chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On December 19 patient (pt) received his influenza, IPV, meningococcal, and Td vaccinations. On December 24 he then received Hep A-HepB #1. He stated he felt fine and approx 1 wk later he developed URI symptoms consisting of a non-productive cough and nasal congestion. He denied fever or diarrhea.  Approx 2-3 days prior to admission he noticed weakness that started in his legs and arms associated with numbness and tingling. Also noticed drooping of his eyelids. Went to the emergency room on Jan 12 and was admitted with a diagnosis of probable Guillain Barre Syndrome (GBS).  Hospital Course as transcribed from discharge summary:  Pt was admitted to neurology service after two days of ptosis, followed by rapidly progressive diffuse bilateral weakness and paresthesias. Pt noted only a recent mild URI with no anticedent diarrhea. Admitted to ICU for close monitoring of neuro-muscular and resp status. EMG c/w GBS. Pt given IV Solumedrol and IVIG (2g/kg) continuous infusion for 48 hours. Head CT was performed which was negative for acute bleed. Pt transferred to MICU service on HD#2 secondary to impending intubation (increasing dysphagia and SOB). Pt electively intubated on 1/14. He then was noted to have a RLL infiltrate that slowly progressed, and on 1/16 he became febrile. Pt started on ABX for aspiration pneumonia. A CT angio was obtained on 1/18 and displayed a collapsed RLL, likely from mucous plug. On 1/19, bronchoscopy was performed, and copious secretions suctioned, but unable to re-expand RLL. Pt began to show increased strength and did well on CPAP trials 1/20-21, and subsequently was extubated 1/21. Pt transferred to 9D and back to the neurology service on 1/22. Pts strength recovering well. Pneumonia resolved with ABX therapy. Residual neuro deficits include: left eye ptosis, some unsteadiness/difficulty balancing, Positive Rhomberg, shuffling/steppage gait, difficulty with fine motor skills, DTRs 0-1+.  Update 4-2-04: Pt is now at home and reports that he is doing well. He states that all of his strength has returned but he is still working on his endurance. He states that he still tires easily and that he is increasing his activity.  Nurse follow up on 06/28/04 states: "ADD: Fine motor skill decreased, decreased HR, decreased BP, Nausea, Ileus."  Follow up on 06/25/04 states: "The final diagnosis is still guillain-Barre syndrome.  The diagnosis was made by a neurologist. The pt experienced other illnesses such as mild upper respiratory infection.  The pt never previously experienced GBS related illnesses. The pt never previouisly received influenza vaccination. "
7 days after vaccine woke up to itching the arm right where I was given the injection. Red spot about the size of a penny  and tender to the touch. 1.5 days later now is fist size tender red puffy and warm to the touch. Not as itchy now. Other that slight tenderness, that had gone away a couple days prior to the reaction, I had no side effects until 7days later.
Patient came to the pharmacy more than two months after receiving the vaccines, She thinks that she had adverse reaction from the vaccines. She said she had Vertigo, nausea (throwing up) , sweating, dizziness, speech sluggish ( Can't talk clearly), nervousness ( getting angry quickly)    Patient said all theses symptoms lasted almost three days
Expired dose of Boostrix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug administered in a 10-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Boostrix. On 16-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired drug administered (Verbatim: Expired dose of Boostrix was administered to a patient). The outcome of the expired drug administered was unknown.   Additional Information: GSK receipt date: 17-May-2023 The reporter was a license nurse practitioner.  Forgot to ask about follow up. The patient was administered an expired dose of Boostrix, which led to expired vaccine used.
Info rec'd fr mom pt developed hives (huge welts) the night vax given; following day took pt to ER temp 103 referred to Md; MD dx Hydroxacine x 4 days; Pt prone to rashes has rash on face & arms constantly, both parents have allergies;
10:15 Complained of throat feeling numb; able to speak; no lightheadedness. Had shot 45 minutes prior to episode. 11:30 no shortness of breath or palpitations. Numbness on left side of throat only. Feeling a little better since she took an advil.
After receiving the injection, I had no adverse reaction; no pain the arm or shoulder,  however, seven days after receiving the vaccine I developed a red bumpy rash at the injection site.  The rash was about 3 inches in diameter.  The site was warm to the touch ( surface temp was 101.5 degrees) and very itchy.  I also felt a burning sesation.  After two days the rash is starting to breakup into splotches instead of one large area.  Itching has lessened and burning has disappeared.  I am not taking any medical action as it seems to be going away.  I have had a slight reaction to other vaccinations but they have always occurred within 24 hours.  I have never had a reaction this pronounced or appearing after 7 days.
I took the shot on 10-8-2020 at around 12:00pm.  Went home was fine until around 10:10pm and got sleepy Took a shower and felt better for a time.. Went to bed around 1:00am on 10-9-2020.  Slept until 10:15 in the morning. got up and had a headache and then eat breakfast.  Had appt with someone and was fine.. after that around noon i was not feeling good very sleepy and laid down around 200pm and got up at around 600pm. Still have a slight headache but feeling much better
I got migraine with a visual aura, severe nausea and headache, pass out while throwing up. I did a televisit.
Heaviness and soreness in central upper chest. No shortness of breath, wheezing, rash, or fever.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site pain and rash. On 21st September 2018, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site pain and rash were recovering/resolving and the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, pain in arm, injection site itching, injection site pain, rash and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. In the morning, the patient received SHINGRIX on the right. The symptoms of redness, sore and itchy presented at the site and also down her arm. Two weeks later, the patient began to have pain in her left arm so severe that she could not raise it. The physician's contact details were provided, however phone number was not available.
Fever from 103-104 degrees 16 days after MMR and Hib. No other symptoms noted. Physician stated probably from MMR. Fever lasted 3 days.
Client reports cough, itching, SOB, heat on arm, fever and indention below site of injection.
A SORE ARM WHEN PUSHED ON THE INJECTION SITE ABOUT 48 HOURS LATER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced a sore arm when pushed on the injection site about 48 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a sore arm when pushed on the injection site about 48 hours later was not reported. This report was non-serious.
Severe local reaction, involving left upper arm and 1/2 left forearm, myalgias, fever - no N/V.
On December 21, 2022, I woke up with a horrible headache. I also had a runny nose and felt very miserable. I tested myself for COVID-19 at home. The result was positive. I called my doctor's office. They scheduled a telehealth call. She prescribed PAXLOVID. I took it as directed for five days. I'm feeling much better now.
Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise kind of spot (blood clot). No numbness, itchiness or pain in that area.
swollen lymph node on Left collarbone.; Pain; swelling; This is a spontaneous report from a contactable other hcp. A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 09Feb2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if COVID prior vaccination Yes. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient tested covid prior vaccination. Patient did not test covid post vaccination. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3249), dose 1 via Intramuscular, administered in Arm Left on 19Jan2021 09:00 as dose 1, single for COVID-19 immunisation. On 11Feb2021 07:00, the patient experienced lymphadenopathy, pain, swelling. 2 days after 2nd dose of vaccine, swollen lymph node on Left collarbone. Pain and swelling. Pain subsided within 4 days, swelling slowly subsided. After 3 weeks patient went to her PCP out of abundance of caution because the lymph node was still swollen. No pain. PCP recommended watchful waiting for 2 addl weeks. Patuent going on week 5 post-first vaccine and lymph node is still swollen and present. The outcome of the event lymphadenopathy was not recovered, Pain with outcome recovered and swelling with outcome recovering.  No follow-up attempts are possible; No further information is expected.
Information has been received from a consumer concerning her granddaughter who was vaccinated on an unspecified date with GARDASIL (lot# not reported).  subsequently the patient experienced an elevated thyroid and the grandmother wanted to know if this was related to GARDASIL.  No further information is available.
Patient had swelling below injection site and soreness.  Come back for 2nd dose and it is still hurting.  Referred back to primary care to evaluate prior to giving her the 2nd dose.
Patient said something "did not feel right" as she was getting the shot...it hurt a lot and felt like a gamma globulin shot she had had years before. She could not get vaccinated in her right arm due to having breast cancer on that side. She started feeling bad that evening, gave it all day on 10/25/2017 and never felt better, then she came in this morning. She had fatigue, malaise but mentioned NOT having any fever. We called the dr's office who recommended she come in immediately, which she did.
Redness and tenderness noted around injection site 2 days after immunization.  Brought in for eval.  No streak, fever, or nausea.  Exam showed poorly demarcated area of erythema without warmth.  Small area of tenderness with slight induration about 1cm in size central to erythematous area.  No other tenderness.  No significant adenopathy.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N012488 with expiration date 20-APR-2019 , lot number reported as N19839 with expiration date 13-JUL-2019 and lot number reported as N14369 with expiration date 09-MAY-2019 and PROQUAD lot number N016113 with expiration date 21-NOV-2018, lot number N015623 with expiration date 15-NOV-2018 and lot number N012490 with expiration date 17-OCT-2018 (dose, route and anatomical location were not reported for the above described vaccines) all for prophylaxis. There was no previous temperature excursion. The vaccines were exposed to temperatures between -9 C (Celsius) to 8 C (Celsius) during 1 hour and 25 minutes. Data digital logger was filled. No adverse effects were reported. Lot number N19839 is an invalid lot number for varicella virus vaccine live (oka/merck). Lot number N14369 is an invalid lot number for varicella virus vaccine live (oka/merck). This is one of several reports from the same source. Sender's Comments: US-009507513-1711USA004033: US-009507513-1711USA004034: US-009507513-1710USA009985.
I tested positive for COVID-19 on June 07, 2022 my symptoms were runny nose, sneezing, extreme fatigue; loss taste and smell also suffers from anxiety.
Gradual loss of vision in left eye.  Went to see eye Dr. 10/22/10 and tests showed reduced field of vision.  Following weekend eyesight deteriorated even further.  Went to see eye Dr. again on 10/27/10 because of further loss of eyesight.  Patient estimated 60% of vision loss.  Eye exams showed significant degradation of eyesight in eye vision and field of vision testing.  Dr. ordered MRI for 10/28/10 and MRI came back negative.  Following week had further decrease in eye sight and eye Dr. ordered second MRI and that was done 11/2/10.  This MRI showed inflammation of the optic nerve.  Diagnosis was Optic Neuritis.  Treatment was IV steroids for three days (11/4/10, 11/5/10 and 11/6/10) with follow on oral steroids for 2 weeks.  Eye exam on 12/1/10 patient has seen some improvement in eye sight (from 20/300 to 20/50) and field of vision has shown some improvement.  Patient has not seen any additional improvement since 20/50 eye test on 12/1/10.  Field of vision is still distorted.
Hives on left upper arm.  Benadryl 25mg give per mouth-ice applied.
No AE; A 12 month old received 4th dose of Rotateq; A 12 month old received 4th dose of Rotateq; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patient was vaccinated with three doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (exact dose, routes of administration, lot#, expiry dates were not provided) for prophylaxis.   On 25-NOV-2020, the patient was vaccinated with the 4th dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml orally, lot # 1684154, expiry date: 24-JUN-2021, for prophylaxis (product administered to patient of inappropriate age and extra dose administered). No other adverse events were reported.
On 10/30/18 patient woke up in the middle of the night with chills/shaking. Didn't know if she had a fever. Went back to sleep. The next morning she noticed she had redness and some swelling above the right elbow, but not directly at the injection site. No pain in arm and still had full mobility. Redness and swelling persisted, moved around toward the back of her right arm. Came back to the pharmacy to report event on 11/2/18 after issue had not resolved.
On 11/27/2001 the patient developed a small, pimple like rash with clear centers on her back, scalp and arms. The patient experienced itching and a temperature of 100.5F. The patient was treated with Benadryl and Aveeno and baking soda baths.
95 year old female, COD listed as 'terminal cerebral vascular accident event on comfort care', received recent booster dose 06/17/2022.  previously had COVID in December 2021  1. Time from vaccination to onset: 12 days 2. Symptoms: weakness, pnemonia, stroke, unable to ambulate 3. Treatment: comfort care measures 4. Outcomes and recovery: died of 'terminal cerebral vascular accident event on comfort care; 07/02/2022
12 hours after receiving moderna booster, started to develop fevers, myalgias, nausea. On day 3 after vaccination (12/20/2021) at 11:00am, started noting shortness of breath and substernal chest pressure with radiation to L arm, constant. Then presented to Emergency Department for evaluation. Was admitted to ED for NSTEMI, seen by Cardiology, medication adjustment made, and follow-up with Cardiology established. Discharged on 12/21/2021. Symptoms resolved during ED admission.
Pt., age 13 Years old, was brought to the vaccination clinic to receive his Covid booster on January 6, 2022.  He was accompanied by both his parents.  He received his  previous Pfizer vaccines on 05/18/2021 and 6/08/2021.  They arrived at approximaely 4:40 P.M.  They completed all appropriate paperwork.  The person administering the vaccine said that he presumed pt wanted the Pfizer.  They replied yes.  He said that he was out of Pfizer but that he can use Moderna.  Father replied I don't know.  The person administering the vaccine said that they are all the same.  Looked at pt.'s age and administered the vaccine.  Pt. then went to the waiting area.  WHile they the app
I was informed by the patient's daughter that the arms were red, swollen and painful. She was taken to walk in clinic. The provider at the location gave her an antibiotic and a pain medication.
Pain at the injection site; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experiencing pain at the injection site from Shingrix administered No other symptoms were noted.  The reporter asked that how long can this be expected and was there anything specific that could be recommended for patient.
anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the first of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505821 different patient/same drug/event;US-PFIZER INC-2020505822 different patient/same drug/event;US-PFIZER INC-2020505823 different patient/same drug/event;US-PFIZER INC-2020505824 different patient/same drug/event;US-PFIZER INC-2020505825 different patient/same drug/event
Rash to the left upper thigh, approximately 3 x 3 1/2 in size. Immunization given on 08/01/2001 and the patients mom states rash noted on 08/10/01. No other adverse reactions reported.
Started having throat swelling approximately 5 minutes after receiving vaccine.. Patient immediately took Benadryl  25 mg PO and Loratadine 10 mg PO.  APN and Natinoal Guard medic assessed patient. Throat swelling subsided 5-10 minutes after taking oral medications. Patient waited at POD clinic for one hour after receiving vaccine and states 'feeling much better.' No distress noted.
Vaccine was administered by drawing up 0.3mL directly from the vial that had not been diluted.   Patient was observed for 10 minutes and did not appear to have any adverse effects.  RN will call patient today (10/28) to verify she is not having any issues.
Bruising lasting > 2 weeks. Bruising was immediate. Soreness lasting couple of days.
Patient received the Moderna vaccine. Patient informed staff after vaccine that she had previously received the Pfizer COVID-19 vaccination #1 in series. She had assumed any manufacture was acceptable for #2 in series. No reaction noted
Confirmed that no symptomatic adverse events were reported; nurse calling to report temperature excursion. HCP states that MMR-II may have been administered to patient; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection that had suffered a temperature excursion (product storage error), at a dose of 0.5 milliliters  (ml) / once (lot #W022640 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with an expiration date established as 15-APR-2024), administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
Pain at injection site. Itching whole body. Injection site size of golf ball. Warm at injection site. Told patient to take BENADRYL, apply cold compress and go to Dr. or call ASAP.
A physician reported that a 4 month old male received his first dose of Prevnar along with HIb titer, DPT and oral poliomyelitis vaccines on 01/09/2002. On 01/16/2002, the child developed a fever of 102.3 deg. F. and colitis described as ongoing episodes of very small amounts of diarrhea with mucus.
6:00 pm, pt. presented with redness and blotchiness in face and upper chest area.  She was given two 25 mg Benadryl immediately after it was assesed that there was no difficulty breathing.  Over the course of the next 30-45 min pt. experienced numbness and tingling in the face and hands. Pt. also experienced chills.  After about 1 hour, redness in face and chest decreased. During this time pt. was observed, and after apx. 1 hr and 15 minutes patient was sent home with an Epi-pen and advised to seek immediate medical attention if difficulty of breathing was to occur.
given 12 to 15 patients expired dose of Fluzone High Dose/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves 12 to 15 patients (demographics unknown) was given expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] VACCINE lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  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 holders 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.  Information on the batch number was requested.  List of documents held by sender: none.