chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient in exam room with mother and older brother post immunizations. Other staff member called for help after finding patient had fainted on exam room floor. Patient was assessed by pediatricians, vital signs obtained, and blood glucose checked. At this time patient was conscious.  Patient was given water and crackers. Patient remained in exam room with mother and brother for approximately 45 minutes for observation.
Patient called and reported having trouble breathing while she was at work.  PharmD recommended patient come to the pharmacy.  Patient arrived and pharmacists administered epinephrine (1 shot 0.3mg) and called 911.  Paramedics arrived quickly, and patient reported improvement in breathing.  BP was elevated.  Patient and paramedics stayed until breathing was much improved and BP had lowered.
Stiffness and pain in my shoulder, slight temperature increase, feeling like I was coming down with the flu.
Patient is fully vaccinated. Chief complaint is shortness of breath. 71y.o. male with a past medical history of arthritis, DM, HTN, sleep apnea presenting for cough. Patient was diagnosed with COVID on 12/22. confusion. In the ED, patient was hypoxic to 70s on 5L NC. He was placed on 15L NRB with improvement in saturations. D-Dimer 874.CXR demonstrated worsened diffuse bilateral pulmonary airspace opacities. Patient's BP was later noted to be 206/78 and he was given IV hydralazine. Treatment:  decadron, oxgyen. DVT prophyaxis, decadron, remdesivir. Discharged to skilled nursing facility.
mass on my eye orbit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), administration date: 22Mar2021, for COVID-19 immunization. The following information was reported: DISORDER OF ORBIT (non-serious), outcome "unknown", described as "mass on my eye orbit".  Additional Information: The patient had COVID vaccines on 22Mar2021 and 13Apr2021 and developed a mass on eye orbit that was removed May2021 and another subsequent lump in Sep2021. Both doctors suggested this might be an adverse reaction to the vaccine, potentially as a result of lingering facial fillers. Patient had any lingering filler dissolved in Nov2021 and asked if it was safe for to have the COVID booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
2 hrs after vaccine head felt swimming lied down to nap. 5-6 hours after vaccine fever noted and joint stiffness. 12-36 hours after vaccine continued head felling swimmy still. Frequent loose Bowel movements noted (about b/d). Fever and chills that evening (Tues). Wed continued head symptoms, swelling in neck noted , slight swelling of face. Continued frequent Bowel movements.
Initially started as eye twitching, then 24 hours after that I started having seizures.  I was taken to Hospital where they said I have anxiety.  I don't have anxiety, I know my body, I have 27 seizures in 2 days and went to my PCP and was put on Keppra.  Seizures stopped for a few weeks as long as I took Keppra.  Saw a Neuro, he did no tests or exam just simply said anxiety.  Now I am into month 4 of seizures, have been to emergency room several times, they finally increased my meds.  CT Scan and MRI normal.  Have to wait 3 months for extensive EEG that is now scheduled for Aug 3. No one will take me serious and I am sure you won't either but I have no idea what to do.  I am a mother of two small children I can barely care for now and I have a full time job.  Someone needs to help before this is life debilitating
Pt recvd vax & devel a h/a & nausea & vomiting approx 24 hrs p/vax/ sx lasted 36-48 hrs; h/a was mild to moderate & treated w/analgesics;
Received flu vaccine 11/3/04: 2pm. Later in the evening she had increased numbness of her extremities, burning, aching in every joint, chills, fever to 99 degrees. Unable to walk morning of 11/4/04. Patient had history of peripheral neuropathy since 1999. Had been in remission for 7 months: Jan 04 - Aug 04. No history diabetes mellitus. Has been tested for Guillain Barre Syndrome and Lupus, but not diagnosed. She has wheelchair and walker. Has been in wheelchair since 11/3/04. History of asthma. Allergist advised her to get the flu shot.
Headache; Fatigue; Chest pressure; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure). On 01-Feb-2021, HEADACHE (Headache), FATIGUE (Fatigue) and CHEST DISCOMFORT (Chest pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable. symptoms  got resolved after 4 days later for both doses after 14 - 15 days later of 2nd dose patient experiencing same symptoms again.
No adverse side effects were reported; TE for vaccines which was also administered to a patient; This spontaneous report was received from a medical assistant and refers to 18-month-old male patient. Information about the patient's medical history, concomitant medications and current conditions was not provided.  On 20-JUN-2023, the patient was vaccinated with improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (formulation pre-filled syringe, 0.5 mL, in right thigh, lot #W039033, expiration date 01-OCT-2024, route of administration was not provided) for prophylaxis (Product storage error).  The suspect vaccine experienced a temperature excursion of 49.1 degrees Fahrenheit (F) for 34 minutes and previous excursions of 35.9 F for 2 minutes and again 35.9 F for 2 minutes. No adverse side effects were reported with the administration of the vaccine. No additional adverse event (AE) information provided (No adverse event). No product quality complaint (PQC).
pt present not movement in body & in eyes & muscle became strong; dx was rxn for pertussis vax;
Swelling, pain, redness running down arm, chills, fever, temperature over 100 degrees, bruising on arm from elbow to shoulder
few days after receiving vaccine occipital headache, light/sound sensitivity, nausea, several days after receivng 3rd dose of gardicil vaccine headache, light and sound sensitivity,vomiting, diarrhea for 2 days,went to primary dr. nausea,vomiting and diarrhea stopped. headache,sound and light sensitivity increased. went to the hospital several times. spinal taps performed. increase spinal pressure relieved. pain decreased before returning. multiple treatments tried. multiple admissions. doctors aware of vaccine. 12/5/08 Reviewed PCP medical record which was essentially just vaccination record. 1/19/09 Reviewed hospital medical records of 9/28-10/3/2007. FINAL DX: chronic daily headache Records reveal patient had persistent occipital HA w/pain in eyes & had missed several days of school.  Initially HA was assoc w/nausea/vomiting & eye pain which began after swimming in ocean.  Had been seen previously & dx w/pseudotumor cerebri due to LP opening pressure of 200.  Tx w/multiple meds but HA worsened & admitted.  Tx w/antibiotic for UTI & multiple oral & IM/IV meds for HA w/minimal improvement.  Neuro exam was WNL.  Reviewed hospital medical recods of 12/10-12/15/2007. FINAL DX: none provided.  Narrative states atypical HA records reveal patient had drainage of spinal fluid approx 350cc.  In PICU for monitoring.  Had some improvement on meds & d/c to home.  Reviewed ER medical records of 4/4/2008. FINAL DX: difficulty walking Records reveal patient experienced difficulty walking, falls, continuing daily occipital HA w/photophobia.  Had been seen by multiple neurologists.  Ophthalmology exam previously WNL.  Now seen per neuro request for repeat LP which was done w/normal pressures.  Referred for neurophthalmogy.  Reviewed hospital medical records of 5/16-5/17/2008 FINAL DX: patent foramen ovale Records reveal patient experienced trivial amount of right to left shunting.
This spontaneous report was received from a female consumer of unknown age regarding herself. Patient's concurrent condition included psoriasis. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and route were not reported). On an unknown date, shortly after the patient received ZOSTAVAX, she developed rash on her body, both the front and back of the trunk, and on the front and back of her legs. On an unknown date the patient visited an unspecified dermatologist and the rash was considered "undefined". The outcome of rash on her body/rash on the front and back of her legs was unknown. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of herpes simplex in a 63-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes simplex and rash. On an unknown date, the outcome of the herpes simplex and rash were unknown. It was unknown if the reporter considered the herpes simplex and rash to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated that their patient developed a rash after SHINGRIX. They confirmed shingles at an urgent care facility, however when the patient went to saw their primary care doctor they stated that it was not Shingles. The healthcare professional stated it was an HSV1 rash.
Rapid heart rate 95 and 90 for two days following injection.  Site swelling and heat at injection site for 5 days.  Very fatigued first day.
No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA) (lot # T016990, which was verified to be a valid lot number, expiration date reported as 11-NOV-2021), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) for a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
p/vax T103.6 w/ear drainage MD called;rx for Augmentin w/diarrhea now;rx Pediazole not doing job;pt cranky & unlike self-rash over entire body by 7/8/99;
Fever; Chills; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12Jun2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin for unknown indication and experienced penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 22May2021 at 12:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN), nitrofurantoin (MACRODANTIN) and pethidine hydrochloride (DEMEROL), all for unknown indication and experienced drug allergy. 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 13Jun2021 at 08:00, the patient experienced fever, chills, muscle aches, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever, chills, muscle aches, fatigue was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist concerning a patient (age, gender unspecified) who thought the patient was vaccinated with a dose of MMR II or dose of MUMPSVAX II (pharmacist not certain what was administered or when) when the patient was a child (date and dose not reported). It was reported that the patient negative mumps titer (dates unspecified). The patient had had acceptable titers of measles and rubella. It is unknown if the patient sought medical attention. No other information reported. A product quality complaint was not involved. No additional information is expected.
Pt started feeling body aches, chills, sore throat and ear pain about three days after COVID 19 vaccine. Feeling better now in clinic on day 4. Pt does have acute otitis media in right ear.
The injection was given very high in the shoulder. The usual tenderness from an injection was there but progressed into pain moving the arm in certain directions over time. Progressively getting worse in a few days to which ADL were compromised. Reported this to my employer and had a Physical therapist evaluate and give exercise to do. I am a Physician assistant and I am going to see a MD at another clinic 11/11 19 as the pain and limitation has continued .
Blood pressure spike above normal.  Took multiple reads via an automated BP cuff/machine: 137/73 and 133/75 and 2 or 3 similar readings over ~ 2 hours.   Friday, 6/26 I checked BP and readings returned to normal range :  114/67, 117/75, 107/61.  Heart rate normal ~ 57 bpm.
A number of blisters of varying sizes on the left arm. Started out small the day after vaccination and grew in size. Left arm also sore to touch and swollen.
PREMATURE VENTRICULAR CONTRACTION; 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-APR-2021, the patient experienced premature ventricular contraction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of premature ventricular contraction was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the RA.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 23-OCT-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 39 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.
I started bleeding vaginally and having cramping on Tuesday morning. I got my 2nd COVID-19 vaccine on Monday morning. I was 5 weeks 5 days pregnant when I started bleeding. I was diagnosed with subchorionic hematoma in the ER. I also experienced bleeding on Thursday and Friday of that week.
The pt complained of rash over abdomen, back, face, neck and arms. Also some joint pain relieved with Tylenol. No fever. Rash is ongoing.
Info has been received from a physician concerning a 19 year old male, with no pertinent medical history reported and no drug reactions/allergies, who on 9/7/04 and 10/7/04 was vaccinated with 0.5 ml doses of varicella virus vaccine live. There was no concomitant medication. In 1/05, a titer was 0.48 ISR with less than 0.9 being negative. Outcome reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
dizzy and really light headed; Tired; dizzy and really light headed; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Aug2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Aug2021, the patient experienced dizzy and really lightheaded, tired. Reporter stated, my 13-year-old got her first shot today (Confirmed Pfizer COVID 19 vaccine) and she is like really dizzy and really lightheaded, Is that normal. Reporter stated, tired she said. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.