chrisvoncsefalvay/vaers-outcomes huggingface dataset:
iagnosed with Ischemic Colitis; then began to have frank blood coming from my rectum.; severe abdominal pain; swelling to area; This is a spontaneous report from a contactable Nurse reporting for herself. This 32-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number 6H9899) via unspecified route of administration on the right arm on 16Dec2020 at 03:15 PM (at the age of 32-year old) at single dose for COVID-19 immunization at hospital. Relevant medical history included hypothyroidism. There no known history of drug allergy and no concomitant medications. On 16Dec2020 after vaccination the patient experienced swelling to area. On 18Dec2020 at about 08:30 PM the patient began to have severe abdominal pain, then frank blood coming from her rectum. She went to the hospital and was admitted for 2.5 days and diagnosed with ischemic colitis after after CTA of abdomen, MRI of abdomen and then finally an EGD and Colonoscopy. Treatment of events was reported to be CTA, MRI, EGD, Colonoscopy, Medications. The events resulted in emergency room/department or urgent care and hospitalization. The outcome of the events was recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Ischemic colitis, Rectal hemorrhage, Abdominal pain) and the administration of the vaccine cannot be excluded.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.
Left arm got swollen, red, warm to touch and itching around the area on Friday - Sunday (two days after vaccine was admnistered).
TIRED; This spontaneous report received from a patient via a company representative concerned a 63 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Day 12 post-injection hard a sharp pain in lower part of torso, then immediately passed a large clot from my vagina, bright blood accompanied.  Then no post-period or anything with it.  I'm post-menopausal and have no women health issues at all and haven't had a period in about one year.
had a prolapse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a prolapse. Therapeutic measures were taken as a result of had a prolapse which was reported as the patient had a surgery and doctor said patient should use the estrogens conjugated like twice a week, 0.05 mg or grams. The outcome of the event was unknown.   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
ADMINISTRATION OF EXPIRED JANSSEN COVID-19 VACCINE DUE TO TEMPERATURE EXCURSION; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the patient experienced administration of expired janssen covid-19 vaccine due to temperature excursion. On 28-MAY-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administration of expired janssen covid-19 vaccine due to temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210913164, 20210915623, 20210915731, 20210916129, 20210916228, 20210916300, 20210916312, 20210916455, 20210916498, 20210916520, 20210916584, 20210916658, 20210916697, 20210916768, 20210916808, 20210916965, 20210916907, 20210916849, 20210916811, 20210916415, 20210916465, 20210916553, 20210916715, 20210916910, 20210916959, 20210917074, 20210917163, 20210915646, 20210915852, 20210916401, 20210917226, 20210917500, 20210917515, 20210917160, 20210917603 and 20210916465.
This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUn-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654.
Per nursing notes:  patient received Moderna vaccine #1 on 2/1/21.    There is no mention of skin issues or rashes in notes until 2/25/21.  Then there is an alert note indicating she has red spots all over skin.  Skin intact on 2/28/21.  Lotion was applied.  No itching.  On 3/8/21, she received Moderna #2.  Hydrocortisone cream started on 3/8 for itchy skin.  Eucerin and hydrocortisone used daily.  On 3/27, Nystatin topical was added.  On 3/30, per primary request, patient went to see Dermatologist.  Triamcinolone cream started.  On 4/2, reddish raised rash on neck and shoulders noted.  On 4/15, she had a fall, hit head and transported to ER.  Suffered a brain bleed and vertebra fracture.  Upon readmission, itching rashes remained upper/lower extremities, back/front of body, with skin intact.  Mention neurodermatitis in notes.  On 4/26 ration noted all over hand and body with left hand swelling.  Triamcinolone cream applied.  On 4/27 rash on body worsening and clear fluid filled blisters noted on left hand, therefore Change in condition noted.  4/28 visit dermatologist.  4/28 blisters with clear fluid open and drained.  Bacitracin applied.  Red raised rash on her body slightly improved.  5/2 rashes on upper and lower body more raised, itching started.  Several small blisters on leg, neck, right hand.  Dermatologist appointment on 5/5 noted.  5/4 multiple blisters with clear fluid on upper and lower body, different sized.  5/6 prednisone oral taper started.  Triamcinolone and mupirocin topical started.  New diagnosis of bullies pemphigoid noted.  Treatment in process.
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 05May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, 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: "No" (unspecified if ongoing), notes: known allergies No, other medical history No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive; (13May2022) Negative; (20May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event start date: 20May2022. If patient recovered: recovering. If treatment ae: No. Known allergies: No. Other medical history: No.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200745233 same patient different drug/events
Fever of 101 last 48+ Hours Swelling of lymph nodes 48+hours  Body aches  48+hours Headaches 48+ hours
Fever 101-101.9. Vomiting on 7/8/04 0600 x4
3 days after receiving shot started feeling pain in left arm pit near lymph node. Over the coming days pain spread to left side of chest. 4/22 rash started in arm pit and moved to chest. 4/26 went to urgent care and was diagnosed with shingles.
received inj #2 Hep B on 6/15/05 at health unit, 24 hours later awoke with headache, blurred vision and nausea and vomiting, was brought to hosp er, problems had resolved by the time he was seen by physician, he was observed with no further treatment given
diabetic; had a heart attack; takes a blood thinner; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manyfacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manyfacturer: Unknown), for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack"; BLOOD DISORDER (non-serious), outcome "unknown", described as "takes a blood thinner". She received a 1st dose and never got second dose. She is now scheduled to get booster tomorrow. She got both vaccines and one booster already. Patient took a blood thinner, had a heart attack and diabetic. Patient also stated it had been over a year since her 1st booster dose. She did not get the second booster shot of Pfizer COVID 19 vaccine. But she is scheduled for the booster dose or what should be the third dose tomorrow. Therapeutic measures were taken as a result of blood disorder with blood thinner.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd 1st dose Hep B vax on 28JUL92 30 mins following exp flu-like sx, weakness, blurred vision, bone pain, burning of the kidneys & bladder, fever, dizziness, n,v, neck & shoulder stiffness; exp pins & needles & numbness, breathing diff
Pt experienced redness, swelling, warm to touch in a 13 x 8.5cm area in the right arm.
Arm sore, red rash at injection site, exhaustion, stomach upset, metallic taste in mouth
Case previously recorded as MA2009-4004. Initial case report received from a nurse via Novartis Pharma on 11 NOV 2009. A 2-year-old boy was vaccinated with S-OIV FLUVIRIN (batch no. 1009235P) i.m., on 10 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007988.
Patient received her first dose of the Covid vaccine without a problem. She was reading a magazine in a chair while waiting for me (her mother) to have the second dose in the same room. About 5 to 10 minutes has passed since patient had received her injection. I looked over at patient, her eyes had rolled back and she had slumped in her chair. I ran over to her - her face was very red and she did not appear to be breathing. Her eyes were open but were not focused. I sat her up as straight as I could while the technician who administered the vaccine ran for the pharmacist. This took a few minutes. By the time the pharmacist arrived patient was gaining consciousness but began throwing up (although mainly dry retching). Her face had gone pale. The pharmacist was very helpful - she gave patient some Coke to drink and took her blood pressure, which was low. After 30 minutes of observation we were allowed to leave. The event was very frightening. Patient was very pale for the rest of the day. She had a severe pain in her left arm (and leg) which gradually improved over the next three days. We are very worried about her taking the second dose of the vaccine.
Wednesday 2/22/12 pt woke up had swelling to left deltoid that was quite noticeable compared to right deltoid. Thursday 2/23/12 pt developed a fever 101.3 degrees F TYLENOL given and body aches. Redness to left deltoid size of softball. Friday left deltoid swelling small amount with redness that is the size of a quarter. Pt has no pain, fever or body aches. No sign of infection.
Broke out in a partial rash. Face and neck was red like a sunburn.  Some areas of arms and torso looked like a medium sunburn. Was a little better day 3, and a little more each day after that.  The rash did NOT itch.  otherwise only a little fatigue.  I did not take any medication for the rash.
headache on day 1 that resolved.  Tinnitus on day 3 that has not yet resolved
strokes; seizures; lungs filled up with blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: PULMONARY THROMBOSIS (death, hospitalization) with onset 12Mar2021, outcome "fatal", described as "lungs filled up with blood clots"; SEIZURE (death, hospitalization) with onset 02Apr2021, outcome "fatal", described as "seizures"; CEREBROVASCULAR ACCIDENT (death, hospitalization) with onset 19Apr2021, outcome "fatal", described as "strokes". The patient was hospitalized for pulmonary thrombosis, seizure, cerebrovascular accident (hospitalization duration: 30 day(s)). Therapeutic measures were taken as a result of pulmonary thrombosis, seizure, cerebrovascular accident. The patient date of death was unknown. Reported cause of death: "lungs filled up with blood clots", "seizures", "strokes". It was not reported if an autopsy was performed. Additional information: Reporter stated, "My mother started having seizures and strokes after receiving the vaccine second dose, she has never in her life had blood clots in her lungs or even had a stroke or a seizure!! She has had continual attacks and I became her primary caregiver and the seizures and stroke wouldn't stop. She got COVID-19 on 03Jan2023 they gave her Paxlovid. They couldn't stop the seizures and she was bleeding and they couldn't stop the bleeding and she died. I was given Paxlovid as well from the same doctor. I started bleeding as well."  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-PV202300032137 same patient, different dose/event;; Reported Cause(s) of Death: lungs filled up with blood clots; seizures; strokes
This is a spontaneous report from a non-contactable physician. A 15-month-old male patient received PREVENAR 13, a dose of DPT vaccine, and an unspecified INFLUENZA vaccine on 19SEP2011 around mid-day. Relevant medical history and concomitant medications were unknown. On 19Sep2011 after vaccination, the patient experienced febrile seizures around 7 PM and fever. The patient was taken to the Emergency Room after the events. Therapeutic measures taken as a result of the events included treatment with ibuprofen and TYLENOL. The patient had recovered from the reported on an unknown date in SEP2011. No follow-up attempts possible. No further information expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender unknown who on 22-JAN-2013 was vaccinated with a first 0.5 ml dose of MMR II subcutaneously (anatomical location was not provided) lot number H012142 expiration date unknown. On 22-FEB-2012 was vaccinated with a 0.5 ml second dose of MMR II subcutaneously (anatomical location not provided) lot number reported as H012569 expiration date not provided. In February 2013 the patient experienced general weakness, lower extremity weakness and tachycardia. The patient also stated that they had similar symptoms approximately in January 2013 after receiving the first dose of MMR II. The patient sought medical attention and was referred to an unspecified workers comp physician with a follow up for an unspecified neurologist. The patient was still awaiting results. The outcome of general weakness, lower extremity weakness and tachycardia after the vaccination with the second dose of MMR II was unknown. The relatedness for general weakness, lower extremity weakness and tachycardia was unknown for MMR II. The primary reporter specifically stated that due to the scheduled neurologist appointment, the adverse event of general weakness, lower extremity weakness and tachycardia were considered "significant disability or incapacity". Additional information has been requested. This is one of several reports received from the same source.
CARDIOVASCULAR EVENT; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cardiovascular event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cardiovascular event was not reported. This report was non-serious.
Mother reports, starting on 8/10/01, pt had rash looking like bug bites with blisters (5-10 lesions total), low-grade fevers of 100F-100.5F. Exam reveals erythematous, macular rash with central papular lesion on trunk X 3-4, on face X 2, in hair X 1, on arm X1 and on leg X 1.
Information has been received from a registered nurse (R.N.) referring to a 26 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015 the patient was vaccinated with an expired dose of MMR II (lot # J006185, expiration date 24-MAY-2015; dose and route not reported). No adverse effects were reported. Additional information is not expected as the reporter did not want to be contacted.
Sharp stabbing pain in right chest when inhaling deeply at rest or activity. Low grade fever, & Occasional cough on Friday October 22nd. On Saturday Oct. 23, symptoms became more frequent, & I went to Urgent Care
MD has been using Tetramune for 1 month & has noticed an inc in frequency of localized inject site react including erythema, induration & tenderness as compared to separate administration of DTP & HIBTITER;
Reported last year after flu vaccine - chest rash x 8 weeks. Given vaccine this year, experienced tongue swelling in 12 hrs sp vaccine tx by PCP with MEDROL dose pk. Sx resolved in 12 hrs. Overall area rash chest resolved x 24 hrs.
Patient reported on 11/19/12 experiencing pain and inflammation in the right shoulder. Patient went to a physician and diagnosed with bursitis of the right shoulder.
Original soreness at injection site lasted 2 days and resolved. On day 7, the shoulder (not arm) became tender with blanching erythema. Currently self-monitoring distribution of erythema at home with marked boundaries on skin.
Problem, Large reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problem, Large reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Problem, Large reaction). At the time of the report, VACCINATION COMPLICATION (Problem, Large reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Tingling and pin-prick sensations mostly in feet and hands, but all over. Started a few days after vaccination. Sensations started in feet, then progressed to hands and face. Numbness and partial numbness mostly in feet, but also in hands, face and mouth. Altered taste(metallic taste). Also have strange sensations of cold, creepy crawly sensations and scratchy feeling in legs. Symptoms were most prominent from 1-3 weeks after vaccination. Saw primary care physician, bloodwork was ordered, results normal.  Referred to a neurologist who diagnosed neuropathy. Most of the tingling has gone away. The partial numbness in feet and hands remain, symptoms seem to resolve, then return.
Patient already received flu vaccine on 10/06/22.  Patient was also on 2nd dose of covid, but received pfizer bivalent (booster).
Initial misuse report received from a healthcare professional on 14 November 2013. It was reported that TYPHIM VI was inadvertently administered to a 14-month-old patient thinking that the patient was a 2 year-old. No adverse event was reported. List of documents held by sender: none.
PATIENT HAD VARICELLA VACCINE ON 09/16/2008, MOM CALLED OFFICE ON 09/17/2008 AND DESCRIBE CHILD'S INJECTION SITE TO HAVE SEVERAL SMALL VESICLES AND RED RASH.
The day after the vaccine I ran errands, returned home and started to do chores. In the middle of cleaning, a wave of nausea and sickness fell over me. I had what I am assuming was a strong immune response of the vaccine working: chills, sweating, achey, nausea, no appetite. As the day went on I started to get neck pain, headache, sensitivity to sound and light, back and abdominal pain, and strong painful muscle contractions. The next day I felt better, mainly sore and achey. The day after my symptoms returned (Monday) and I had a very hard time moving or eating or drinking. Tuesday and Wednesday I felt a little better, but still not well. Telemedicine appointment with my doctor on Wednesday, and blood work was drawn which was unremarkable. Thursday was also difficult, and Friday I forced myself to push through to cover office duties at my job. Saturday I felt better and saw a couple of friends, and Sunday I felt better as well until the evening when I felt a lot of neck pain, acheyness and weakness, headache, nausea, tingling and tremors. Monday was a repeat of this, and found if I lay down and don?t move it isn?t as bad. Tuesday was also difficult, a visit to the chiropractor temporarily reduced symptoms for a couple of hours. I also had night sweats and sometimes if standing too long sweats and balance problems. Motrin and Tylenol did not bring much relief, zofran helped with nausea.