chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre - Miller-Fisher - hospitalized, treated IVIG. 10/23/08-records received for DOS 5/9/5/15/08-DC DX:Guillain-Barre Syndrome with Miller-Fisher Variant. Developed blurred vision 1 week ago along with numbness and tingling in fingertips. Headache 3 days ago. Recent travel to China and returned this past Wednesday. Difficulty walking. Nonproductive cough.  PE: decreased sensation from midcalf distally and decreased vibration from ankles distally. Treated with IVIG.
Discomfort in left side of upper chest when exercising.  As an active and fit person all of my life, this was a strange and disrurbing feeling.  I have to decrease my effort when cycling, and  I had to take a break while shoveling snow yesterday, despite it being a minor snowfall of medium weight snow.  Pre-covid-vaccine (e.g. early in 2021), I never experienced these problems.
This spontaneous report was received from a 81 years old female consumer reporting on herself, with allergy to penicillin, sulfa, iodine and most unspecified antibiotics and a history of by-pass surgery thirteen years ago, in approximately 1999 and a few transient ischemic attacks, who on 24-JUL-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included PLAVIX, clonidine, timolol (manufacturer unknown), LOVAZA and insulin. The consumer reported that on 28-JUL-2012, she experienced a rash after getting ZOSTAVAX. No treatment was given for the experience. Lab diagnostics studies performed included annual check-ups and cardiologist. At the time of the report, the consumer was recovering. The patient did not seek medical attention. The relatedness for patient experienced a rash was unknown for ZOSTAVAX. Additional information has been requested.
Experienced flu like symptoms (body ache, headache, low grade fever, lose of appetite), within hours of receiving vaccination. Symptoms persisted to varying degrees over the next 3 months. Developed a persistent dry cough after a couple of weeks. Developed a large (tennis ball size) infection in lower back area at site of a previous surgery (performed in 2002). The culture came back as Serratia Marcescens. Required emergency surgery to clean site of infection and use of antibiotics.
they had a Baptism to go to this weekend and she wanted to wait to give the patient the dose she was supposed to receive today; after the patient received her first dose of ROTATEQ,  she had more frequent bowel movements; This spontaneous report was received from a registered nurse referring to a 4-month-old female patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.  On 28-JAN-2022, the patient received the first (1st) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to prevent rotavirus (dose, vaccination scheme, lot number, and expiration date were not reported).  On an unspecified subsequent date in 2022, after receiving her 1st dose, the patient had more frequent bowel movements.   According to the nurse, the patient's mother stated they had a baptism to go to over the weekend; therefore, she wanted to wait to give the patient the second dose that was supposed to be received on 01-APR-2022 (intentional dose omission).   The patient's outcome from frequent bowel movements was not reported.   The registered nurse causal relationship assessment between frequent bowel movements and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Fever, sweat, h/a, diarrhea; sx started p/2nd dose;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AUROVELA 1.5/30. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (25Jul2022) Negative, notes: tested negative for Covid-19; (31Jul2022) Positive, notes: tested positive for Covid-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was given paxlovid from 20Jul2022 through 25Jul2022 as a treatment for covid 19. Patient took other medication in 2 weeks. Patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse event noted.  No signs and symptoms verbalized by patients family. Novartis vaccine given to a client under fda approved age range.
ENTIRE BODY HURT SO BAD THAT COULD NOT SIT/ STAND/LIE DOWN; ENTIRE RIGHT ARM ACHES; FEVER; A CONSTANT DULL HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 MAR-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 MAR-2021, the subject experienced entire body hurt so bad that could not sit/ stand/lie down. On MAR-2021, the subject experienced entire right arm aches. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced a constant dull headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a constant dull headache, and the outcome of fever, entire body hurt so bad that could not sit/ stand/lie down and entire right arm aches was not reported. This report was non-serious.
Extremely high fever, chills, head ache and muscle ache. Started the very next morning and has gotten worse, last night temp was 101.6 and my normal temp is 97.4, some better today. Was told today that the second shot is the one that normally makes you sick. God help me.
Headache, Sedation, Myalgia, Fever, injection site pain, chills Narrative:
Fatigue, soreness in joints and muscles of entire body, dizziness (3+ days), shaking, hot and cold.
This is a spontaneous report from a contactable pharmacist. A 65-year-old Caucasian male patient received PREVNAR 13 (Lot # S89081, Expiry Date Dec 2019, NDC # Unknown) at single dose on 05Nov2017 or immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (FLU) on 05Nov2017 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect: none, this is the first time patient received PREVNAR 13.  On 05Nov2017 the patient experienced arm he received the vaccine was sore and painful so much that he is not able to sleep at night, arm was very swollen, and can't move his arm because it was very swollen. The AEs arm being swollen, sore and having difficulty sleeping at night required a visit to Physician Office. The patient's physician referred the patient back to the pharmacy per the reporter. His symptoms have worsened and were of a serious nature, clarified as medically significant, per pharmacist.; Sender's Comments: Based on the information currently available, the occurrence of events with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
experiencing diarrhea; fever; This is a spontaneous report from a Pfizer-sponsored program, via contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 10Mar2021, as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 30Mar2021, the patient experienced experiencing diarrhea, and fever. Patient took Imodium as a treatment for experiencing diarrhea. Patient was asking if she can still proceed on receiving the 2nd dose tomorrow, scheduled on 31Mar2021 (21 days apart). The outcome for all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a healthcare worker concerning a 4 year old female with environmental allergies (not specified) who was vaccinated with 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 656034/0182U). Concomitant therapy included varicella virus vaccine live (Oka/Merck) (MSD) and diphtheria toxoid (+) pertussis acellular vaccine. Subsequently, the patient experienced a rash with warm swelling at the injection site. She was seen in the office by the physician for follow-up medical attention. Treatment and current patient status were not reported. A product quality complaint was not reported. No further information was available. This is one of two reports from the same source. Additional information has been requested, A lot check was requested by the reporter. The records of testing prior to release of the lot check in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
I received my vaccine Tuesday @ 1300, I felt good Wednesday morning taking Motrin alternating with Tylenol around the clock. At 1400 I felt achy with mild chills, at 1700 symptom were a lot worse. Shaking chills, temp 100, back, neck, and leg pain.  I went to bed slept off and on. Woke up this morning, Thursday feeling a little better thought I could work but after getting to work symptoms got worse again.
Vagal incident with LOC.  I am an RN, I saw what was happening and eased my daughter to the ground, elevated legs, etc.  Recovery took 30 minutes - as she remained symptomatic when she attempted to sit or stand.  Rehydrated with Gatorade 20 oz.
large erythematous area - 3" circumference area soft cool to touch;dad states pt not walking (non wt) bearing lt leg;pt walked out of clinic w/o diff;
bad sinus infection; excess secretion coming out of their nose; excess secretion in their lung,have been coughing; This spontaneous case was reported by an other health care professional and describes the occurrence of SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Foramen ovale patent, Atrial septal defect repair and Thyroidectomy. Concurrent medical conditions included Lymphedema since 2011, Lipedema since 2011 and Asthma. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR) for Asthma, APIXABAN (ELIQUIS) for Clot blood, CORTISONE for Foramen ovale patent, OMEPRAZOLE for Reflux gastritis, LEVOTHYROXINE for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing). The patient was treated with LEVALBUTEROL [LEVOSALBUTAMOL] ongoing since an unknown date at a dose of UNK UNK, q6h. At the time of the report, SINUSITIS (bad sinus infection), RHINORRHOEA (excess secretion coming out of their nose) and COUGH (excess secretion in their lung,have been coughing) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   they need 2 knee replacement. Patient had Lymphedema and Lipedema for which they use a leg compression chamber due to a condition called degenerated osteoarthritis that is at their final stage. They had this for 10 years now but it got worse about 20 months back and they can hardly walk and had to stop working and retired.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in November 2011 the patient was vaccinated with a first dose of VARIVAX, (dose, route and Lot # not reported). On an unknown date the patient experienced generalized rash (after receiving a vaccine). The patient sought medical attention via doctor's office visit. Additional information has been requested.
Soon after vaccine developed severe headache, diaphoresis, tachycardia - 109, B/P 156/104. Sat down with feet elevated until b/p was checked.  Ice pack to back of neck. Refused EMS and transport to ED. RN assumed responsibility for patient and escorted him out.  Patient went to local Urgent Care  with a guard driving.
Information has been received from a physician referring to a male patient of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unspecified date of 2012, the patient was vaccinated with his first dose of GARDASIL (dose, route and lot# were not reported). 1 year later after the first dose, on an unspecified date of 2013, the patient received his second dose of GARDASIL (dose, route and lot# were not reported) (inappropriate schedule of drug administration). Then, 1 month after the second dose, the patient received his third dose of GARDASIL (dose, route and lot# were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm red, swollen, uncomfortable. Advice: cool packs, Tylenol.
Started having Hypertension, intermittent palpitations 1 hour after Covid-19 booster today. Persistent occipital headache rates 5-7/10 and mild dizziness throughout today.
About 90 minutes after my second dose vaccine on 02-18-2021  I experienced atrial fib episode and within five minutes after my heart rate went up to 75 - 180bpm. The next day I felt bad all day. It was 36 hours of unpleasantness and after 5 months of no atrial fib episodes, I do have a difficult time with atrial fib. I want to get the booster shot but I do not want it to cause other heart problems. My cardiologist also believes this stimulated from the vaccine.
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Systemic: Fever-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Heart flutter, very high blood pressure and heart rate, 103 degree fever, skin pain, painful urination - patient went to ER
Vaccinations on 12/11/2002 rash high fever for at least three days, loose stools called said to give Tylenol, Flu on 11/14/2002-same as above. Information from 60 day follow-up report states: Autism - expressive/receptive language delays.  Follow-Up Info:  Autism, GI Issues, Sensory Issues
I noticed another small lump when in the shower. I had a follow up appointment to check the October 19 to have the lump checked that I received previously. Upon checking she felt an additional smaller lump. I have a follow up appointment in January. I also had my flu shot 2 days prior to the booster. She prescribed 600 mg of MOTRIN and muscle relaxer. I had helped slightly. I take it at night, so it does not wake me up. The doctor has not done anything to treat it, she is just keeping an eye on it. She may possibly do a biopsy in the future if I wanted, I want to have it done. The pain comes and goes. Some days are better than others. It normally bothers me at bight when I try to lie down.
Red rash, warm, itchy, firm beneath skin; appeared a week after vaccination and lasted about a week. No other issues then and none at this time. Notified primary physician.
Temp of 105F; Redness @ inject site; poss redness @ PROHIBIT site; MD thought poss PROHIBIT rxn but discussed w/nurse 105F temp believed to be related to DTP;
mom states 24hr p/vax pt arms & legs began to swell;pt had high pitch cry;24hr p/swelling started getting hives;pt taken to ER when swelling started, pt put in observation for 24hr;DPH given;
PASSED AWAY; SEPSIS; This spontaneous report received from a consumer via a company representative via social media and concerned a male of unspecified age. 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, and batch number were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sepsis and passed away. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. Reporter stated that "Took the j &j now have stents in my legs, had a blood clot, hubby had Sepsis and passed away. I trusted because they had been around forever and should know what they are doing". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of passed away on an unspecified date, and the outcome of sepsis was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20221222579.; Sender's Comments: V0-20221222577-passed away. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221222577-Sepsis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
12 X 12CM RED EDAMATOUS REACTION (LEFT ARM SQ)PT SEEN AT AFTER HOURS PEDIATRIC AND WAS PLACED ON BACTRIM. SITE WAS WARM TO TOUCH.
Massive rash, started in the lower back and after 2 days appeared on the limbs. Rash did not itch and receded on the limbs after 48 hours and a week for the lower back.
gastrointestinal disturbance, severe aches and pain throughout body, fever x approximately 36 hours
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 14:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "Sulfa allergy" (unspecified if ongoing), notes: Known allergies: Sulfa; "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Range Of Motion Decreased; Injection site erythema; injection site swelling; pain - Information has been received from a registered nurse concerning an 11 year old white female patient who was inadvertently vaccinated on 24 July 2000 with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) IM in the left deltoid rather that the recommended SC route (lot number: 634035/37103).  concomitant vaccinations that  same day included a first dose of hepatitis b vaccine (engerix-b) IM in the right deltoid (lot number: em 33232a4).  Follow up information from a relative  of the patient indicated that one hour and fifteen minutes post-vaccination, the patient developed increased pain and decreased range of motion with localized redness and swelling for approximately one week before symptoms were completely resolved.  On 01 Aug 2000 the patient recovered.  The patient sought unspecified medical attention.  Attitional information has been requested.