chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional adverse event; patient was inadvertently administered a 4th dose of PEDVAX HIB.; This spontaneous report was received from a health care professional and refers to a 7-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's drug reactions or allergies.  On 16-FEB-2022, the patient was vaccinated with a first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); on 13-APR-2022, the patient was vaccinated with a second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); on 15-JUN-2022, the patient was vaccinated with a third dose of dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); On 13-JUL-2022, the patient was inadvertently vaccinated with fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, exact dose, route and site of administration, lot # and expiration date were not provided for all vaccines) for prophylaxis (extra dose administered). No additional adverse events was reported (no adverse event).
No additional AE reported.; Patient was administered improperly stored, separate GARDASIL 9 on 07/15/2022; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date (reported as "within this past year") there was a temperature excursion registered for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) of 46.8 Fahrenheit degrees for 40 minutes; and on 24-JUN-2022, there was another temperature excursion registered below 36 Fahrenheit degrees (34.7 Fahrenheit degrees) for 20 minutes.  On an unknown date, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #U019412, expiration date: 30-OCT-2023 (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error). No additional adverse event was reported.
Information has been received from a registered nurse (RN) concerning a 9-year-old patient who "within last week", approximately on 12-Jun-2007, was vaccinated in the arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot number unknown). "Over the course of last week", starting approximately 12-Jun-2007, the patient experienced an induration in the arm, redness and itching at the injection site. It is unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
16yoF was accompanied with an adult who was present for the vaccination. The COVID-19 Vaccine Pfizer-BioNTech 0.3mL administered IM in right deltoid while patient was sitting. Patient remained sitting for 10 minutes after administered dose. Patient reported feeling well after the injection. Patient stood up while we continued to talk, after 2 more minutes passed out while standing. Suddenly, patient begain to go limp and her eyes crossed and rolled back. Patient fell backwards into the privacy curtain and into aisle 13 of the store. Patient's head bounced off the floor. Immunizer  knelt next to patient. Patient was unresponsive until immunizer placed cold hand on back of neck and front of chest to check if she was breathing, immunizer calmly  guided patient to breath, slow deep breaths into the belly and patient's eyes fluttered open. She said her head hurt really bad. Immunizer offered to the accompanying adult to call EMS because patient should be evaluated after hitting her head so hard. The accompanying adult denyed EMS, then stating that patient had previously fainted while walking and said that she would be fine. Immunizer advised patient to remain laying down while immunizer got some ice. Ice was then placed on the back of the head. Patient slowly stood up after laying for 10 minutes and was walked over to a sitting area to put feet up and continue with ice for another 5 minutes before the accomanying adult wanted to leave.
SOB, fever wheezing, sore throat, pneumonia on xray SX x 3 days
punctured vial more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (punctured vial more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) 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 EXTRA DOSE ADMINISTERED (punctured vial more than 20 times). At the time of the report, EXTRA DOSE ADMINISTERED (punctured vial more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The doctor's assistant stated that They have been administering Moderna COVID19 Vaccine, but the pharmacist has been puncturing the vials more than 20 times. They want to talk about what to do about those folks who received those extra doses. There were four extra punctures yesterday 07Dec2021 with lot number 032F21A. There were three extra punctures on 03Dec2021 with lot number 032F21A. There were five extra punctures on 19Nov2021 with lot number 032F21A. They don't know which patients received the extra doses on those dates. There is a total of 72 patients who were vaccinated with doses that were drawn more than 20 times on those three dates.  No concomitant medications were reported No treatment medications were reported
Pt. received 1st Gardasil injection IM left deltoid on 04/04/08-pt. calling today with continued pain since injection near site in the muscle, esp. with certain arm movements and more so at nite time. No redness, no lumps
Woke up one morning about 7-10 days after receiving vaccine and could not walk. Intense pain in both feet. Joints in both hands, elbows, and knees also greatly affected. Saw Podiatrist who sent me to Rheumatologist who made diagnosis after blood test. Presently on methotrexate and prednisone.
Site: Swelling at Injection Site-Mild, Additional Details: Patient had a large lump (marble size) develop at the injection site. It developed immediately (within seconds) after the shot. They had no other issue (no pain, discomfort, etc).
on 1/22 left arm hurt really bad . Went to doctor because she could not use arm . Had to hold arm in place. Had surgery April 2nd .
Myalgias, neck pain, HA, fatigue 5/5. Fatigue intensified by 5/9 and onset of clear rhinorrhea;home COVID test negative then. By 5/13, all symptoms resolved except marked fatigue, low grade fever up to 99.2 and minimal dry cough. Evaluated at office appt 5/16 with extensive exam neg except mild right temporal tenderness and trace ankle edema. Admitted to anorexia/mild nausea without emesis and passage of small soft BMs with voiding. UA showed E.coli UTI but she denied symptoms. Was treated with Keflex 500 mg BID for 7 days for lack of any other diagnosis. CMP was normal, WBC 12,100 with mild increase in pmns but 600 eos, WESR 78, CRP 22.1, procalcitonin 0.21. Gaviscon allowed her to eat without gagging and she was started on famotidine 20 mg BID. Called on 5/21 to complain of vague high substernal tightness that was not exertional. A couple hours later she felt a "panic attack" with SOB returning from the mailbox that resolved with 0.25 mg Ativan. She slept well without orthopnea or PND but awoke in the AM with watery diarrhea, vertigo and nausea with vomiting. She had DOE that she attributed to anxiety. Called EMS and ER evaluation showed only minimal nonspecific EKG changes, BNP 3157, hs-troponin I 14,012, CRP 14.3, stable BUN/creat 13/0.9, CXR showed pulmonary vascular congestion. CT abdomen showed small bilateral pleural effusions, no pericardial effusion. Echo showed LVEF 30-35%, globel hypokinesis (last Echo 2009 with EF 65%). Full respatory viral PCR panel was negative. Hospital course: cath 5/23 with normal coronary arteries, global hypokinesis and LVEF 35-40%, elevated LVEDP 18 mmHg. Patient remained very fatigued and anorexic or nauseated throughout her hospitalization. hs-Troponin I trended down but remained markedly elevated w/ last measurement 10,617 on 5/24 w/ CPK down to 145 from maximum of only 366. DOE on 5/25 with increased pleural effusions on CXR. Required NC O2 that PM. Repeat Echo 5/26 with globular mass on the mitral valve leaflet apparatus or chordae, significant MR and LVEF 25-30%. By the AM of 5/27, she had ARF with BUN/creat 52/1.9, K+ 6.1 and drop in BPs to 105 systolic. TEE on 5/27 showed a 1.1x1.0 cm apparent vegetation on the chordae of the anterior mitral leaflet, moderate MR, EF 25-30%, Blood cultures are negative at 2 days. She was clinically much weaker and lacked any of her usual animation on the morning of 5/28. Another Echo excluded pericardial effusion. She expired on the morning of 5/28.  Of note, this was her 5th body stimulus to COVID as she had Moderna 1/20/21 & 2/17/21, first booster 10/26/21, mild COVID-19 infection that did not require professional care 11/22/21 and second booster 5/4/22. Perhaps FDA needs to be watching for reactions to 2nd boosters more closely!
Extremely high fever that led to a seizure; Extremely high fever that led to a seizure; This is a spontaneous report from a contactable consumer (patient's parent) received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Jun2021 at the age of 12 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at the age of 12 years old, dose 1 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jun2021 at 20:00, the patient experienced extremely high fever that led to a seizure. The adverse event did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of extremely high fever that led to a seizure, which included emergency medical services (EMS) support, paracetamol (TYLENOL), and ice bath. The patient recovered from the events on an unspecified date.  Information on the batch/lot number has been requested.
This spontaneous report was received from a healthcare worker referring to an unspecified patients of unknown age and gender. On an unknown dates, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were not reported, lot # L029631 with exp. date 14-AUG-2017 and L025738 with exp. date: 14-AUG-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has requested.
Flu vaccine leaked out the side of the syringe (BD integra) where the needle attaches. Vaccine dripped down her arm and got on her face. 0.3 ml (adjusted dose) was then readministered.
Given in (R) anterior thigh. Red and swollen to knee. Difficult to walk, used a crutch. 2 1/2 - 4 hrs after shot began. Still red and tender 3 days later.
Very bad stomach cramping, nausea and vomiting. Started when I woke up this morning around 7am.    Also, I go from being hot to being cold.
anaphylaxis-SOB, wheezing, cyanosis, angioedema to lips, drooling;pt responded to SQ epi & ventolin aerosol tx;
sore left arm, accompanied by severe pain in left hand. Treated with Tylenol and cold compress, began in evening after shot and was better by next AM.
About two and a half weeks after receiving my Moderna booster shot, my body started having random rash/welt areas pop up and disappear in a matter of 30-40 minutes. After about a week of these symptoms, I went to Urgent Care to see if they could determine what was going on. The doctor didn?t know what to make of it but the Sunday following, I received a follow up call from Urgent Care and one of the nurses had me explain my symptoms to her and I was diagnosed as having chronic spontaneous urticaria.
Onset of tonic-clonic seizure and fever of 105 about 1900h. Rescue was called. Seizure lasted 3-4 minutes. -spontaneous resolution, no abnormalities by EMT - transported to ER awake alert and acting normal -observation in ER discharged 2056. Fever resolved no further seizures.
Pt walked in for her 1st Covid shot as Janssen. It was given on 8/2/21.  but it was 3rd shot . She received Pfizer vaccine on 5/8/21 at a pharmacy and 7/27/21 at another pharmacy.  I found out when I do reports at the end of the day.  She confirmed it to me finally today morning on 8/3/21 (9am). She doesn't have any side effects at this point, but I am reporting for her unauthorized 3rd vaccine.
Approx 24 hrs post vax, inject site had 3" raised circle red, hot to touch, itched. Lasted about 5 days with gradual to normal.
Nauseous,  hard at breathing, healthcare professional provided prednisone 20mg, albuterol hfa, banophen diphenhdraymine.
Rheumatoid Arthritis flare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EN8737) at the age of 67 years as dose 1, single and administered in arm right, administration date 20Apr2021 09:00 (Lot number: EN8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (ongoing); "HTN" (unspecified if ongoing); "Aortic valve leak (minor)" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN; OMEPRAZOLE. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination and no known allergies. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Apr2021, outcome "recovered" (2021), described as "Rheumatoid Arthritis flare". Therapeutic measures were taken as a result of rheumatoid arthritis included Prednisone and NSAIDS. Clinical course included Rheumatoid Arthritis flare (first in 6 years; was in remission and on no maintenance meds) appropriate 9 days after first dose, 4 days after second dose. Patient was incapacitated.   No follow-up attempts are possible. No further information is expected.
Single bump/bite noted on back, which subsequently spread as a rash isolated to same site.  Not apparently itchy or painful. Appears to be shingles to the examiner.
Local redness and pain. Fever, nausea, L side body pain. Arthralgias.
pt recvd vax & 4 days p/vax exp hives;tx atarax;sx subsided;
TWINRIX admin at 1126. Pt had dry mouth, shortness of breath difficulty swallowing approx. 10 min after. Pt has headache 3hrs after.
Sudden onset of severe vertigo as she was getting out of bed, increased with change of position or head motion, + nausea, - vomiting, - vision change, slight imbalance when walking.
pt recv vax in DEC95 & w/in 24 hr post vax pt exp fever, vomiting & numbness in the inj arm & shoulder;sx resolved;
DIFFUSE ERYTHEMA SCLERAL INJECTION DIFFUSE CONFLUENT URTICARIA GLOSSAL EDEMA PERIORAL PARASTHESIAS PHARYNGEAL EDEMA TACHYCARDIA  Patient treated with Benadryl 50 mg IM, with resolution of symptoms within 30 minutes.
Patient stated later in the day of 2/18/2022 (after immunization), her left arm was numb and tingly. She reported up to 6 episodes of dystonia within 48 hours post vaccination.
Patient reported "one giant lump" and "one inner lump" at the injection site that caused major pain for >2 weeks. Symptoms started the morning after injection and "got worse before they got better." Patient iced site and took aspirin to attempt to relieve pain, with nominal effect.
Lightheaded, eyes went back in his head, fainting, violent body shakes, followed by sweating, hot and cold flashes, weakness, nausea.  15 minutes later my son began vomiting which lasted for 5 hours and required Zofan for nausea.  We had to stay at the Dr. office for over 2 hours until he was stable enough to return home.  Upon returning home he continued with vomiting, nausea and chills for the entire day.
A 17-year-old male patient of an unspecified ethnicity received first dose of TRUMENBA, on 09FEB2016 at 0.5 ml, single. The patient medical history was not reported. There were no concomitant medications. On 10FEB2016, 24 hours, after vaccine administration, the patient experienced fever, headache and arm soreness. Patient recovered from the events on 11FEB2016. The patient is expected to receive two  more doses of the vaccine. Follow-up (31-MAR-2016): Follow-up attempts are completed. No further information is expected.
Vaccine was given almost 24 hours after vial had been at room temperature. Patient is not currently experiencing any side effects.
Had a little temperature; Under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen/Like the under pit and a little bit down there; Itchy; This is a spontaneous report from a consumer (patient's daughter) reported for the patient. A 82-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 02Jun2021 (age at vaccination was 82 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The reporter stated that her mom got her Pfizer vaccine shot (unspecified vaccine) the second one on 02Jun2021 and she was fine maybe had a little temperature but now she saw under her shoulder, arm as her whole arm, the bottom of her shoulder it's just swollen, asked if that was normal. Like the under pit and a little bit down there. This was the same site she got a needle. It was little itchy too. The reporter was informed about Pfizer Medical information department and was provided with the number. The reporter was informed for the role of Pfizer drug safety. The reporter stated that last night, she noticed it. She didn't know he just checked today but last night it started. Last night, she found out she didn't know if it was like maybe after and she noticed it now. The reporter stated that she just really needed to call to see if she gets the info, they were almost done. The outcome of the events was unknown.  Follow attempts are needed; information about lot number/batch number can be requested.
On Saturday night (4/10) I had some chest pains that seemed to not go away in my upper left chest and left arm. I tried to sleep it off until the pain was unbearable at around 7:00 am on Monday (4/11). I then admitted myself to the ER and was given an ECG and multiple EKG?s as well. Upon lab results I had high triponin levels (28) leading the doctors to believe I had a heard attack of some sort, eventually they ruled it as acute pericarditis possibly due to my second dose of the Pfizer vaccine.
Infant taken to ER per ambulance. Pronounced dead in ER. No other current date. Post mortum will be done. 6/8/06 Received medical records from ER which reveal patient arrived in full arrest & was unable to be resuscitated.  6/13/06 Received medical records from PCP which reveal Mom had hx of HSV II & was neg for beta strep at delivery.  Apgars were 6 & 9 at 1 & 5 min.  All cultures were neg.  Developed allergic rhinitis & had frequent cough/cold symptoms.  On last visit 10 days prior to vax, note indicates well child visit. 8/3/06 Received autopsy report which stated COD as asphyxia.  Patient had been placed face down on baby blanket covering adult size comforter which had been folded.  Patient was not on baby blanket when found.  Comforter had looe nylon type fabric.ss
The vaccine was #3 in the series. FAV081 lot. Patient had swelling within 20 minutes after vaccination and intense erythema. The erythema and swelling took approximately 2 weeks to resolve. The patient had knot over the vaccination site for about 2 months thereafter. The patient returned to duty the day following the vaccine.  The patient did see health care provider administering the vaccine, but documentation of these episodes of care have been lost.   An exemption was added to the patient's medical file.
PATIENT HAD ANAPHYLACTIC REACTION SHORTNESS OF BREATH AND RASH.
a GARDASIL 9 inadvertently given to a 5 month old.; This spontaneous report was received from a physician referring to a 5 months old patient of unknown gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.     On 24-AUG-2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). The outcome of product administered to patient of inappropriate age was unknown.
Patient verbalizes being fearful of "shots"; this nurse attempted to explain getting the vaccine would be quick and fairly painless. After several minutes an attempt to give vaccine was noted. The patient did pull his arm away to stop needle. The needle was partially inserted into the arm causing a small amount of bleeding, no medication was injected. (this section completed)
Started itching at site, developed hard, hot knot, progressed to palm sized red area over next day, and stayed the same for 6 days.  Mild flu-like symptoms first 3 days (fever between 100 and 101, aches all over, lethargy).  Improving but still red and itchy after 12 days.