chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had an almost immediate reaction after administration including dizziness, nausea, sweating, lightheaded. Pharmacy provided me with water and a snack and symptoms improved. 12 hours in I experienced the mostly expected "flu-like" symptoms - fever, headache, body aches, and muscle soreness particularly in buttocks area, which mostly subsided within 48 hours. In the following days, I developed shortness of breath, chest pain, abdominal pain/cramping, waves of extreme nausea, and fluctuating headaches. I remember my veins looking unusually noticeable in certain areas (example: noticeably purple and bulged veins in ear lobe area). On 4/13/2021, my symptoms persisted and as I did not have a primary care physician at the time, I went to clinic, where Dr. did blood work and ordered a chest CT Scan (no notable findings) and told me to continue monitoring symptoms. On 04/15/2021, I started experiencing sensations in my legs ranging from pins and needles, numbness, and burning in certain parts of my legs. The back of my right knee was a particularly sensitive area. These sensations made it uncomfortable to walk and I felt like it was more difficult to balance. On 04/19/2021, I wet the bed in the middle of the night, which has not occurred since childhood. I went back to clinic on 04/19/2021 detailing my experience, and Dr. referred me to a neurologist. To date, my symptoms have fluctuated and/or changed over time (better to worse, worse to better) or have resolved. I experienced the leg sensations (pins and needles, numbness, burning, tingling), and continued to develop these same symptoms in my arms, plus blurry vision, brain fog, and extreme fatigue. My neurologist conducted a nerve conduction study, which had no notable findings, and ordered a brain MRI that showed a few lesions in the right parietal white matter, subcortical white matter (of left parietal lobe), and left cerebellum. He put me on a B12 supplement (5,000 mcg) once a day, which I believe had a positive effect on my neurological symptoms (pins and needles, numbness, burning, tingling) and these symptoms were noticeably improved by mid-January 2022, except the blurry vision. Other symptoms that developed or re-emerged over time were insomnia, shortness of breath, waves of nausea, wrist pain (left), brain fog, chest pains (aches and random shooting pains), and heart palpitations after minimal activity. I eventually went to a cardiologist over concerns about my symptoms, in which an echo-cardiogram and cardiac MRI were ordered, showing no remarkable findings. I was recommended a vitamin D supplement which I continue to take. My current symptoms consist of random chest pains (shooting or ache), insomnia, intermittent blurry vision, brain fog, and fatigue.
This case was reported by a healthcare professional via a manufacturer and described the occurrence of reaction to flu vaccination in a 14-year-old female subject who was vaccinated with influenza virus vaccine (Seasonal Influenza vaccine, manufacturer unspecified). Co-suspect medication included ENBREL injection. Concurrent medical conditions included juvenile idiopathic arthritis and ulcerative colitis. The length of disease was 8.5 years. In 2003 the patient started etanercept (subcutaneous at an unspecified dosage and increased to 50 mg weekly approximately 2.5 years age. On 14 December 2009 the subject received unspecified dose of Seasonal Influenza vaccine(unknown). On 15 December 2009, 1 day after vaccination with Seasonal Influenza vaccine and approximately 2.5 years after starting etanercept 50 weekly, the subject experienced vomiting, dehydration and reaction to flu vaccination. This report was received from a manufacturer, is a solicited report sourced from the enhanced drug safety surveillance project for subject with Juvenile Idiopathic arthritis (JIA). A 14-year-old subject began receiving ENBREL 7 years ago at an unspecified dose, which was increased to current dose, 50 mg subcutaneous weekly, 2.5 years ago. The subject received the seasonal flu shot on 14 December 2009. On 15 December 2009, the subject developed severe vomiting and dehydration. The reported serious adverse event was severe reaction to influenza vaccine, which was medically significant. The subject was hospitalized for three days on IV fluids. Etanercept was held that week and restarted three days before the time of this report to a manufacturer (04 January 2010). The duration of the event severe reaction to influenza vaccine was from 15 December 2009 to 18 December 2009. The subject was hospitalized for 3 days and the healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with IV fluids. On 18 December 2009, the vomiting, dehydration and reaction to flu vaccination were resolved. The healthcare professional considered the events were probably related to vaccination with Seasonal Influenza vaccine and unlikely related to therapy with etanercept.
Phone call received from patient today, who reports that 15 minutes after receiving the flu vaccine 11-05-04 she "felt funny, burning all over, couldn't breathe, sweating, heart racing, nose itching, chest swollen". Reports difficulty breathing and tightness in chest all night, next morning "face and eyes puffy" , by Sunday, 11-07-04 all symptoms were gone.  Reports did not go to ER, but has talked to her MD office today.
No adverse reaction. Patient received vaccines that had already been given in the past. Second dose of varicella 10/08/2013 Influenza 10/08/2013. Were not supposed to be administered.
Pt received booster dose as part of a vaccination clinic at a long term care facility. She had already received her booster shot (3rd Pfizer vaccine) on 10/11/2021 and received another booster again on 11/1/2021. Due to her dementia, she didn't mention she had already received her booster and the staff had her paperwork filled out to receive on 11/1. Staff, power of attorney daughter and PCP were notified and advised to monitor for side effects.
Headaches, Blurry Vision, Dizziness, Excessive Tiredness, Cloudy Head, Stiff and Painfull left shoulder and left elbow joint (All started on 12 Oct and are still present at present).  I went to see 3 different flight doctors, all 3 saying different things.  I was put on DNIF (Duties not including flying, essentially, put on bed rest) for 48 hours.  Symptoms became a little less apparent, but still very present, but was still returned to work.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.   This case involves (an elderly) female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
Received the shot at 5:15pm.  Before bed around 9pm, my neck and arm was hurting.  Woke up next morning for work around 3am with a sore throat and sore arm. 2nd day, sore throat was gone, however I felt fatigue for 2 days and had a runny nose for about 5-7 days.
pt recv vax 24JUL97 & w/in 1hr pt devel gen urticarial rash;DPH given 1hr p/inj;
Swollen, red, tense left arm below vaccine site all the way to elbow. Occurred 24 hours after vaccine and resolved in 3 days.
1/7/05 Received flu vaccine. 1/15/05: had cough, non-productive. 1/17/05: had temperature 102, vomiting, decreased appetite. 1/18/05: Seen in ER. 1/19/05: Seen in PCP office; diagnosed virus. 1/20/05: Couldn't walk. Information from discharge summary states deminished reflexes. msv Information from medical records states crackles in lung bases, retractions, rhinitis, headache, otitis, viral infection. msv
Sick since took this vaccine; want to get rid of this sickness; Chills; Fever; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that ever since receiving the vaccine last Tuesday, the patient had been sick and wanted to get rid of the sickness. Reportedly, the patient was "tired to be" (pending clarification) in sick." The patient had fever, nausea and chills. The outcome of the events was unknown.   No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Patient was 11 years old at time of vaccine administration. Patient received the Pfizer Covid vaccine for ages 12 and up.  Patient's mother listed incorrect DOB on consent form, this mistake made him 12 years old when he was actually 11 years old.
Sore arm for 36 hours. Onset within an hour after recieving the vaccination, Slight malaze for 24 hours. Onset the next morning post vaccination.
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
patient gots it every time he gets a flu shot.; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2020SA300039.  This case involves a male patient who got it every time he gets a flu shot (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got it every time he gets a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 9/27/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient's mother reported lethargy, diarrhea and cramps following the third self administered dose of VIVOTIF. Symptoms treated with loperamide and oral hydration. Symptoms resolved within 24 hours and the fourth self administered dose was taken on schedule with no adverse events.
Patient died March 19. 2021 my husband of almost sixty years.  He was fine, as always, worked in the yard and garage, had breakfast and was going for a haircut (9am appt).  He came to the kitchen to say 'goodbye', grabbed my back at the shoulders and slide to the floor.  EMS to hospitals, neurosurgeon removed clot above left ear.  First hospital had given 'clot buster shot'.  He was kept 'alive' until May 19.  He had just had a visit with cardiologist and had been under a cardiologist's care since 2000 when he had CAB surgery.  His blood cholestrol was checked frequently and always excellent.  However, coincidentally, at the appt occurring after the Moderna, his count had not remained excellent!!!  Coincidence?   It seems unlikely.  Caused by the Modernas?  Probably.
Low fever; nose blockage; skin rash which last weeks so far; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 10:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive other medications within 2 weeks of vaccination. On 17Apr2021 at 12:00, the patient experienced low fever, nose blockage and skin rash which last weeks so far. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events low fever, nose blockage, skin rash which last weeks so far was resolving at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08May2021 at 10:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a infant female patient who received MENVEO (batch number M17077, expiry date July 2019) for prophylaxis. On an unknown date, the patient received MENVEO (intramuscular) .5 ml. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported.
This spontaneous report as received from a licensed practical nurse to an unspecified number of patients of unknown demographics. NO concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored MMR II injection (lot # reported as M001200 (HSA) with expiry date: 28-AUG-2016; lot# L041455 (rHA) with expiry date: 22-OCT-2017; L024265 with expiry date: 01-JUL-2017 and lot# L030162 (rHA) with expiry date: 11-AUG-2017; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "date logger". No concomitant medications were reported. NO adverse effect reported. This is one of several reports from the same source.
Loss of appetite no energy, breaking out in cold chills, nausea, headache - hurts when I walk and open my eyes. Took some tylenol, it suppressed the headache but it feels like it might coming back.
suspected vaccination failure; had the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not repoted. In only one unknown year the patient experienced flu after vaccination. This is suspected vaccination failure case.
Client report receiving second COVID vaccine on 04/12/21 at 1:10 pm.  Client noticed a small pink spot at injection site that day but did not pay much mind to it to do being busy throughout the day.  On 04/14 or 04/15, time not known, then noticed a a rash on her arm at injection site that is red, itchy, sore, warm to touch and swollen.  Client measured rash site, it is 2 inches in width and 1.5 to 1 3/4 in height.  Client seen by PCP on 04/19/21, for this adverse reaction.  PCP prescribed Allegra, Benadryl, and Cefalexin.
pt devel fever of 103, nausea, h/a, back & neck pain during the noc;
fever; chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), Lot number: Expiry date: Unknown, dose 1 via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified sate the patient experienced fever and chills. Outcome of the event was recovered on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No Adverse event; Patient received the bivalent vaccine without receiving the primary series of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine) and NO ADVERSE EVENT (No Adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062f22a) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine).    Concomitant medication list was not provided. Patient received the bivalent vaccine without receiving the primary series of the vaccine or any other dose of any COVID19 vaccine. Treatment information was not provided.
Fever 102, pulse 110, very lightheaded, nausea, severe fatigue, shart muscle pain in my back and neck.
tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19) in a 54-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (tested positive for covid-19). At the time of the report, COVID-19 (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication were not reported. Treatment medication were not reported.
varicella vax 1hr late rash, ?wheezing, swelling of eye;
Some swelling by my elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Some swelling by my elbow) 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 JOINT SWELLING (Some swelling by my elbow). At the time of the report, JOINT SWELLING (Some swelling by my elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Headache lasted 24 hours Arm ache at injection site for 48 hours Fever for 24 hours Body aches for 36 hours Eyes felt like they were burning for 2r hours
patient was rushed to the hospital .and was diagnosed wit TIA. patient was put on 80 mg of lipitor and 75 mg of plavis and 81 mg aspirin.
At approximately 15:45 on 12/14/2021, I administered a 2nd pediatric dose of Pfizer lot# FK5618 to patient in the left deltoid. Upon plunging the syringe, an amount of vaccine ran down her arm. The amount was approximately ½ the 0.2mL dose. It appeared the needle and syringe were not tightly attached; therefore resulted in a decreased dose. After consulting the clinic manager, pharmacist and the website, a second dose of 0.1mL of Pfizer lot# FK5618 administered inferior to the first dose in the left deltoid with good success.
Individual received COVID 19 vaccine. Started to feel dizzy approx. 15 minutes after vaccine. Pt then started to have hypertension and increased confusion. EMS called, pt transported to hospital.
left hand was paralyzed for 45 minutes, 8 hours after shot in left arm.