chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I saw the patient in consultation during his hospitalization for pancytopenia which proved to be severe aplastic anemia   after bone marrow biopsy. He has been a blood donor.  1/4 Moderna vaccine HGB 1/8 12.8 - blood bank refused him to be a donor due to the HGB being too low. Recommended to repeat CBC at his primary care office. 1/26 7.8 1/29 7.1 1/30 5.7 No reticulocytes
Vaccinated and still got them / Suspected Vaccination failure; Vaccinated and still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
The patient has redness appearing a top of arm and extended across to arm pit. Areas felt hot and sore to the touch. This took place approximately 30 hours after pneumonia shot was administered.
Nose bleed. Body aches. Headache. Malaise. Thirst. Weakness
Local erythema from biceps (LVZ) to approximately elbow area. Slight swelling and tenderness.
Swollen lymph node in left armpit. Reported to pharmacy on 10-2-15 FLUARIX administered on 9-30-15 at 2:30 pm. On 10-2-15 patient states lymph node is still  swollen but improving.
Fatigue/extremely tired; Wants to fall over and cannot stay awake; She gets the vaccine in her hip; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as dose 2, single for covid-19 immunisation. Medical history included mastectomy (she has had a double mastectomy). The concomitant medications of patient were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation, patient received vaccine in her hip (Product administered at inappropriate site). Caller stated she had no side effects immediately following either dose of the vaccine, and she got the vaccine in her hip because she has had a double mastectomy and could not get shots in her arms. Since late May she was having instantaneous fatigue, can be all of the sudden and wanted to fall over and cannot stay awake. And it most recently happened this past Saturday and it can last all day once it has happened and can get a headache with it. She was seeing a physician today (unspecified date) to talk about the issues, but the doctors do not know anything about this, she has already asked her primary care, and no one knows what she was talking about. Caller would like to speak with someone who could answer side effect questions for her. One second she will be fine and the next is extremely tired. This was the fourth time this has happened to her. However, this was happening before getting the vaccine but at that time the fatigue would only last 1-2 hours but since the vaccine it lasts longer and was getting a headache with it and because of the headache she was getting nauseous as well. The outcome of events was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
20 hours post-vax the patient developed a fever. 32 hours post vax the patient experienced a 10-15 minute episode of stiffening, crying, arching back and neck, and staring into space. Resolved spontaneously. 48 hours post vax the patient was fine and with indurated the red area at the injection sites. RN verified that reaction occurred on both thighs where injections were given.
I awoke at 3:00 AM the morning following my vaccine with a headache.  I also experienced leg cramps.  The headache progressed throughout the day and was accompanied by nausea to the point where I was not able to eat anything.  At times I did feel cold but there was no fever.  It felt like a bad sinus headache and continued throughout the evening. I did take Advil and sinus medication for relief. I was fine the next day when I awoke.
Vaccine was given to patient that was under 18 years of age.  Patient had soreness in left arm on day of injection. Troubleshooting: The vaccinator checked ID but did not catch age < 18.
Dizziness, vision blurred,dry mouth, BP 108/67,HR 80, O2 sat. 97%,Resp 18 Monitor, go home
Severe runny nose with major drainage.  Started approximately 24 hours after vaccination, Lasted approximately 48 hours
A pharmacist reported the occurrence of stumbling in an approximately 28 year old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  Additional information was received from the subject, who is a paramedic.  The subject claimed that he had a history of hepatitis, but pre-vaccination testing was negative for markers.  Concurrent medications were not reported.  On 07/31/1992, the subject received his first injection of Engerix-B.  That night, he developed flu-like symptoms, high fever, dizziness, stumbling and body aches.  He stated that he "felt like he was going to die".  The events were treated with paracetamol (Tylenol).  The events resolved by the evening of 08/01/1992.  The pharmacist reported that the subject received his second injection of Engerix-B as recommended by the emergency squad's assistant medical director, without adverse event.  The most recent information was received from the subject on 04/18/2003.  The subject stated that the events recurred after his second and third injections of Engerix-B, but with lessened intensity after each subsequent injection.  The events resolved after each injection.
pt recv vax 28AUG96 & 2-3 days p/vax pt exp pain in knees w/swelling;pt was seen in employee hlth;tx symptomatic;
Developed red round circles noted 1 on chest and back, 2 on each arm 3-4 on each leg, and several on "web" of toes, yesterday after vaccine, mother took temp this am 99, and daughter told mother she was crabby. Has appt with CNP - seen - hives - on BENADRYL and ZYRTEC.
arm was a little sore; head felt a little funny for a couple of hours; lost her balance; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), HEAD DISCOMFORT (head felt a little funny for a couple of hours) and BALANCE DISORDER (lost her balance) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Loss of energy (before the first dose). Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (head felt a little funny for a couple of hours) and BALANCE DISORDER (lost her balance). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 10-Mar-2021, HEAD DISCOMFORT (head felt a little funny for a couple of hours) had resolved. On 11-Mar-2021, BALANCE DISORDER (lost her balance) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient also included unknown Herbs.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-255333, MOD-2021-370450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Additional information received and dose 1 details and Concomitant product details were added. On 29-Jul-2021: Telephone contact report was received and contains no new information. Previous FU was amended. Added med history and deleted the reporter's sister information. Action taken updated. On 01-Nov-2021: Events her head felt a little funny for a couple of hours and she lost her balance added. Previously added events were deleted from this case as those were pertaining to dose 2 case.
Pt recvd vax 10JUN92 & 11JUN92 had episodes of apnea was adm to hosp by MD; d/c 13JUN92 on monitor;
Sore arm 2 days, 4th day flu symptoms, tired, numbness tingling(feels like ice going down veins arms) nausea. 1month still not feeling well.
Janssen COVID-19 Vaccine EUA  Based on the paperwork I received at my vaccination, I am reporting my side effects for your records.  I received the dose (1805029) on 3/12/2021 (Friday) at 4:30 in the afternoon. At around 10:30 p.m. I began to feel unwell with chills, shaking/tremors of my hands/arms, and overall aches. I had trouble sleeping through the night due to these symptoms in addition to night sweats (fever).  These conditions persisted through the next day (Saturday) and evening (24 hours).  I managed to sleep 8 hours and had only a headache the following morning (Sunday).  I treated my symptoms by taking Tylenol which was helpful.  Hope this helps with your research/records.
Pt complains of shortness of breath worse than baseline with fever and chills.  Pt admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia and acute COPD exacerbation.
Parent states child's left arm became reddened and swollen one hour after injection was given. Parent states redness and swelling have spread across the child's arm and is now warm to touch and hard. Parent states she gave the child benadryl and ibuprofen to the child. Parent states she applied an ice pack to the left arm.
A 32 year old female reported that she received a dose of Flumist on 12/8/03, and experienced "feeling like I was coming down with a cold" afterward. On 12/10/03, 2 days post-immunization, the reporter experienced "feeling like I was coming down with a cold," characterized by sneezing, nasal congestion, and dry throat. As of 12/11/03, all symptoms were unresolved. No additional info was available at the time of this report.
Information has been received from a Nurse Practitioner and a 70 year old male with no known allergies and an "unremarkable" medical history who on 02-NOV-2007 was vaccinated SQ in the right arm with 0.65mL first dose of zoster vaccine live (Oka/Merck) (Lot # 658395/0966U). There was no concomitant therapy. On 04-FEB-2008, the patient went to the doctor's office for a pruritic and painful rash on his back that started on 02-FEB-2008. The patient was seen by the physician and diagnosed with shingles, described as vesicular lesions on his back. The patient was treated with VALTREX. On 14-FEB-2008, the patient called the office complaining of pain (post herpetic neuralgia) so he was started on LYRICA 75mg bid. There were no lab studies performed. The patient recovered on 29-FEB-2008. There was no product quality complaint involved. Additional information is not expected.
Fever 101-102 through the evening responsive to APAP; Unresponsive to stimuli; hypotonia starting @ 7AM 10APR; transferred to PICU , currently doing well;
pain in the tooth; swollen face; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (pain in the tooth), SWELLING FACE (swollen face) and VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (pain in the tooth) and SWELLING FACE (swollen face) outcome was unknown and VACCINATION SITE PAIN (pain in the arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also has problems with a tooth. It hurts; but stated that tooth has been bothering patient from before vaccination and after first dose ate something hard which caused pain and swollen face.Patient took Tylenol to treat symptoms and pain started to fade away Patient was taking  antibiotics for the tooth situation
Pt recvd flu vax 9AM 26NOV91 by 10AM pt felt hot & flushed; rash appeared on face & chest, "felt funny", vision blurry, couldn't concentrate, sl hoarseness; returned to clinic 1PM; MD felt pt had "mild allergic rxn";
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Client fell back in his chair, seem to get stiff and did a few body shakes. Was not responsive for 5-10 seconds. He said that  did not remember the episode. His mother requested that he be taken to the hospital for testing and evaluation.
Client called clerk on 9/27/15 c/o of Rt arm hurting and swollen from flu shot. Today 10-1-15 called stating arm is bruised at site (RA), barely moving rt arm without assistance. C/O of pain in rt arm and shoulder area. Applied ice to arm today for several minutes.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Shingrix. On 5th August 2019, 5 days after receiving Shingrix, 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 Shingrix.  Additional case details were reported as follows: The patient experienced shingles 5 days after receiving dose of Shingrix . The reporter consent to follow up.
Bright red rash similar in appearance to cellulitis appeared on both legs. Warm to touch. Spread slightly x 3 days.  There were no events leading to this or exposure to irritants.   No response to topical hydrocortisone.   note that this exact rection and resolution occurred in Feb 2021 several days after dose 2. Contacted PCP, scheduled allergist visit but rash had cleared before a date could be scheduled.
they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it wasn't and three doses were administered, no AE; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case from a pharmacist via regulatory authority (under reference 00792823).  This case involves a 74 year old male patient who was administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] of which the shipment was delivered too late and it was supposed to have been returned but it was not, and three doses were administered (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 29-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ763AC and expiry date: 30-Jun-2022, Frequency: once) via an intramuscular route in the left upper arm for prophylactic vaccination.  It was an actual case of medication error due to incorrect product storage.  It was reported "pharmacist/manager states a shipment of FLUZONE HIGH DOSE (HD) Quadrivalent (QIV) (522 - FLZ HD HV QIV) was delivered too late and caller had already spoken to Pasteur CS. However, 3 of the vaccines in the shipment were administered to patients so Pasteur CS transferred her to us to get more information about how to move forward. Call transferred from Pasteur agent Caller states that they received a shipment of FLUZONE HIGH DOSE that has been in transit for a few days. It was supposed to have been returned but it was not, and three doses were administered."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   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 the 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.
4 PM ON MARCH 04, 21 I DEVELOPED A RED RASH ON FACE, ARMS, UPPER CHEST & BACK, BOTH LEGS KNEES TO TOES BOTH FEET SWOLLEN, HOT & RED. TEMP 99.8. WENT TO EMERGENCY ROOM LATE EVE 3/24-3/25. HAD BLOOD CULTURS DONE (NEG) CBC ( ^WBC 12.41. METABOLIC PANEL (BASICALL NEG). GIVEN ANTIBIOTIC FOR A WEEK AND PREDNISONE (40 mg 2X/D THEN TAPERED ) REFERRED TO DERMATOLOGIST - HAD 3 BIOPSIES -
Awoke approximately 3 AM (approximately 12 hr post vaccine) with severe H/A, fever, stiff neck, myalgias. Missed 3 days of school.
FLUMIST given 11/7/13. Couple weeks later red maculopapular rash appeared. Dermatology diagnosed as Gianotti-Crosti. Steroid cream prescribed. Rash has improved. Following up with Dermatology.
Patient received pfizer covid-19 booster vaccine day prior to arrival to hospital. at that time pt experienced near syncope, weakness/fatigue, decreased appetite. pt found to have sepsis like picture with acute renal failure. also found to have likely mild UTI.
Rash started at injection site, whole back within the first 15 mins of injection. Rash spread to left arm.
Approximately 1 month post vax, pt developed a blistered rash. Pts father notices a few red dots which began to look like a blister and had spread all over the pts thighs. there are reportedly 50 - 100 blisters. Physician indicated that the pt was diagnosed with hand, foot and mouth disease which had no relationship to varicella.
(L) deltoid area sore, difficult ROM in 24 hrs. then swelling, redness and warmth.
Information has been received from a physician concerning an approximately 11 year old male who "10 years ago", in approximately 1997, was vaccinated with varicella virus vaccine live (Oka/Merck). "This week", in May 2007, the patient experienced normal breakthrough. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Became trembly, shaky, rapid heartbeat, thought I was going to black out.
Non-anaphylactic reaction. Patient began to experience tingling/numbness on her fingers and Itching on chest area. Patient was given 4 ml of Benadryl at 6:15 patient was discharged home at 6:35 with improving signs and symptoms.
Patient experienced elevated resting heart rate >100 BPM (his normal resting HR is ~50 BPM) and vomiting. Patient went to the emergency room.
The day after her 2nd dose of Novavax the patient experienced a fever of 101 degrees and body aches.  The patient called me 8/24 and I told her to take some Tylenol or Ibuprofen, rest and push fluids.  I called the patient on 8/26 to ask how she was doing, she explained that the fever and body aches were gone, but she had a bruise at the injection site and the arm was a bit swollen.  She came in and I was able to visualize the swelling and the bruising.  Placement of vaccine looked good.  She stated that the swelling has started to subside.
Patient was given the Moderna Covid 19 vaccination in error as his second dose instead of the Pfizer-Biontek vaccine that he had previously received. Patient is not complaining of any adverse effects.
After vaccine was administered 4 days after, I noticed little bumps on her forehead and over her legs. This is not the first time she's gotten these bumps after vaccination.
Severe erythema multiforme for 5 - 6 days, post vax. Pt was given Benadryl for 2 days with resolution.
Dizziness, HYPERtension, Light headedness Narrative: Light headed, dizzy HTN (BP meds taken this AM), SOB (anxiety), Ate and drank this AM. Observed for 30 mins d/t/h/o allergy to sauerkraut has EpiPen. BP 172/84-180/96. PT called her PCP. Sent to ER
Diaper Rash/Rash in the gluteal fold that caused skin breakdown and persistent skin changes/scarring.
Patient received pfizer vaccine when asking for Moderna. IT informed the site lead of the issue and ut was then brought to the nurse attention to ask what mistakes might have been made/ what happen. The patient did speak over any questions she had about the pfizer vaccine.
Fever, myalgias, arthralgias.  Progressed to dropping things at first from right hand and then left hand.  Had difficulty driving in particular braking.
6:35PM C/O HEADACHE, ITCHING ALL OVER AND SLIGHT RASH TO RT ARM. 6:45PM  PT STATES SHE 'FEELS BETTER NOW'. NO RASH NOTED AT THIS TIME. NO SOB/DYSPNEA. A/O, PINK, W/D, RESP WITH EASE. 4-7-21 9AM TC: PT STATES SHE 'NO LONGER HAS THE RASH OR HEADACHE - STILL HAS SOME ITCHING THAT IS RELIEVED WITH BENADRYL.
pt recv vax 28FEB96 & 20MAR96 pt devel gen rash consisting of greater than 20 lesions, on scalp, face & trunk;tx w/Famvir;@ the time of report pt sx persisted;no further info was provided;
pt began crying in a persistent & unusally high pitched cry; pt cried w/o stopping for 1 1/2 hrs; very unusual for; MD was called & pt brought to ER;
The patient was vomiting for 10 days, and diarrhea for 3 days. Onset 24 hours after shots. No fever.  MD not advised or seen until 12/06/2000.
I started feeling dehydrated.  Approximately 5 days after my vaccine I felt like I was having a continuous anxiety attack all the way up into my throat. I have bad headaches & a couple of migraines. I'm out of breath walking
Onset of dull headache which worsened. Continued worsening into a massive migraine(cluster, light sensitive). After several hours I took a migraine relief OTC medication. The headache subsided with minor headache into the following day.