chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From patient "Today I woke up and was feeling really weak, dizzy with double vision. The area has had a reaction with it being hot and swollen down to my elbow. I am also experiencing itching skin and I feel like I have a fever. I have taken some Benadryl for a headache and some ibuprofen for a fever. My arm feels numb down to the finger. My tongue and throat feels sore but I don't think it is swollen."  RN Assessment: Vitals: Pulse Ox 97% BP: 127/86 HR 98 Temp: 97.7  PERRLA No obvious signs of tongue or throat swelling Redness at site of injection  She initially had similar reaction to the 1st Varicella vaccine but it happened 2 weeks after receiving the shot. She states reaction started on 4/18/23 at 9:30pm as a general ache. She woke up on 4/19/23 with worse symptoms and took a benadryl and ibufrophen at 5am.  Currently, she c/o of itching all over. she states she has a headache, is feeling dizzy and has light sensitivity. Also states her tongue feels "floppy" and it feels strange when she swallows.   Patient was sent to clinic to be evaluated on 4/19/23 at 1:30pm.
BLOOD CLOTS; SOME PROBLEMS; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total, dose not reported, between March- 2021 and April- 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that patient had some problems after receiving the Covid 19 vaccine (1st shot), but did not knew what were those problems. On 09-JAN-2022, the patient went to the hospital. Laboratory data included: COVID-19 test (NR: not provided) Positive. The patient was currently in the hospital with 4 blood clots. The patient also experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some problems, had not recovered from covid-19 test positive, and blood clots, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000211275.; Sender's Comments: V0.20220118491-covid-19 vaccine ad26.cov2.s -Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220118491-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
PATIENT HAS BEEN HAVING 4-6 LOOSE WATERY STOOLS DAILY SINCE VACCINATIONS.  TODAY IS 10TH DAY
Approx. 30 min after receiving H1N1 FLUMIST child stated he was having trouble breathing and his muscles hurt. Vital signs were okay. Father of child was called and fa. stated he did not mark on the consent form that child had asthma as he did not think it was important. Father indicated he felt the child reacted to floor cleaner that was being used to clean the hallway near where the H1N1 FLUMIST was being administered. Father stated in a ph call from nurse later that once child was removed from the school the child started feeling better so the father did not seek medical treatment.
Two years ago 12/1998 pt received the chicken pox vaccination. The next day he became very lethargic, developed a rash all over his body and developed a fever 103-105. He had convulsions at the doctor's office. Motrin was administered by a nurse. He had no cold nor developed any cold or flu or virus. Pt recently had a febrile seizure which made mother recall the 12/1998 febrile seizure, although this time his diagnosis was an ear infection.
Headache, joint aches (back, hip, general), pain at injection site.  Treated with acetaminophen and abated.
metabolic acidosis; failure to thrive; developmental delay; feeding difficulties; lactic acidosis; acute cardiopulmonary failure; Information has been downloaded from regulatory authority(HQWYE953231AUG07)  This spontaneous report was received from an other healthcare professional, regarding a 2-month-old male patient. The patient's concurrent condition included congenital anomaly. The patient's historical conditions, past drugs and concomitant medications were not reported. On 23-AUG-2007, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX); the lot/batch number, expiration date and route were unknown for both the products, pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (batch/lot number B53981A; expiry date not reported) via intramuscular route and received all three vaccines received at a dose of one dosage form for immunization. On 25-AUG-2007, 3 days after onset of therapy the patient experienced metabolic acidosis, failure to thrive, developmental delay, feeding difficulties (poor feeding infant), lactic acidosis and acute cardiopulmonary failure (cardiopulmonary failure) and was hospitalized due to the events and on same day, the patient died. The cause of death was reported as lactic acidosis, cardiopulmonary failure and metabolic acidosis. The outcome of the events failure to thrive, poor feeding infant and developmental delay was reported as unknown. Autopsy was not performed. The relatedness between the events and the suspect therapy was not reported.; Reported Cause(s) of Death: Lactic acidosis; Metabolic acidosis; Cardiopulmonary failure
Hospital Principal Problem (Discharge Diagnoses): Suicidal ideation   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis ? Principal Problem: Suicidal ideation ? COVID-19     Assessment & Plan Note:     Post Pfizer vaccination for COVID 3/12 and 4/2 Test positive by PCR 6/4 This likely reflects either an asymptomatic infection or at worst a mild one She is currently asymptomatic and does not fit criteria for COVID therapy Would maintain isolation for now ×10 days out of caution Your supportive care No further ID recommendations, please contact if clinical situation warrants   ? Electrolyte imbalance ? Alcohol withdrawal syndrome with perceptual disturbance ? Bipolar 1 disorder     Overview Note:     This patient with a history of bipolar illness and alcohol abuse presents in a manic state. She appears to be still intoxicated and has very poor judgment as she is trying to leave.   ? Hypertension ? Chronic back pain   Resolved Hospital Problems No resolved problems to display.   Consultants:   Provider HCP From To    MD Consulting Physician  Psychiatry 06/05/21 1156 ?    DO Consulting Physician  Infectious Disease 06/05/21 0227 06/05/21 1352 DO Consulting Physician  Family Medicine 06/05/21 0138 ?     Procedures Performed: none   Pending Tests at Discharge    Order Current Status   Drugs of Abuse with Confirmation, Urine Preliminary result     Evaluation on Day of Discharge: Yes.   Hospital Course:  60 yrs old female admitted with suicidal ideation and positive covid test, she has stable respiratory status, cleared by psych service to be dc home  Pt informed to quarantined for total of 10 days
Face, arms, trunk, legs - red, flushed - anaphylactic reaction - airway tight - used EPI-PEN - treated in ED.
I developed a pain in my back on the right side.  Then developed a rash on Wednesday, Sept 15. I was then given an antiviral by my dr for the shingles that had developed.
Patient reports redness at injection site R arm, denies fever, chills.  reports pain 3/0 .  Right arm, deltoid are with redness measuring 130 cm length no cm width.  Warm to touch, no edema noted, no open areas.  Patient afebrile temp 97.6.  Patient reports improvement since yesterday.  NP in to see patient.  Instructed to apply compress, tylenol for pain,   if Sx worsen.
Hands and feet numb and tingling, back pain from my back all the way down my left leg, tremors in my body, weakness, difficulty walking - medicine by mouth, and all of the things in box 12.
Been in a lot of pain/body aches; joints hurt; This is a spontaneous report received from a contactable consumer (patient himself) via Pfizer sponsored program via Medical Information Team. A 50-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history included COVID-19 in 2020. The concomitant medications were not reported. In 2020 patient had Covid-19, then this year he had both of vaccine shots. About 3 weeks after second vaccine he had been in a lot of pain. All of his joints hurted and things were getting difficult. Now he know at 50 your body aches but had never had so many places hurt at one time. The only thing can think of was a possible side effect after having Covid prior to vaccines. He was not blaming anyone on anything. He just wanted to know if we have heard this before, and anything that might help. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): AE-010766 (Biontech).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (ongoing). Concomitant medication(s) included: NEEM taken for supplementation therapy. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches".  Additional information: The reporter (patient) is a scleroderma patient in PRIVACY CITY and wanted to report marked improvement he/she had by taking Neem supplements while getting Pfizer vaccine shots every few weeks. He/she observed decrease in inflammation and clearing of the skin, with slow, gradual disappearance of hard patches. It seems that the vaccine induces some processes which make Neem work on the pathogen causing it. The synergy effect only lasts for 15 days, with sharp drop-off thereafter. His/her rheuma docotor said that it's very interesting and didn't want him/her to take any systemic drugs. Instead, the doctor wants to continue doing this thing, though it's getting harder as no boosters are authorized.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, muscle pain, chills for 5+ days Vivid nightmares on the evening of vaccination
Runny nose; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included citalopram hydrobromide (CELEXA). The patient experienced runny nose on 29Jan2021 08:00. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering.   Information on the lot/batch number has been requested.
Pt recvd DTP/HIB/OPV & exp high pitched crying, redness & warmth @ inject site immediately p/immun lasted 15 mins;
This spontaneous report as received from a consumer via a company representative refers to a patient of unkonwn age and gender, who was related in an unspecified way to the reporter. Information regarding concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not provided) that was expired by 1 day. The lot# and expiration date were unspecified. No known adverse effects was reported. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning to a 73 year old male patient. The patient had no illness at time of vaccination. No pre-existing physician-diagnosed allergies, birth defects, or medical conditions were reported. The Pharmacist reported that on 15-SEP-2015, the patient received a first dose of ZOSTAVAX (strength, dose, route, lot and expiration date not provided). On 27-OCT-2017 the patient was vaccinated with a second dose of ZOSTAVAX (subcutaneously, in the left arm, lot # N025565, expiration date 21-DEC-2018) for prophylaxis.  On the same date, the patient also received a dose of PREVENAR (intramuscularly, in the left arm, lot # S58702). No other concomitant medications were reported. The Pharmacist said that he was administering the ZOSTAVAX and explained that the patient might experience redness or swelling at the injection site, and at that point, the patient said it did not bother him "last time". Then, the Pharmacist finished the vaccine administration and checked the Immunization Registry (IR) and saw the patient had had a previous dose in 2015 at another pharmacy.The patient experienced no adverse event/reactions. Prescription drug treatment was not required. The patient's outcome was reported as "recovered".
Very sore arm immediately following hot, right rah that stayed for twenty minutes the rash did not recur the sore arm continued for a couple of weeks, developed a fever around 11:00pm the day f the shot fever temp was 101 F had a heart rate over 100 racing heart all night the fever came and went 36 hours after the shot the fever went down to 99 F, fever went away three days later, was very nauseated and fatigue for about a  week, had a very sore ball at left foot was swollen couldn't put weight on my foot and could barely walk went away a week later then later resolved and also had morning stiffness in elbow that still is recurring
Ongoing sporadic nausea, bloating, stomach cramps.   Severe fatigue.  Noticed left side supraclavicular node swollen to 2 cm a few days after vaccination--no change so far.  Continued feeling of pressure, heartburn or chest pain.
Critically low sodium (117) and spike in high blood pressure 200/110.  Spent 5 days in hospital to control the sodium and changed blood pressure medication to bring BP down.
First Skin itching (migrating itching, no visible hives); Then Dizziness and Lung Congestion.  I immediately took my Asthma inhaler (albuterol) and took Benadryl and Guifenesen.  The reaction ran it's course, got better, and I slept most of the day.
arm was Itchy; arm was blotchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm was Itchy) and RASH (arm was blotchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Obesity.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (arm was Itchy) and RASH (arm was blotchy). At the time of the report, PRURITUS (arm was Itchy) and RASH (arm was blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
In less than 15 min after vaccine given child's face and eyelids became red and swollen. No swelling of lips or tongue. No itching to his throat. No trouble swallowing. No respiratory difficulties. Dr notified. 5mg BENADRYL given. Symptoms began to resolve within 10 minutes of BENADRYL. Monitored child in office for over 30 minutes after the BENADRYL was given. Father was advised to continue the BENADRYL every 6 hrs for the next 24hrs. Child did go to Urgent Care about 5 pm later that night after his face began to swell and redness returned. Parents had not given the BENADRYL at 3:30pm on 10/7/17 as instructed. BENADRYL given in the urgent care and symptoms resolved. Child monitored in the Urgent Care and he was discharged home with parents and instructions to give the BENADRYL every 6 hrs for next 24hrs. Dr did call the home and left message on identified voice mail reinforcing the need to give the BENARYL. Dr also sent the office encounter from 10/7/2017 to the allergist.
This spontaneous report as received from a physician via company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had six temperature excursion of 29 F (-1.6 Celsius Degrees) for 256 hours, 34 F (1.1 Celsius Degrees) for 88 hours, 33 F (0.5 Celsius Degrees) for 168, 32 F (0 Celsius Degrees) for 288 hours, 31 F (-0.5 Celsius Degrees) for 360 hours and 30 F (-1.1 Celsius Degrees) for 264 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". This is one several cases from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 5 yr old Hispanic female who was vaccinated IM with a dose of varicella virus vaccine live. The reporter indicated that the pt was vaccinated in a clinic and then last week on approx 24Mar05, experienced breakthrough chickenpox with greater than 50 lesions. The reporter indicated that it did not last as long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health dept.
Patient presented to provider on 10/15/2015 with round, red, raised, rough, warm to touch rash approximately 4 inches in diameter at the injection site.
At 1045am, c/o tingling in lips and mouth. Gave Benadryl 25mg PO at 1048am and contacted Dr. Started shaking at 1050am. At 1100am, no tingling in lips. At 1110am, shaking stopped. At 1116, c/o tingling in throat and right hand swelling. EMS called to assess. At 1120am, monitored by EMS. At 1140am, left site feeling better. Instructed not to schedule second dose at drive through setting and to contact PCP for further recommendations. Instructed to take another Benadryl at home or go to ER for any further reactions. Also instructed to keep Epi-Pen at all times.
Since 09/28/2021 I have felt extremely tired. My body has been aching and I constantly have the chills. After I received the vaccine on Monday 09/27/2021 I was in bed for 3 days and could not get up to do anything. The fourth and fifth day I was extremely fatigued after I tried to do any simple activity like wash dishes or cook. My legs feel extremely heavy and my feet hurt and feel hot all the time. I am an active person and I have never been so fatigued and tired. Headache lasted for 4 days and got better with Motrin.
had symptoms on 16May2022; tested positive on 18May2022; had symptoms on 16May2022; tested positive on 18May2022; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 06Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unknown if ongoing); "AFib" (unknown if ongoing). Concomitant medication(s) included: METOPROLOL MYLAN [METOPROLOL SUCCINATE]; XARELTO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "had symptoms on 16May2022; tested positive on 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive, notes: he patient did a self test of the COVID test on 18May; (23May2022) positive, notes: done by a laboratory on 23May of this year. Clinical information: The patient had COVID booster on 30Apr2022, received a message from (Pharmacy name) 21May2022 that booster was ineffective. She left for a cruise to the (Place) on 12May2022 and had symptoms on 16May2022, tested positive on 18May2022. Had she not received the booster, she would have been ineligible to board the ship as (Country) Cruise Lines requires vaccine no more than 270 days. Passport was confiscated in the (Country). It was asked what was Pfizer's explanation for ineffective booster. The patient like to know how this happened and what Pfizer has do about it because the patient got COVID, while she was on ship. The patient did a self test of the COVID test on 18May and it was positive and it was done by a laboratory on 23May of this year (Date not clarified) and it was positive COVID so the only test I have recently.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Drug ineffective and Covid 19, cannot be completely excluded.
arm discomfort day of vax;itching that arm evening (12hr) p/vax; gen hives 48hr p/vax; also dx w/acute OM;