chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt experienced numbness in the right arm immediately following the vax. The pt also experienced discoloration of the arm and swelling of the right hand, and flushed face. By 10:30 am, the face became pale and a red rash appeared. BP 163/103 and a rapid pulse of 103-105. Diagnosis of anaphylactic reaction treated with Benadryl.
patient passed out about 5 minutes after vaccination. 911 was called, patient was put in a comfortable position by the parent, but woke up immediately after, he was given water and Benadryl but refused. 911 personnel came and attended fully to the patient, then took him to the hospital.
This was a vaccination error, not a adverse event.  This patient was previously vaccinated with 3 primary series doses of covid-19 vaccine, then had undergone an autologous stem cell transplantation (ASCT) for treatment of Multiple Myeloma in April 2022.  The patient then was to be revaccinated with new primary vaccine series and was to get dose 1 of primary series vaccine on 9/27/22.   However a booster dose of bivalent moderna vaccine was given instead.  Patient is aware. A revaccination is planned and a correct action plan is finalized and will be implemented
Fatigue, brain fog, memory problems, easily chilled no treatment and it is still ongoing.
EYE STRAIN; WREAKED HAVOC ON  KNEES, SHOULDERS, AND JAW; WHIRLIES; BRUTAL HEADACHE; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced eye strain, wreaked havoc on knees, shoulders, and jaw, whirlies, and brutal headache. The action taken with covid-19 vaccine was not applicable. The outcome of the wreaked havoc on knees, shoulders, and jaw, brutal headache, eye strain and whirlies was not reported. This report was non-serious.
PT RECEIVED A BOOSTER DOSE PRIOR TO APPROVAL FOR AGE GROUP. PT IS NOT SHOWING ANY S/S OF ADVERSE EFFECTS.  FACILITY NURSE DENIES ANY FEVER OR COMPLAINTS FROM PATIENT
covid; covid; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The physician inquired whether a person with previous history of COVID would experience more significant reaction to the COVID vaccine than a person without a previous diagnosis due to having already produced antibodies. Reporter's colleague (physician) had the vaccine 2 weeks ago, had a severe reaction (unspecified) wherein he got a shot of epi. Patient recovered and was okay. At the time of reporting, patient now had Covid or maybe he had Covid before, reporter was not sure. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for event "Covid".
On 1/13/21 my 2nd injection I was fine the next day I felt fine but in the afternoon around 2:30 I noticed my left side of my neck was swollen so I had asked 2of the M.D.'s and a N.P. to check it and they felt 2 lumps along with the swelling and asked me to keep a eye on it, After a few days the swelling in my neck was gone but the lumps were still there so they asked me to contact my PCP which I did and a few days later she ordered a ultra sound which I had done on 2/4/21 and the results showed there were 3 lumps. I was asked by my PCP to wait 2-3weeks to see if they subside and if not she will order a new ultra sound(which I am waiting to hear back from her)
Patient's mother called to report a new fever 3 weeks post-vaccination. Fever reported was 102.6. Patient also experiencing muscle spasms in his mid to upper back as well as a swollen lymph node in his leg.
7/07 Severe headaches going from neck to front of head and eye socket, numbness, muscle weakness, difficulty work mostly left leg. Problems with sight.  9/04/2008 Pt seen 5/1/2007 for 3rd HPV. Pt c/o R middle finger and ankle swelling. 11/3/2008 MR received from neurologist which includes H&P and consult for admission 9/27/08 for intractable headache, agitation, sweating, photophobia, low grade fever.  Admitted to r/o meningitis. DTRs 3+ in upper extremities, decreased sensation on L side. 12/16/2008 Additional records received. DX: Severe h/a as adverse effect of steroids. Pt developed loss of vision of L eye in summer 2007 and given dx of MS. Had been started on Solumedrol for MS exacerbation  and developed severe h/a with photophobia unrelieved by pain meds. PE (+) for decreased sensation in the L face and extremities, DTRs elevated in upper extremities. Pt agitated with labile emotions. Admitted for o/n observation.
Patient reports feeling lightheaded. Patient reports being at a track meet this morning and thinks he is just dehydrated. Assisted patient to wheelchair and wheeled him to private observation area and assisted him into recliner. Patient reports no reaction to first dose of vaccine. Vital signs at 1255 were BP 135/76, P 48, 100% on RA. Gave patient water, Gatorade, and granola bar. After about 20 minutes patient reports feeling back to baseline.
Cardiomyopathy, dyspnea on exertion 8/10/2021 PT is a 36 YO M with PMH of HTN who presented to the ER after being seen in clinic and ECHO showed an EF of 25-30%.  The patient was admitted for management.  The patients cardiomyopathy was felt to be from either a viral myocarditis or a vaccination induced myocarditis.  The patient was diuresed with Lasix, started on Lisinopril and spironolactone.  The patient was stable with this regimen and DC home with close follow up with cardiology.
Vaccine 5/22/07 on 3/25/07 mom called to say fever 104 with hives and mon thought was a reaction to the HIB on 5/22/07 then was requested to come in for check to clinic (did not come in 2 hr to needs ride from friend). Then called MD on call with same sx, seen 9 days later no sx exam, no fever no hives.
major loss of balance; fluid build up in my right ear behind my eardrum; All joints in my whole body hurt for 6.5 weeks; Dose number:1/Brand:Pfizer CoVid Bival; vaccine received same date: Flucelvax Quad 2022-2023; vaccine received same date: Flucelvax Quad 2022-2023; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 10:00 as dose 1, single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 07Oct2022 as dose 1, single (Lot number: 348374) for immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Oct2022, outcome "unknown" and all described as "vaccine received same date: Flucelvax Quad 2022-2023"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 07Oct2022 at 10:00, outcome "unknown", described as "Dose number:1/Brand:Pfizer CoVid Bival"; ARTHRALGIA (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "All joints in my whole body hurt for 6.5 weeks"; MIDDLE EAR EFFUSION (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "fluid build up in my right ear behind my eardrum"; BALANCE DISORDER (non-serious) with onset 07Oct2022 at 11:00, outcome "recovering", described as "major loss of balance". The events "major loss of balance", "fluid build up in my right ear behind my eardrum" and "all joints in my whole body hurt for 6.5 weeks" required physician office visit. Therapeutic measures were not taken as a result of balance disorder, middle ear effusion, arthralgia.  Additional information: the patient did not receive any other vaccine in four weeks. The patient had not tested for COVID prior vaccination and post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pneumonia; tested positive for COVID-19; sore arm; A spontaneous report was received from a consumer concerning a 74-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia, sore arm and tested positive for COVID19.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included baby aspirin, morphine sulfate, vitamins, and unspecified antihyperlipidemic medication.  On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Jan 2021, post vaccination, the patient developed sore arm. On 08 Feb 2021, the patient tested positive for COVID19. On 12 Feb 2021, the patient went to the Emergency Room for symptoms and was diagnosed with pneumonia. The patient was not hospitalized. Treatment for the event was not reported.    There was no change planned to the dosing schedule of mRNA-1273 in response to the events.   The outcome of the events, was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported event- vaccination site pain and the administration of the mRNA-1273 cannot be excluded. However, the event of Covid-19 is Unlikely related to mRNA-1273. and a very limited information regarding the event (pneumonia) has been provided. However, the subject's concurrent history of COVID-19 may remain as a risk factor for pneumonia.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL and her hair started falling out. The patient's mother called the clinic. At the time of reporting, the outcome was unspecified. Additional information has been requested.
15-30 minutes after receiving I felt tingling as it moved . Lips and front of tongue felt flushed tingling . That progressed and gradually over next 4 hours left face began to feel numb , up cheek then to eye . Had metallic taste in mouth and tingling for next day. Tingling and numbness remained until next day went to dr as face drawn up , eye watering , pulled to one side . Pa states Bell?s palsy .  Had dizziness on fri evening. Today ear eye, and left nostril feel full fluid. And slight itching where numbness was.
pretty sick; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (22Jul2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: EN6200) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "pretty sick".  No follow-up attempts are possible. No further information is expected.
feeling even worse; miserable right now; tired; dizzy; nauseated; short of breath; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included hydrochlorothiazide.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (soreness). On 22-Apr-2021, the patient experienced FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated) and DYSPNOEA (short of breath). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now). On 17-Apr-2021, PAIN (soreness) outcome was unknown. At the time of the report, FATIGUE (tired), DIZZINESS (dizzy), NAUSEA (nauseated), DYSPNOEA (short of breath), FEELING ABNORMAL (feeling even worse) and FEELING ABNORMAL (miserable right now) outcome was unknown.            Treatment was reported as tried some motion sickness pills.
12/22 Pt to ED via EMS from a hotel parking lot . Per EMS pt's friend was with him and states he has hx of substance abuse, heroin use. Pt was given 6 mg total of narcan PTA with minimal response. Pt respirations are regular and maintaining spo2 >97%. Arousable to vigorous stimuli.  COVID-19 positive test result. Asymptomatic.
erythema, swelling, heat- increased to size of entire upper arm from shoulder to elbow
Patient developed high fever 102.3 degrees within 3 hours of receiving vaccination, followed by diffuse urticarial rash <12hr from vaccination as well as cough, arthralgias, wheezing, and hoarseness.  She was given oral steroids by a covering physician over the weekend. No prior history of egg allergy or reaction to any vaccine.
Itchy in left arm; Prickly feeling in left arm; Minor arm pain in left arm; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy in left arm), PARAESTHESIA (Prickly feeling in left arm), PAIN IN EXTREMITY (Minor arm pain in left arm) and INJECTION SITE PAIN (Pain at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure high.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Itchy in left arm), PARAESTHESIA (Prickly feeling in left arm), PAIN IN EXTREMITY (Minor arm pain in left arm) and INJECTION SITE PAIN (Pain at injection site). On 06-May-2021, PRURITUS (Itchy in left arm), PARAESTHESIA (Prickly feeling in left arm), PAIN IN EXTREMITY (Minor arm pain in left arm) and INJECTION SITE PAIN (Pain at injection site) had resolved.            Treatment details included that patient used cool and warm packs on their left arm and used witch hazel to clean the injection site.   This case was linked to US-MODERNATX, INC.-MOD-2021-123077 (E2B Linked Report). This case was linked to MOD-2021-065563 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-May-2021 contains no new information regarding the case. Patient would be preferred to be contacted via telephone only and does not want any email correspondence. On 16-Jun-2021: Follow-up received on 16-Jun-2021 included patient city name. Patient doesn't wanted to provide her email address and preferred to contact verbally through phone.; Sender's Comments:  INC.-MOD-2021-123077:
Information has been received from a registered office nurse manager and a consumer concerning her 12 year old daughter who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660387/1967U) intramuscularly in her right deltoid. The patient's mother reported that her medical doctor noted she was in good physical condition at the time the vaccine was administered. She also reported that the patient's vaccine site was extremely tender and sore for a complete week after she received the vaccination. Within a few days of receiving the vaccine, in February 2008, the patient began complaining of persistent stomach cramps and nausea. The nurse office manager reported that the patient developed stomach cramps and nausea after the vaccination. According to the nurse, the patient was treated as the physician's office as follows: on 07-MAR-2008 for a diagnosis of bronchitis (treatment unspecified) on 23-APR-2008, for symptoms of a left ankle sprain (treatment unspecified), on 15-MAY-2008 for symptoms of stomachache. On 16-MAY-2008, an ultrasound of the liver, kidney, pelvis and spleen were performed and the results were within the normal range. On 23-MAY-2008, upper gastrointestinal air contrast, hematology test, routine immunology test, blood chemistry test were performed and the results reported to be within the normal range except for serum Epstein-Barr virus antibody test positive for EBV IgG, EBV IgM and EBV nuclear antigen. Results suggested recovery or reactivation. The provider will recommend a gastrointestinal consult. No other symptoms or treatment noted. The patient's mother reported that the patient's stomach cramps and nausea continued until the time of this report despite a series of medical testing. The outcome of the patient's bronchitis, L ankle sprain and positive mononucleosis test was unknown. The patient sought medical attention.. Additional information has been requested.
No Additional AE/PQC; patient was administered GARDASIL 9 ( not supported )after TE; This spontaneous report was received from a nurse prescriber regarding a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 28-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml as prophylaxis (lot number (w015188) and expiration date (06-JAN-2025) both confirmed as valid (no more vaccination details provided) after a temperature excursion (TE) (temperature: 0.0 Fahrenheit (F), time frame: 0 hours 20 minutes 0 seconds) (product storage error). No additional adverse event (AE) happened (no adverse event).
Hot and cold shivering. Temperature of 102.2 degrees. Fever broke after 25 hours.
upset stomach; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. Patient reported upset stomach after eating some Mexican food.
Developed behavioral problems in Sept '12 shortly after beginning daycare for the first time. Behaviors are most suspicion for sensory integration problem, though an autistic spectrum disorder has not been ruled out yet.
Within 2 days of vaccination, I began to experience moderate constitutional symptoms: headache, low grade fever of 99, and mild chills. Sunday AM I noted the onset of intense vaginal itching and burning.  By the evening, I was clearly having an HSV2 outbreak.  While it was similar in ?scope? to past outbreaks (none for more than 2 yrs.), it was more intense.  Lasted slightly longer at 6 days rather than 4.  No  MD contact made as 1) I cannot take antivirals as they precipitate arrhythmia; and 2) taking antivirals at this time would clearly seem antithetical given the circumstances.  This was shot #1.
Information has been received from a physician concerning a female patient who on approximately 01-AUG-2007 "about a week ago", was vaccinated IM with a dose of Gardasil.  It was reported that other vaccinations were given within the same visit but specifics were unknown.  About a week ago, the patient fainted in the office.  No medical attention was sought.  Before leaving the office, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
no additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# 1879864 experienced a temperature excursion above 46 Fahrenheit (F) (62.8F) for a timeframe of 8 hours 0 minutes and 0 seconds; no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number 1879864 confirmed to be valid, expiration date reported and stablished as 19-OCT-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002779: US-009507513-2209USA002722:02242101 US-009507513-2209USA002532:02242101 US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002510: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606:
Pt grew light-headed, fell/lowered himself to the floor. Complains of dizziness and nausea, no vomiting. Drank approx 4-6 oz of water, recovered, walked out of the office under his own power.
Mother phoned to state that child has hives that began the day the child got HepB (8/24/04). F/U: Recommended allergist eval before addtional vaccine doses.
Mid chest felt full and loose.  Felt like she was going to "pass out" but did not.  Denies SOB, CP.