chrisvoncsefalvay/vaers-outcomes huggingface dataset:
05/20 pt took 1st dose of Tylenol at 1:45pm, second dose at 6:45pm when felt hot. 8:45pm baby screamed and could not be consoled for 10-15 mins. About 9:45pm baby's whole body started shaking but did not lose consciousness. 12am, woke up and wouldn't take bottle. 05/21 2am, given Tylenol, 6am, woke and wouldn't suck to take bottle 12:30pm, finally took bottle but still didn't cry. Still seeing little jerks of hands and feet, was looking but not reacting. Seen by private pediatrician at 12:30pm on 05/21/02 and told should be better in 24-48hrs. Told to continue immunizations as scheduled.
This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038B21A) for COVID-19 immunization. No medical history reported. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 9, 2021, patient had dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles). On Apr 23, 2021, dyspnea (could not breath), cough, vaccination site mass (lump at injection site), burning sensation (arm was burning) and rash (like shingles) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications. Treatment medication included steroids.
Large local reaction w/erythema, induration at site of immun. 11 x 13 cm.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
This spontaneous report as received from a nurse practitioner refers to an 87 years old female patient. The patient was vaccinated with ZOSTAVAX (lot number, route, site not reported) on an unknown date. No other co-suspects or concomitant medications were reported. On an unknown date the patient experienced a rash, "but it was not a bad rash, and then the patient was admitted to the hospital with weakness in limbs" for an unspecified length of time. The nurse stated that the hospital was looking into if she had Guillain-Barre syndrome and also stated that the patient was losing feeling in her legs. No treatment information was reported. The events did not improve. All the events were considered medically significant by the reporter. Additional information is not expected.
Within 20 minutes of my shot I started to have pain around the injection site, within two hours it was difficult to move my arm due to the pain, this persisted until about 36 hours after my shot.   About 12 hours after the shot I started to experience high fever in the range of 102, body aches, extreme chills, and exhaustion. About 36 hours after the shot I finally started to feel more normal, and my fever finally broke.  Now just short of 48 hours after my I have developed a red rash like spot on top of my injection site.
At 13minutes face flushing, lip tingling,chest warm At 26 minutes arm heavy, chest pressure,confusion,dizzy At 7hrs burning in stomach and face throbbing and pressure where previously tingling. Sense of surroundings moving or spinning if eyes closed At 10hrs twitching throughout left arm lips and fingers, vision getting blurry At 19hrs lower ext weak and clumsy,headache,vision blurry continued and more involved twitching in left arm and both legs..speech slurring improving but word finding deficits. 24 to 48hrs pvc ,twitching, brain fog and severe focal cramps in arms and legs, chest pressure reduced but breathing labored and not automatic.. At
Information has been received from a RN at a county health dept concerning a 34 year old male refugee from another country who was exposed to an outbreak of varicella in the refugee camp prior to coming to this country, and has no preexisting allergies or medical conditions, who on 29Sep2003 was seen by a health care professional for an assessment. On 02Oct2003 at 13:00 PM he was vaccinated SC in the left arm with a dose (previous doses unknown) of varicella virus vaccine live. Concomitant vaccines administered at 13:00PM on 02Oct2003 included a dose (previous doses unknown) of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) administered SC in the right arm, and an IM dose (previous doses unknown)  of diphtheria toxoid (+) tetanus toxoid administered in the left deltoid. On 09Oct2003 the pt started feeling tired and developed a slight fever. On 10Oct2003 he developed a rash on his trunk, back and neck. On 11Oct2003 he was seen in the ER and was diagnosed with full blown chicken pox. The RN reported that the pt was seen in the ER for evaluation, given an unspecified treatment and sent home. The RN reported that initially there was concern that the vaccination had caused the disease. The nurse reported that she then received notice from an organization which sponsors the refugee, that there had been a varicella outbreak in the refugee camp prior to the pt coming to this country and prior to him receiving the vaccination. It was noted that as part of the refugee organization screening program, the pt had the following diagnostic tests performed: CBC, hepatitis, TB, HIV, and syphilis screening. The RN reported that as of 28Oct2003 the pt's recovery status was unknown. Follow up information received from a RN reported that while in the ER the pt had a basic blood test and he was given an antihistamine. The RN reported that the pt was without illness at the time of vaccination and it was unknown as to whether the pt had an adverse event following prior vaccinations. The pt's outcome is recovered. NO additional information is expected.
On the morning after the shot, I woke up with heart palpitations. The palpitations lasted all day and into the night.   I went to the emergency room  and they said my heart was showing Premature ventricular contractions (PVC's) on my EKG. They referred me back to my primary care doctor and my cardiologist.
pt recv vax & 1 or 2 days later pt devel urticaria;pt was seen by MD tx w/DPH & recovered by 2OCT96;
Information has been received from a registered nurse, for the GARDASIL a Pregnancy Registry product concerning a 14 year old female patient who on 29-MAR-2007 was vaccinated with the first 0.5 mL IM dose of GARDASIL (lot # 654535/0960F) and on 20-MAR-2009 with the second 0.5 mL IM dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy included unspecified birth control pills, and on 20-MAR-2009 received MENACTRA), HAVRIX, and unspecified therapy for urinary tract infection.  It was reported that on 20-MAR-2009 the patient received her second dose of GARDASIL and was pregnant.  Her LMP was 23-FEB-2009 and her EDD was 09-DEC-2009.  Laboratory test performed included urine pregnancy test with positive results.  Follow-up information received on 01-MAY-2009 from an initial pregnancy questionnaire completed by the physician stated that the patient was a 14 year old Hispanic female, with no previous pregnancies, who on 20-MAR-2009, was vaccinated with the second dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy given on 20-MAR-2009 included MENACTRA, 0.5ml, BOOSTRIX, 0.5ml, HAVRIX, 0.5ml and BACTRIM, DS BID for urinary tract infection.  Her last menstrual period was on 23-FEB-2009 and the estimated delivery date is 09-DEC-2009.  The estimated conception date was 09-MAR-2009.  It was reported that none prenatal testing had been performed at the time of the report.  Follow up information received on 06-MAY-2009 from an initial and an outcome pregnancy questionnaire completed by the physician and the registered nurse stated that on 20-MAR-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 661703/0651X).  Concomitant therapy included MENACTRA, BOOSTRIX (lot # AC52B03AA), HAVRIX (lot # AHAVB260AA) and BACTRIM, DS BID for an uncomplicated urinary tract infection on 20-MAR-2009.  Follow up information was received from a Registered Nurse (R.N.) who stated that the patient has not delivered as of 21-MAY-2009, her LMP was reiterated as 23-FEB-2009.  Follow up information was received from a registered nurse who indicated that the patient had no significant past medical history.  Additional information has been requested.
Information and follow up information has been received from a healthcare professional concerning a 12 month old female patient with mild pulmonic stenosis and an allergy to nuts who on 27-Apr-2004 was vaccinated with a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 646119/0608N) into the right arm. Concomitant medication on 27-Apr-2004 included a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 648251/1286N) the patient presented to the office because she was very irritable and not sleeping and had rhinorrhea. The patient was treated with acetaminophen (TYLENOL) and brompheniramine maleate (+) phenylpropanolamine hydrochloride (DIMETAPP). The reporter stated that the patient could be teething. The patient recovered 8 days later.  Additional information is not expected.
Loud ringing in the ears followed by room spinning very fast, vomiting, no equilibrium. Spent six hours in emergency room and diagnosed with severe vertigo.
on 05/28/2021 patient recieved a pfizer (covid 19) vaccine lot ew0180 expiration 08/2021 which was diluted with 0.8ml of the correct diluent lot 6023824 expiration 03/23 instead of 1.8ml. patient was injected 0.5 ml by IM route to left arm at 05:01 pm. parent was contacted by pharmacist and informed on possible local and systemic side effects.  no adverse effects reported.
tested positive 7 days after completing course of paxlovid; tested positive 7 days after completing course of paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "not recovered" and all described as "tested positive 7 days after completing course of paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive 7 days after completing course of paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Developed COVID 19 symptoms and tested positive 7 days after completing course of paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine have been administered to patients post excursion with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age female patient who have been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [Adacel] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Jun-2023, the patient received an unknown dose of 0.5 ml (frequency: once) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection of standard strength of lot 2CA24C1 and expiry: 20-Dec-2024 via unknown route in unknown administration site for immunization, post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 06-Sep-2023 from Consumer. Patient details, date of administration, clinical course updated and text amended accordingly. Case has become non valid to valid.
16APR97 through 20APR97 arm very red w/blotches, painful arm, nausea & a general feeling of malaise;states felt very ill went to ER 19APR97;
I have asthma that is primarily seasonal or exercise- induced.  About 2 days after the vaccination,  I experienced asthma symptoms that lasted for about 5 days. This was not related to exercise, humidity,  or seasonal allergies- I woke up struggling to breathe on day 3 after the vaccine.  I had shortness of breath,  wheezing,  resulting lightheadedness, and some dry coughing. Symptoms were worst first thing in the morning and at night. I am still experiencing some lingering difficulty breathing 10 days out from the vaccine, but no wheezing.   It is very likely that I had COVID-19 in early February 2020, before testing was available in the here (My coworker returned from abroad very ill; another coworker and I became sick shortly after,  and she lost her sense of taste and smell. I experienced low grade fever,  intense nausea,  diarrhea,  shortness of breath,  and extreme fatigue.  The fatigue lasted for about one month.) Following this illness,  I saw a sharp increase in my asthma symptoms for about 6-7 months,  which gradually tapered off. Again, there was no other trigger for these symptoms such as exercise or humidity. It seems likely that I contracted COVID-19, which damaged my lungs in some way,  and that the vaccine has resulted in irritating or "re-activating" that damage at a lesser intensity.
pt recv vax APR98 & 27APR98 pt exp a 45second to 1min afeb sz & was hosp;
I got the vaccine on 2/3/21, On 2/6/21 I had bad stomach cramps. My stomach was very bad I was in a lot of pain. I called my doctor on that Monday - He did a nasal swab, it was negative. He diagnosed me with diverticulitis - he prescribed antibiotics for me to take 3xday. The next day I went for a CT scan - that Wednesday I had no more pain; all pain was resolved. I continued to take the medicine, that Thursday I had light fever. That Friday I was so sick again, I called my doctor back, and he prescribed a lighter antibiotic. I had 102/103 fevers, I had bad chilis, my tongue red yellow and so was my bowel movements. I ended up stopped taking the antibiotics. I would get out a feel a little better but when I got out, I felt bad again. I went back to doctor and had a blood test done and it came back that I had COVID-19. I still have issues I don't feel that great, my head feels foggy still. I don't sleep at all because I just don't feel right. I don't feel stable walking.
Extremely achy, tired ,rundown, headache. I took Tylenol, used a heating pad ,rested ,drank plenty of fluids, was fine by the next day
I was admitted overnight 1/27/2018 to 1/28/2018 and underwent an I&D for a vulvar abscess 1/28/2018 AM. At time of discharge, I was offered the pneumonia shot. I consented and received a subcutaneous injection to my right posterior upper arm. The nurse pinched the skin lightly about halfway between my shoulder and elbow (posterior upper arm) over my triceps muscle. She then injected the vaccine horizontally starting cephalad and moving caudally (parallel to triceps muscle in subcutaneous fat tissue). I have never had a pneumonia shot before, so I was not familiar with the process of injection. I was discharged home. As the day progressed, my arm became more and more tender. By 7:00 PM, I had a tender palpable lump about the size of a quarter at the injection site. Upon awakening AM 1/29/2018, the lump had increased in size to about a small plum, skin became reddened and warm to touch. Pain was increased, as well. I was awakened overnight 1/29/2018 to 1/30/2018 by moderately severe pain. My posterior right upper arm was angry red and the hardened lump was about the size of a tennis ball. I went to work 1/30/2018, I was in significant pain. I received a post-discharge follow-up call from hospital. I told the nurse that my vulvar area was much improved with very little pain or discomfort; however, I told her about my pneumonia injection site reaction. She spoke with a physician in my gynecologist's office, I was told to trace the outline of the reddened area with a sharpie or pen and if the size of the reaction increased, I was to go to the ER if redness spread. It did, I went to the ER that evening and was given oral antibiotics (BACTRIM and clindamycin) as well as a gluteal injection of an antibiotic (I think clindamycin). I was discharged home and instructed to return if redness continued to spread. It did spread, continued to experience high level of pain. I returned to the ER and was given IV vancomycin then IV clindamycin for approximately 2.5 days. I was told by staff and pharmacist that the vaccination should have been administered intramuscularly, not subcutaneously. Sent home on oral clindamycin.
At 3 PM  felt tired and warm, temperature 99.1, total body aches. By 8PM still warm, chills, headache. Went to bed. Night sweats, feverish. 8 AM no fever, clammy, headache, body aches, no appitite. Took 2 Aleve gels. By 11 AM felt fine.
headache; nausea; S.O.B.; racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Jul2021 (Lot number: EW0217) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Date (dd-Mmm-yyyy): 10Jun2021, Time (24hr): 12:10, Anatomical Site of injection: left deltoid muscle, Route of administration: Intramuscular, Batch/Lot number: Pfizer EW0172, 1st dose:, 1) Headache, 2) S.O.B, 3) Racing Heart, 4) Nausea, 5) Lethargy), administration date: 10Jun2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "Headache", "SOB", "Racing heart", "Nausea", "lethargy". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DYSPNOEA (non-serious), outcome "unknown", described as "S.O.B."; PALPITATIONS (non-serious), outcome "unknown", described as "racing heart".  Follow-up attempts are completed. No further information is expected.
-Pt fainted ~ 10 minutes after receiving vaccine while sitting in designated post vaccine waiting area -He became alert almost immediately and laid on his back for ~ 15 minutes -A cold pack was placed on this head and a pillow was supplied -He drank apple juice per his request and started feeling better -He stated he faints when he gives blood occasionally -He felt fine after ~ 30 minutes and got a ride home with a friend
Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced an injection site reaction which was reported to be an "extreme local reaction". However no specifics of the reaction were known. Unspecified medical attention was sought. Additional information has been requested.
Painfully sore joints in hip and back. Painful swollen gland on collarbone.
PT REPORTS DELAYED PAIN IN ARM, DIFFICULTY RAISING ARM, NUMBNESS DOWN THE OUTSIDE OF THE ARM AND TERMINATING INTO THE LEFT PINKY/RING FINGER. ADVISED PT USE OTC PAIN RELIEVER OF CHOICE AND THAT I WOULD FOLLOW UP IN 2 DAYS, IN THE MEANTIME CALL DOCTOR IF SYMPTOMS WORSEN
According to patient, he received the COVID vaccine on 1/18 and endorsed typical vaccine symptoms  (myalgias, fatigue, lymphedema on right axillary, sweats and chills).  He was taking ibuprofen for prophylactic symptom relief and was able to attend work the following day.  The patient stated to still endorses symptoms of the vaccine days after but did not seek medical attention because he thought the symptoms would resolve.  The morning of 1/21, patient sustained constant, nonradiating chest pain located along the sternal that was  moderate to severe in nature and exacerbated with deep inspiration that lasted 2 hours.  Lying on the side provided minimal relief but the pain was still moderate.  Nausea also accompanied the pain but the patient denied any vomiting.  Patient decided to go to the ED for work-up.   Patient had two further episodes of chest pain and EKG revealed diffuse ST elevations. Troponin level peaked at 3.02. He was diagnosed with myopericarditis and started on colchicine, with improvement of chest pain.
SMALL COLD SORE ON CENTER OF TOP LIP; SWELLING ON LIP; NERVE PAIN ON LEFT SIDE OF FACE AND UP AROUND EYE; TINGLING; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced small cold sore on center of top lip, swelling on lip, nerve pain on left side of face and up around eye, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small cold sore on center of top lip, swelling on lip, nerve pain on left side of face and up around eye and tingling was not reported. This report was non-serious.
Headache, Arthralgia, sore throat Narrative:  Other Relevant History:
Big red welt starting the day after and much soreness for 2 days. Redness and welt remained but soreness became less. Now 8 days out, redness and welt still exist and is now itchy.
Patient is 14 years old and received the Moderna first dose (0.5ml) on 12/2/2021.  Moderna is currently not approved for under 18 years old.  Patient did not have any adverse reactions to the Moderna vaccine.  She felt fine and had no side effects at all.  She is doing very well.  However, because Moderna is currently not approved for 17 and younger, pfizer will be given to the patient when she comes back for her second dose.
Red rash spots on arm that was vaccinated. Itchy and red total spots = 4, located on lower forearm.