chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a ,93 y.o. female known to have a background history of coronary disease, CHF, chronic kidney disease, dementia,, hypertension, paroxysmal atrial fibrillation presented on 2/15/2022 with    Urinary retention-patient presented to the emergency room as she was unable to pass urine from yesterday and subsequently she developed abdominal discomfort mainly in suprapubic area. She was brought to the emergency room and then subsequently she was able to pass urine but not significantly and her creatinine got more worse than her baseline. Also tells me that she was not able to eat and drink properly from last couple of days. No active vomiting at present. Evaluation in the emergency room found to be positive for ascites, incidental pancreatic and renal cysts. Denies any fever or acute shortness of breath or body aches. Patient is vaccinated as per database. Tested positive for coronavirus infection while getting admitted. Denies sick contacts. Caretaker tells me that she did not get out of the home after her discharge previously from this facility and this is the first time she is getting out of her home. Will be admitted for further evaluation"   Hospital Course:   The patient was admitted to the hospital and was evaluated and treated per below.     * Acute cystitis without hematuria Description of the Problem/Progression: acute. ESBL Plan:  - cefepime -> merrem x7 days  (finished course) - ID following.     C diff colitis -Diarrhea worsened. Increased by mouth vancomycin dose per ID -Flagyl was added and symptoms improved.  -Continue to monitor symptoms, supportive care.   Placement. SNF will accept 10 days from initial +, tentatively the 25th. Social workers following   aki on ckd 3b. Ascites on imaging. Creat 1.8 today, stable  - nephrology following, continue IVF's   Covid-19. On baseline O2 - uses 2L intermittently at home. Same here.  - Cxr with possible mild infiltrate. Remdesivir x3 days completed. Pt high risk (age, cad, did not have booster) - supplements per COVID-19 order set.    Metabolic encephalopathy due to uti - treatment above - resolved symptoms.
I have had a fever on and off for 8 days since the second shot. It comes and goes but I can't shake being sick.; I have had a fever on and off for 8 days since the second shot. It comes and goes but I cant shake being sick.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 27Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient previously had taken apple skins and Debrox from unknown date to unknown date for unknown indication. Concomitant medications taken within two weeks prior to vaccination included cetirizine hydrochloride (ZYRTEC), escitalopram oxalate (LEXAPRO) and montelukast sodium (SINGULAIR) started on unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 22:00, the patient had a fever on and off for 8 days since the second shot. It came and went but he could not shake being sick. The event resulted in doctor or other healthcare professional office/clinic visit. On 05May2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event fever and being sick was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
CONVULSIONS/SEIZURES:  HEAD TILTED AND LOCKED TO BACK(LOOKING UP) WITH EYES LOCKED TO TOP WITH WHITE OF EYES SHOWING.  EYES TENDED TO LOOK FOR LIGHT (LIGHTBULBS AT HOME).  LENGHT:  1-3 MINUTES OCCURRING APPROX. 5-15 MIN. IN BETWEEN.  VACCINATIONS GIVEN ON 10-28-04 AT APPROX. 1000 HOURS.  THREE SHOTS: REQUIRED AT 4 MONTHS OLD.  DOSAGE NOT MENTIONED BY DOCTOR'S PERSONNEL OR DOCTOR.  BABY ALSO TAKING (GENERIC-METOCLOPRAMIDE)/REGLAN 5MG/5ML SYP ON SAME DAY OF VACCINATION.  DOSAGE:  .5 ML BY MOUTH 3 TIMES A DAY. BABY WAS HOSPITALIZED, AS ORDERED BY DR. PARENT NOTICED THAT DR. LOOKED AT PATIENTS CHART(RECORD) AND IMMEDIATELY ADVISED PARENT THAT REGLAN CAUSED SEIZURES IN PATIENTS BEFORE. PARENT ASKS DOCTOR IF THE COMBINATION OF REGLAN AND THE VACCINES (DPT) CAUSED THIS SEIZURE/CONVULSION REACTION AND DR. DID NOT ANSWER. CHILD STILL HOSPITALIZED. PARENTS ATTEMPT SEVERAL TIMES TO ASK DR.(S) IF THE VACCINES PLAY A ROLE AND DR.(S) DO NOT ANSWER PARENTS.  PLEASE HELP IN THIS MATTER.  WOULD DR.(S) REPORT THIS INCIDENT TO YOU BECAUSE IT RELATED TO VACCINES AND REGLAN AT THE SAME TIME? Follow up on 11/12/04 states: "Father of pt states baby took Reglan for 1 week at age 6 weeks for spitting up. When the spitting up recurred at 4 months when baby was placed on original type of formula, parents gave 2 doses of Reglan only. These were at 9AM and 3PM on 10/28/04.  The date of vaccination. Discharge Summary received on 1/25/2005 states Seizure confirmed. Other diagnoses were fever, resolved, dystonic reaction to Reglan, GERD, hyponatremia, resolved.
Allergic reaction at injection site seven days after injection.  Round welt approx. 1" dia.  Extreme itching at site.  Administered Benedryl to relieve itch. Disappeared in four days.
Since receiving 2nd moderna vaccine, I have experienced irregular, painful periods and monthly reoccurrences of cold sores. I usually get 1, maybe cold sores each year x15 yrs but literally can?t get rid of them.
Papules/Macules scattered, Dx: chicken pox post vaccination, Tx: Atarax, Bactroban.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Twitching of one side of the face pale and lasted for about 3 minutes according to the mother. 5/23/06 Received hospital medical records which reveal pt admitted 3/24/06 w/dx partial seizures & d/c 3/27/06.  2 episodes of left side facial twitching/drooling/staring approx 20 s/p DTP booster witnessed by PCP.  Continued to have left facial twitching despite medication.  CT & MRI were neg except for almost complete opacification of max/ethmoid air cells bilaterally.  WBC 22.6 on admit. Had been hospitalized 1 week prior to vax for high fever but all tests neg.  Referred to neurologist for f/u after d/c/ss
During vaccine clinic power hour, I was called to come out of the exam room to the waiting area PCT for someone having a reaction. Upon arrival to waiting area I found her slumped over in a chair. I immediately assessed her pulse and was in the 50-60 range. Pt was pale and not responding. called 911.Pt was breathing. Due to pt size and weight I was not able to safely get her the floor to elevate her legs. After a few minutes pt did wake up. She says that she is diabetic and has not checked her sugar since this morning. Pt then passed backed out. I checked her sugar and it was 175. At that time EMS had arrived and checked her BP. Paramedic stated it was 90-palp. Pt was waking back up and they did get her on the cart and transported her to the ER.
Expired vaccine administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 14 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment : This case concerns a 20-year-old, male patient, with no relevant medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.; Sender's Comments: This case concerns a 20-year-old, male patient, with no relevant medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
my eyes are watering; severe allergic reaction; eye issue started on the corner of the left eye/spread to both eyes; itching eyes/itchiness; irritation eyes / irritation of my eyes; inflammation/inflammation around the eyes; This spontaneous case was reported by a non-health professional and describes the occurrence of OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes) and EYE INFLAMMATION (inflammation/inflammation around the eyes). On an unknown date, the patient experienced LACRIMATION INCREASED (my eyes are watering) and HYPERSENSITIVITY (severe allergic reaction). The patient was treated with FLUOROMETHOLONE (ophthalmic) for Eye inflammation and Itching eyes, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) had not resolved and HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.            Patient reported that eye issue was a mild problem but now it is an acute problem. He is waiting to get the topical steroid ointment. Patient booster shot is schedule for the 15-DEC-2021. No relevant concomitant medications were reported.
Mom states that child had shots 06/22/01.  Rash appeared 06/24/2001 states rash comes and goes- child itches a lot.  Seen in clinic 06/25/01- 3pm rash noted on face and trunk - child states he itches a lot.  Seen by Dr- mom states he has an appointment in one week.
Pt recd Varicella vaccine on 3/13/07 during well child clinic. Rash developed to neck, hairline, torso and underarms with fever on 3/14/07. Mother reports no fever prior to this. Mother states she feels child exposed to Varicella prior to receiving the vaccine. No other problems reported.
Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lung Cancer" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Patient received 2 COVID shots. Patient  feel that after the two weeks of tiredness following the second vaccine that patients breathing has improved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Anaphylaxic reaction. Throat started closing up, hives on my arms. 1105 50mg benadryl IM. 1120 went to the ER.  There I received Decadron and Benadryl IV push. Left the ER around 1400, with prescriptions for a Medrol dose pack, which I took for one week.
COVID-19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following morning woke up very dizzy, couldn't lift my head up and get out of bed, slight blurry vision
It made my Anxiety worse so much that I ended up at the doctor's office. He changed my medication, now I am on 3 different medication. I am not employed anymore due to the Anxiety.   I still continue to take Celexa and he added Trazodone and a generic for Xanax.
Hives; Itchiness; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration from 04Jan2021 to 04Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing prediabetic and hyperlipidemia. Concomitant medication included metformin for prediabetic and pravastatin for hyperlipidemia; both ongoing. The nurse reports that the patient developed hives and itchiness 48 hours after the administration of the first dose. The patient received Benadryl and it is getting better with Benadryl. The outcome of the events was recovering.
8 days after injection, I developed an itchy red and warm rash about 2 inches in diameter at injection site. I had no reaction other than soreness before this time.NOne
The patient developed shoulder pain shortly after the vaccine administration. He was prescribed indomethacin on 10/20/18 and then naproxen on 10/25/18. He stated his prescriber thinks the vaccine was administered too high and caused some tendonitis. He is being treated with NSAIDS.
pt was given injection in right arm and she started feeling sore and woke up this morning with a swollen red arm
This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date after two weeks after administration of ZOSTAVAX, the patient experienced itching at the injection site. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-05-12.
Slightly raised, slightly itchy red rash fading to tiny bumps on both sides of neck and left top of chest.
Received TDAP on 5/10/06. On 5/13/06, a localized reaction. Was seen in ER c/o itching, pain, redness and swelling. On 5/15/06, seen at follow-up with persistent sympotoms, increased pain on movement of arm. Red and indurated area 7.5 cm in diameter also 15cm area of redness and heat.
The injection site was swollen, red, hot, had small blisters and very painful. On 9/7/19 I saw  Dr. at Urgent Care. I was diagnosed with Shingles in that area only and prescribed Acyclovir, Amoxicillin, Doxycycline Monohydrate. As of 9/10/19 the blisters had dried up and the other symptoms had dissipated. The area is healed but the skin is darker.
Myalgia, Fever, chills Narrative:  symptoms lasted 2 days  Other Relevant History:
Initial unsolicited report received from a Physician on 27 August 2016. This case involves a 18 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, site of administration was not reported) intramuscularly on 24 August 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 24 August 2016, within 30 minutes following vaccination, patient became ill, patient had developed fever of 102-103 Fahrenheit, severe nausea, vomiting and abdominal pain that comes and goes. Patient was seen in emergency room for three times for these symptoms and on the third time patient was admitted. Lab data included white blood cells was within normal limits. The patient received corrective treatment with IV fluids and medications (unspecified) to ease nausea vomiting. The patient was recovering from events. List of documents held by sender: none. Sender's Comments: Abdominal pain and severe nausea are unlisted with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but fever of 102-103F and vomiting is listed. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Information has been received from a physician concerning a 26 month old female patient who was vaccinated with a dose of MMR II vaccine and the patient had a mumps antibody titer that was negative for mumps. The patient's mother asked if mumps virus vaccine live (unspecified) was available through the physician's office since the patient had a titter negative for mumps. There was no additional information because the vaccines were administered elsewhere and the child was not a patient at the physician's office. No product quality complaint was involved. No further information is available.
This spontaneous report was received from a Nurse refers to a 14 month old patient. The nurse reported that on 28-MAR-2014, the patient was supposed to receive TDAP and was inadvertently vaccinated a dose of GARDASIL (0.5 ml intramuscular). No adverse effects were reported. No further information provided. Additional information has been requested.
The night of my vaccine date (6 hours after) I was fatigued and started a fever with chills and acheyness which kept me in bed all night. I got up to shower and get some food as I was going upstairs I grew very faint,  my vision grew black and my hearing faded. I was able to make it to my bed then ask for some help. After taking Tylenol, my fever began to be very hot instead of chills. I was able to fall asleep until I woke back up to chills again and taking more medicine.  The next morning, I was still dizzy when I walked around but the fever was gone. I was still very fatigued which made me unable to go to class or work. Day 3 I was back to my normal self.
Soft tissue swelling, erythema, induration in upper right arm each compassing an area apprx. 10cm x 12cm. Pain in upper arm, shoulder and upper back. loss of normal range of motion. Symptoms of pain with injection. reaction as above in 2 hours.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-09-25.
Delayed reaction -- EIGHT DAYS AFTER my innoculation, I developed some swelling and itching in my upper left arm around the injection site. The area is oval shaped, about 2 by 3 inches, and the skin is pink. The swelling and itching have abated somewhat in the last 36 hours but not disappeared completely. I have twice applied ice to the area briefly, but have taken nothing else for the swelling and itching. I had no other reaction to the shot except slight soreness only the day after the shot. I find it strange that this swelling & itching arose so much later (8 days).
From a telephone contact received on 09/03/2002, it was reported that a 16 year old female received one dose of TD ADS ADULT vaccine (Lot # U0529AA) in the left deltoid on 08/30/2002.  The patient presented at the MD office on 09/01/2002 with a 4 cm circular area of erythema, induration, swollen, hot and tender to touch.  The MD diagnosed it as cellulitis.  No other symptoms were reported.  The date of prior booster is not known at this time.  See case U2002-00702 with the same reporter.
pt recv vax 21FEB96 & 11APR96 & lab eval determined that pt failed to seroconvert;
p/recv vax pt devel erythematous rash, some edema to joint area, warm to touch. pt won't lift arm above mid chest.
Approximately 3-5 mins after administration the patient stated he felt like he was going to pass out. He became dizzy, sweaty and stated  he couldn't hear as well as before getting the vaccine. Pt remained seated the entire time and never loss consciousness.  Vitals at 1835: 02=100%  BP=107/53  RR=18   HR=53   At approximately 1840 he stated feeling better and his symptoms resolved completely a few mins afterward.  Vitals at 1840:  02= 100%   BP=117/72   RR=20   HR=57.  Pt stood up slowly after last set of vitals were taken and left the vaccine site at approximately 1845 with no signs or symptoms of distress or complication from the reaction.