chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; fever 101.5; fever of 101.4 for 2 day; lethargy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports regarding dose 2.  A 14 -year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0186) via intramuscular in left upper arm on 03Jun2021 at 11:15 AM, at patient age of 14-year-old, as a single dose for COVID-19 immunisation. The patient medical history included ongoing oral food allergy (anti histamines 6 months per year), ongoing tree nut anaphylaxis (removed tonsil, Adenoids at age 8. carries an epinephrine injector always). The family medical history included Food allergy to Tree Nut: cashew/pistachio; Pollen allergy- ongoing rhinitis. The patient concomitant medications included ongoing oral antihistamine cetirizine hydrochloride (ZYRTEC) from March (unspecified year) for allergy to pollen.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8735) via intramuscular in left upper arm on 13May2021 at 11:30 AM, at patient age of 14 -year-old as a single dose for COVID-19 immunisation and experienced headache. The patient had none prior vaccinations within 4 weeks. On 04Jun2021, the patient experienced headache with seriousness criteria: persistent/significant disability/incapacity. The patient had 3 days fever 101.5. The event required to visit physicial office call. The patient received Ibuprophen for treatment. The patient experienced fever of 101.4 for 2 day and lethargy after the second vaccine. The outcome of the events was resolved.   Follow-up attempts are completed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021579117 same reporter/patient, different dose/event
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 9 weeks old patient of unknown gender. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Initial report was received from a health care professional on 30 August 2013 which involved a cluster of two patients (two siblings). The other patient has been captured in case number 2013-09269. A male patient (age and date of birth not reported) had received a fifth dose injection of DTaP "some years ago" (manufacturer, lot number, route and site of administration unknown) and an unspecified amount of time later, the patient developed urticaria and lip swelling. It was unknown if the patient had any concurrent illness, pre-existing allergies or medical conditions. Outcome was recovered. No additional information was provided at the time of the event. Documents held by sender: None.
Woke up 1/11/21 at 0700 with left axillary swelling and tenderness. Still having adverse reaction 1/12/21.
Patient received a concentrated dose related to an error in drawing. Received a dose of 1.3 versus a dose of 0.3 post reconstitution of the 1.8mL of Sodium chloride.
Nausea, uncontrollable chills, bone pain through out entire body, tired, sore arm, stomach cramps, headache
In April pt.'s blood pressure went up the roof--Called and went in to cardiologist about 10 times---Dr had to change Rxs--give a stres test!!! Also went to a dermatologist 6 times for rash that wont clear up
Initially diagnosed with COVID-19 pneumonia.  He required intubation shortly after arrival to the ED.  He required significantly elevated ventilatory support since the beginning.  He has required high ventilatory settings since the beginning of his ventilation course.  Throughout his course he was treated aggressively with COVID-19 treatments, his baracitinib was stopped due to concern for concomitant bacterial infection.  He remained on steroids and was increased to higher doses of steroids due to continued lack of improvement.   He was started on therapeutic anticoagulation due to high concern for PE.  He was never stable enough for CT scan unfortunately.   He had difficult to control blood sugars during his course and was at one point in time on an insulin infusion.   On the morning of 9/22/21 he had worsening of his oxygenation into the low 80s with a po2 of 51.  Despite no changes to his ventilator and attempts to diurese he continued to decline.  His sats dropped to the 70s and his po2 dropped to 41.   He continued to decline throughout the morning with persistent hypoxemia and worsening hypotension despite pressor support and early afternoon and became bradycardic and subsequently asystole.
Interchange of vaccine products; small red raised rash on left forearm, back and left side of torso; Itching; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 10:00 as dose 1, single (Lot number: HG4680) at the age of 61 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Drug Allergies: sulfa" (unspecified if ongoing); "Drug Allergies: Penicillin" (unspecified if ongoing); "Drug Allergies: DYE IV" (unspecified if ongoing); "IVP" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE [INFLUENZA VACCINE] taken for influenza immunisation, on 07Oct2023 as dose number unknown, single, on 07Oct2023 as dose number unknown, single. Past drug history included: Codeine, reaction(s): "Drug Allergies: Codeine"; Compazine, reaction(s): "Drug Allergies: Compazine". Vaccination history included: moderna (COVID 19, Moderna dose 1, lot number: 012L20A, administration time: 10:00 AM, vaccine location: Left arm), administration date: 10Jan2021, when the patient was 59-year-old, for COVID-19 Immunization; moderna (COVID 19, Moderna dose 2, lot number: 012L20A, administration time: 10:00 AM, vaccine location: Left arm), administration date: 03Feb2021, when the patient was 59-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 3 (booster), single; lot number: 33030BD, vaccine location: Left arm), administration date: 27Nov2021, when the patient was 59-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 4 (booster), single; lot number: FM0173, administration time: 10:00 AM, vaccine location: Left arm), administration date: 18Jun2022, when the patient was 60-year-old, for COVID-19 Immunization; bnt162b2 (COVID 19, Pfizer; dose 5 (booster), single; lot number: GH9693, administration time: 10:00 AM, vaccine location: Left arm), administration date: 30Oct2022, when the patient was 60-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 17Oct2023, outcome "recovering", described as "Itching"; RASH (non-serious) with onset 17Oct2023, outcome "recovering", described as "small red raised rash on left forearm, back and left side of torso"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of rash, pruritus.  Additional information: On 17Oct2023 noted small red raised rash on left forearm, back and left side of torso. Itching. Rash is closed with no drainage. Facility type vaccine was reported as Pharmacy or Drug Store. Patient received other vaccine in four weeks included Influenza Sanofi.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021 at 4:35 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Sep-2021 at 4:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Sep-2021 at 4:35 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-405465, MOD-2021-405476, MOD-2021-405484, MOD-2021-405489, MOD-2021-405498, MOD-2021-405503, MOD-2021-405517, MOD-2021-405535, MOD-2021-405538, MOD-2021-405541, MOD-2021-405544, MOD-2021-405545, MOD-2021-405550, MOD-2021-405551, MOD-2021-405568, MOD-2021-405575, MOD-2021-405579, MOD-2021-405585, MOD-2021-405588, MOD-2021-405590, MOD-2021-405600, MOD-2021-405608, MOD-2021-405611, MOD-2021-405613, MOD-2021-405622, MOD-2021-405633, MOD-2021-405636, MOD-2021-405642, MOD-2021-405645, MOD-2021-405652, MOD-2021-405653, MOD-2021-405656, MOD-2021-405659, MOD-2021-405660, MOD-2021-405661, MOD-2021-405675, MOD-2021-405676, MOD-2021-405678, MOD-2021-405682, MOD-2021-405685, MOD-2021-405691, MOD-2021-405695, MOD-2021-405696, MOD-2021-405699, MOD-2021-405701, MOD-2021-405702, MOD-2021-405705, MOD-2021-405711, MOD-2021-405721, MOD-2021-405723, MOD-2021-405735, MOD-2021-405738, MOD-2021-405740, MOD-2021-405743, MOD-2021-405749, MOD-2021-405751, MOD-2021-405756, MOD-2021-405758, MOD-2021-405760, MOD-2021-405761, MOD-2021-405766, MOD-2021-405770, MOD-2021-405775, MOD-2021-405780, MOD-2021-405785, MOD-2021-405789, MOD-2021-405793, MOD-2021-405790, MOD-2021-405797, MOD-2021-405804, MOD-2021-405810, MOD-2021-405837, MOD-2021-405840, MOD-2021-405843, MOD-2021-405846, MOD-2021-405847, MOD-2021-405851, MOD-2021-405852, MOD-2021-405854, MOD-2021-405855, MOD-2021-405856, MOD-2021-405858, MOD-2021-405860, MOD-2021-405862, MOD-2021-405864, MOD-2021-405865, MOD-2021-405867, MOD-2021-405868, MOD-2021-405869, MOD-2021-405874, MOD-2021-405875, MOD-2021-405877, MOD-2021-405880, MOD-2021-405881, MOD-2021-405882, MOD-2021-405896, MOD-2021-405897, MOD-2021-405898, MOD-2021-405899, MOD-2021-405900, MOD-2021-405901, MOD-2021-405903, MOD-2021-405904 (Patient Link).
Admission Date: 10/19/2022 Discharge Date:  10/21/2022  PRESENTING PROBLEM: Hypoxia Acute on chronic congestive heart failure, unspecified heart failure type COVID-19 virus infection Acute on chronic systolic heart failure   HOSPITAL COURSE: The patient is an 80-year-old male with a history of chronic systolic heart failure, atrial fibrillation on Eliquis, hypertension, dyslipidemia and coronary artery disease who presented on 10/19 with increased shortness of breath.  Patient's symptoms had been present since 10/18, and had not improved, prompting him to come to the ER on 10/19.  The patient does weigh himself daily, and states that his weight had been stable.  In the emergency room the patient was noted to be mildly hypoxic, requiring 2 L/min per nasal cannula.  Patient was also positive for COVID infection.  ProBNP was elevated at 35 95, with chest x-ray showing mild pulmonary venous congestion.  Patient was started on Decadron as well as IV Lasix and admitted to the hospital service.  In the ER, the patient was also noted to have intermediate troponins with positive delta, although EKG was nonischemic.   After admission, the patient was treated with Decadron and remdesivir.  He was also treated with IV Lasix.  Echocardiogram was performed showing and EF of 55% with moderate mitral annular calcification and mild mitral stenosis.  With Decadron, remdesivir and diuresis the patient had significant improvement in his dyspnea, energy level and appetite.  The patient did have improvement in his O2 requirements.  He was evaluated by pulmonary rehab prior to discharge, and found to have no O2 requirements.   As patient was clinically stable, he was discharged to home on 10/21/2022.
I had a headache during  the night and on waking the following morning after the vaccine.  I passed out twice whilst making breakfast.  Not sure how long I was out each time but don't believe it was very long.  Took some tylenol and laid down. I experienced chills after taking the tylenol but otherwise felt well enough to get up and fix myself something to eat after about 30 minutes.  Stiff and sore the rest of the day from the falls - sore/pain around coccyx/lower back area, right elbow and left shoulder bruise. Ongoing soreness/pain today (Monday)
Rash around the site of vaccination one day after vaccination. Pt took BENADRYL 50 mg three times daily for 2 days. The rash disappeared and pt feels better now.
Client had flu shot 9-11-2012 and had mild transient soreness at injection site. The next day had "hot and cold flashes" and started having headaches on 9-12-2012 or 9-13-2012. Headache persists today on 9-14-2012. Has not spoken to doctor.
swollen, hot to the touch, itchy at site of injection. No treatment to date. Outcome: ongoing
Uncontrolled tremors lasting in the Hands for nearly 1 week straight . Was experiencing muscle weakness until yesterday but the tremor has not left and it affecting my ability to do my job as a healthcare professional. The tremors worsen the longer I hold things and when trying to grasp or squeeze.  When I?mm not using my hands it is more subtle and as soon as I go to use them the tremor becomes more intense.
given Moderna Covid vaccine and begin feeling the need to swallow more, clear throat, 50 mg of Benadryl taken by mouth with no relief sent to the ER
This spontaneous report was received from a registered nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II dose scheduled and route of administration not provided (lot # L024266, expiration date 01-JUL-2017). There were no concomitant medications reported. It was reported that temperature of excursion reported was 32.2 degrees Fahrenheit for 12 hours. There was a previous excursion on 18-OCT-2016 at 52 degrees Fahrenheit and on 23-OCT-2016 at 34 degrees Fahrenheit for 30 minutes according to the data logger. No adverse effects were reported. Additional information has been requested.
Immune system disorder; Psoriasis was back; This is a spontaneous based on the information received by Pfizer from another company (MFR control no.: 21K-163-4079417-00). A contactable 56-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date were not reported) via intramuscular on 23Apr2021 (at the age 56-years-old) as dose 1, single and dose 2 intramuscular on 14May2021 (Batch/Lot number was not reported) as dose 2, single both for covid-19 immunization. Patient had also received adalimumab (HUMIRA), subcutaneous from 2010 (Batch/Lot number was not reported) to an unspecified date, for unknown indication. Medical history included psoriasis from an unknown date to 2021. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, in 2021 the patient experienced immune system disorder; Humira killed Immune System. And also experienced Psoriasis was back on unknown date in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of event immune system disorder was unknown, and it was not recovered for event psoriasis was back. The reporter's causality for the events of humira killed immune system and psoriasis was back with suspect products was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got the shot 8:15 p.m. on Tuesday the 5th of January. Wednesday my right arm was a little sore. On Thursday I felt fine until 6:00p.m. then I got an upset stomach and diarrhea. I took Imodium ad. This morning  I still have diarrhea not as bad, but now I have the chills and a fever of101 degrees.
Within 10 minutes of MMR vaccine single hive noted adjacent to injection site. No other symptoms.
Subsequent to receiving first and second doses of varicella virus vaccine live the pt experienced a lack of seroconversion. The pt sought unspecified medical attention.
Medical provider consults the DOD call center regarding a 24y/o male who noted a skin rash ~ 2 days after AVA # 2 and 16 days after AVA # 1 and primary SPV vaccines. Symptoms: Rash, diffuse, Rash, pruritic.
This spontaneous report as received from nurse (B.S.N.) via a company representative refers to 2 sisters of unknown age. Both of the 2 sisters received their first dose of GARDASIL (lot#, dose and route not reported) 2 years ago (unknown date in 2011). On 08-JUL-2013 they received their second doses of GARDASIL. It was unknown if the patients had sought medical attention. No adverse effect reported. Additional information has been requested.
Ichy rash from injection site down arm about 5 to 6 inches.  Warm to touch
On 4/4/21- 4/7/21  I had swollen lymph nodes in the left armpit and left chest. On 4/9/21 I woke up with swollen groin lymph nodes and a fever of 100.7. Fever spiked to 102. On 4/10/21 I went to the urgent care and was told to take Tylenol to control the fever. That night the fever spiked to 103.4. On 4/11/21 went back to the urgent care. They took a urine sample and chest x ray. (said all was normal). They said to continue with the Tylenol. Fever spiked that night to 103.4. On 4/12/21 - fever spiked to 103.4. Got a comprehensive blood test
I had gone to an event, and I took a rapid test and it came back negative. I started to feel like my sinuses were burning and I could smell smoke, but there was no smoke. I experience a postnasal drip. I was experiencing a sore throat. I also experienced body aches I was taking vitamin C and Zinc supplements. I took another Rapid test on 01/11/22 and it came back negative. On 01/12/2022 I did a PCR test, and it came back positive. I still experience symptoms. I still experience brain fog. I also feel like my lungs can't expand as well and I have trouble breathing and feeling more fibrous. I would have shortness of breath walking up stairs and even when chewing food. On 04/08/2022 I had a CT scan done on my chest and I have air trapped in my lungs. Mild bronchial thickening. My total lung capacity is 127. My FEZ1 divided SVC is 62.  I have been diagnosed with long COVID.
She got the vaccine, only had the real sore arm.  She went to bed and trying to get ready to go to work, had a slight fever, headache, chills, aches, stomach didn't feel right.   Felt like she had the virus again.  She was in bed all day on Friday, and then that night she still had chills and 101.1 fever.  Did not feel well on Saturday and was out of work for 2 days.  She is feeling better, tired.  The arm is still sore to touch, but not as bad.  She just felt sick, and is feeling better today.   Her stomach is still not right, but overall feeling better.   She did take Tylenol which helped and a couple of other times for the symptoms.
5/7/21 - 28 hours after shot-hives covering arms and legs-intense itch. Allegra taken and gone. 5/8/21 - 6pm stomach and back covered with a sea of red skin. Arms, neck, legs, butt full hives.  Intense itch and uncomfortable. Doctor told me to take Zyrtec twice a day for 3 days. Both days have swollen armpit, very uncomfortable.Took Advil.
29nov96- woke up feeling fine, w/in hr felt picky numbness, muscle weakness & eventually could not stand;went to med outpatient ctr; 30nov96- sx worse- went to ER admitted & still hospitalized; GBS
itching; Weight: Commented she is losing weight; burning; lump underneath the swelling painful to touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; lump underneath the swelling painful the touch and heat as heat on my arm; redness; Rash; Swelling/slight swelling; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Right on 02Sep2021 (at the age of 77-years-old) as a single dose for covid-19 immunization. Time administered: She mentioned she got it either somewhere between 12:30-12:45 or 1:00. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Right on 12Aug2021 as a single dose for covid-19 immunization. It was unknown, whether the patient was pregnant or not, at the time of this report. Medical history included ongoing asthma, arthritis, atrial fibrillation and pain from an unknown date and unknown if ongoing. Prior vaccinations included Flu shot 20 years ago she had a slight rash on her arm. It's not like it is now, very light. Concomitant medication(s) included diltiazem; budesonide, formoterol fumarate (SYMBICORT) taken for asthma; paracetamol (TYLENOL ARTHRITIS) taken for pain; apixaban (ELIQUIS). The patient recevied first vaccine and had no reaction; second vaccine on 02Sep2021, on an unspecified date in Sep2021. the patient experienced rash slight swelling lump underneath the swelling painful the touch and heat as heat on her arm she still have the rash. The patient underwent lab tests and procedures which included weight: losing. She does not know her exact weight, but the last time she weighed she was 280 pounds. Therapeutic measures were taken as a result of itching, burning. She placed a little Benadryl Cream on it the 4th day. The adverse event did not let patient to visit emergency room and physician office. Outcome of the event rash, swelling was recovering and all other events was unknown.