chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was informed that while standing there waiting on his mother to get some paperwork at the front desk he had fallen/was having a seizure in the lobby-I arrived he was lying on the floor with his head in his mother's lap-I noted he was trembling/skin was clammy-staff informed he had fallen back hitting back of his head on the floor-patient was alert to mother speaking to him-I assessed patient's head for noticeable injuries and glanced at entire body for noticeable injuries-I called for my supervisor-before my supervisor arrived patient's mother had him stand/walk to a nearby chair-he did without any noticeable problems-my supervisor and NP arrived and we helped him to a w/c vital signs were taken and assessed by NP.
Fever, chills, muscle aches, hip joint pain, dizziness, vomiting, fainting, high heart rate
A report was received from a health care professional on 11/12/03, concerning a 15 month old male vaccinee who inadvertently received Fluvirin on 11/12/03. On 11/12/03, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficiently information to determine the reporter's causality assessment. Update 1/2/04: A follow up report was received on 1/2/04 which indicated that the vaccinee had experienced 2 seizures due to increased temperature on an unspecified date. The vaccinee was hospitalized on 11/14/03 and was discharged on 11/15/03. The vaccinee had also received a DTP vaccine and a combined Haemophilus influenzae B and hepatitis B vaccine. It was not reported if the vaccinee had recovered at the time of the report. Follow up pending. Update 2/3/04: Further information was received from a health care professional on 2/3/04 indicating that the vaccinee experienced one febrile seizure on 11/13/03 due to an elevated temperature. The vaccine's mother stated that she had experienced febrile seizure as a child. The vaccinee received the DTaP vaccine and combined Haemophilus influenzae B and hepatitis B vaccine on 11/12/03. The vaccinee was seen in the emergency room on 11/13/03 and subsequently hospitalized on 11/14/03 to 11/13/03 for observation. The vaccinee recovered on an unspecified date. Follow up pending.
6 hours after VZV, pt had pain at site right deltoid, became swollen and red approximately 30 hours later doubling in size 2-3 hours before office visit. Fever, red streaks up arm. warm compresses and Augmentin.
fever (up to 101)  for three days after receiving vaccine. Diarrhea several days following vaccination   Muscle aches and generalized body aches  continue as of this reporting date.  Seeing PCP today.
armpit is swollen; lymph nodes are huge; pain in armpit radiating down my arm & bicep and thru my shoulder blade; This is a spontaneous report from a contactable health professional reporting for herself. A 39-years-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 25Jan2021 as a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 on 05Jan2021 at 09:00 AM. The patient medical history and concomitant medications were not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. The patient didn't receive other medication in two weeks. On 25Jan2021 patient experienced armpit is swollen, lymph nodes are huge and pain in armpit radiating down my arm and bicep and through my shoulder blade. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
very dejected; he's very, very sick; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. On an unspecified date, patient had no adverse effects to the COVID Vaccine after seven days that was patently false and knows a physician now after spending tens of thousands of dollars on a sick kid who was a star athlete in the state, who had not been able to find his butt with both hands after nine weeks after receiving the second COVID Vaccine and he was very, very sick and very dejected. Patient wanted to talk to a doctor who was studying the adverse effects report from the second virus from the second vaccine and wanted to talk to whoever was collecting information about the other people who had long term side effects from the COVID Vaccine. The outcome of both the events was unknown.  Information on the lot/batch number has been requested.
both in bed for 2 days; didn't feel good for about 4 days; couldn't get out of bed; felt sick for 4 days; fever of 107; chills; both arms hurt for almost a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days) and PYREXIA (fever of 107) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days) and ILLNESS (felt sick for 4 days) had resolved and MOBILITY DECREASED (couldn't get out of bed), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) fever of 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was tested positive for COVID-19 a year ago  Concomitant product was not provided by the reporter   This case was linked to MOD-2021-301937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional information included lab data and new event.
Syncope lasting one hour after vaccine, patient transported to ER for evaluation because syncope persisted.
ED visit and treatment for COPD. Hospital admission. Patient found to be in atrial flutter with RVR and decompensated CHF. 3/10 S/P TEE guided DCCV with early return of atrial flutter after 3/11 S/P successful ablation of typical atrial flutter in the cavo-isthmus. 3/15: EP discontinued amiodarone in the setting COPD. Continue rivaroxaban 20 mg PO daily. ED visits and hospital admission within 6 weeks of receiving the COVID-19 vaccine.
8 days post vaccine patient developed rash on left arm that spread to b/l arms and legs.  Over the next few days developed increased fatigue, severe joint pain, fever and worsening rash.  Was seen in ER on 4/23/2021.  Extensive work up showed increased CRP, Eosinophilia, increased LFTs, increased WBC.  Skin biopsy was taken and revealed Superficial and deep perivascular and interstitial dermatitis, histiocyte-predominant and with eosinophils.  ANA was positive 1:640, Ferritin was elevated.  The patient was admitted.  .  Patient had CT scan of the chest on 4/28/2021 which showed bilateral pulmonary embolism and possible mass in the right side of the liver.  Patient was started on anticoagulation.  Next day, patient had severe abdominal pain with pain in the right lower quadrant.  He as found to have Ogilivie's Syndrome with  colon ischemia and peritonitis.  Now s/p resection with septic shock.  The patient is in the ICU and intubated.
Redness, tenderness, warmth, swelling from deltoid to elbow treated with two days of IV ceftriaxone followed by oral cephalexin.
This spontaneous report as received from a pharmacist refers to a 86 year old male patient. Medical history and concurrent conditions were not reported. On 31-JUL-2014, the patient was vaccinated with ZOSTAVAX, 0.75 ml, subcutaneous. Lot number and expiration date were not reported. The pharmacist reported that another pharmacist administered ZOSTAVAX to the patient. Patient's daughter called Pharmacist on 04-AUG-2014 initially stating that she believed her father may had received ZOSTAVAX 10 years ago, but as the phone call went on Pharmacist reports that patient's daughter said she was not sure when or if her father received the vaccine prior to the dose administered on 31-JUL-2014 and she would be called her father's Physician to find out. Pharmacist would call back with more information if patient had actually received the vaccine twice. No other information available. No adverse effects noted to patient. The patient did not seek medical attention. Additional information has been requested.
Red, Itchy, swollen rash around injection site. Did not begin itching until a week after shot.
Clinical Support, 5/4/2021, Family Medicine -  LPN, Close exposure to COVID-19 virus, Dx, Covid-19 Screening Reason for Visit. ED to Hosp-Admission Discharged  5/6/2021 - 5/8/2021 (2 days), Hospital, DO, Last attending, Treatment team COVID-19 virus infection, Principal problem, Medical Problems , Hospital Problems, POA, (Principal) COVID-19 virus infection- Yes, Hypokalemia- Yes, Diarrhea- Yes. Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] COVID-19 virus infection [U07.1] Severe sepsis Hospital Course, Pleasant 55-year-old female admitted to the hospital with signs of severe sepsis with associated acute hypoxic respiratory failure.  Was found to be febrile, tachycardia, tachypneic, hypoxic on admission. Chest imaging did reveal patchy infiltrates consistent with viral pneumonia.  Was diagnosed with COVID-19. Started on antiviral, corticosteroid, and received antibiotic therapies while in hospital.  Improved significantly over the course of 2 days and was able to titrate back to room air.  I recommended discharge home, she will continue to isolate until 14 days from initial diagnosis.  Recommended the use of albuterol as needed, and she will continue a taper of prednisone. She will follow-up with PCP in 7 to 10 days
shingles with blisters on left side of neck and left side of head and face down to the front of my neck. I was treated with Valtrex 3 times and am suffering with the nerve endings itching. Very unpleasant.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse), VACCINATION SITE ERYTHEMA (Described it as red) and VACCINATION SITE RASH (Rash had spread outside the margin) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.  No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse) and VACCINATION SITE ERYTHEMA (Described it as red). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash had spread outside the margin). At the time of the report, VACCINATION SITE REACTION (Huge amount of reactivity in the arm), VACCINATION SITE WARMTH (Hot and hard), CONDITION AGGRAVATED (Arm blew up and its worse), VACCINATION SITE ERYTHEMA (Described it as red) and VACCINATION SITE RASH (Rash had spread outside the margin) outcome was unknown. 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. Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt passed out becoming flaccid for ? length of time about 3 hrs p/DTP/OPV/Measles vax; temp 102 @ ER;
woke up at 4 am the day after vaccination with pain in injection site arm 8/10.  Had general muscle/joint pain that made it difficult to get out of bed.  Nausea and low grade fever.  Unable to go into work.  Felt I was not able to get out of bed to even take medication.  Fianlly took 600mg of ibuprofen at 1:30 p.m.  Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued.  Slept well then next night and felt 90% better the next morning.  Feeling much better today.  No s&s.
pt recv vax 2DEC96 & the next day 3DEC96 pt devel redness @ the inj site;pt reported that has improved;
Just after midnight of the day I received the shot, I started getting the chills although I wasn't cold.  The shaking escalated into seizure-like shaking, quivering, jerking.  This lasted until approximately 7:00 a.m.  My husband had to physically hold me and walk me to the bathroom.  He gave me a bottle of water but I wasn't able to unscrew the cap nor hold the bottle and sip from it because my head and hand were shaking uncontrollably
torso started to itch and she wasn't sure if it looked like a heat rash or it just got irritated/the back of her neck and her shoulders also started to itch and they were red; torso started to itch and she wasn't sure if it looked like a heat rash or it just got irritated/the back of her neck and her shoulders also started to itch and they were red; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 08Feb2021 16:15 (33-Years-old at the time of vaccination), (Lot Number: LN6201, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient stated that she had the first dose of the Pfizer COVID-19 vaccine yesterday (08Feb2021) at 4:15PM. On 08Feb2021, at 10:30 PM, her torso started to itch, and she wasn't sure if it looked like a heat rash or it just got irritated. On 09Feb2021, the back of her neck and her shoulders also started to itch, and they were red. Realized it could be from the vaccine, states she looked at her body, it was red, can't tell if it was because she scratched or a reaction. States now the back of her neck and shoulders have started itching, states it was little, red and bumpy. The clinical outcome of the event redness was unknown, and itch was not recovered.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (05Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks. Patient received treatment of Covid-19 from 28May2022 to 01Jun2022. Rebound, symptoms returned 2 days later, tested positive 05June2022. Patient having known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Lightheaded, blurry vision, decreased hearing. 24-36h later, had some tingling in the arms. Was seen @ an urgent care facillity.
Patient fainted / 3 episodes of fainting attack; Feeling bad; Headache; High fever; Vomiting episodes; slept for more than 3 hours after the fainting attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Patient fainted / 3 episodes of fainting attack) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 57A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced SYNCOPE (Patient fainted / 3 episodes of fainting attack) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack). At the time of the report, SYNCOPE (Patient fainted / 3 episodes of fainting attack), FEELING ABNORMAL (Feeling bad), HEADACHE (Headache), PYREXIA (High fever), VOMITING (Vomiting episodes) and HYPERSOMNIA (slept for more than 3 hours after the fainting attack) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-073768 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-073768:linked case
Pfizer vaccine was given externally reported by patient.  G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 9/17/2022 CHF EXACERBATION, UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 9/17/2022 CHF EXACERBATION, UNSPECIFIED I20.8 STABLE ANGINA 3/18/2022 CHF EXACERBATION, UNSPECIFIED I95.9 HYPOTENSION 8/12/2022 CHF EXACERBATION, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/13/2022 CHF EXACERBATION, UNSPECIFIED G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 9/17/2022 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS G40.909 EPILEPSY, UNSPECIFIED 9/17/2022 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS I20.8 STABLE ANGINA 3/18/2022 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS I95.9 HYPOTENSION 8/12/2022 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS J96.00 ACUTE RESPIRATORY FAILURE 10/13/2022 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 9/17/2022 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY G40.909 EPILEPSY, UNSPECIFIED 9/17/2022 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I20.8 STABLE ANGINA 3/18/2022 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I95.9 HYPOTENSION 8/12/2022 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY J96.00 ACUTE RESPIRATORY FAILURE 10/13/2022 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 9/17/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G40.909 EPILEPSY, UNSPECIFIED 9/17/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I20.8 STABLE ANGINA 3/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 8/12/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 10/13/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 9/17/2022 CARDIAC ARRHYTHMIA G40.909 EPILEPSY, UNSPECIFIED 9/17/2022 CARDIAC ARRHYTHMIA I20.8 STABLE ANGINA 3/18/2022 CARDIAC ARRHYTHMIA I95.9 HYPOTENSION 8/12/2022 CARDIAC ARRHYTHMIA J96.00 ACUTE RESPIRATORY FAILURE 10/13/2022 CARDIAC ARRHYTHMIA
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 02-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient  said the day after her shot, she woke up and was feeling very dizzy.  In her kitchen, she turned and fainted, hitting her head on the counter and causing a concussion.
Presyncopal - laid down on stretcher. Father states that child does this after every injection. Child had played tennis in am and come without eating or drinking. Given snack and juice. Felt better and improved quickly.
Pt seen at ED on 03/24/2014, transferred to another hospital, admitted on 03/25/14 at 1:00 AM for respiratory distress MD plans on discharge 03/26 or when a safe discharge plan is in place.
Injection site red, hot, swollen and hurt. Rash developed, spreading across chest and neck. Welts formed on neck and chest.
Headache, Arthralgia, NauseaVomiting, anorexia, hot/cold chills, fatigue, nasal congestion, soreness at injection site Narrative:  Per nursing report: "took 2nd Moderna vaccine on yesterday [2/20]. C/o started having chills last night and hot flashes. C/o having pressure around both ankles and wrists this morning, with no c/o swelling. States feels like a vibration in her joints. Also c/o nausea, no appetite, headache, congestion and right arm pain where vaccine administered."  Other Relevant History: