chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTaP given in the right lateral thigh on 01/18/05, later that day the injection site became inflammed, red and warm to touch. The area became bigger over time. The patient was seen on 01/21/05 and the area was 7 cm wide, red and warm to touch. Patient instructed to apply heat and given a script for Augmentin.
An RN reported that a 7 week old male received a 1st dose of Prevnar, Infanrix, Polio and Comvax vaccines on 10/31/01. On 10/31/01, 8 hours post vax, the infant developed generalized hives and fever of 101F to 103F. The infant was admitted to the hospital on 11/1/01 and dx'd with "viral syndrome". The pt was observed and treated with Benadryl. On 11/2/01, the child was discharged from the hospital. On 11/8/01, the infant was seen for follow-up by his healthcare provider and he recovered. No additional information was available as of the date of this report. From follow up correspondence received at Aventis Pasteur Inc. on 02/22/02 from Aventis Pasteur SA regarding a report from Merck(WAES0202USA)0390). It was reported "On 11/05/01 palivizumab (Synagis) was given." The correct lot numbers for the products administered were also provided. Upon internal review at Aventis pasteur inc, it is noted that U2002-00158 may be a duplicate of U2002-00117. However there are differences in the lot numbers for the products and the lab data provided. Note that the two reports were faxed together from Merck. From additional correspondence received at manufacturer on 3/13/02 it was determined that U200200158 is a duplicate of report U200200117. Therefore, U200200117 will be referred to as the report of reference. A 15-day follow up report received 03/14/2003 adds: Follow-up (latest received date 01/07/2003: During internal review of this case, it was confirmed that case U2002-00158 is a duplicate of this case. Case U2002-00117 will continue to be referred to as the report of reference. No new info was provided. The case is closed.
Severe headache Extreme urgency for urination, pain (abdominal near bladder, and left back), bladder pressure, weakness, also loss of control of bladder.  Received diagnostic test for UTI on 3/29/21 - no infection found, referral was made by doctor to urologist possible link to vaccine.
Per his son:  LEFT ARM TURNED BRIGHT RED FROM HIS SHOULDER DOWN TO HIS ELBOW  Reportedly has improved slowly; son was concerned as his dad did not have this reaction to the first dose, and is on Plavix.
Joint locking; Worsening arm pain; Worsening arm pain, left shoulder; Pain waking patient up at night; This is a spontaneous case, reported by other health professional and initially received on 17-Oct-2019 from agency (SEQ19-05008), concerning a female patient of unspecified age.  The patients relevant medical history and concomitant medications were not provided.  On 06-Oct-2019, the patient was administered  Afluria Quadrivalent [influenza vaccine, dose, route of administration, anatomical location, batch number and expiration date: not reported] for influenza prophylaxis.   On an unspecified day in Oct-2019, after vaccination, the patient experienced worsening arm pain, left shoulder, waking up at night and joint locking.  The outcome of the event was reported as unknown.  The reporter assessed the case as non-serious and did not provide causality criteria.  Follow up received from the reporter on 23-Oct-2019: report type changed from invalid to spontaneous (patient gender provided), second reporter added (nurse). The narrative was amended accordingly.  Company comment: The patient developed joint lock, musculoskeletal pain, pain in extremity and sleep disorder after administration of Afluria Quadrivalent. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.; Reporter's Comments: The reporter assessed the case as non-serious.; Sender's Comments: The patient developed joint lock, musculoskeletal pain, pain in extremity and sleep disorder after administration of Afluria Quadrivalent. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect vaccine cannot be excluded and it is assessed as possibly related for all events.   .
Caller received 1st dose of Moderna and 2nd dose Pfizer accidentally; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Caller received 1st dose of Moderna and 2nd dose Pfizer accidentally) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Caller received 1st dose of Moderna and 2nd dose Pfizer accidentally). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Caller received 1st dose of Moderna and 2nd dose Pfizer accidentally) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. Patient received 1st dose of Moderna and 2nd dose Pfizer accidentally,
second dose- had achy joints; This is a spontaneous report from a sponsored program. A contactable male consumer (patient) reported that: A 64-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unknown date (at the age of 64-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration on unknown date as dose 1, single for COVID-19 immunization. The patient experienced second dose- had achy joints. The outcome of the event was recovered on unspecified date.   Communication: Declined to complete a report at this time. Unable to obtain further details.  Follow up needed, further information was requested.  Follow-up (16Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
3 hrs p/vax pt pale & limp mom took pt to ER; mom states everything was neg @ hosp stated hosp will adm if happens again;
Constant headache. Sore throat with phlegm. General tiredness and fatigue. Neck pains.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 1, single (Lot number: FE3590) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300075974 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300285293 same reporter/patient/product, different dose/AE;
Patient had red, inflamed, and blistered skin at injection site. Stated it was extremely itchy and she has been scratching a lot. Reported headache, low grade fever, and stinging for approximately 3 hours. Per MD, the site appeared to be contact dermatitis from the band-aid. MD also told the patient she could be contagious and advised not to go to work. Vaccine given 10/22/16, visited MD on 10/25/16.
Information has been received from a registered nurse concerning an approximately 23 year old female (patient 4 of 4) who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations.  Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn".  The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient".  Bleeding resolved and the patient was sent home. Additional information has been requested.
Fever same day  as vaccine in the evening.  Following week swollen glands on neck for about a week. Arm site very tender at point of shot for over about 8 weeks.
chipped her bone; right foot numbness; fell; right torn meniscus; tore a muscle; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single and dose 1 via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date in 2021 she fell a month ago and has a right torn meniscus, chipped her bone, tore a muscle, and has complaints of right foot numbness, and that her right leg was "killing her".  Caller was asking for information on how to obtain her vaccination card for the Pfizer Covid-19 vaccine. The outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hospitalized 7/1/2021 - still inpatient. Pneumonia and hypoxemia
"I received the second Moderna vaccine at a Med Com Camp on morning of 6 Feb.  As the day progressed I began to feel body aches, chills, fatigue, rapid heart rate, shortness of breath, and numbness in my neck, arms, and hands.  These symptoms are still persisting.  The numbness that has since spread throughout my body (from my head to my feet), body joint and muscle pain and burning sensation, muscle cramps and twitching, and continued fatigue.  Additionally, I have had a few of episodes of pressure in my eyes and head resulting in vision issues and issues with my hearing"
ITP onset 29JUL94 platelets got down to 5000;got bone marrow test cleared w/6wk pred;
Body went limp followed by shaking & contortion follow by eyes rolling back in her head. Non-responsive, catatonic. Happened 2 minutes after she receive injection. Tx - BENADRYL & ibuprofen.
persistant crying;irritability & vomiting w/in 2hr p/vax;poor feeding cont for 48hr w/o fever or diarrhea or other signs of systemic illness;
This spontaneous report as received from a consumer refers to himself, a 80 years old male patient. The patient's medical history included heart attack and "two stents put in". The patient reported none drug reactions or allergies. Sometime in 2008 the patient was vaccinated with ZOSTAVAX (route reported as "injection", dose and lot number not reported) because he thought it was necessary. Concomitant therapies included lovastatin (manufacturer unknown), lisinopril (manufacturer unknown) and carvedilol On 24-APR-2013 the patient had a case of shingles. The patient stated he had blistering on his body and felt pain and discomfort. Patient received treatment with acyclovir (manufacturer unknown). The patient visited the doctor. Lab diagnostics studies included blood work (results not provided). The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
June 7th dianoised with Gullian Barre syndrome  .June 8th spinal tap was done
I had tinnitus and it was a very extreme case & it was so bad I went to 4 diff doctors.
0830-approx 1300: Nausea, vomiting, severe cramps & diarrhea. 0900- one episode of syncope lasting less than 5 minutes. 0900-approx 1230: numbness/difficulty moving legs & "feeling like arms are heavy". 0830-approx 1700: general weakness pallor & nausea.
He presented with 2 weeks of cough, fatigue and dehydration found to have acute on chronic hypoxemic respiratory failure.  He was subsequently admitted.   Acute on chronic hypox respiratory failure due to COVID-19 pneumonia causing COPD exacerbation:   Baseline oxygen requirement 2 to 3 L at rest up to 4 L with exertion for underlying COPD.  He is fully vaccinated against COVID-19.  Onset of COVID symptoms 2 weeks prior to admit.  Tested positive on 1/2/22.  CXR on 1/2/22 w/ b/l infiltrates.   CRP back to normal range.  Initial D-dimer was 1.24.  Procalcitonin level was 0.04 thus superimposed bacterial pneumonia unlikely.  He has been requiring O2 supplement 3 to 4 L NC since admit, which is his baseline.  He received Decadron 6 mg daily x3 days and Solu-Medrol 80 mg IV q8 hr x1 day.  He has received Enoxaparin 1 mg/kg sq q12 hr throughout this hospitalization since admit d-dimer was 1.24.  He received Tessalon Perles and Robitussin with codeine for cough.  Noncompliant with proning, Aerobika and I-S use.  He is at his baseline thus will discharge him to home with Decadron 6 mg po daily x6 more days (for treatment of Covid pneumonia and COPD exacerbation).  He is on 3 L NC O2 supplement at the time of the discharge which is his baseline.  Follow-up with PCP in 1 week.  He was advised to quarantine himself for 6 more days.   COPD with acute exacerbation:   Precipitated by COVID-19 pneumonia.  Treated with steroid, DuoNeb and albuterol MDI.  He is back at baseline of 3 L NC O2 supplement.  No wheezing on exam at the time of the discharge.  He was discharged to home with Decadron 6 mg daily x6 days.  He will remain on his PTA DuoNeb and albuterol MDI   Mild pancytopenia:   Likely due to viral infection, resolving.  WBC is 4.2, Hgb 11.7 g and Plt count 142K at d/c.     Dehydration:   He has received 1 L of crystalloid in ECC.  He did not received additional IVF because of active COVID pneumonia   Chronic stable medical conditions:    ---   Crohn's disease/ulcerative colitis, squamous cell carcinoma, COPD, PADM HTN, essential hypertension, GERD, hyperlipidemia
Heart block, presumed cardiac inflammation. Awoke on 10/06/2022 with neck pain, left arm pain, headache, fatigue,  vision disturbance, chest tightness and shortness of breath. Intermittent episodes of syncope between 10:20-10:45 AM with feeling of heart "constriction"/squeezing sensation and very strong feeling of pins & needles in arms, some numbness in legs during episodes. Unable to get up off floor for 25 minutes or so. Heart rhythm resolved by 11:00 AM, feeling of chest tightness, shortness of breath, fatigue, neck & arm pain greatly reduced, resolved completely after 3 further days--by 1:00 PM on 10/10/2022.
After the first vaccine of Pfizer Covid-19 (1/29/21), the reaction I had was fatigue (lot# EL3247). The second shot given 2/19/21, Lot #EM9810), seven weeks post second shot of Pfizer Covid-19 Vaccine I had the following reactions: Low sodium levels, Muscle pain so intense had to start using a walker, fatigue, sleeping 12hrs a day, Nausea, lost 8 lbs, Chills. These symptoms lasted over 6 months. Now I'm starting to feel better.
Patient said he was feeling weak, dizzy, nausea, blurred vision after receiving a flu vaccine the previous night. Went over the VIS statement with patient and most symptoms he was having was under problems that could happen after any injected vaccine section and for him to contact his health care provider (doctor).
Chills, Teeth chattering, muscle aches, joint aches and throbbing pain, severe pain in the back of neck, fatigue, 96.5 fever for 6 hours, then fever went to 100.1 for 5 hours
Extreme fatigue, barely able to get up to move around.  Nausea, too.
w/in 12hr of vax pt devel diffuse myalgias, nausea & global h/a;
History of Present Illness:  Patient is a 80 y.o. female presenting from home with c/o SOB.   Per emergency room report, patient presented to emergency room for evaluation of shortness of breath.  Patient has been feeling short of breath over the past few weeks and this is worsened over the past few days.  Patient reported nonproductive cough.  Patient denies any known fever.  Patient recently had COVID in October.  Patient denies any chest pain or increased leg swelling.   #1 acute on chr systolic CHF secondary to cardiomyopathy with ejection fraction of 37% We had pt on lasix but weaned it down due to climbing creat 2/4 0300: developed SOB. CXR showed pulm edema. Has now received 2 doses of IV lasix.  2/5: creat stable  2.  Anemia and positive Hemoccults  2/3: C-scope: severe diverticular disease 2/4: EGD: mild gastritis. Biopsy taken  3.  Acute hypoxic respiratory failure with hypercapnia secondary to COVID   patient is done with the Decadron and her isolation is off and her COVID test was positive in January 19 and was positive before in October of last year not sure if this is a new infection 2/5: room air oO2 sat runs 86-88. On 2 L NC O2 sat > 90 % 2/5: before DC today home oxygen will be set up 2/5: face to face done on 2/1 by Dr. for home O2  4.  Hypertension Quite stable  5 diabetes Hosp gluc goal is < 180: goal being met Will cont with current tx plan  6.  New onset paroxysmal A-fib  Due to pt's age and mental state, cardiology deferred Full dose ASA for anticoag Will cont Amiod and Toprol  8.  Baseline dementia  9.  History of depression and anxiety and blindness   10. herpes zoster (L) upper buttock Valtrex for 7 days    Patient is a DNR CCA We have talked several times about sending her to snf but husband refused
2 days p/immun given soreness & redness began swelling began 9APR & pain progressed that PM; called MD-seen by MD 12APR cont ice & APAP or Advil for pain;
Erythema inferior to injection site 11x6cm initially noticed 9 days after vaccine
hyperflexion of arms & legs x 1 9/21/99 PM & x 1 9/22/99;also x 1 @ MD office;T101-controlled w/APAP;started on phenobarbital elixir x 3 days then shop;
No additional adverse effects reported; patient was administered an improperlystored dose of either VAQTA, PEDVAX HIB, or GARDASIL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot number S010727 has been verified to be a valid, expiration date reported and validated as 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S006471 has been verified to be a valid, expiration date reported and validated as 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1621926 has been verified to be a valid, expiration date reported and validated as 28-NOV-2021), as prophylaxis (for all vaccines concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  According to the reporter, the temperature excursion was 34.9 degrees Fahrenheit for a time frame of 7 minutes and 48.2 degrees Fahrenheit for a time frame of 5 hours, on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.
This spontaneous report as received from a registered nurse refers to a 2 month old patient. On 10-SEP-2013, the patient was inadvertently administered VAQTA (lot # H012669, expiry date 17-APR-2015), 0.5 milliliter (ml), intramuscular instead of RECOMBIVAX HB. No adverse events reported. Patient sought no medical attention for the same. Additional information has been requested.
patient got two flu shots at once and didn't have a problem, no AE; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient who got two INFLUENZA VACCINE shot (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination at once on an unknown date (extra dose administered)  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   It was a case of an actual medication error due to extra dose administered (latency same day).  It was unknown if patient's physician provided consent to be contacted and age group is actually not provided  At the time of reporting, patient had no adverse event.  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 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.  There will be no information available on the batch number for this case.
confused; couldn't talk well; dizzy; lethargic; fever of 103.4 F; This spontaneous case was reported by a nurse and describes the occurrence of CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Hypertension.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CONFUSIONAL STATE (confused), APHONIA (couldn't talk well), DIZZINESS (dizzy), LETHARGY (lethargic) and PYREXIA (fever of 103.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 103.4 f (High) 103.4 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications reported.
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
Patient describes "fluid accumulation" around neck and shoulders, which she herself did not notice, but was noticed by her chiropractor at her appointment approximately 4-5 days after receiving first dose, and again after her second dose of moderna vaccine, which was administered on 4/15/2021. After each dose, the swelling lasted approximately one week.