chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a LPN concerning a retired 66 year old white female with non insulin dependent diabetes mellit8s, hyperlipidemia, high cholesterol, hypertension, an  allergy to Bactrim and sulfa meds and Dx 250.00, 272.0, 401.9 who on 16OCT1998 was vaccinated with a first dose of pneumococcal vaccine 23 polysaccharide vaccine and on 29OCT2003 at 10:45am was vaccinated IM in the right deltoid with a second dose of pneumococcal vaccine 23 polysaccharide vaccine. The pt reported that she was not sure if this was her second or third dose of pneumococcal vaccine 23 polysaccharide vaccine.  In the am, on 29OCT2003 the pt was also vaccinated in the left arm with a dose of Fluvirin. Other concomitant therapy included Glucophage, Lipitor and Zestril. The pt returned to the physician's office at 14:45 with a local rxn described as swelling about 3 inches in diameter, with slight redness, warmth and tenderness.  There was no fever. The pt was prescribed Benadryl and Zyrtec. On 01NOV2003 the pt recovered. A product quality complaint was not involved. Follow up information was received from the LPN which indicated that on 29OCT2003, in the pm, the pt developed redness, swelling and warmth at the injection site. It was reported that the pt recovered on 05NOV2003. No additional information is expected.
Pt became distant, regressed and lost milestones after the vaccine. Mom noted a change from mid October 2000 on.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three and half years old female patient who received the first dose vaccine PENTACEL (Batch number, expiry date and dose not reported) when she was 20 months old on an unknown date via unknown route in unknown site of administration. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603 with expiration date 18-FEB-2017, therapy type rHA; lot # M007965 with expiration date 15-AUG-2017, therapy type rHA; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion. Data logger was involved. No adverse effect was reported. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of PROQUAD with lot number M022401 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Day one 1/3/2021 of reaction there was a knot and tenderness at injection site, day 2 1/4/2021Redness and itching at injection site (area approximately 1.5-2 inches in width and length. Drowsiness and dizziness were also present on 1/4/2021.
Approx 20 seconds after receiving vaccines, mom noticed child had bitten his tongue. About 5 seconds later his entire face was red with hive like lesions. He was drooling and tongue began to swell. Mom was driving home so she turned into ER for TX. Was given steroid, EPIPEN and BENADRYL. Total time to treat approximate 40 seconds.
Nauseous; slight headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NAUSEA (Nauseous), HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm). On 22-Feb-2021, HEADACHE (slight headache) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown", described as "sore arm".  Additional information: The patient's age was reported as 71, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No Additional AE; patient who has been vaccinated with 2 doses of VAQTA received his 3rd dose of VAQTA too early and was not; patient who has been vaccinated with 2 doses of VAQTA received his 3rd dose of VAQTA too early and was not; This spontaneous report was received from a medical assistant referring to 4-year-old male patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 09-MAY-2023, the patient was vaccinated with thrid dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (0.5 mL, lot #X001293 was considered as valid for formulation vial, expiration date 21-JUN-2024, route of administration and anatomical location were not provided) for immunization. That dose was administered too early and was not supposted to be given (Inappropriate schedule of vaccine administered, Extra dose administered). No additional adverse event (AE). No product quality complaint (PQC).
Difficulty with exercise, heart felt weak and remains a long term concern.  Now includes galloping heart occasionally during sleep.  Not entirely feel like I did before this one booster
Large lump on arm at site of administration.  Pt also diaphoretic and sweating all night
Vaccinated at 12:31 pm on 2/13. No side effects during the day except for the injection site being a little sore when any pressure was applied. At around 6:00 am on 2/14, I woke up with some brain fog and my skin being incredibly sensitive to touch and textures. Even just the sheets or blankets touching me was painful. After sleeping for a couple more hours the sensitivity has decreased but is still significant. The sensitivity is all over, not restricted to one area.
Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Erythema and induration about 3 cm at site of MMRV. Immediate reaction after vaccination, still present 4 days.
Moderna COVID-19 Vaccine EUA Developed chills around 8:30pm 4/6 and that continue for a few hours, then 101.8 fever throughout the night. Tired and weak in morning, low fever 99 rest of day. Possibly unrelated, but next day on 4/8 developed abdominal cramping at around same time, 8:30pm, and nausea. Vomited 5+ times and was admitted to the ER. No exact cause, but possible food poisoning was given and intestine issues.
0n 8/11/10: Pt. got immunization - DTaP. LD. painful, and swelling, fever. Starting same day. Night time. (L) delt. Received antibiotics treatment.
Patient reports receiving vaccine at 4:00pm 4/7/21. Around 12:30am on 4/8/21 she developed severe nausea, vomiting, diarrhea, lethargy, confusion, and syncopal episode. Went to ER at 4am and was given IV fluids, nausea meds, labs. Was told a liver enzyme was elevated. Sxs persisted. She was seen for f/u at urgent care on 4/12/21 c/o upper abdominal pain and cramping, persistent nausea and vomiting, diarrhea, lethargy, dry mouth, dizziness. Patient was referred from urgent care to nearby Emergency Room for IV fluids and further evaluation/treatment.
Pt received a single dose of Janssen. His birthday was miscommunicated and represented incorrect in system. He was registered and waiting for vaccine administration, the vaccinator administered the vaccine. A few hours later, the vaccinator took a look at her MA sheet and realized he was underage. No side affects during the 15 min.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L016428, expiration date 30-JUL-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within 1 minute of vaccination administration patient complained of extreme dizziness and was noted with increased blood pressure. Approximately 20 minutes later, complained of nausea. Symptoms resolved approximately 40 minutes later.
I got a burring  feeling in my vagina.  I went to the doctor and they said I have a UTI.  It has happen May, June, and August.  It is happen more frequents since I have got my vaccination.
Patient stated presented to ER with redness, swelling, pain in arm where vaccinations were given day after were administered - patient was admitted to hospital, however, physician diagnosed as bursitis/cellulitis.
At 12:30 am I woke up feverish and sweating for the rest of the night, threw up for about an hour then tried to go back to sleep but was hallucinating as I tried to sleep. Fever finally broke arounf 7am and I was able to sleep. Body remained achey for 48 hours after vaccine.
Information has been received from a pharmacist concerning a 68 year old female who on 17-DEC-2010 was vaccinated with one dose of 0.65ml ZOSTAVAX (Merck) through subcutaneous. On 19-DEC-2010 the patient experienced pain in arm at the injection site especially when moving her arm, with redness and warmth to below the elbow. Unspecified medical attention had been sought. The patient was given BENADRYL and ADVIL for treatment. No laboratory diagnostics studies were performed. At the time of reporting, the patient was not recovered. Follow-up information was received from the pharmacist who reported that the patient with no illness at time of vaccination or pre-existing allergies, birth defects, medical conditions on 17-DEC-2010 was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 669533/1383Z) through subcutaneous. On 19-DEC-2010, the patient experienced redness, tenderness and warmth at injection site which spread towards shoulder and elbow and was treated with BENADRYL and ibuprofen and symptoms resolved by 23-DEC-2010 (also reported on 20-DEC-2010). There was no illness at time of vaccination. There was no pre-existing allergies, birth defects, medical conditions. No further information is available.
Within less than 5 minutes of receiving 4 yr vaccines listed above child developed sneezing, large urticaria over entire body, nasal congestion lip and eye swelling. Resp 28 AP120 At 3:45pm first dose of Benadryl given 12.5mg/5ml gave 7.5ml by mouth. 3:52pm Epi 0.18ml given IM Resp 24 AP 140 @3:55pm 02 Sat at 92% before epi given 96% after epi Had some coughing but never in respiratory distress. Respirations were regular and unlabored throughout. 1600 patient was transported via ambulance with his mom to Hospital.
immed dizziness, hyperventilating, chest tightness, diff breathing, anxiety; Epi given refused further treatment-left ambulatory
Chronic dizziness, Chronic arm swelling, redness, and hot. Chronic headache frontal.
The patient had three dosis of the vaccine before the administration. He has a esophageal cancer, HTN and its receiving treatment. The patient is classify as immunocompromised. The dosis that should be administrated was a Booster of Moderna (0.25mL). The dosis administrated to the patient was a full dose of Moderna (0.5mL).
Started on left arm at injection site the area was raised.  Then her upper back began to hurt.  When that went away her upper chest/shoulder area in the front right started to hurt.  This area in the front still hurts a little bit.
3 DAYS AFTER MY VACCINE  I CAME DOWN WITH BRONCHITIS? PNEUMONIA
pt recv vax rt thigh-mom noticed swelling & knot about 1 1/2 inch-area, bright red inside knot;cold cloth for 1st 24hr;pt is irritable;
pt recvd vax 8OCT93 & 11OCT93 arm itched @ vax site; 14OCT93 noted redness & rash below inject-difuse rash small papule; patch of papular roughly 2" across;
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic sinusitis" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing), notes: known allergies: shellfish; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) (Other medication in 2weeks) included: THYROXIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from Aug2022 to Aug2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was seen in the Emergency Room for syncope and a fall. Pt had to receive 2 liters of IV fluids, an EKG and multiple labs over the course of 4 hours.
Baby had several rare congenital anomalies  1.) Cri du chat syndrome 2.) large deletion in chromosome 5 3.) congenital diaphragmatic hernia Conception happened 14 days after 2nd Covid shot and these types of anomalies happen in the cell division portion of gestation or the early stages of gestation. There is a 1 in 50,000 chance of getting Cri Du Chat and a 1 in 2500 chance of getting Congenital Diaphragmatic Hernia. There is an even rarer chance of getting both.
elevated heart rate which was 130 (it has been 127 to 132 which was higher than normal); felt like his heart was racing; vomiting; Dizziness; This is a spontaneous report received from contactable nurse.  A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm right, administration date 28Feb2022 (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history and family medical history. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: On 01Mar2022, around 15:00, the patient began having vomiting, dizziness, elevated heart rate which was 130 (it has been 127 to 132 which was higher than normal) and felt like his heart was racing. The nurse stated he seemed fine and ok. The events did not require a visit to emergency room and physician office. The reporter stated that the elevated heart rate was medically significant, but the vomiting and dizziness were not serious. The patient underwent the following laboratory tests and procedures: heart rate: (02Mar2022) 127-132, notes: higher than normal; (02Mar2022) 130, notes: elevated. The patient recovered from vomiting on 01Mar2022. The outcome of dizziness was unknown. The patient has not recovered from the rest of the events. The events "vomiting", "felt like his heart was racing", and "elevated heart rate" were assessed as related to BNT162B2.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Diarrhea started day 2 after vaccination.  Diarrhea continued for 10 days.  Patient experienced vomiting on day 7.  Patient had returned from Nicaragua 2 days prior to vaccination. Patient was seen by physician and no diagnostic test were performed.
Nodules then mild swelling L deltoid 1-2 days after vaccines, advised warm compress if worsens, Given hydroxyzine and calhalomin.
This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a child patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The office reported that the patient who received FLUARIX vaccine resulted positive for influenza. This case was considered as suspected vaccination failure case since the time to onset were unknown at the time reporting. The reporter did not agree to follow up from GlaxoSmithKline. This case was linked with US2019GSK000798 and US2019GSK000802, reported by the same reporter. Lab Comments: on an unknown date, the patient did laboratory test.
Information has been received from a physician concerning a children patient who on an unspecified date was vaccinated with the third dose of ROTATEQ (Lot # and date of administration were not reported). It was reported that the patient became infected with rotavirus after receiving all three doses of ROTATEQ. It was reported that the patient was hospitalized but then went home within 14-24 hours. It was reported that the patient received intravenous fluids. It was reported that the patient had recovered at the time of the report. The reporting physician considered that the patient received intravenous fluids to be other important medical event. This is one of several cases from the same source. No further information is available.
This case was reported by a nurse and described the occurrence of fainting in a 34-year-old female patient who received FLUARIX (batch number 3227Z, expiry date 30th June 2015). Previously administered products included FLUARIX with an associated reaction of no reaction on previous exposure to drug. Concurrent medical conditions included drug allergy. On 3rd December 2014, the patient received FLUARIX .5 mg. On 3rd December 2014, an unknown time after receiving FLUARIX, the patient experienced fainting, lightheadedness and sweating. On 3rd December 2014, the outcome of the fainting, lightheadedness and sweating were recovered/resolved. It was unknown if the reporter considered the fainting, lightheadedness and sweating to be related to FLUARIX. Additional information received: The reporter is a Nurse Practitioner who reports a patient experienced a fainting episode with the symptoms noted above that lasted about 3 minutes before the patient improved. She treated the patient by elevating her legs, gave her water to drink, having her take deep breaths, gave her a cold damp washcloth for her forehead, the patient's blood pressure read as 100/80 and pulse was 68, when taken 2 minutes later her blood pressure was 110/80 and her pulse was 78 and the patient felt better. The Nurse Practitioner states she believes this was a psychological response and not systemic or local reaction to the vaccine.
Reported abscess extremity - I&D - no growth on culture. Happened at both legs vaccine sites - sent to general surgery to excise. 1/10/08-surgery note received for DOS 12/19/07-Seen by surgeon 6-7 weeks out from an injection on his left thigh. Appeared to be an evolving infectious process whichas of 2 days ago was improving, now increased in size. Incision and drainage with large amount of purulent material.