chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Estimated date of conception June 11, 2022. Vaccine received July 11, 2022, 1 month pregnant at this time. Due Date March 18, 2023. Vaginal delivery. baby was full term prenatal care unremarkable.  Baby had a positive Coombs test, elevated bilirubin w/hemolytic anemia requiring higher level of care NICU admission where she received aggressive phototherapy, IV/IG  and albumin infusions, Iv fluids, blood transfusion. At the time of infusion it was discovered that the baby had acquired antigen C , the source of the problem. Prior to delivery baby mother and baby father both had blood work with no indication of the antigen C.
Severe and unbearable migraine Fever, profuse sweating Teeth hurt Extreme sensitivity to light Weird taste and sensation in mouth Extreme exhaustion and weakness Chills and shivering Totally unable to function
Patient had red dots that formed that night and was itchy. In the morning the itching intensified and small welts formed. Pt went to student health and was given prednisone as a treatment about 1 to 2 days later. 10 days later patient went to the Urgent Care facility and was given diflucan and recommendation to start Frojen probiotic.
Shortly after I developed chills and muscle aches.  I went home and went to sleep but when I awoke I had a  100.7 fever which I took tylenol and motrin for and continued to rest and the next day it had broke. I was very fatigued but I was also 34 weeks pregnant at the time so that could have had a part in it as well.
Within 24 hours, typical flu like symptoms appeared.  Low back pain, joint aches, runny nose, lack of energy
Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Caller also reports that her nurse at the clinic as well as her brother in law died because of the vaccine.
I have congestive heart failure and AFIB. I saw my family doctor in March and he got me in to see a cardiologist. They tried to DE-FIB me one time, and I stopped breathing. He told me I have sleep apnea, and I have something wrong with my thyroid. They were going to shock my heart and try to get it back into rhythm, but they didn't because I stopped breathing and they thought they saw a blood clot. I went back in to get DE-FIBED in August and it lasted for a day and I went back into AFIB. So, my thyroid levels are real low. I got off my medication to try to get the levels up. Once I get my thyroid levels up, I will be able to get shocked back into sinus rhythm.
Patient and nurse practitioner believe patient administered the shot in the shoulder joint rather than the deltoid muscles, FNP examined patient 10-15-13 and believes the site of injection is the cause of patients tendinitis.
A few hours after my second dose my left arm was very sore. Could not really touch the area where the vaccine was given. cannot lift my arm very high.  More than 48 hours later and this has not resolved. About 7:00 pm the day I received the vaccine I started to get bad body aches. I took tylenol and went to bed. At some point around 1-3 in the morning I woke up freezing cold with chills, I layered up with sweats and extra blankets, took what felt like forever for me to get warm again and fall back asleep. I was so uncomfortable due to the body aches that I tossed and turned a lot. Finally fell back asleep. Woke up and hour or so later drenched in sweat. At this point my body hurt so bad that I left my bed and moved to another room for relief. Fell back asleep for another hour or so. Woke up feeling horrible. Weird pains in all my joints, every time I opened my eyes I got extremely dizzy and nauseas. Could not get myself out of bed, no energy. Had my 12 year old son get me something to drink and eat so I could take more tylenol. Took more tylenol and passed out around 8:30 am to 1 pm. Took a hot bath to help my joints and muscles. Got another fever (100.9) around 9 pm. My dad noticed a rash on my neck during video chat with me around 8:30 pm, I thought it was from a heating pad to help with muscle and joint pain. I went to bed. Woke up drenched from sweat twice during the night. Woke up feeling very tired and very sore. My arms feel very heavy. Was up for an hour and half to eat and drink something. Went back to sleep until noon. Noticed a bad rash going all the way around my neck. Red spots near the injection site. Rash near right breast and on right arm. I called my doctor who was not in today. Called the pharmacy that gave me the shot, he told me to take benedryl for the rash and to go to doc if it continues to get worse or if I start having breathing problems. So far benedryl has not helped the rash and it appears to be spreading.
0910 - Flu shot given IM (L) deltoid. 2:30 pm - Pt began experiencing pruritus - face, torso, upper extremities. 3:30 pm Pt reported to RN at flu clinic. 4:00 pm pt seen by clinic, Rx ZYRTEC. 5:15 Pt home - showers changes clothes. 6:15 pm pt experiencing pruritus on all mentioned body parts now legs, feet and toes. Pt. takes ZYRTEC. This calms it but does not completely stop itching. Pt awakens in middle of night - buttocks & legs itching. Pt was only given one ZYRTEC tablet at clinic. Following day pt continues with pruritus mostly torso, lower extremities, feet. Pruritus subsides that evening.
Child developed fever approx. 20 hrs. after vaccination of up to 104.4, also had diarrhea.  Was seen in ER evening of 5/6, treated with Tylenol, Motrin & PO fluids.  Was not admitted. Fever resolved by afternoon of 5/7.  Seen by PCP on 5/8 who thought it was a reaction to vaccines.
Skin peeling; Rash all on chest, back and face; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021  as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 27Apr2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient had rash all on chest, back and face, following with skin peeling. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and skin peeling. The clinical outcome of the events rash all on chest, back and face and skin peeling were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
local raised redness 3X3 area at injection site left deltoid, warm to the touch, no fever or systemic process.
Patient received the Varicella vaccine on 3/20/1997 at a office.  On 10/6/2003 he was diagnosed with chicken-pox.  He developed less than 50 pox and has recovered without any complications.
1st dose 04Apr2023, 2nd 09Apr2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 09-APR-2023, the patient received the 2nd dose of Shingrix. On 09-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 04Apr2023, 2nd 09Apr2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The pharmacist reported that the patient was not immunocompromised. The reporter reported that the patient received second dose of Shingrix early. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Patient received Flu shot at 10:45am and started reaction at about 12:00pm. First reaction was quarter size within 1 hour of shot. Patient at that time took Benadryl, Ibuprofen, and hydrocortisone cream. 8 hours later reaction got larger about hand size. Patient is having itching, and pain at touch. Site looks red and swollen.  Medical Doctor recommended ice and prescribed steroid.
Eight days after getting the first dose of the vaccine I experienced blood in my stool. It happened again every two or three days. Five days after the second dose I had the problem again. It was a lot worse and there was a lot of blood in my stool. I also had lower abdominal pain. I have been diagnosed with Ulcerative Colitis. I have lost 20 pounds because I have had digestive issues and abdominal pain. I have food sensitivities. It has improved a little but it has caused me depression. I have been prescribed Mesalamine.
Patient's arm was red and swollen 3 days post vaccination.  She reported it was improving.
Pfizer Bivalent (5-11 y.o.) ordered, accidentally administered Pfizer Monovalent (5-11 y.o.). No symptoms or adverse effects have occurred as a result.
Swollen, red, hot patch around injection site; Swollen, red, hot patch around injection site; Swollen, red, hot patch around injection site; Swollen lymph node in armpit; Arm hurt all the way down to finger tips; Nausea; Headache; Fatigue; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 08May2021 at 11:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included diabetes and unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 11Apr2021 at 11:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 18:00, the patient experienced swollen, red, hot patch around injection site, swollen lymph node in armpit, arm hurt all the way down to finger tips, nausea, headache, fatigue, and joint pain. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen, red, hot patch around injection site, swollen lymph node in armpit, arm hurt all the way down to finger tips, nausea, headache, fatigue, and joint pain were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
SWOLLEN, RED, TENDER TO TOUCH AND VERY WARM , HARD AND ITCHES/HURTS.
4 inch by 4 inch area of increased erythema with increased warmth, mild induration and mild edema. Area was located on upper left thigh.
UTI Infection; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 74-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9269, expiration date was not reported), via an unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization, amoxicillin for urinary tract infection. Medical history included urinary tract infection from an unknown date She unfortunately came down with a UTI Infection which she usually gets. The patient's concomitant medications were not reported. On Feb2021 the patient experienced uti infection. Caller mentioned that she received the 1st dose of the vaccine 06Feb2021. She mentioned that she had no problem with it. It was very smooth, great and didn't feel it.  She unfortunately came down with a UTI Infection which she usually gets. Her doctor prescribed her Amoxicillin. She is asking if that medication would have any adverse effects with her 2nd dose which is due tomorrow. She is planning to hold off on the amoxicillin until Wednesday after getting the 2nd dose. Up on follow up(01Mar2021) Patient stated that I just want to know should I not take the Amoxicillin before I get my dosage tomorrow for my vaccine (Unspecified Vaccine) should I put that off, and take it later or can I take it today and not take it tomorrow, and take it back up on Wednesday, The Amoxicillin going to have any negative effect on the vaccine, is to not take the medicine (Amoxicillin) for urinary tract infection and just go ahead and get my vaccine since I already have one dose. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8132), in left arm, on 24Apr2021 as dose 2, single (Lot number: EL00170), in left arm, on 08Dec2021 as dose 3 (booster), single (Lot number: 330308D), in right arm and on 09Jun2022 at 14:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Negative, notes: Tested negative on evening of 16Jul22; (18Jul2022) Positive, notes: tested a strong positive on morning of 18Jul22. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID on 08Jul2022 less than 24 hours after symptoms appeared. Patient took PAXLOVID (Lot number: GC9422) from 08Jul2022 to 12Jul2022.
I have soreness in my arm; This is a spontaneous report from a contactable consumer. A female consumer (patient) reported that:  A 62-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EJ1685) via an unspecified route of administration, administered in Arm Right on 01Mar2021 17:00 (62-year-old at the time of vaccination) at a dose number unknown, single for covid-19 immunisation. Medical history included hypothyroidism (Synthroid 125mcg) and food allergy (sometimes egg yolk) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates and unknown if ongoing (medication the patient received within 2 weeks of vaccination). The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 02Mar2021, the patient experienced soreness in arm. The patient reported that her arm was sore for a couple of days after the vaccine. She was doing fine now. The patient received no treatment for the event. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
2hr p/vax mom reported pt shaking & skin was mottled;mom was instructed to take pt to MD;pt adm to hosp;(shaking lasted about 10min;mom also reported pt did not respond well when spoken to;mom reports MD called this an allerg rxn to vax
Redness, hardness, itchiness, and "heat" at injection site for 24-48 hours  "COVID arm"
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Postural Orthostatic Tachycardia Syndrome (POTS)" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: XYREM; TIROSINT; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measure of Paxlovid was taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
burning sensation; A febrile with no other symptoms; tingling in the fingertips; Red rash at tips of toes; This is a spontaneous report from a contactable physician. A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9262), via intramuscular route of administration, administered in arm left on 28Jan2021 at 18:00 (06:00 PM) (at the age of 56-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included estradiol, progesterone, both drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. Patient was diagnosed with COVID prior vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EK9231), via intramuscular route of administration, administered in arm left on 07Jan2021 at 06:00 PM (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. On 14Feb2021 at 15:00 (03:00 PM), the patient experienced burning sensation, a febrile with no other symptoms, tingling in the fingertips, red rash at tips of toes. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: Red rash at tips of toes, with burning sensation. Also, some tingling in the fingertips. A febrile with no other symptoms. COVID PCR test pending. The patient underwent lab tests and procedures which included COVID PCR test was pending on 02Feb2021. Patient was COVID tested post vaccination. The patient received topical hydrocortisone as treatment medication for the events. Outcome of the events was not recovered.  Follow-up (PRD/SRD 14May2021): Follow-up attempts completed. No further information expected.
Pain in the left arm, tingling down to fingers and up to the neck into the head. The patient developed expressive aphasia, extreme fatigue, weakness and stupor Pulse: 76 Resp. 16 SPO2 99 BP 130/88 Discharge to emergency room/ department or urgent care
Patients states that starting on Thursday 5 days ago pt developed generalized pruritic macular papular rash. It did not start in any particular area, but just presented and was wide spread. He denies any new medicines. No new pets, no new detergents or sheets. No sick contacts. No sore throat, throat closure, shortness of breath. Pt chronically feels warm or cold at night, but not over the weekend. No documented fevers. No new arthritis pain. Pt has not used any meds. He did received a Td shot during his visit to the office 5 days ago.
Hives, nausea, dizziness, drop in O2 saturation level .  Seen and discharged from Hospital ED.
expired IPOL being administered to patient; with no AE; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7 years old male patient who received expired IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 23-Dec-2020, the patient received a dose of suspect IPV (VERO) (with unknown strength, formulation, dose and frequency) (lot P1F541M and expiration date: 07-Dec-2020) via unknown route in unknown administration site for prophylaxis vaccination.    It was a case of actual medication error due to expired product administered.  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 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.
Started To Feel flu like on 2/14/21 vision impaired w/flashes of light, blood pressure started to rise. By 2/17/21 Blood pressure was extremely high, left arm pain, chest pain, vision impaired w/flashes of light, light headed heart stopped for seven seconds while in hospital
Patient reported that approximately 2.5-3 weeks after receving flu shot, she began experiencing numbness that began in her fingers/toes/feet, and progressed up to her knees. She also reported double vision. She called 911 and was taken to the ED, where a neurologist ordered an MRI and confirmed Guillain-Barre syndrome. Patient spent 11 days in ICU, and was then transitioned to progressive care. After being admitted, she experienced progressive numbness, including in head and face, and inability to walk. She reported that she received 7 doses of IVIG while in ICU. She reported that since being discharged, she has been able to walk with a walker and is taking some steps on her own. She is still having numbness as of 12/20/20, for which she is taking gabapentin and methocarbamol. She also completed a taper of prednisolone eye drops for her ohpthalmic symptoms. She was also given home health care exercises to complete daily.