chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reports red, raised and blistery rash to his left abdomen and back. He denies pain, itching or draining from the site. The patient was prescribed Acyclovir as directed.
Systemic: Fainting / Unresponsive-Mild, Systemic: FAINTED RESPONSIVE-Mild, Additional Details: PATIENT FAINTED
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature. Orgainzation has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. No known adverse outcomes.
My adverse event is small to moderate generalized pericardial effusion, diagnosed with a 4/15/21 echo cardiogram. Cardiologist said it can go away on its own, so she performed another limited echo cardiogram on May 25; results showed pericardial effusion still present.  A 7/26/21 cardiac MRI confirmed I have an enlarged heart from the pericardial effusion. On 8/6/21 cardiologist began treating me with 90 days of Colchicine 0.2mg, tablet taken orally two times per day. I am 30 days into treatment. Cardiologist will perform a limited echo cardiogram on 9/7/21 to check pericardial effusion. IMPORTANT: Symptoms such as chest pain, dry cough, and reduced speed when walking for exercise were experienced back in 2020. 6/29/20 visit to the Emergency Room for chest pain, dry cough, and reduced endurance while walking for exercise ruled out heart attack, blood clot, pneumonia, but the emergency doctor believes my chest pain was muscular/skeletal in nature or inflammatory such as pericarditis or pleurisy. If I had this pericardial effusion on 6/29/20, that was well before my first COVID-19 vaccination on 1/27/21. I do not believe I have ever had COVID-19; however, I was sick with a respiratory illness and flu-like symptoms for two weeks while onboard ship during the period of 1/4/20 through 3/22/20, traveling. My symptoms were much like a cold, but I also had a low temperature, and the worst cough I have ever experienced.
took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine; took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blind in one eye" (unspecified if ongoing), notes: I am feeling sorrow and I am blind in one eye (History), I do not want to lose my other eyesight.". The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took two of the vaccine (Unspecified Vaccine); I have COVID; I did not trust the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I only took it last night because I started feeling bad again because I have COVID and the side effect is worse then the COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200974112 same patient, different product and event;
Bruise around injection 6 1/2 cm X 3 1/2 cm with swollen area around that measuring 8 1/2cm X 7 1/2cm. Pt reported pressure and slight itching.
This spontaneous report as received from a registered nurse refers to unknown number of patients unkonwn age and gender. On unknown date the patients were vaccinated with GARDASIL lot # J002641, expiration date: 10-DEC-2015 (strength, dosage, frequency and route unknown). There was temperature excursion during vaccine storage. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient received 0.2ml of the regular Pfizer vaccine instead of the Pfizer 0.2 ml.
headache on right side of head and sinus drain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to iv dye. Concomitant medications included acetylsalicylic acid (ASPRIN) used for unknown indication from unspecified dates, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 11:00 (at the age of 52-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 15:00, the patient experienced headache on right side of head and sinus drain. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache on right side of head and sinus drain was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
I was diagnosed with placenta previa about 3 months ago. I had a bleeding event so I was hospitalized on the 27th. I was discharged on the 30th of March (3 days). I had another bleeding event on April 16 and I was discharged today (4 days). No medications added.  Pregnancy history - I had a miscarriage in September 2020; this is my first full term pregnancy  (getting there)- June 25th, 2021. I will still be on disability and not working for at least a few weeks.
peeing every 2 hours; body aches; Chills; fever 99/100 °F; headache; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (peeing every 2 hours), PAIN (body aches), CHILLS (Chills), PYREXIA (fever 99/100 °F) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic kidney disease stage 3.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (peeing every 2 hours), PAIN (body aches), CHILLS (Chills), PYREXIA (fever 99/100 °F), HEADACHE (headache) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, POLLAKIURIA (peeing every 2 hours), PAIN (body aches), CHILLS (Chills), PYREXIA (fever 99/100 °F), HEADACHE (headache) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.            Concomitant medication Thyroids pills, Cholesterol pills, Blood pressure pills Treatment medications were not provided.
Given DT in left arm 7/7. Several days later noted numbness and tingling in arm to hand and up to neck which is now improving.
6cm x 10cm area of erythema on left anterior thigh (site of DTAP inj);
Developed slurred speech, jaw cramping, tongue fasciculations and weakness in my left hand 4 weeks after receiving my 2nd dose. Have been referred to the ALS clinic for further testing for Bulbar Onset ALS.
rash lasted approximately 3 weeks with each shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash lasted approximately 3 weeks with each shot) in a 69-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash lasted approximately 3 weeks with each shot). At the time of the report, RASH (rash lasted approximately 3 weeks with each shot) had resolved.            No concomitants were reported  No treatment was reported.   This case was linked to MOD-2021-005655  (Patient Link).
had the vacination-,had them afterwards /suspected vaccination failure; had them; rash; itches; This case was reported by a consumer  and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pruritus. The patient was treated with ethanol (Alcohol). On an unknown date, the outcome of the vaccination failure, shingles, rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, after the shot, had shingles, spine a rash and itching. The reporter stated that, after the shot not to bad about itches. The patient used alcohol to dried up. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with cases US2021AMR195007 and US2021AMR195008, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195007:same reporter
Patient is a 68 y.o. male here today for a nurse visit for a covid vaccine. Patient noted with complaint of pain on his left chest wall upon sitting down in observation room 3 seat C. BP 142/80 P 86 R 18 O2 99%, no complaint of SOB noted. Patient remarked that he had two stents in his heart.  First RN and Second RN  were made aware, patient was transferred to the ED at 5:12 pm.
o Musculoskeletal symptoms Pain in upper left arm at site of h1n1 shot that she received about 3 wks ago, with discomfort down the midaxillary line only on same side.  Feeling of swelling but not tingling, nor rash.  Lesions: induration of approximately 3 cm diameter size noted at site of recent injection in upper left arm.  ° General appearance was normal.  ° Texture was normal.  ° Turgor was normal.  ° Color and pigmentation were normal.  ° Moisture was normal.  ° Temperature was normal.  PLAN:  Trial Nsaids, ice more time.    Reporting to VAERS.    Pt will keep me posted.
Inflammation of sciatica, or something in left leg/hip. Painful to stand up and walk/stretch. Otherwise, reactions included 101 degree fever, chills, etc.
Patient states he felt a "head rush"  and then lost consciousness and fell out of his observation chair to the floor. Immediately had return of consciousness and sat up and returned to the chair. Observed and released to family and instructed patient to be taken to local Urgent care for evaluation. No obvious injuries from the fall.  Patient reported his back teeth felt jagged. VS were stable
Discoloration to the vagina & rectum, redness around the vagina.  Spreading spot over the body & vagina, rectum.  Uncomfort odor.  A lot of numbs in hands & arm the injection was place in.  Muscle ache, headache, weakness and nausea.  Abdominal pain.  Discomfort during monthly menstruation.
fatigue, fever (101.2), vertigo,   lasted all day, fine the next day
severe body and joint pain, 101.1 fever, chills, nausea  started approx 5 1/2 hours after injection.    Next morning, approx  20 hours after injection strong head ache in top of head and nausea.   30 hours after injection, all negative effects subsided.  48 hours after injection, normal function- no effects.
One week post injection I developed a rash a couple inches below where the injection was received that spread down my outer arm (to a little above my hand).  Within a few hours the same rash appeared on my other arm the same way.  I later realized it was also on my stomach and sides down to my upper thighs.  Those rashes were gone within 12 hours or so.  I did continue to get small rashes on my inner thighs and small rashes or itchy spots on my lower legs and ankles for a week or so.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt said she "felt weird" and fainted/passed out on floor for 5-10 seconds. Mom declined EMS. After laying on floor for a few seconds, pt said she felt better and stood up and was able to walk to chair to continue to lie down. Looked pale, but she said she felt fine. BP was 100/83mmHg, HR was 75 bpm. Patient said she felt completely fine and left with her mom after ~45 mins without issue. No further follow up needed.
Uterus fibroids; Vaginal bleeding; Soreness in arms and legs that never went away; Couldn't walk, shower get in and out of her car; Had trouble with basic movement; Bad belly pain around belly button area/Belly pain on and off for about week; Inflammation in back of both legs and knee area; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced INFLAMMATION (Inflammation in back of both legs and knee area). On 24-Jun-2021, the patient experienced ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week). In August 2021, the patient experienced PAIN IN EXTREMITY (Soreness in arms and legs that never went away), GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) and MOVEMENT DISORDER (Had trouble with basic movement). On an unknown date, the patient experienced UTERINE LEIOMYOMA (Uterus fibroids) and VAGINAL HAEMORRHAGE (Vaginal bleeding). The patient was treated with PREDNISONE on 12-Oct-2021 for Adverse event, at an unspecified dose and frequency and Surgery (DNC done on 30JUL2021) for Uterine leiomyoma. At the time of the report, UTERINE LEIOMYOMA (Uterus fibroids), VAGINAL HAEMORRHAGE (Vaginal bleeding), ABDOMINAL PAIN (Bad belly pain around belly button area/Belly pain on and off for about week), PAIN IN EXTREMITY (Soreness in arms and legs that never went away) and GAIT DISTURBANCE (Couldn't walk, shower get in and out of her car) outcome was unknown, INFLAMMATION (Inflammation in back of both legs and knee area) was resolving and MOVEMENT DISORDER (Had trouble with basic movement) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Uterus fibroids were found.         No other medications were provided.  The patient went to GYN but they said she was anomaly and found no issues. The patient started taking Prednisone on 12OCT2021 and started feeling a lot of better. It relieved the inflammation.
Two months in July I start to have joint pains. I am currently going to doctor to find the issue.
Injection area mid upper arm. Edema to injection area , discoloration,  2 inch circular demarcation, pain to local area, itchiness numbness and tingling to left hand during first 7 days. Day 8 hard mass at injection site, rash, discoloration still present. Itchiness still present. PO benadryl taken, topical benadryl applied when PO not taken. Minimal relief from benadryl.
client called this facility and stated that since she was administered her Td vaccination in the right deltoid on 3/27/09 she has had "pain off and on in the right arm and decreased range of motion to the point of 50% motion in arm". Client responded that there were no areas of swelling, redness, or itching in that arm. There was no palpable masses in right deltoid. Client advised to call primary care physician by this nurse and have her arm examined.
Patient received a dose of vaccine outside expiration window (thawed, refrigerated vaccine beyond 30 days-vaccine error). Error discovered 07/06.
Near-syncope - lightheaded, generalized weakness, thigh cramps beginning around 15' post vaccination Was placed supine, BP transiently elevated Pt transported to emergency dept. where he felt better, vitals normalized, observed In ED pt denied any focal weakness
Chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event chronic graft versus host disease and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 29-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # H020901, expiry date 05-JUL-2015) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On or around 02-MAY-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (date not further specified), the patient suffered acute respiratory failure, acute systolic congestive heart failure, shortness of breath, and pneumonia requiring admission into an intensive care unit. The patient was diagnosed with myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. As a direct and proximate result of these injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 27-MAR-2017. As a direct and proximate result of ZOSTAVAX, the patient suffered serous and dangerous side effects, including death, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The cause of death was considered to be myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia. Causality assessment was related. Upon internal review, myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia were considered to be medically significant events. The lawyer considered myocardial infarction, acute respiratory failure, acute systolic heart failure, and pneumonia to be disabling. Additional information has been requested.; Reported Cause(s) of Death: acute respiratory failure; myocardial infarction; pneumonia; acute systolic heart failure.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 (also reported as within the last week) on dose of improperly stored (Merck) VARIVAX injection (strength, dosage, route, lot number and expiration date were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Slight fatigue & chills with dizziness in the first 5 days, then developed a cough, followed my an extreme allergy infection like I've never had before.  The allergy infection was accompanied with extreme dizziness, nausea & vomiting.   I had to miss 3 weeks of work due to the daily vomiting due to dizziness/nausea.   I was given Prednisone and physical therapy for vestibular neuropathy.   After 3 weeks of PT, the dizziness is improving but no nausea/vomiting since May 26, 2021.   I am a Flight Attendant and have missed several weeks of work due to this reaction.  When I return to flying on June 15, 2021 if it triggers the symptoms again I will have to take Short Term Disability until the dizziness is under control.  The constant nausea & vomiting has been exhausting to say the least and caused slight depression initially.
symptoms: dizziness, diarrhea, mid epigastric pressure vitals : tachycardia, leukocytosis admitted for monitoring and IVF
Cellulitis pt had red, hard arm, very painful and unable to move arm the evening after he received the vaccine started on antibiotics 2 days later. Symptoms abated after 1st dose. Follow up with MD on day 4 symptoms resolved.
Right shoulder pain - Aug 6-8 2020. Self resolved.   tiredness/Sleepiness  - Aug 5-8, 2020. Self resolved.   Left chest pain - August 14 to present ? when I lay in bed to sleep ?mild to moderate.