currently is only authorized for age 18 and older. The patient did not experience any adverse signs or symptoms.
rash; Erythema; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Erythema) and RASH (rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Erythema) and RASH (rash). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Erythema) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Tylenol is being  taken as a treatment medication. no concomitant medication provided by the reporter. patient denied follow-up.   This case was linked to MOD-2021-080060 (E2B Linked Report).; Sender's Comments:  MOD-2021-080060:Second dose of vaccine case
I just wanna report I don't know if Coincidence to getting 1st Vaccine But I had a Horrible cough trouble breathing like my COPD came on right after the Vaccine I felt feverish and had cough cold symptoms for 3 weeks. Called Dr to get prednisone usually works but it didn't touch this. Started feeling better just before my 2nd dose. No problem with 2nd dose. Could be a Coincidence that I was sick 2 days after the Vaccine with my COPD So I am not sure if other COPD'rs experienced this. Dr. Recommended ER but I refused. Had to ride it out. Over the counter cough syrup with cough drops and my inhalers. Pro Air Albuterol. With Nebulizer treatments
pt recv vax 26MAY95 & 31MAY96 pt devel fever & varicella-like rash w/200 or more lesions which lasted 7 10 10 days;mom did not bring pt to MD ofc because the mother worked in pharm & was very confident of illness;
Sneezing; runny nose; sore throat; This is a spontaneous report from a Contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 12:15 (Batch/Lot number was not reported) (at the age of 36 years) as dose 1, single for covid-19 immunisation. Medical history included obesity from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccines in 4 weeks. No other medications in two weeks. No COVID prior vaccination. Patient was not tested for COVID post vaccination. The patient experienced sneezing, runny nose, sore throat, all on 28Feb2021 with outcome of not recovered, without treatments.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse practitioner via field employee refers to a 4 year old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. The patient had no drug reactions/allergies. On an unknown date, the patient was vaccinated with first dose of M-M-R II (strength, dose, route of administration, lot # and expiry date were not reported) for routine vaccination. The patient had no apparent side effect with the prior dose. On approximately 02-AUG-2018 (reported as 'three weeks ago'), the patient was vaccinated with second dose (reported as 'possible 2nd injection in the series') of M-M-R II (strength, dose, route of administration, lot # and expiry date were not reported). On approximately 02-AUG-2018 (immediately as the dose was being administered), the patient experienced "sneezing repeatedly, his eyes started watering, and a large swelling appeared around the injection site". The clinician gave the patient BENADRYL and sent him to the hospital emergency room. The patient walked to the emergency room to sought medical attention. In the emergency room (ER), the patient received unspecified DECADRON. It was unknown if any lab diagnostics/studies were performed. The patient was not given any intervention to prevent serious criteria. When the clinician called the patient's home later that evening to check his condition, the patient's mother said the patient was "doing fine" and had fully recovered. On approximately 02-AUG-2018 (also reported as 'later that evening'), the outcome of sneezing, injection site swelling and lacrimation increased was recovered. Causality assessment was not reported. There was no product quality complaint (PQC) reported.
Pt visited local ER on 9-7-13 with s/sx of cellulitis of the left arm. Was prescribed KEFLEX and Hydrocodone.
pt recvd vax & 2 days later exp sl diarrhea for 24-48 hrs; treatment: none; pt did not recvd 2nd dose;