chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Had hives starting a evening of injection. Patient reported 4 inch bump at injection site. Hives better after taking Benadryl. Patient advised to speak with her primary care doctor to determine if he recommends she continue with second dose or needs further evaluation.
This initial spontaneous report was received from an adult female patient of unknown age who submitted information on website. Medical history and concomitant medications were not provided. On an unspecified date, the patient received GARDASIL 9 (dose, route and lot # not provided). Subject of the email was "question about recent orders". Under "question", the following was noted: "adverse event to 9. Adult wants to join an ongoing lawsuit". The patient did not specify what the adverse reaction was or the outcome. Additional information is not expected as there was no contact information.
Elevated temp 102.5, headache, stomach ache, soreness and pain to injection site. Tylenol for symptoms. 8/31/06 feeling better returned to school.
Bolt of energy; Fast heartbeat; Dizzy; Tired; Weak; A spontaneous report was received from a consumer concerning herself, a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events; dizzy/dizziness, weak/asthenia, tired/fatigue, bolt of energy/increased energy and fast heartbeat/heart rate increased.  The patient's medical history reported include removal of thyroid five years ago, maybe COVID in the beginning of Mar/Apr 2020 as she had no taste or smell  Concomitant medications reported were bupropion, levothyroxine, multivitamins and turmeric.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) via unknown route in an unspecified arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, after receiving mRNA-1273, at night the patient felt like her breathing was not as deep as usual. She has a pulse oximeter and upon measuring her levels her oxygen never went below 95, and her pulse was fine. On 27 Feb 2021 the patient felt dizzy and weak. On 28 Feb 2021 the patient felt tired. On 1 Mar 2021 the patient reports waking up early morning with a bolt of energy, which was not normal for her. She describes in further detail as having a fast heartbeat; not rapid, but just like lots of energy. The patient also reported that she did not have injection site reactions (pain, rash, etc.). The patient had her usual lab tests two weeks ago, and all levels were fine. Treatment provided for the events include diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events; dizzy, weak, tired, bolt of energy and fast heartbeat was considered to be unknown.
Moderna vaccine was administered to a patient from a vial that was past the 12 hour beyond use date. The vial was opened the day prior. No result of sign/symptom from patient to date.
Seizure like episode; Migraine; Vomiting; Nausea; Flu-like symptoms; Information received on 14SEP2019 from a consumer via a website.  A 35 year old female experienced seizures like episode (PT: Seizure like phenomena), flu-like symptoms (PT: Influenza like illness), nausea (PT: Nausea), vomiting (PT: Vomiting), migraine (PT: Migraine), following the administration of BioThrax.  The consumer claimed to have suffered progressively worse symptoms after anthrax vaccinations in December 2017, April 2018 and August 2018. It was reported that after the first vaccine, she experienced flu-like symptoms including headaches, sweats and coughing. After the second shot, she experienced nausea, vomiting and migraines, in addition to her prior symptoms. She also received emergency room treatment for migraines during this period.  The progressively worsening reactions to the first two vaccines led the consumer to withdraw her informed consent to the third administration of the vaccine, and she repeatedly requested a waiver from vaccination from the doctor, her patient advocate, and her chain of command. Although she received a week-long delay in vaccine, she did not obtain a waiver.  After the compulsory administration of the third anthrax vaccine, she developed nausea within a day. More symptoms developed over the course of weeks resulting in multiple overnight stints at the hospital. Medical staff instructed her and her husband, to wait out the reaction at home and avoid seeking treatment, as reported by the consumer. But when she became non-responsive during episodes of seizure-like shaking, her husband paid out-of-pocket for emergency room treatment. The seizure-like episodes continued for at least three weeks after the administration of the vaccine.   Outcome of the reported events was unknown at the time of report.   Company Comments: The described events of seizure-like episode, flu-like symptoms, nausea, vomiting and migraine have been reported with reasonable time relation to intake of Biothrax, with flu-like symptoms having recurred with repeated administration.  No medical history nor diagnostic evaluations were reported in the article, therefore causality cannot be ruled out.  That being said,  the causality assessment is considered to be probably related to the administration of vaccine.; Sender's Comments: Company Comments: The described events of seizure-like episode, flu-like symptoms, nausea, vomiting and migraine have been reported with reasonable time relation to intake of Biothrax, with flu-like symptoms having recurred with repeated administration.  No medical history nor diagnostic evaluations were reported in the article, therefore  causality cannot be ruled out.  That being said, the causality assessment is considered to be probably related to the administration of vaccine.
Patient developed vomiting and loose stools on 4/ /15. Admitted on 4/12/15 to hospital for vomiting. Developed bloody stools and lethargy. Had evaluation for head trauma and intussusception on 4/12. Negative initial U/S but symptoms persisted. Review of initial ultrasound w/ possible intussusception and U/S repeated confirming this. Reduced by air contrast enema w/ surgery team.
Hives all around body. Mainly lower body around legs, back of leg, butt, pelvis area
Patient presented to the ED and was subsequently hospitalized for sigmoid volvulus within 6 weeks of receiving COVID vaccination.
Within 1-2 hours:  runny nose and headache. Congestion.  Within 24 hours:  chills, fever, dizziness, severe headache, confusion, weakness, severe noise sensitivity, swelling around my left eye, extreme lethargy.
Having trouble and breakage in a little attachment of the vial, the reason why Abrysvo leaked; Having trouble and breakage in a little attachment of the vial, the reason why Abrysvo leaked; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Having trouble and breakage in a little attachment of the vial, the reason why Abrysvo leaked".  Additional information: A Pharmacist wanted to talk to someone because they were having trouble and breakage in a little attachment of the vial, the reason why Abrysvo leaked.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
stomach issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269), administration date: 06Feb2021, when the patient was 65-year-old, for COVID-19 Immunisation, reaction(s): "stomach issues"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9266), administration date: 27Feb2021, when the patient was 65-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2589), administration date: 09Oct2021, when the patient was 66-year-old, for Covid-19 Immunisation. The following information was reported: GASTRIC DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "stomach issues". The event "stomach issues" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastric disorder.  Additional information: It was reported that she had stomach issues couple of days after the fourth one and had really bad stomach issues, it comes and goes but it would not go away. Had been taking Bentyl (the prescription for it) and trying to get that to work; nothing was helping with it; nothing at all. Consumer stated that, whenever she had the first one back to the first one now, had stomach issues couple of days after, a day or two after and called the other night and asked if that was one of the side effects and they really don't know whole lot about it but they put it down. Then had second and third one and did okay, but had her fourth one and had really bad stomach issues and had been to the doctors and can't find anything wrong with her or anything else because of this problem. The patient had a lot of lab tests in past 3 weeks. She had lab work done on 30Aug and back in 15Aug in the hospital. The patient had an MRI done and a CT scan done (Further not clarified) both with contrast to see if she could find something wrong with her stomach. But can't find anything. No prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201131859 Same reporter/Patient/event; different Dose;
Injection site pain a few hours following injection. About 7 hours after injection started feeling body aches and every bone in my body hurt. Teeth too. Felt like I had a sinus infection. Head and eye ached. Bad headache the next am. Took Tylenol at 10 am and felt better. Nothing more after that.  Just tested the remainder of the day.
1503pm   Pt states that he feels that his tongue is swelling. denes sob/difficulty breathing, itchiness or rash. RN and another RN with pt. reviewed pts allergies with pt as he circled NO allergies on his consent form.  pt states that he has multiple allergies to meds and has had tongue swelling to antibiotics in the past which he did not disclose on his consent. BP- 142/82 P-62 SAO2- 96% called for Dr to assess pt.  1513pm Dr came to assess pt. lungs are clear bilat with good air exchange. tongue with some mild swelling per pt. no throat swelling.  pt denies sob or difficulty breathing, itchiness or rash. V.O. Dr  Benadryl 25 mg IM now and observe pt for another 15 mins  1514pm administer Benadryl 25 mg IM R del RN  1530pm BP- 126/74 P-60 SaO2- 96% Pt states that he still has some tongue swelling however he thinks it is getting better. denies throat swelling.  pt denies sob or difficulty breathing, itchiness or rash.  1545pm BP- 126/78 P-60 Sa)2- 97% Pt reports decrease in tongue swelling, almost gone. still no throat swelling.  pt denies sob or difficulty breathing, itchiness or rash.  Dr came back to assess pt.  pt is okay to go home.  advised to take his evening dose of hydroxyzine tonight.  pt given ER precaution for serious side effects and precautions for Benadryl.  pt states he is familiar with Benadryl usage as he uses Benadryl and hydroxyzine.  cautioned pt to always inform healthcare personnel of all allergies any time he is receiving any meds, vaccines, procedures or testing just to be on the safe side given his allergies and history of allergic reactions.  pt verbalized understanding ..... RN  April  8, 2021.
Left leg swollen and red. Cried for 4 hours. Unconsolable crying 4-5 hrs.
This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a single dose of PNEUMOVAX 23 one dose, 0.5 ml, intramuscularly, lot # N012840 and expiration date: 20-JAN-2019. The medical assistant reported a leaking PNEUMOVAX 23 Luer-Lok syringe during administration of the vaccine. No adverse effect was reported. No causality assessment was provided by the reporter.
I was hospitalized with Covid.I took the antibody test and it was +. I feel as if I have Covid all over again. COVID-19-like symptoms; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; I was hospitalized with Covid. I took the antibody test and it was +. I feel as if I have Covid all over again. Dizziness, fatigue, wicked headache, body aches, coughing overall horrible.; chills; nausea; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Ep7534, Expiry date: Unknown), dose 1 via an unspecified route of administration in Arm Left on 18Mar2021 08:30 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included patient was COVID positive on 22Nov2020 and was hospitalized 3 days later. This was prior to the vaccine. Then she did an antibody test and was positive and was oozing antibodies. This was prior to the vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient have not tested for COVID-19. Patient did not have allergies to medications, food or other products. The patient's concomitant medications were not reported. On 18Mar2021 13:00, the patient reported that she was hospitalized with COVID she took the antibody test and it was positive, she felt as if she had COVID all over again, COVID-19 like symptoms dizziness, fatigue, wicked headache, body aches, coughing overall horrible, chills and nausea. Received call from consumer regarding the Pfizer COVID vaccine.  She thinks she had a bad reaction. Then she did an antibody test and was positive and was oozing antibodies. She wanted to travel and needed the vaccine.  Last night felt like the very night she had COVID.  It was horrible. She had a wicked headache and all the symptoms again. She wanted to know if she still needs to get the second shot and was this a normal experience. Therapeutic measures were not taken as a result of adverse events. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I began to feel a pins and needles type feeling throughout my body, that was then accompanied with a low-grade fever (reached 101.1 the last I checked) along with some dizziness. Throughout the night, my body went from cold to hot causing me to have chills and sweats.
dizzy; I had face and mouth swelling and could not eat solid foods due to the discomfort; I had face and mouth swelling and could not eat solid foods due to the discomfort; tingling in my muscles and nerves; extreme headache; emotional; upset stomach; diarrhea; I had joint aches and popping in them; fatigue; lymph node swelling it caused after each vaccine shot; stiff neck , shoulders; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration at the right arm on 04Jun2021 10:00 (at age of 61-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Other medical history was reported as patient was healthy person with no chronic conditions and illness. Known allergies was reported as some past prescription medications also the patient is sensitive person and had the uncommon side effect. Concomitant medication(s) included multivitamins and magnesium supplements. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ew0180), via an unspecified route of administration at the right arm on 14May2021 10:00 (at age of 61-years-old) DOSE 1, SINGLE for covid-19 immunisation and experienced a racy feeling and a bit of needing to take deep breaths and had an extreme headache for 3 days along with fatigue, along with the lymph node swelling. After the second dose, on 05Jun2021 (following day), the patient had joint aches and popping in them, fatigue during the whole weekend along with the lymph node swelling and stiff neck, shoulders. On 07Jun2021 (on the day 3), the patient had upset stomach with diarrhea, on 08Jun2021 (on day 4), a very extreme headache that lasted all day on the same day patient being very emotional. On 09Jun2021 (on day 5), the patient had tingling in my muscles and nerves and on 10Jun2021 (on day 6), the patient had face and mouth swelling and could not eat solid foods due to the discomfort. On an unspecified date, patient had a day of feeling a bit dizzy. At the time of report, patient still dealing with the emotional side effect. The events resulted in doctor or other healthcare professional office/clinic visit. The patient went to see her doctor so she could make sure her throat was not swelling also (it didn't). The patient took no treatment for the reported events. Outcome of events were reported as recovering.  No follow-up attempts are possible. No further information is expected
headache at 12 hrs post vaccine. Then fever (max 101), chills, muscle aches, fatigue starting 16hrs after vaccine.  All symptoms resolved by 30hrs post vaccine
This spontaneous report was received from a former Merck field employee via company representative regarding a patient of unknown age and gender. The patient was diagnosed with unspecified cancer. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, strength, dose, frequency and route of administration) (medication error). On an unknown date the patient died. The exact cause of the death was unknown. Causality assessment was not reported. Additional information has been requested.
Tremor developed shortly after second vaccination in early February and does not appear like it will go away over time.  Upon questioning, tremor occurs both with intentional movement and at rest.  Tremor severity varies without a clear pattern for time of day.  It occurs almost continually now.  Sometimes it is mild, but still annoying.  At times it can be severe enough to interfere with daily life and work activities.  could not think of anything else except vaccination to explain the sudden occurrence of the tremor.  He has no family history of tremors.  He reports that he thinks that he had COVID in March 2019, but no testing to confirm.  There was not sign of a tremor until after the second vaccination.
Shortly after administering vaccine, patient said she felt dizzy and woozy.  She slumped back in chair and shook her head a little bit and became unresponsive for less than a minute. Her pulse was fine and breathing was normal. At this time, I directed technician to call 911 and EMS was on scene in less than 5 minutes to evaluate patient. She walked to their stretcher on her own and the took her to their ambulance for further evaluation with her mother present
Information has been received from a nurse concerning a 16 year old female patient who on 29-JUN-2009 was vaccinated with a dose of GARDASIL (Lot: 661954/1131X) intramuscularly in the upper deltoid. There was no concomitant medication. On 29-JUN-2009 after receiving GARDASIL the patient fainted and fell on the floor of the waiting room. The patient went to the emergency room but was not admitted to the hospital. A CT scan of the head was performed (results not reported). On the same day on 29-JUN-2009, the patient recovered. Additional information has been requested.
patient had 1st Dose of Moderna administered on 05/04/2021, 2nd Dose was due on 06/01/2021. However, patient returned on 05/12/2021 (8) Days after initial dose  for 2nd Dose of Moderna. We administered vaccine not realizing patient was not  due till 06/01/2021.  (Lot # 021C21A Administered on right arm Date of Administration 05/12/2021)
Patient received a flu shot incorrectly. The pharmacist was standing facing her and gave the shot in her shoulder. She poked her once took the needle out and poked her again. The patient called 2 days later to see if it was supposed to hurt. The patient has been in physical therapy since administration due to damage to her supraspinatus muscle and tendon.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH MRNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "High BP" (unspecified if ongoing), notes: Other medical history: High BP; "hashimoto thyroiditis" (unspecified if ongoing); "renal cell carcinoma (kidney removed)" (unspecified if ongoing), notes: Other medical history: renal cell carcinoma (kidney removed); "renal cell carcinoma (kidney removed)" (unspecified if ongoing), notes: Other medical history: renal cell carcinoma (kidney removed). Concomitant medication(s) included: NORVASC, start date: 08May2013; BENICAR, start date: 08May2013; SYNTHROID, start date: 08May2013; ZINC, start date: 08May2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.