chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via field employee refers to multiple unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the multiple unspecified patients were vaccinated with ZOSTAVAX vial 19400 PFU (lot number/expiry date and dose not reported) subcutaneously. On an unknown date, the patients had experienced "tingling at injection site". The patient did not receive any treatment for the event. No Product Quality Complaint (PQC) was involved. The outcome of the event was recovered. The reporter did not provide any causality assessment between event and ZOSTAVAX. Additional information has been requested.
day 1 post: pain in all arms and legs, chills, lethargy days 2 and 3 post: pain in left shoulder and upper arm
Loss of balance, nausea, falling on Tue Oct 5 most of the day. Resumed on Wed Oct 6 to a point when I was unable to walk upright at home (falling) thus went to Urgent Care with these "stroke like symptoms" and they sent me down to ER. Cat/MRI/Xray from neck up but no signs of stroke. Was given Meclizine. After 4 hours symptoms improved.  6 weeks later I had what I assume was a massive clot in right thigh inside. Violent paint and passed out at home. After 30 min was able to pull myself together and BP dropped a little. Did not go to hospital due to cost from first visit. After this point (Nov) I developed  chronic heart and blood pressure issues (tachycardia and 160/100 bp). Later EKG late Jan 2022 at Primary Care in Jan suggested "inferior infarct" and I was referred to cardiologist. Have been working with Cardiology since Mar 2022 for further diagnostics. Have been working on general health on my own. Now 6 months later BP is down to normal again but sleep heart rate is still never go below 67 bpm, but much better than 95 which I had from Dec 2021-Feb 2022.
Information has been received from a physician concerning her 17 year old daughter who on 06-JUL-2007, was vaccinated IM with a first 0.5ml dose of Gardasil. On 12-SEP-2007 and 06-JAN-2008, the patient was vaccinated with a second and third dose of Gardasil (Lot# 657872/0515U), respectively. Concomitant therapy included PROZAC and vitamins (unspecified). On 08-JAN-2008 two days later, the patient experienced nausea. On 09-JAN-2008 the next morning, she vomited. On approximately (09-JAN-2008 )since the last vaccination), she experienced myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping. Unspecified medical attention was sought. Laboratory diagnostic studies included a complete blood cell count which was reported as normal. As of 10-JAN-2008, the patient no longer had a fever or sore throat but she was experiencing an increase in her myalgia. As of 14-JAN-2008, it was reported that the patient started to feel better. It was also reported that the patient had not been able to attend school since 08-JAN-2008. On 15-JAN-2008, the patient returned to school. No product quality complaint was involved. Nausea, vomited, myalgia, headache, sore throat, fever, loss of appetite and difficulty sleeping were considered to be disabling by the reporter. Additional information is not expected. This is in follow-up to report(s) previously submitted on 1/18/2008; 1/25/2008. Information has been received from a physician concerning her 17 year old daughter with anxiety who on 06-JAN-2007 at 6:00 pm, was vaccinated IM into her left deltoid with a third dose dose of GARDASIL (Lot# 657872/0515U). On 08-JAN-2008, the patient experienced nausea for 4 days and she vomited three times. She also experienced myalgia, a severe headache for 1 week, a mild sore throat for 3 days, loss of appetite for 1 week, diarrhea for 2 days, prolonged sleeping and fatigue for 1 week. On 12-JAN-2008, the patient experienced a fever of 101.8F with rigors just before spike then she had a fever off and on for another day. Unspecified medical attention was sought. Laboratory diagnostic studies included monospot test, liver function tests and a blood chemistry panel which were all reported as normal. On 15-JAN-2008, the patient returned to school and recovered. It was also reported that on 06-JUL-2007, the patient was vaccinated IM with a 0.5ml dose of GARDASIL and on 12-SEP-2007 she was vaccinated with a second dose of the vaccine (Lot# 657872/0515U). Additional information is not expected.
8/17/22 Myocarditis. Had 12+ months of dull pain in center of chest following 2nd dose. Nearly 9+ months after third dose, was intensely exercising and sat down 11:15pm with acute chest pain, bilateral arm numbness and diaphoresis (full body sweat). No coughing, nausea, diarrhea or headaches. No history of heart issues or Covid19 infection. Went to ED, RHR 45bpm. Labs were significant for troponin 11,111.8 (went up to 25,000 a few hours later), elevated WBC 11.58, low Hgb 13, CRP<1, LDL 167. EKG showed sinus bradycardia, ST depression in I, aVL, and V4-V6, with no STEMI present. No CXR. Given ASA load, atorvastatin, and started on heparin gtt and admitted to CCU for NSTEMI. Vitals: BP 118/71 | Pulse 85 | Temp 97.5 °F (36.4 °C) | Resp 19 | Ht 182.9 cm (6') | Wt 70.3 kg (154 lb 15.7 oz) | SpO2 95% | BMI 21.02 kg/m²
This spontaneous report as received from an immunization coordinator refers to unspecified patients (ages and gender unknown). The immunization coordinator reported that unspecified patients, on unspecified dates, were vaccinated with improperly stored PEDVAXHIB, GARDASIL 9 and GARDASIL. No adverse effects were reported. Vaccines involved that were stored at temperature 29.9F, time frame: 273 hours 35 minutes: PEDVAXHIB (Lot number M014927, Expiration date 2/18/2019), PEDVAXHIB (Lot number M025192, Expiration date 3/21/2019), GARDASIL 9 (Lot number M013636, Expiration date 2/15/2018), GARDASIL 9 (Lot number M016193, Expiration date 4/24/2018), GARDASIL 4 (Lot number L035105, Expiration date 5/14/2017). Additional information is not expected.
initial SARS-CoV-2 mRNA vaccine administered 1/31/2021 and 2/23/2021.  Began to feel symptomatic on 11/14/21, had booster dose administered on 11/18/2021. Hospitalized 11/21/21-11/26/21. Experienced shortness of breath,  cough and low SpO2
Got shot at 9am  on 4/23/21. By 3pm, fever was 101.  During the  night, I think my fever must have hit 104 at least with the worst headache I've ever had in my life. 4/24/21.  Extreme headache.  Fever/Chills, Nausea and vomiting 4/25-26.   Continue slight fever and chills.  Heart was fluttering. 4/23 to present day (5/8/21).  Fatigue. Still feel slightly achy, some light lung pain, and hot/cold in the morning and evening hours.  Have to take Tylenol several times a day to calm my immune system.   I don't feel like I need to see a doctor at this point, but I still don't feel 100%.    I'm am concerned about getting a 3rd Pfizer booster shot that may be required.
Blurred, dimmed vision in left eye and tremors in left hand. Tremors began one week after injection so may be unrelated. The blurred and dimmed vision began almost immediately after injection and was significantly worse the following morning.
para neocerebellar degeneration; This is a spontaneous report from Pfizer-sponsored program. A non-contactable consumer reported a female of unspecified age received a dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on an unspecified date for COVID-19 immunization. There was no medical history or concomitant medications reported. The consumer inquired if para neocerebellar degeneration was a reported side effect of the vaccine. The outcome of the event para neocerebellar degeneration was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
spots on her legs and her arms, they were kind of fluffy; rash on her right cheek/ rash on the right cheek was bright red; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included paracetamol (ACETAMINOPHEN), aspirin [acetylsalicylic acid] (ASPIRIN) Baby coated, calcium carbonate, colecalciferol, copper sulfate, magnesium oxide, manganese sulfate monohydrate, zinc oxide (CALTRATE PLUS WITH VITAMIN D AND MINERALS), carmellose sodium (CARBOXYMETHYLCELLULOSE SODIUM), cetirizine hydrochloride, famotidine, hydrochlorothiazide, oxybutynin hydrochloride (OXYBUTIN), simvastatin and Multivitamin. The patient had this vaccine on 21Jan2021 about in the afternoon and everything seem to be fine at that point and she stayed '30' minutes extra for observation and then she was released. About 9 o'clock in the evening she developed a rash on her right cheek. The next morning 21Jan2021 the rash on the right cheek was bright red but it did not itch. By evening, last evening 22Jan2021 the redness had began to fade some also last evening about bed time she noticed spots on her legs and her arms, they were not bright, they were kind of fluffy and again they do not itch." No treatment received for the events. Outcome of rash on the right cheek was bright red was recovering.    Information on the lot/batch number has been requested.
Woke the next morning with SEVERE shaking, chills, body aches, fever, nausea, dry heaving, generalized weakness, and malaise. Symptoms resolved at home later in the day with rest and Tylenol.
tongue swell; This is a spontaneous report from a contactable consumer (patient herself; a therapist, but was not clarified). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; batch/lot number: EK5730, expiration date: unknown), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization administered at the workplace. Relevant medical history included bipolar II disorder, hand tremors, and sleep (disorder). Concomitant medications included lithium and lamotrigine (LAMICTAL), both for bipolar II disorder; carbidopa, levodopa for hand tremors; and trazodone for her sleep. The patient had the vaccination and her tongue swelled on 26Dec2020, probably about 15 minutes after she had the shot. The patient had no investigation assessment. In response to the event, the patient had taken diphenhydramine (BENADRYL) at 25 mg, once; just one time. The outcome of the event was unknown.
On Monday, 4/12/21 around 7 am I noticed my left ankle was extremely swollen.  After my workday was over (3:30 pm) I went home and elevated/iced the ankle the rest of the day.  Swelling moved up a bit to my lower calf - continued to elevate/ice over night & swelling went down significantly.  That Friday,4/16/21 I noticed that same foot felt weak/heavy.  Didn't think much about it until the next day when it was still heavy and weak feeling and I noticed that I had decreased mobility in toes on left foot and my left foot.  Went to urgent care where I was x-rayed - no bone issues discovered.  I was told to go to ER for an ultrasound to check for blood clots.  The ultrasound was negative.  Told to follow up w/ primary
dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine, no ae; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00446341) and transmitted to Sanofi on 26-Jan-2021.  This case involves an one year old male patient who was vaccinated with 0.5 ml  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ336AAA and expiration date :05-Jul-2021) via intramuscular route (other dosing details were unknown) for prophylactic vaccination on 22-Jan-2021 and reported that a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine (Product preparation issue). Also reported that Caller reported two patients were administered the vaccine but unsure of which patient was only administered the DTap-IPV portion of the vaccine and asked when to re-vaccinate both patients.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE.  It was a case of actual medication error due to an inappropriate reconstitution technique (same day latency).  It was not reported whether the patient had any adverse event.  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 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.
mom states that 9 days p/vax pt devel a rash all over body then fever started & rose from 102 to 105 in 30min;went to ER sx gone p/ 2 days;ER MD said had ear infect;
decided not to get the second dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient decided not to get the second dose.
Body chills, did not take temperature but could tell I had low grade fever, it was about the same symptoms as first dose but not as severe. Felt like recovered faster than 1st dose. Felt like my coughs were more productive than 1st dose though. More phlegm. Lasted about 3 days. I also felt like had tachycardia, like my heart beat was off, I felt it around the 3 day and it is still ongoing. I did have a heart work up after my covid and it came back normal. I also came back that I had a very small episode of tachycardia when I wore the halter monitor. Also had chest pains and decided to go to the hospital on 03/07 to get checked. The lab work they did included a D Dimer that was very high. Higher than when I had COVID. They did a CT with and w/o dye and they also did an Xray (chest and lungs) and it showed that I had a lesser lung expansion. I did not have that with the last CT done in end of January or 1st week of February. I also still have to this day period chills (like I need to add a heating pad on my feet, on my legs or my arms to feel comfortable). I also have periodic headaches that come very rapidly and very severely and sometimes it can just last a little while or it can last some hours. I also have dizziness with the headache episodes. This has been going on for the last 2-3 weeks along with terrible joint pain.
an expired dose of ActHIB was given with no adverse event; Initial information regarding an unsolicited valid non-serious case from other health care professional via Regulatory Authority (Reference number- 00697016) and transmitted to Sanofi on 26-Jul-2021.  This case involves a 01-year-old female patient for whom it was reported that an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was given (expired product administered) to her (lot number: UJ352AAA and expiration date: 13-Jul-2022) at a dose of 0.5 ml via intramuscular route in the right thigh for prophylactic vaccination on 23-Jul-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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.
Feeling of extreme swelling and soreness of left arm radiating to left breast area and back. Could not lift arm.  Referred to urgent care.
Swollen supraclavicular lymph node on left side (began <24 hrs post-vaccination and is on-going). Sore and tender with no touch.   Swollen lymph node in underarm area on left side (began <24 hrs post-vaccination and is on-going). Sore and tender with no touch.
Patient was given the Moderna vaccine at age 15 years. Moderna is currently approved age 18 and older.
2 P.E.s 1 in each lung, and DVT in the right thigh, hospitalized for 4 days, given heparin,  resolved, continues with Eloquis
No additional AEs; Nurse reported that a historical medical record showed that more than a decade ago a 38 years old adult patient might have received a pediatric dose of possibly RECOMBIVAX HB back on 9/17/2009.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 17-SEP-2009, the patient was vaccinated with child dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # 1689x and expiration date 28-AUG-2011, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Heart attack; Serious Diaphoresis; Serious discomfort in chest; sort of dull chest pain; dull chest pain; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Pain radiate into my neck and to my left shoulder that did not scare me although it got my attention; Tachycardia; Felt extremely weak; This is a spontaneous report from a contactable consumer (patient). A 73-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 28Jun2021 as single dose for covid-19 immunisation. Medical history included aortic valve replacement in March. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Jun2021 as single dose for covid-19 immunisation and had no reaction until 4 days, later on three day had bowel and felt like a lousy flu. Patient had second injection (second dose) on 28Jun2021 and had no reaction, had nothing and then past Friday morning and patient did not know what the date it was about 3 o'clock, had some serious discomfort in chest, it was sort of a dull chest pain it wasn't really bad but it was there, but every time patient would take a deep breath, he/she would have pain that would radiate into neck and to left shoulder that alone did not scare patient too much although it got his/her attention. Patient woke up and saw it was about 3 o'clock in the morning and about 7-8 o'clock in morning, patient finally get out of bed and started having more chest discomfort and had sudden onset of tachycardia about 122 to 126 each minutes at the same time. Patient had a serious onset of diaphoresis now, patient was scared maybe he/she was having a heart attack, so patient decided to go to Emergency room which patient did and all laboratories, chemistry, scans, EKG, Blood work and Troponin all  levels were normal. Patient really felt extremely weak, diaphoretic and tachycardia. Patient didn't know any better and if he/she was sitting and if someone came into office and told patient that it was time to see what was going on with EKG was normal at the same time, physician stated that he can probably be hold patient for at least 24 hours because patient was 73 years old and had an aortic valve replacement (History) in March, so it really had a concern. Cardiologist came in and listen to the patient and said EKG looks good, pulse was ok and thought they all to do Echo just to make sure cardiac aortic valve was doing well and supposed to do well. Outcome of the events was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
significant dropped in her systolic pressure; Feel like her heart is racing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) for Blood pressure management.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) (seriousness criterion hospitalization) and HEART RATE INCREASED (Feel like her heart is racing). The patient was hospitalized from 26-Apr-2021 to 28-Apr-2021 due to ORTHOSTATIC HYPOTENSION. At the time of the report, ORTHOSTATIC HYPOTENSION (significant dropped in her systolic pressure) and HEART RATE INCREASED (Feel like her heart is racing) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: decreased (Low) decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable.  On 26-Apr-2021, it was reported that the patient was admitted to the hospital for the adverse event and was discharged on 28-Apr-2021.  On 03-May-2021, the patient was re-admitted to the hospital and treatment provided included intra-venous fluids (IV fluids). It was also reported that concomitant medications, hydrochlorothiazide and triamterene were stopped.   This case was linked to MOD-2021-116530 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.