chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/4/21 1005am pt started complaining of feeling flush, restless, and anxious.  pt states that she does not feel right and that there is something wrong.  then pt reported that her legs felt numb.First RN and Second, RN was present to assist pt.  pt was put on 4L of O2 by mask.  Dr  was called to assist.  pt was moved from sitting in chair to laying on floor with legs elevated.  pt reporting that her hands and legs were feeling numb.  per Dr  pts lungs were clear with good air exchange.  pt alert and oriented to self, place, and time. 1012am BP 141/81 P 71 SaO2- 100% BS 99 pt still feeling flush and restless with anxiousness increasing.  upper lip swelling.  questionable tongue swelling.  hand and feet numbness.  pt states does not feel right. V.O. Dr 25mg Benadryl IM now administered to the right deltoid IM, RN 1020am BP- 162/100 P- 72 SaO2- 100% pt still feeling flush and restless with anxiousness.  still with some upper lip swelling.  questionable tongue swelling.  hand and feet numbness is still reported.  pt states she still does not feel right.  husband is now with pt at her side and trying to calm her.  pt is c/o some SOB, per Dr  pts lungs are still clear. pt remained alert to self, time, and place. V.O. Dr. Albuterol neb treatment now attempted to start neb treatment however pt was not tolerating neb.  ok by Dr  to stop neb treatment. 1025am called AMR V.O. Dr 1mg Epinephrine now administered 1mg Epinephrine IM right deltoid. P. , RN 1027am pt wanting to sit up. states cannot get comfortable laying down.  assisted pt to sit up.  pt is less anxious.  reports to feel less restless.  decrease upper lip swelling and tongue swelling.  pt reports that she is starting to feel a little better.  pt is feeling less numbness in hands and feet. BP-141/58 P-99 SaO2-100% 1037am pt starting to complain of feeling flush, restless, and anxious again  pt states that she does not feel right and that there is something wrong again.  pt again reporting that her hands and feet felt numb.  per Dr - pts lungs still clear with good air exchange.  pt remains alert to self, place, and time.   per Dr  draw up another dose of Epi  while waiting for AMR, AMR arrived prior to drawing up second dose of Epi.   1039am AMR arrived.  transferd pt from floor to gurney and trnsported pt to ER. ................................................................... RN  March  4, 2021 3:20 PM
Patient described a rash that covered injection site and spread down left arm. Patient did not state any treatment was done for it and let the rash heal on its own.
PATIENT 17 YEARS OLD AT TIME OF VACCINATION. MODERNA VACCINE IS APPROVD FOR 18 YO AND UP.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA339302 same reporter. This case involves a 4 years old male patient who experienced swelling in the leg and thigh area with a slight limp, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Food allergy. The patient's past vaccination(s) included INFLUENZA VACCINE in 2015. The patient's past medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious swelling in the leg and thigh area (peripheral swelling) and swelling in the leg and thigh area with a slight limp (gait disturbance) 24 hours following the administration of FLUZONE QUADRIVALENT. (Other relevant tests included no lab data.) Final diagnosis was swelling in the leg and thigh area with a slight limp. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by sender: none.
I'm now suffering from full blown Ra; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "I'm now suffering from full blown Ra".  Clinical course: Patient had took shots because of covid 19 why am I'm now suffering from full blown Ra I was fine could do anything now I'm going to hell in a hand basket.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PT STATED THAT BEGINNING THE AFTERNOON/EVENING FOLLOWING THE VACCINE HE HAD A SPELL OF VERTIGO.  HE HAS NEVER HAD VERTIGO PREVIOUSLY.  HE CONTINUED TO HAVE INTERMITTENT SPELLS OF VERTIGO THAT CONTINUED AND WORSENED OVER THE NEXT 48 HOURS.  HE STATED THAT HIS EYES DIDNT FOCUS WELL AND HE SAW EXAGGERATED LIGHT IMAGES.  HE GOT A WALKER OUT THAT HAD BEEN USED FOR A PREVIOUS HIP REPLACEMENT SURGERY DUE TO HIS UNSTEADY GAIT.  HE HAD A SEVERE HEADACHE AND FELT GENERALLY UNWELL.  HE STATED THAT IT WAS "THE WORST THING HE HAS EVER BEEN THROUGH AND HE IS 68 YEARS OLD.  HE WOULDNT TAKE ANOTHER DOSE IF I PAID HIM AND HE FELT LIKE HE WAS ON SOME KIND OF TRIP."
Vaccination given in left deltoid.  Patient developed eosinophilic cellulitis.  Fever, chills, pain in left arm, redness/swelling/warm to touch from left shoulder to left elbow.  Patient using ibuprofen for discomfort and applying ice.  Assessed in office 12/22/10 and will be doing daily phone check in with patient.
no adverse symptom; patient was administered a dose of proquad instead of MMR II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.     The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported. On 11-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R021095, expiry date: 20-JAN-2020, strength, dosage information, route of administration and anatomical locations were unknown) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (wrong product administered). No adverse symptoms reported. No further clarifying information was provided. No additional information was reported.  The outcome of wrong product administered and no adverse event was unknown.
Localized redness, swelling, and mild itching. Cold pack given and instructed to take BENADRYL/TYLENOL if swelling and itching persists. Return to clinic if symptoms worsen or persist for longer than 3 days from today (Per MD).
This non-serious spontaneous case, initially received from other health professional (nurse) on 17-Sep-2018, concerns a 12-year-old, male adolescent patient. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX QIVc was out of temperature and exposed to temperature 55F for 1 hour and 45 minutes. On 15-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 252381, expiry date: 31-May-2019) which underwent temperature excursion. At the time of this report, no adverse effects were noted after the vaccination.
Sweats; chills; muscle aches; Joint pain; Headaches; Fatigue; Insomnia; Mouth sores; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the right arm on 17Apr2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:15 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. On 18Apr2021 at 06:00, the patient experienced sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sweats, chills, muscle aches, joint pain, headaches, fatigue, insomnia and mouth sores was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
patient had not received the 2nd dose of the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  on 20th December 2018,batch number 273BZ,expiry date 15th May 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose of the Shingrix vaccine which led to incomplete course of vaccination. No further details were provided at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The HCP (Healthcare professional ) did not consent nor declined follow-up and wanted to answer to MI question. No further details other than ones mentioned were provided at the time of call.
1cm by 3.5cm thickened texture at injection site. Really pink with a faint purple color. No pain or itch, but mark has been present from day of injection April 1st, 2016 to October (about 6 months).
NO ADVERSE EVENT IDENTIFIED , NO SIGNS OR SYMPTOMS.  THE BOOSTER VACCINE WAS ADMINISTERED BEFORE THE 6 MONTH  WAITING TIME PERIOD BETWEEN 2ND COVID19 DOSE AND THE BOOSTER.
8 days after initial shot the injection site became swollen, firm to the touch, and itchy. The entire arm was sore and stiff, more so than on the first day. The arm is less sore on day 9, but the injection site appears to have a rash and is still swollen.
big red rash 7inx5in warm to touch almost 2 weeks after shot  no treatment as of this report
Headache, Myalgia, Fever, Nausea Vomiting, fatigue Narrative: experiencing headache, body aches, fatigue and at times nausea. took naproxen last night and this morning. + fever 100.0
3 day old recieved comvax. Nurse was instructed to go give 1st hep b but instead gave comvax. No known symptoms. mom never called stating her baby was having a reaction.
Received my booster on 27-Dec-22 and my husband received his booster on 28-Dec-22. Both of us tested positive for Covid-19 on 20-Apr-22 (symptoms include fevers, body aches, dry cough, congestion, fatigue, itchy throat for both of us). Symptoms are manageable at home, but wanted to report since we were diagnosed within 4 months of receiving a booster.
This spontaneous report as received form a Medical Assistant, refers to an unspecified number of patient of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date: 02-MAR-2017, (administration routes were not provided). No concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
Flu symptoms within hours of of vaccine. Two days in bed. 10/30 ER-couldn't breathe. Sent home. ER again 11/1. Admitted. Discharged 11/7. I was sick. Discharge Summary received on 12/31/2003 states anxiety, bronchitis and exacerbation of COPD.
This spontaneous report as received from a healthcare workers refers to a 17 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 09-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (injection strength: 2.5 mcg/0.5 ml, lot # K019502, expiration date: 04-FEB-2016) (exact dose and route of administration were not provided). No concomitant therapy was reported. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
mom states pt cried for 6 hrs p/receiving vax; temp did not take; called MD who ordered DPH; pt felt hot & irritable; had bump red area to lt leg; on 24FEB92 pt had fever of 102-103; taken to MD office;
Developed severe itching overnight Feb 15 into 16th. Woke up to red, raised, circle rash 3-4 inches long around injection site.
Information has been received from a RN concerning a male child who was vaccinated with MMR. Subsequently the pt sought unspecified medical attention and was diagnosed with autism. Upon internal review, autism was considered to be an other medical event.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with PROQUAD (Merck) (lot, dose and route not reported), exposed to temperatures outside of the proper range. Concomitant medication was not reported. No adverse effect reported. This is one of two reports from the same source (1406USA006620). Additional information has been requested.
Patient presented to the ED for suicidal ideation and was subsequently hospitalized within 6 weeks of receiving COVID vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired) and VACCINATION SITE PAIN (Sore at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Neck pain, Asthenia, Headache, Joint pain, Myalgia, Fatigue and Vaccination site pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Pain in the back of my neck), ASTHENIA (It took more energy to do things/Weakness), FEELING ABNORMAL (Just didn't feel like myself), FATIGUE (Very tired), VACCINATION SITE PAIN (Sore at the injection site), MYALGIA (Body aches), HEADACHE (Headache/pain in the back of my head) and ARTHRALGIA (Joint pain) outcome was unknown. No concomitant medication details were provided. On 13-May-2021 patient  felt very tired, weak, had a headache, and joint pain. On 14May2021 patient felt tired. It took more energy to do things. Patient didn't see a Doctor  for any of the side effects. This case was linked to MOD-2021-301173.
Reported allergy to COVID-19 mRNA vaccine. High severity - anaphylaxis.
This spontaneous report received from a registered nurse referred to an unspecified patient in their 20s of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was administered PROQUAD (lot: M041084, expiry date: 04-APR-2018) (drug administered to patient of inappropriate age) alone with sterile diluent. No adverse effects reported. No further information provided.
This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow-up information has been received from a physician concerning an 18 year old female with an allergy to sulfa and a history of lightheadedness, nausea, sweating and headache (but, not related to vaccination) and syncope on 21-JUN-2001 with negative MRI, and workup results. There was no illness at the time of vaccination who on 10-SEP-2007 was vaccinated with the first dose of Gardasil (Lot# 658560/1062U) in the left deltoid IM. Concomitant therapy included a first dose of meningococcal vaccine (unspecified) (lot# U22768A) IM and a second dose of tuberculin purified protein derivative (PPD TIME TEST) (lot # C2861A) intraderm. Within a minute of the vaccine, the patient experienced lightheadedness, nausea, sweating and headache. The patient's blood sugar was 101, blood pressure was 110/70 and pulse rate was 64. The patient waited in the office for 20 minutes, felt better and went home recovered on 10-SEP-2007. The patient was seen in the office 2 days later and was fine. Additional information is not expected.
Significant vomiting most of the night, Chills for severl hours. a headache lasting 2 days.
Approximately 70 minutes after vaccinatin the patient reports a tingling feeling along both sides of his face. Vitals signs taken as follows: 0930  BP 170/84, P 82 PO2 94 0945 BP  158/82  P 86 PO2 94 1002 BP  142/82  P 95 PO2 95 Patient reported 0935 tingling sensation continues on lateral aspects of face and has also progressed to anterior thighs. Benadryl two 25 mg tablets given at 0944. Patient self reported from home where he is monitored by his wife that he is feeling less tingling , but groggy. Patient instructed to call 911 if urgent care is needed.
The patient received their 1st dose of Pfizer COVID vaccine and was standing during the 15 minute observation period. A few minutes after receiving the vaccine, the patient fell to the floor. Per the patient and witnesses, he did not hit his head when he fell. The patient was helped up and sat in a chair. The patient looked woozy and unwell. A few minutes later, the patient passed out in the chair. Patient was unconscious  for ~15 seconds. 911 was called and paramedics came to assess the patient. While waiting for the paramedics to arrive, the patient's O2 saturation and pulse were checked. Patient was given water and candy. Color came back into the patient's face fairly quickly after coming to, and gradually started feeling better. The patient was assessed by the paramedics and later left on his own.
Severe urticaria, rash, dermagraphism.  Dermagraphism is continuing even now (March 2022)  I was treated with Prevacid, prednisone, benadryl, Vistaril.  I continue to take prevacid and vistaril without much relief most days.
Dizziness-Fell from chair to floor. Pale, diaphoretic-vasovagal. Moved from floor to stretcher by EMS, brought to med screening for evaluation. B.P :103/60 Rechecked 116/74. Left in stable condition at 12:53 . Recorded by RN and Medic.
Pt was given two different vaccinations.  The first was Pfizer and the second one was a Moderna.  No side effects to report as of now.
4?x3? inch rash developed at injection site 7 days after injection. Raised and swollen, is red and warm to touch. Still present 9 days after injection.  No treatment needed.
Two days after the vaccine I noticed a bump on my left shoulder near my clavicle. My provider identified it as a lymph node. I had one Lymph node removed after investigation. There were two lymph nodes that were inflamed. I got an Ultrasound and a CT scan, and I had the Lymph Node removed 02/04/2021 which was within two weeks of my vaccine.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The reported stated that they gave expired FLUMIST to patient that week, the FLUMIST expired on 03-DEC-2012 which started on 05-DEC-2012. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
No additional AE reported; adult patient was dosed with pediatric dose inadvertently; Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient was dosed with pediatric dose (1mL) of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot number, expiration date and route of administration not provided) inadvertently (product administered to patient of inappropriate age) in December 2022. No adverse event was reported.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years 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: "High Cholesterol" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Positive COVID test after 2 negatives, 7 days after finishing Paxlovid; Also TERRIBLE burnt metal bitter taste in mouth the entire 5 days taking Paxlovid.  No follow-up attempts are possible. No further information is expected.
No adverse reaction at the time.  Two days later pt had episode of apnea, went limp.  Lasted about 30 seconds