chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an unknown number of patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M016193, expiry date: 24-APR-2018) (dose and route of administration were not reported). No concomitant therapy was reported. The temperature excursion was 31F for 14 hours. No adverse effect was reported. Additional information has been requested.
No additional adverse event; Inbound call from physician calling to report AE for PEDVAXHIB.  Caller states that she has a 6 month old patient who received a 3rd dose of PEDVAXHIB.  Patient received their 1st dose at 2 months and their 2nd dose at 4 months.  No symptomatic adver; month old patient who received a 3rd dose; This spontaneous report was received from a physician concerning a 6-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2023, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided) at 2 months old. The patient received a second dose when they was 4 months old.   On 30-MAY-2023, when the patient was 6 months old, the patient received a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter lot#W015928, expiration date: 24-FEB-2025 (Inappropriate schedule of product administration) (Product administered to patient of inappropriate age). No symptomatic adverse events were reported.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 18-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date o8-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Chills nausea dizziness fever ?foggy ness? light headed leg cramps
Saturday: Intense chills, and body aches, that were unmanageable through 1,000mg Tylenol every 4-6hours and Gabapentin 1,200mg every 6 hours.   At approximately 2:30 AM on 4/11/2021 I awoke to extreme chills and uncontrollable tremors. The tremors were so bad that I had issues walking to the kitchen to take additional medication, and could not hold a glass in my right hand steady - as it slipped out of my hand while my hand was uncontrollably shaking. Additional Tylenol, Gabapentin, and Zanaflex calmed my nerves enough to where I was able to return to manageable chills for the next 12 hours.
Patient resides in a group home, and was seen in the ED on 11/15/22 with increasing generalized weakness over the past 2 days as reported by his caretakers. COVID-19 PCR test was done in the ED which was positive. Ultimately, patient was admitted on 11/15 with weakness secondary to COVID, bacterial pneumonia, and thrombocytopenia. He did not require oxygen. Patient was discharged 11/21/22 to his group home.
Left neck and left upper back pain radiating down to left buttock. Began after vaccination; IBP PO has helped, bending worsens.
five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the third of five reports.  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not reported), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event for different patients.
Dizziness, lightheadedness, light sensitivity, sweats starting 2 minutes after vaccination lasting for about 10 minutes
pt fainted <1min post vax & BP 104/55;pt pasty & sl clammy;pt fainted again 30min later;BP 108/58;pt on side,lying down, ice pack to forehead;EMS called, mom & RN bedside @ all times;
hives that have progressivly become worse and worse over the last several months/bruising and welts that seemingly are not manageable with drugs; bruising and welts that seemingly are not manageable with drugs; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 41 years of age), intramuscular on 04Feb2021 12:00 (Batch/Lot Number: EL0142) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. She has not been tested for COVID-19 since the vaccination. The patient experienced hives that have progressively become worse and worse over the last several months. She was now on high dose steroids and have bruising and welts that seemingly are not manageable with drugs. The events started on 12Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included pooled test was negative (Other) on an unspecified date. Therapeutic measures were taken as a result of the events. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.; Sender's Comments: Considering a plausible drug-event temporal relationship, a causal association between the reported 'hives/welts and 'bruising', and the administration of the vaccine BNT162B2 in this patient cannot be completely excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Broke out with rash next morning (12/5/09) on one side of belly and leg (same side). Mother reports rash "looked like chickenpox" at first but looks like " regular rash" and itchy by the date of the report to the child's physician. Did respond to follow-up phone calls, so tx and response unknown.
baby developed facial flushing/rash to face/head only. Erythematous macular areas that blanched/ had normal interaction, normal respiratory exam and continued to act normally. heart rate and 02 sat remained normal, redness/rash resolved over 15 min. mom and grandmother noted he had now had a flushing reaction like this to precious vaccines and the vaccines were the exact same at his 2 and 4 moth well child exams.
Arthralgia, Fever, NauseaVomiting, fatigue; nightmare of black ants all over, mornigntemp was 101.3 and shaking chills Narrative:
5-11 Pfizer Vaccine  inadvertently, given to client today.  I called and spoke with her mother and informed her of the error.  Client has no chronic health conditions.
Seen 4/14/06 cellulitis vs allergic rxn w/in 24 hrs on right thigh. Omnicef 1/2 tsp PO bid x 5 days. Motrin prn fever or PCN. Benadryl 1 tsp q6. Rev'd on 4/17/06 was better.
IT WAS DISCOVERED BY NURSE THAT THE PATIENT WAS ONLY 15 YEARS OF AGE AFTER THE VACCINE WAS GIVEN. PATIENT WAS OBESERED FOR 45 MINUTES. SPOKE WITH MOTHER AND EXPLAINED THE VACCINES AND REASONS FOR EXTRA OBSERVATION. MOTHER VERBALIZED UNDERSTANDING. PATIENT AND MOTHER STATES , HE FELT FINE. PATIENT HAD NO ADVERSE REACTION OR SIDE EFFECTS OF VACCINE. EXPLAINTHAT MOM NEEDS TO CONTINUE TO MONITOR PATIENT AND TAKE PRECAUTION FOR ANY ADVERSE REACTION.
No additional AE reported; PROQUAD was administered after a temperature excursion to patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, once, lot #W023870, expiration date: 24-JAN-2024, administered for prophylaxis after a temperature excursion (strength, and route of administration were not provided) (Product storage error). It was reported that temperature and time frame were 5.9F for 13 Minutes and 33.4F for 1 Hour 54 Minutes. There were no previous temperature excursion. No further information provided. No additional adverse event (AE) was reported (no adverse event).
Generalised urticaria, no resp probs, Occurred 2 hrs /p inject.Active & playing well.Had benadryl @ home.Improved for 1/2hr & the rxn started again.Brought back to ofc, given benadryl, adrenalin & Pediapred as lips became cyanosed.Adm hosp.
pt stated was a little red p/got shot then each day it has gotten redder & it was hot to touch; also knot around area; red area about the size of fifty cent piece;
TOOK A NAP. WOKE UP SHAKING,NAUSEATED, DIFFICULTY BREATHING, DIZZY AND COULDN'T MOVE LEFT ARM. WENT TO HOSPITAL.
sore arm; Temp of 100.4 fever; Chills; felt wiped out like fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL), ATORVASTATIN, CARVEDILOL, CLOPIDOGREL, GABAPENTIN, GLIPIZIDE, HYDRALAZINE and LISINOPRIL for an unknown indication, METFORMIN, PANTOPRAZOLE and LIRAGLUTIDE (VICTOZA).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg three times a day. On 29-Jan-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (Temp of 100.4 fever), CHILLS (Chills) and FATIGUE (felt wiped out like fatigue) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 100.4 °F (High) High.     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 fainted a couple of minutes after receiving immunization, patient regained consciousness immediately, stayed for another 20 minutes under observation and was feeling fine after 10 minutes. No treatment was needed or given.
c/o muscle aches, sweats, dizziness, nausea & dec appetite; seen by MD @ which time stated had the same sx following the 2nd Hep B vax 5APR93; did not report to anyone;
new cough; muscle soreness in chest and bilateral arms; severe arm pain; fever; chills; fatigue; severely swollen lymph nodes in neck; sore scratchy throat; headache; neck ache; ear pressure; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), on 19Jul2023 as dose 2, single (batch/lot number: unknown) at the age of 18 years, in left deltoid for immunization. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medications included: SERTRALINE, start date: 01Mar2021; ABILIFY, start date: 03May2021; NEXPLANON, start date: 14Jun2023. The following information was reported: CHILLS (non-serious) with onset 19Jul2023, outcome "not recovered"; EAR DISCOMFORT (non-serious) with onset 19Jul2023, outcome "not recovered", described as "ear pressure"; FATIGUE (non-serious) with onset 19Jul2023, outcome "not recovered"; PYREXIA (non-serious) with onset 19Jul2023, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 19Jul2023, outcome "not recovered"; NECK PAIN (non-serious) with onset 19Jul2023, outcome "not recovered", described as "neck ache"; PAIN IN EXTREMITY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severe arm pain"; LYMPHADENOPATHY (non-serious) with onset 19Jul2023, outcome "not recovered", described as "severely swollen lymph nodes in neck"; THROAT IRRITATION (non-serious) with onset 19Jul2023, outcome "not recovered", described as "sore scratchy throat"; MYALGIA (non-serious) with onset 21Jul2023, outcome "not recovered", described as "muscle soreness in chest and bilateral arms"; COUGH (non-serious) with onset 21Jul2023, outcome "not recovered", described as "new cough". The events "severe arm pain", "fever", "chills", "fatigue", "severely swollen lymph nodes in neck", "sore scratchy throat", "headache", "neck ache", "ear pressure", "new cough" and "muscle soreness in chest and bilateral arms" required emergency room visit. Therapeutic measures were taken as a result of pain in extremity, pyrexia, chills, fatigue, lymphadenopathy, throat irritation, headache, neck pain, ear discomfort, cough, myalgia.  Additional information: The patient informed that the facility type was doctor's office/urgent care. On 19Jul2023, the patient experienced severe arm pain within 1 hour followed by fever, chills, fatigue, severely swollen lymph nodes in neck, sore scratchy throat, headache, neck ache and ear pressure. These worsened over 24 hours, only slightly responsive to Advil, Benadryl, sinus medicine and Tylenol. These persisted on day 3 post vaccine and now with new cough, muscle soreness in chest and bilateral arms. The patient went to urgent care and was treating symptoms with OTC.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
pt recvd vax; pt devel facial neck & hand edema & a sharp pain in midchest when she breathed;
Swelling below injection site LD.  Pain at site.  Vomiting, swelling/warmth/pain lasted 2 days with complete resolution of symptoms.
Approx. 30-40 lesions/excoriated papules on arms, legs, forehead and hand, post vax.
Diagnosed with pericarditis   Presented to the emergency department on 7/18/2021  with chest pain (substernal) and does not radiate, but reports heaviness and pressure.  The pain was severe at onset. This is exacerbated by exercise but are relieved by nitroglycerine and fentanyl.  Family history of CAD.  Also reports shortness of breath.  Pain onset was abrupt while riding his bicycle.   ECG shows diffuse ST selevation in multiple coronary distributions with P depression.  Bedside ECHO showed normal heart.  EF was ~60%.  Hemodynamically stable.  Given one dose of Toradol., SL nitro 0.4mg Admitted to the hospital Started on colchicine 0.6mg bid  and ibuprofen 600mg tid with plan of 10 days of treatment.
High fever, barking cough, wheezing, muscle cramps, pain, weakness and spasms throughout the body, including the back and stomach. 11/10/2009 ED notes for 11/5/2009. patient with c/o's sore throat, fever, cough, nasal congestion and headache. Tx: Motrin, Amocicillin. DC Dx:Acute pharyngitis
Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All    1/8/2021    Date:  1/8/2021                                                                                                  Subjective Patient is a 38 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination. He denied any history of previous adverse reactions to other vaccines, but does note he had tingling to the right side of his face after his first dose that lasted 3 days.   He was given the Pfizer vaccination in the right deltoid muscle.During his 15 minute waiting period after the injection, the patient began to experience tingling to right side of face. He denied difficulty breathing, throat tightness, itching, lightheadedness and facial swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms.   ALLERGY REVIEW OF SYSTEMS:  Patient denies chest tightness, shortness of breath, wheezing, rash and dizziness    +right sided facial tingling.:   Previous Reactions: Patient states he had right sided facial tingling after receiving his first vaccination, but was not evaluated in the medical bay. He states the numbness and tingling lasted approx. 3 days. Denied weakness in right sided facial muscles at that time.     Objective    Vitals Vitals:   01/08/21 1318 01/08/21 1337 01/08/21 1342 BP: (!) 153/101 137/88 125/85 Pulse: 69 71 60 SpO2: 98% 99% 98%     Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling or lips or tongue.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: antihistamines and Tylenol 1000mg. Tylenol was given by patients wife at 1331. Follow up response to treatment: Patient continues to have tingling to right side of his face. His respirations have decreased however and he is feeling better. BP and HR have improved throughout visit.  Patient discharge: Stable to go home and follow up with PCP. Discussed returning to work for the remainder of the day.    Instructed to F/U in ER if symptoms worsen.   Electronically Signed 1/8/2021 1:44 PM
approx 5 mins p/vax pt noted urticaria type rash appearing on both arms; no resp problems or flushing; seen w/in 10 mins by MD;
Initial pregnancy report received from a healthcare professional on 06 September 2013.A 33-year-old female patient had received an intramuscular first dose of ADACEL (lot number: C4432AB, expiry date: 18 October 2015) in the right deltoid on 04 September 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was  03 February 2013 and the estimated date of delivery was reported as 10 November 2013. The patient's health during pregnancy, risk factors (e.g. : alcohol, tobacco or recreational drugs), and concomitant medications were not reported. At the time of this report, the patient had not experienced any adverse event. List of documents held by sender: none.
6cm x 7.5cm red, warm, no induration, no streaks, no discharge left deltoid area over 24 hours.
When patient came in for 2nd shot, she said after the 1st shot , 2-3 weeks later, she had severe chest tightness and difficulty breathing, she also had fever, chills,  body aches. Due to the severity of the breathing and chest tightness she explained,  the 2nd shot was denied.
Give Moderna at age 17-going to be 18 in 6 days.  Had flu like symptoms after shot but resolved in 24hrs-was Covid positive in the past.
Narrative:  70yo male patient with the following problem list: Carbuncle of perineum (ICD-10-CM 1/31/2019 L02.235) Insomnia (ICD-10-CM G47.00) 09/05/2018 Hyperlipidemia (ICD-10-CM E78.5) 07/07/2017 Type 2 diabetes mellitus well controlled (ICD-10-CM E11.9) Hypertensive disorder (ICD-10-CM 12/29/2016 I10.) Noncompliance with medication regimen (ICD-10-CM Z91.14) Upper respiratory infection 06/01/2015 (ICD-9-CM 465.9) Sinusitis (ICD-9-CM 461.9) 06/01/2015 Cough (ICD-9-CM 786.2) 06/01/2015 Heel pain (ICD-9-CM 729.5) 06/01/2015 Plantar fasciitis (ICD-10-CM 07/07/2017 M72.2) History of polyp of colon 07/07/2017 (ICD-10-CM Z86.010) Depressive Disorder NOS 02/16/2017 (ICD-10-CM F33.42) Degeneration of intervertebral disc (ICD-9-CM 06/15/2006 722.6) Received one covid vaccine on 2/8/2021. Pt died of unknown causes & unknown place or circumstances on 3/21/2021. Unable to assess if vaccine related to this death. No notes in chart about pt's death.
Suicidal thoughts, negative thoughts, crying, anxiety, difficulty managing emotions  Currently 31 weeks pregnant. Did not have these emotions prior to vaccination.
Per statement from patient: On 8-14-07 symptoms began with a headache. There was swelling, warmth, tenderness, and itching at the injection site. Also, there was soreness in neck and right arm. Patient stated she felt sharp pains in left arm and leg. Fever x 2 days; felt nauseated with hot flashes. Went to MD on same day. Received steroid injection. Pain/headache stopped that day. Swelling lasted until Sunday evening 8/19/07.
Tiredness started 7 hrs after injection, then woke up at 330am with chills,.nausea, fever, muscle cramps, headache, and pain, swelling, and redness at the injection site all throughout the next day. Day 2, no fever or chills, some vomiting, very fatigued and arm reaction seems more inflamed.
Please note that flu vaccine was also given same date but in contralateral arm to both TDap and eventual pathology. TDap administered high in L arm without pinching muscle. Progressive pain and immobility of L shoulder and arm over 1 week culminating in urgent care visit on 9/24 with no imaging or testing and ED visit on 9/25 with MRI. Has required assistance in ADLs such as dressing, bathing, cooking, cleaning, driving. Limitation and ROM including abduction and flexion of the arm. No weakness noted. MRI revealed fluid in fascial planes of left shoulder including "along the posterior aspect of the shoulder, notably adjacent to the infraspinatus and teres minor muscles... extends to the myotendinous junction of the infraspinatus. Would be difficult to entirely exclude the possibility of an interstitial partial tear. There is a small amount of fluid likely within the deltoid musculature. It does not appear that the fluid extends into the shoulder joint." Requires rest, acetaminophen, exercises for mobility.  28 weeks pregnant at the time with EDD 12/17/23
Pain and limited mobility in right upper arm starting immediately or day after injections. I struggle to get dressed, undressed, and reach certain areas (i.e. reaching across, over, or behind my shoulder) WTH my right upper arm.  I also have bicep pain in the same arm.
Rash on both thighs where shots were given. Patient will return to office if rash gets worse.