chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms began Saturday late morning - shortness of breath, throat felt closed by Sunday shortness of breath got much worse, had to yawn to get air or sit and breath through my nose. I used an 90 MCG Inhaler (that I had from a year and a half ago).  That was not helping enough.  My primary care  called in a prescription for Flovent HFA 110mcg (2 puffs X 2 a day). That and the Pro Air kept me from going to the emergency (just barely) Sunday night - nasal congestion and mucus in throat.   Added Flonase  and a few days later Mucinex. by 2/9/21 sore throat and swollen (lymph nodes), especially on left side 3/3/21 breathing is finally improving still have swollen area in neck, though it is much better. I did not get my scheduled 2nd dose
patient reports shortness of breath and racing heart episodes that began on 4/12/21 and persist until today (4/15/21) the day of reporting.
nausea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient developed nausea after receiving the first dose of the vaccine which lasted for a day. The next day he was asymptomatic. The outcome of the event was recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) in a 55-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
patient began sweating profusely, shaking, vomiting and eventually fainted. She was only out a few moments then recovered fully.
Pt. states she received injection in (L) arm. Didn't hurt when she got it but had pain in (L) shoulder by the end of the day. States by that time it hurt to lift her arm. States symptoms lasted 1 1/2 days then resolved.
Hives. all over his body. not itchy no fever. Received Benadryl liquid 1/2 tsp p.o every 6 hours.
Initial report received from a healthcare professional on 29 JULY 2013. A 22-year old female patient had received an intramuscular dose 2 of ADACEL  (batch number: U4426AA) in left deltoid on 22 JULY 2013. The patient had no illness at the time of vaccination and had a history of PCN (penicillin) allergy. Concomitant medications were not reported. The patient had received first dose of ADACEL (lot number, route and site of vacinnation was not reported) on an unspecified date in 2009 previously. The patient's health during pregnancy and specific risk factors were not reported. Patient had not received any treatment for infertility. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 JANUARY 2013. The estimated date of delivery was 12 OCTOBER 2013. On 22 JULY 2013 after vaccination, the patient developed throbbing from the left shoulder to fingers and the conditioned worsened at night and the patient felt numbness in the left fingers. There was no redness or swelling at the injection site and no other symptoms were reported. Laboratory investigations and corrective treatment was not reported. At the time of this report, patient had not recovered from the events. Documents held by sender: none
Patient received pneumovax vaccine on 8/20/13 L upper arm 15:57 PM. On 8/21/13, the left arm from the deltoid to the left antecubital area was reddened and warm. The patient complained of soreness. Patient was placed on Keflex 500 mg po every 6 hours starting 8/21 at 13:00 PM.
This spontaneous report as received from a other health professional refers to a 9 year old female patient. No pertinent medical history and no drug reaction/allergies. On 15-NOV-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular ("without any issues"). On 16-DEC-2013 the patient was vaccinated with GARDASIL lot # J008423 dose 2, 0.5 ml, intramuscular. No concomitant medication. At an unknown date, post administration of second dose, the patient developed a cough. The nurse stated that the patient had a fever of 100F and the cough became "non productive". The nurse stated that the grandmother tried unspecified cough medicine at home. The nurse stated the patient is now in office with unspecified physician diagnosing condition as "atypical pneumonia". A chest X ray was performed, but the result was not specified. The outcome of atypical pneumonia is unknown. The causal relationship was not provided. Additional information has been requested.
5 minutes after vaccine administration pt. complained of dizziness, nausea, pt was sweaty and pal. Called emergency service. Pt was taken to hospital.
Twenty minutes after recieving tetanus injection, she became dizzy, lightheaded and experienced loss os conc for 5 secs.
Patient was administer 0.3 mL of undiluted Pfizer Vaccine.  Pt. offered MD exam to include EKG and troponin levels with follow up.  Pt complains of sore arm.
swelling of 2 fingers and pain in the arm.  given prednisone and gabapentin by md and has improved.
pt recv vax 17JUL96 & 11hr later fever 106 & sz-fever another 24hrs;now fine;
This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (subcutaneous). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown. Additional information: BOOSTRIX admin to a 300lb man with a 1 inch needle instead of 1.5 inch needle. Reporting PharmD thinks it may have gone into fatty tissue and not IM. No lot/exp date available, and no further patient specific details available.
smelling bad smells/everything smelled bad 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; breasts felt like on fire 24 hrs; muscle/bone pain left forearm and right left thigh in back of leg.; Headache 2 days; very tired 4 days; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient (patient was not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208 and expiration date was not reported), via unspecified route of administration in left arm on unspecified date in Feb2021 at 12:00 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unspecified date in Feb2021 at 12:00 PM patient experienced headache 2 days, very tired 4 days, smelling bad smells, everything smelled bad 24 hrs, breasts felt like on fire 24 hrs, muscle/bone pain left forearm and right left thigh in back of leg. The patient did not receive any other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not test COVID prior and post vaccination. The outcome of the patient events was recovered on an unspecified date in 2021.
severe headache, fever of 101.2, shaking from the chills, sluggish, nurse came to take blood and when she was taking the blood he had blood clots
The day after the vaccine, the patient states she suddenly became very dizziness, to the point she could not move then once that passed she felt a tingling from her elbow to her index finger on the left arm.  It did not last long, the next day she noticed in in the pinky, and is still having slight numbness in the hand on the pinky side.
None. Was told to report H1N1 LAIV intranasal vaccine given to patient. Patient HIV (+).
Injection administered IM to R deltoid on 1/23/2023. Injection site reaction occurred shortly after administration (48 hours) and spread around 72 hours post-administration to a greater area of the upper arm, estimated 6 inch diameter. Injection site was firm, erythematous over a large portion of upper arm, with some clearing between the injection site and outer edges of the lesion. The lesion began to clear another 24 hours after to a small size, around 2 inch diameter. She came into the clinic for in person assessment today and the injection site remains firm, warm to touch, and erythema is greatly improved. There is R axillary adenopathy, and the patient reported rhinorrhea, cough, fatigue, and malaise during this episode. Her symptoms improved with Tylenol and she appeared well with a normal exam other than the injection site and lymphadenopathy of the right axilla. NO additional treatment was recommended and patient will continue to monitor.
Hives to trunk and extremities 12-26-09. Treated w/BENADRYL and prednisone taper.
3/23/04 mother reported T- 100.8 axillary (4:00 am).
This spontaneous report was received from a nurse concerning an 8 weeks old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strength, dosage schedule, anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111.
Experienced ulcerative colitis starting 2/5/14, about 2 months after receiving vaccine.
Chest pain and pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in left arm, on 01Mar2021 at 11:30 AM (at the age of 73 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), stent, and allergies to penicillin (possibly). The patient's concomitant medications included atorvastatin, ezetimibe (ZETIA), metoprolol tartrate, and ergocalciferol (VIT D). No other vaccine was administered in four weeks. On 02Mar2021 at 07:00 AM, the patient experienced chest pain and pressure. No treatment was administered for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults > or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject's outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject's death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications.  Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough."  6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.
Swollen tongue; Sore throat; Swollen lymph node near armpit under left arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 09:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received  the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 09:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 11:00 the patient experienced swollen lymph node near armpit under left arm, swollen tongue and sore throat as well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node near armpit under left arm, swollen tongue and sore throat were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Immediately after withdrawing needle: headache, severe nausea, dizziness, vertigo 30 min after vaccine: bloody nose, sore arm  (lasted 3 days and greater stiffening with time) 6 hours after vaccine: diarrhea and abdominal distention  Next 2 days: severe diarrhea throughout the entire day  3 days later: sore throat  4 days later: sore throat and muscle aches  5 days later: sore throat, fatigue, and stifled chest. Abdominal distention still present and worsens with any consumption of food.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 23-APR-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a health care provider (HCP) for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Rash, hives, swelling right leg, trunk, face, arms, MMR ON 1/17/02,  treatment-Benadryl po
I received the Modera half dose for my booster vaccine. In the afternoon and several hours later, I  had pain down my right arm, down my shoulder and fingers. I did not have any fever. It was really painful for 2-3 days. Then I went back from my regular pain from 2AM to about 6AM, and it is still a continuation from my second vaccine. My doctor advised me to get this dose because if I got COVID I would die. On 01-26-2022 I saw an orthopedic doctor and had an office appointment and that I could think about getting an injection that possibly might help. On 03-16-2022, my doctor gave me a cortisone injection and at that time my doctor he still felt it was a possible serum reaction.  He also stated that he could possibly do surgery and look around and that the surgery would be long recuperation. I did not have the surgery just for them to look around. The doctor recommended for me not to get the second booster. I continued on with same right shoulder pain from 2am to 6am up until I got a good amount of coffee in me to get relief.
My small finger on the arm with the shot is extremely sore. It feels like I broke my finger.
At 1524 on 10/19/21 employee notified Nurse Practitioner at facility that gradually started having symptoms after 1st dose of CV19 Pfizer vaccine, which was administered on 10/19/21 at 1405. Employee waited the required 15minutes after the vaccine was administered with no report of symptoms. Reporting over the phone that tongue and jaw became increasingly numb on  drive home shortly after getting vaccine- "feeling like dental anesthesia". Left hand reported to feel cold. Denied breathing difficulty or swelling in throat, tongue or mouth. Advised to monitor and report to nearest ED if any difficulty breathing or swelling of face. Nurse Practitioner at facility had f/u phone call to check on employee at 1600 on 10/19/21 (30 minutes later). At this time, employee reporting now with left forehead "feeling different" and heart rate beating fast in the neck. Nurse Practitioner advised that she seek immediate medical evaluation at nearest ED. Employee went to ED, was triaged, and reports waited 2 hours 15min before leaving . Not evaluated. Phone call follow up 10/20/21 at 1000 by facility nurse practitioner.-Employee reporting jaw and tongue numbness is mild and better today. Left side of head, temple area, with "tingle" intermittently. Heart rate does not feel elevated. no breathing problems, no facial swelling. No fever or headache. Left arm is painful but left hand does not feel cold.
Due to pharmacy substitution, pt received Infanrix Dtap vaccination rather than Adacel Tdap vaccination. University drug information center indicated that the pediatric Infanrix version contains the same amounts of tetanus and pertussis and in creased amount of diphtheria component. The patient should be adequately immunized. They may, however, be at an increased risk of adverse reaction due to the elevated diphtheria component. The patient was contacted and did not experience any serious adverse reactions. Follow up corrective actions are being taken at center.
Tingling and weakness in feet and legs, severe pain in back. Numbness and tingling in hands, fingers, toes, weakness that spread to upper body. I couldn't walk and barely move arms, fatigue. Had facial drooping and slurage speech. Hospitalized and given IVIG treatments, therapy and rehab.
Breakthrough COVID-19; Breakthrough COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were none. On an unspecified date, the patient experienced breakthrough COVID-19. The patient stated that event took place after use of product. The patient underwent lab tests and procedures which included Covid-19 testpositive on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt claims it is difficult to move her left arm due to pain and soreness. Per pt, the pain started to bother her about 1 week ago. She has taken several doses of pain relief medication. Per pt, no bruises or swelling were observed after vaccination.
Swollen (L) deltoid after HPV imm'n (L) arm swollen/red/tender > (R) arm (Tdap & MENACTRA given).
On 12/13/2021 patient awoke with pain in left arm which progressively worsened.  By the evening of 12/13/2021,  patient could not lie down flat due to inability to breathe/shortness of breath and could not sleep all night.  On 12/14/2021, patient presented to reporter's medical office where symptoms were verified (unable to lie at 45 degree angle without immediate inability to breathe/shortness of breath) and patient then sent to Emergency Department.