chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 06 October 2014. This case is a part of cluster of 3 cases (same vaccine, vaccine lot number and reporter) and is linked to case numbers 2014SA138930 and 2014SA143203. A patient (out of 4 patients). whose demographics were not reported, had received a dose of FLUZONE QIV, (batch number UI158AA, dose in series, route and site of vaccination were not reported) on an unspecified date (mentioned as 30 September 2014 and 02 October 2014). The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not asked. On an unspecified date, the patients experienced a band of redness around arm with swelling and also complained of low grade temp and chills. Corrective treatment was not reported and no lab tests were performed. The patient recovered on an unspecified date (24 to 48 hours). Documents held by sender: none.
Pt developed a fever within 1 hour, post vax. He had Tylenol before and after, per mom. His temperature ran 100.8F most of the afternoon (Tylenol was given every 4 hours). Mom took temperature prior to leaving child with grandmother and it was 101.6F. Mom says he had a seizure between 20:00 and 21:00. She called MD and then child was taken to ER. Child was iced down and used a wet cloth in ER until fever decreased and returned to normal at 01:00.
A report has been received from a consumer, concerning a 44 year old Male consumer, Height: 71.0 Inches; Weight: 165.0 Pounds, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Once/Single administration. Concomitant medications included Finasteride for hair loss and Ergocalciferol for lack of sunlight. FLUMIST Quadrivalent (Intranasal) started during Nov-2015. The patient experienced chronic drippage from nose which started during Nov-2015. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of chronic drippage from nose is unknown. The report was considered to be non-serious.
Patient presented to pharmacy with a rash on her left arm around the area of the injection. She was not having any issues breathing or symptoms of anaphylaxis, just an annoying rash. She has taken benadryl without any relief so she will be contacting her doctor for a prescription to help with the itching.
Got the Shot and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and one year late got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
I had fevers of 103.4 starting 6 hours after receiving vaccine. The fevers lasted for about 48 hours and would go down to about 101 when i took Tylenol. I had a consistent heart rate of 110 with spikes up to 150. I also experienced full body aches, chills, fatigue, and a sensation that my skin was boiling. I also developed a welt on my arm about 6 inches in length about 12 hours after first dose that felt like a giant bee sting. The red lump at the injection site lasted about 5 days.
Diarrhea started on 6/26/21 and has not resolved. Doctor ran stool tests and all tests were negative. This has never happened before and we think it could be a delayed adverse reaction.
Left arm swollen, hot, tender, red, and painful. Entire deltoid is swollen.
This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient of an unspecified ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of unknown.
Very stuffy nose, shortness of breath-needed an inhaler.  (Wheezing.) Nausea, vertigo, runny nose, cough, watery eyes.
Rash of large, red, itching welts all over torso; welts became scaly. Intense itching for a week, took ten days to fully resolve.
For 6 years I have had severe headaches, crippling arthritis, Facial paralysis, pain and tingling of limbs, neurological problems, 3x's hospitalized, 2 Emergency my life has been a living hell. This did not happen immediately in Dr office. I took my first dose of Lymerix in Oct 1998. Took 2nd dose in March 1999. In Oct of 1999 I had to leave my job because of severe complications. After years of suffering, I began to research my problems. I have no doubt now that my illness is the result of Lymerix. I have developed every problem associated with Lymerix's side effects. I am now on full disability and my life has been a living hell. I have constant extreme headaches, I was hospitalized for Bell's palsy, I have crippling arthritis and neurological problems. I have six years of extensive documentation. The problem is associated with Lymerix.  Records rec'd 11/23/05 additional term -- TIA.  As per follow up report: I suffer constantly with crippling arthritis, extreme fatigue, and excruciating headaches. Since receiving vaccine my life has been ruined. I was an active person and now can barely cope with living day to day. 1/4/10 I feel my condition is becoming continuously worse. I suffer from severe headaches, back, neck, spine and joint pain; and I becom extremely fatigued after any activities. I am on Duragesic Patch 75UGH and Vicodin to help cope with the pain.
Positive Ag test then; Positive Ag test then; Cough; Fatigue; ST arthralgias; Chills; Sick; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 28Apr2022, outcome "unknown"; COUGH (non-serious) with onset 28Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 28Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022, outcome "unknown" and all described as "Positive Ag test then"; ARTHRALGIA (non-serious) with onset 28Apr2022, outcome "unknown", described as "ST arthralgias"; ILLNESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: covid test name post vaccination: hOME aG covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, cough, fatigue, arthralgia, chills, illness.  No follow-up attempts are possible. No further information is expected.
Fever 103.1, vomiting, diarrhea, dizziness, (all started afternoon of vaccinations) fussy/crying, tired, hives (started Thursday, 8/23).
1st adverse event - Pain at injection site that started approx. 8hrs after first vaccine injection 2nd adverse event (main concern) - Pain at the left fibular head. This pain was noticed as soon as I woke up on Sat.  1/9/21 @ 7:30am. The pain was intense & constant. It felt as if the fibular head was bruised, but there was no bruising & no possible injury to that site. The pain subsided by the time I woke up on Thursday, 1/14/21. No pain in this area since 1/14/21.
pancreatitis; acute lower abdominal pain; This is a spontaneous report from a contactable pharmacist.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly on 18Dec2020 at 08:00 (as reported) at 46-years-old at a single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient had no known drug allergy (NKDA). Concomitant medications included acetaminophen (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), sertraline hcl (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT); all taken for an unspecified indication from an unspecified date to an unspecified date (which were received within two weeks of vaccination).  On 18Dec2020 at 17:00, the patient experienced pancreatitis and acute lower abdominal pain; which required hospitalization and were assessed as medically significant. The patient was hospitalized for pancreatitis and acute lower abdominal pain for 3 days on unspecified dates.  The clinical course was reported as follows: The patient received the vaccine " at some point in the AM on 18Dec2020 (as reported)." That evening, the patient presented to the emergency department (ED) with acute lower abdominal pain. The patient was diagnosed with pancreatitis and was admitted overnight. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of pancreatitis and acute lower abdominal pain.  The clinical outcome of the events was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association , there is no evidence or argument to suggest a causal relationship between BNT162B2 and the events pancreatitis and acute lower abdominal pain. The events are likely due to an underlying medical condition. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
Began with verbal sounds, slight twitching of all extremities, drooling. Lasted 1-2 minutes. Pt. lost control of bladder. Pt. than feel into a deep sleep for 3-4 minutes, afterward awoke, and seemed alert and responsive, with no obvious lasting effects.
Information has been received from a pharmacist concerning a related who was vaccinated with a dose of PNEUMOVAX 23. Subsequently, the patient developed a rash post vaccination. At the time of the report, the patient was recovered. Additional information has been requested.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On 22-JAN-2014, the patient was vaccinated with expired GARDASIL lot # 1317AA (Expiry: 13-OCT-2013). No adverse effects were reported. No further information was provided. Additional information has been requested.
Swollen lymph node under armpit of the arm I received the second dose vaccine.  Armpit looks swollen, tender to touch and motion.  Pain and swelling of area of vaccination.   Unable to lift arm and moderate pain when arm is down.  Both doses of vaccines were given on Left arm.
MINOR SORE SHOULDER; This spontaneous report received from a consumer concerned a female of unspecified age. 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 06-MAR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced minor sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor sore shoulder was not reported. This report was non-serious.
Received Pfizer 5-11 product instead of intended Moderna 6m-11y product. No noted side effects or concerns
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheaded), TREMOR (uncontrollable shakiness), DECREASED APPETITE (loss of appetite), ABDOMINAL PAIN UPPER (stomach ache) and ARTHRALGIA (Arthritic pain and her joints were painful) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (lightheaded), TREMOR (uncontrollable shakiness), DECREASED APPETITE (loss of appetite), CHILLS (Chills) and NAUSEA (Nauseated). On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (Arthritic pain and her joints were painful) and FATIGUE (tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded), TREMOR (uncontrollable shakiness), DECREASED APPETITE (loss of appetite), ABDOMINAL PAIN UPPER (stomach ache), ARTHRALGIA (Arthritic pain and her joints were painful), CHILLS (Chills), FATIGUE (tired) and NAUSEA (Nauseated) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment details included Ibuprofen. No relevant concomitant medications reported. Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a registered pharmacist concerning a female who was vaccinated with first dose of Heb B. Within a minute post vax, the pt experienced extreme agitation, chills, dizziness and was crying. It was indicated that the pt had similar experience with loratadine. Additional information has been requested.
Information has been received regarding a case in litigation concerning an 18 month old male who on 1/7/97 was vaccinated with a dose of hep B vaccine (lot 619303/1282D, reported). Concomitant therapy included doses 1, 2, 3, and 4 of Tetramune vacicne (429-972) administered on 11/29/95 and 2/2/96 (432-656) administered on 4/22/96 (444-257) administered on 5/5/97; HIB conjugate vaccine (M270PA) administered on 5/5/97; doses 1 and 2 of hep B vaccine (1817A2) administered on 11/29/95 and (1943A2) administered on 2/2/96; and pneumococcal vaccine 23 polyvalent (441/213) administered on 10/20/97. It is alleged that through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via and IM injection of mercury, the pt suffered devastating, permanent, neurologically devastated by the accumulation of mercury in his body, having been exposed via IM injections and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engag in in repetitive behavior and the loss of language skills, motor skills and affect. Upon internal review, merucry toxicity and neurological disorders were considered to be other important medical events. No further info is available.
12 mo female received MMR/Varivax at 1 yr well child visit. The next day had vomiting, diarrhea and high fevers. Vomiting/diarrhea stopped after first day, but fevers continued, not defervescence for long with Ibuprofen. T in office 104.7 rectally.
felt pretty bad for a day or two; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt pretty bad for a day or two".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Nov2021):This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event; The vaccine was administered to patient post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA377293 and 2022SA379737.  This case involves a 68 years old female patient who was administered vaccine post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE was exposed to a temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event (product storage error).  On 07-Sep-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ875AD, expiry date: 30-Jun-2023; formulation not reported) via intramuscular route in the left deltoid for immunization.  On 07-Sep-2022, (latency: same day) the patient was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE post temperature excursion of 28.2 degrees Fahrenheit for 2 hours and 29 minutes and 30 degrees Fahrenheit for 6 hours and 11 minutes with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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.
Swollen lymph glands started at day 2. Currently still have swollen lymph glands in collar bone and unable to lift arm on day 4.
General fatigue, soreness in left shoulder, low grade fever 99.2 degrees at 36 hours
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 28-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
L arm pain starting after nap following vaccines. Patient unable to lift arm because of pain. No swelling or warmth. Low grade temp 99. No additional signs/symptoms.
closed for Covid/ never got second shot.; This case was reported by a consumer and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ill-defined disorder. Previously administered products included Shingrix (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, got 1st dose in March 2020 and had bad reaction. The reporter stated that, his or her physician's office closed for Covid shortly thereafter, and then she retired, hence never got the second shot, which led to social problem. No additional event details provided via form. Medical Information specialist sent email on 20th September 2021 requesting reporter follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198884:same reporter
I was scheduled to get the vaccine at 9:30 on Feb. 27th, 2021 and most likely got it around 10 due to waiting. Around 6:30 that evening I got very dizzy and shaky and needed to sit down. The next day I was very tired, had a headache, very foggy minded, an upset stomach, and the injection site hurt bad. I slept a lot that day. On the 1st of March I am feeling tired and have an even worse headache and have had an upset stomach and am tired.
Prevnar caused rash on arm. Arm around injection site was swollen and warm for several days. Pt will be going to doctor
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient recovered pretty quickly. Original BP 159/90 HR 71 and 2nd reading 160/89 HR 65. Patient was also anxious will recheck once she gets homoe.
1/12/2022 Severe allergy symptoms, scratchy throat , sneezing, cough. Also had a headache off and on. A fever that lasted 2 weeks. Had to work from home because of fever, not allowed to go into office. Tested positive for COVID.
No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 6 years with 11 months old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768: