chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant concerning unspecified patients of unknown age and gender. No concurrent conditions, medical history and allergy/drug reactions were reported. Approximately in 2017 (reported as between 01-JUL-2017 to 16-AUG-2017) the patients were vaccinated with improperly stored VARIVAX lot # N000681 with expiry date: 05-JAN-2019 (dosing details, anatomical location and route were unknown) for prophylaxis. Concomitant therapy included MERCK STERILE DILUENT (no details provided). It was reported that the vaccines were exposed to a temperature range of 6F to 14 F for a duration of 1 hour 59 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is second of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA007795.
pt recv vax 4NOV97 noticed itching all over & 2hr palms of hand & bottom of feet red;approx 2hr p/that broke out all over red raised rash;c/o diarrhea, n/vx1, tongue swelling & diff breathing;
She had significant fatigue the day after the injection along with a sore arm and intermittent headache. Starting about 72 hours after the vaccine she noticed a swollen lymph node at the base of her neck on the side of the injection. The lymph node, sore arm and intermittent headache are still present.
Right arm pain. Muscle wasting right bicep right deltoid. Weakness right biceps right deltoid right supmator/pronutis.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of VAQTA, which had the lot # L001445, with expiration date 15-FEB-2016 (dose, dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On an unspecified date the vaccine experienced a temperature excursions of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
pt devel a 4cm area of redness & induration w/in 24 hr of receiving vax;
Red swelling from injection site to elbow  Hot to touch Painful to touch Hard around injection site  Itchy at injection site
pt recv vax 26JAN99 & 27JAN99 inflammation @ inj site w/sl edema both hands, t99.7 ear;inflammation @ site 4cm diameter;
CHEST PAIN, BREATHING PROBLEMS, EXACERBATING ASTHMA ( WITHOUT HISTORY), DIAGNOSED WITH PERICARDITIS, ELEVATED CARDIAC ENZYME TROPONIN; INJECTED WITH PREDNISONE, CURRENTLY SEEING A CARDIOLOGIST AND PRESCRIBED WITH IBUPROFEN, COLCHICINE , INDOMETHACIN
When I woke up my neck was hurting and I thought I slept on it wrong. Later that day I started to think it was from the vaccine since it was the same side I was vaccinated. The paint was consistent over the next few days. I did not take any medication for it. On 03/14/2022 I woke up in the middle of the night with a severe pain on my head. It felt like I had a sunburn on my head. It hurt so bad I was having trouble sleeping. I did start to take some Tylenol and ibuprofen throughout the day but it did not really help. On 03/21/2022 I had a doctor appointment for something else, but the nurse noticed that the top of my ear looked infected. I told the doctor I thought I had a sunburn. She did a swab test and I was told I had shingles. She didn't treat me for it because she stated it was too late for an antiviral and my other medication would interfere with it. I do still feel it now but not as intense.
Headache; This is a spontaneous report received from a contactable consumer, the patient. A 25-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in left arm on 18Mar2021 at 18:45 as single dose, for COVID-19 immunisation. Medical history and concomitant medication was not reported. Past drug history included allergies to Dramamine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced headache. The patient did not receive any treatment for headache. The clinical outcome of headache was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Delayed cutaneous hypersensitivity,,?Covid arm? with Moderna vaccine after 7 days had passed. Area is swollen, hot, and painful to touch. She is currently taking antihistamine for the swelling and ibuprofen for the pain
headache, "feels foggy", feels like having problems swallowing, increased secretions  - continued for week plus after injection took benadryl on 1/6 with good relief of symptoms
Patient got the flu shot at approximately 3:50pm 9-18-2020 and left the store with no issues. Husband called the store approximately 8pm on 9-18-2020 asking if she could take Benadryl because she was experiencing hives and shortness of breath. He mentioned she is asthmatic. I advised to get the liquid Benadryl if they had none at home and to call 911 if the shortness of breath got worse. They did call 911. Patient spent the night in the hospital. She called around 11am 9-19-2020 and stated that she did go to the hospital via ambulance and spent the night. She also stated she took Macrobid after she got home from getting the flu shot. She stated the doctors at the hospital were unsure if the reaction was caused by the flu vaccine or the Macrobid. She was given two medications from the hospital doctors, Keflex and Prednisone.
Stomach cramping, diarrhea that started quickly after taking first dose.  Symptoms still occurring at time of submission of this report.
Itchy, swollen rash/hives over entire body, not just "COVID arm."  Widespread on chest, legs, arm, wrists, back, face.
Upon vaccine administration, patient began to bleed a good amount. Vaccine administrator cleaned up his arm and then he appeared to have a vasovagal response. Patient sat back down in chair, his dad lifted his legs to help the blood flow to his head. We provided cold water, and pharmacist applied a cool/damp paper towel to his forehead. Patient's dad periodically checked his pulse manually and we both monitored to be sure his condition improved. After about 15 or 20 minutes, patient was feeling better. We gave another bottle of cold water and he and his dad sat in the waiting area for 5 or 10 more minutes. Patient was able to walk out of the store afterward and seemed to be just fine.
tinnitus; ear fullness; nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: FA6780), via unspecified route of administration, administered in left arm, on 29Jul2021 17:00 (age at the time of vaccination 54-year-old) as single dose for COVID-19 immunization. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient was allergic to penicillin. On 29Jul2021 at 19:00, the patient experienced horrible non-stop tinnitus, ear fullness and nausea. The patient visited emergency room and physician office. The patient had not received any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The seriousness was reported as disability. Device Date was reported as 15Aug2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a nurse and refers to a 17 year old female patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. Concomitant medications were not provided. In 2014, the patient was vaccinated with an unspecified dose of GARDASIL for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Then, on 31-MAY-2017, the patient was vaccinated with an unspecified dose of GARDASIL 9 for prophylaxis (lot number M034780 with an expiration date of 15-APR-2019) (dosage, route and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Pronounced redness, warm-to-touch for 3 wks occurred 48 hrs. after shot - 2" diameter. She just now reported this. Completely recovered.
bells palsy; Pregnant at the time of vaccination?: Yes; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; slight tingling on left ear; This is a spontaneous report from a non-contactable consumer, the patient.  This is a maternal report.  A 33-years-old pregnant female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 33 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and  concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Historical Vaccine includes  BNT162B2 on 15Mar2021 Dose 1. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 05Apr2021 The patient experienced bells palsy,  pregnant at the time of vaccination,  had a sore arm for about 12 hours but I also got numbness on the left side of my face, slight tingling on left ear. The patient  reported she became pregnant while taking bnt162b2.  The patient is due to deliver on 14May2021.  The patient underwent lab tests and procedures which included covid-19: negative on an unspecified date. The clinical course was reported as follows got my second shot and honestly have felt great since. Did have one weird symptom. Patient  had a sore arm for about 12 hours but I also got numbness on the left side of my face. All of that disappeared overnight and reported she is doing just fine. Patient is going to talk to her  doctor about it today to make sure it is not  like Bells palsy or something. It  went away overnight. Maybe a slight tingling on left ear still but its same side I got my shot.  No Treatment was given for the events. The clinical outcome of the events Bell's palsy, Pain in arm, Numbness in face, Tingling sensation was recovering while exposure during Exposure during pregnancy was unknown.   No follow-up attempts are needed. No further information is expected.
When needle was withdrawn there was an immediate free flow of fluid from the site. There was a red tinge but the flow was too fast and thin to be purely blood. Therefore I fear I did not get full dose.
** I DO NOT HAVE Lot number or expiry date of Vaccine--we were not the issuing facility --this should be available to you under the CDC reporting sheet that those who vaccinate fill out and send to CDC.   Pt. began having SOB on 9/12 and was admitted to hospital on 9/14 with Multiple Subsegmental Pulmonary Emboli
Vaccinated 10/28 in the afternoon, fever, headaches, muscle aches, shortness of breath, and fatigue 10/29 evening; headache, loss of appetite, chest pain, fatigue 10/30; loss of appetite, fatigue, chest pain, shortness of breath, headaches, loss of salivation; 10/31  loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue; 11/1 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue; 11/2 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue; 11/3 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue, difficulty sleeping ; 11/4 confusion, loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue, shaking, difficulty sleeping; 11/5 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue, shaking, difficulty sleeping, anxiety, confusion, tremors; 11/6 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue, shaking, difficulty sleeping, anxiety, confusion, tremors; 11/7 loss of appetite, chest pain, shortness of breath, headaches, loss of salivation, fatigue, shaking, difficulty sleeping, anxiety, confusion, tremors
9/13/08 Client to urgent care with mom with acting ok - had .50 size knot with itchy and warmth to touch. Placed on Amoxicillin 1/2 tsp. BID x 10 days - hydrate liquid 7.5 ml q6 PRN. Prednisolone 2 tsp. BID x 5 days.
Heart Arrhythmia, Palpations started on Monday. sent to ER (3/4/21) by employee health, EKG read bigeminy
initial exposure to coronavirus; COVID-19 PCR test positive; COVID-19 PCR test positive; when he woke up the next morning he had a 5 minute interval of indescribable burning sensation on the face and upper torso/being hot; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 28-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly on 31Dec2020 in arm at a single dose to prevent COVID. There were no medical history or no concomitant medications. He confirmed he is the physician and the primary doctor for the patient. The patient is a pharmacist and he received the first dose of the Pfizer COVID vaccine on 31Dec2020. The next day (01Jan2021), he woke up with a 5-minute interval of indiscernible burning sensation on his face and upper torso that went away after about 5 minutes. The patient reported being hot for a few seconds after taking the Pfizer COVID vaccine. The patient came in to contact with some with coronavirus and then the patient tested positive for coronavirus on 17Jan2021 with a PCR test. He had no symptoms since a week after his initial exposure to coronavirus. No adverse reactions but turned up with infection. The outcome of event burning sensation on the face and upper torso was recovered on 01Jan2021, outcome of the other events was unknown.   Reporter assessed seriousness for burning sensation on face and upper torso: Medically significant. Causality between burning sensation on face and upper torso and bnt162b2 was related by Primary Source Reporter per Global Introspection.         Information on the batch number/lot number has been requested.; Sender's Comments: Based on the current available information , Exposure to SARS-CoV-2 is most likely related to an intercurrent condition which is not related to the suspected drug. Based on the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of other events cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient stated that after she got vaccine, she had some soreness in her are and pain on the left and middle part of her chest. Patient went to ER, and was told that there was some inflammation in her heart and her chest. Patient states that the steroids she has been taking have been helping with pain, though her chest is still hurting.
Extensive dermatomal shingles outbreak Lt back to umbilical area (T10 distribution).
On 19 Jan 07 pt was evaluated for general malaise, myalgia, sore throat, R axillary lymphadenopathy. This was 11 days post smallpox vaccination. In addition to the above, he also c/o stiff neck. Exam essentially neg. Some axillary lymph node noted VSS A febrile.
new employee accidentally only gave the DTAP/IPV portion of the PENTACEL vaccine with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 year old male patient who accidentally received only the dtap/ipv portion of the pentacel vaccine with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 27-Sep-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection (Strength, dose, frquency unknown) (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the right thigh for Immunization who accidentally only recieved the dtap/ipv portion of the pentacel vaccine with no reported adverse event (incorrect dose administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Flu shot given in right deltoid on 11/29/01. Shoulder and arm sore and warm. Upper forearm hurts at night. Can't lift left arm straight out or to reach to back such as to hook bra or retrieve seat belt. Saw doctor and tried ibuprofen 800mg with heat on arm with no relief. Dx'd with bursitis and then given anti-inflammatory with no help. Saw Ortho doctor and was given cortisone. Dx'd with tendonitis and to do exercises X 1 week.
Arthus reaction on injection arm; 4 days later, developed numbness and tingling of his left arm, joint pain in the left arm and right shoulder, rash on left arm.
rash erythemic, macular, scattered spots erupting 26JAN97;also was on agumentin for ear infect;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 15:30 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 at 15:30 as dose 2, single (Lot number: EN6208), in left arm and on 23Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications with in 2weeks. Past drug history included: Asprin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Asprin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown Result. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid.
Vaccine was drawn up appropriately. Patient was stuck with needle. At the point of pushing the plunger for injection, the majority of the dose failed to exit through the needle endpoint. Instead, the dose was flushed through the luer-locking spiral between the needle and barrel and dripped onto the floor. Due to very little to no dose reaching the patient, a second dose was redrawn and administered to the patient in the same arm, but area greater than or equal to 2 inches in distance from the original needle stick. Patient verified she felt no administration on first attempt, but definitely felt dose entering arm on second attempt. Used the same arm because there was no guidance from the CLINIC released to used opposite arm in this scenario. Patient confirmed plan to administer 2nd attempt and requested same arm at that time. No issues or significant side effects occurred anytime after actual administration of second attempted dose.
This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 06-MAR-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Received 3 doses of AVA between 24 Mar 08-21 Apr 08. She was evaluated on 11 Nov 08 for folliculitis x 2 mos on her legs. Lesions persisted and she was assessed as having eczematoid dermatitis. She was evaluated by dermatology in Feb 09 and underwent patch testing where it noted that she had redness and induration at formaldehyde, and redness and vesicles at quaternium-15. Derm follow up in June 09 reported that she was doing well with no lesions since May. In Oct 09 she received AVA #4 she reported that she developed a large urticarial rash on the arm where she received AVA without systemic symptoms and dev a skin flare in March 2010.