chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain; rib /lung pain; rib /lung pain; tachycardia; high pulse; high blood pressure; heart lbs were high; echo cardio was abnormal; pleurisy; heart rhythm was completely off; rapid heart beat; chest tightness and had difficulty breathing/noticed fluttering and almost like an anxiety; chest tightness; difficulty breathing; anxiety; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:30 (Lot Number: EN6203) as dose 1, single, then on 23Mar2021 at 12:30 (Lot Number: EP7534) as dose 2, single, then on 01Sep2021 at 15:30 (Lot Number: FC31837) as dose 3 (BOOSTER), single for COVID-19 immunization (at the age of 37 years old). Medical history included asthma, systemic lupus erythematosus (SLE), hypergammaglobulinaemia benign monoclonal (MGUS), known allergies; all from an unknown date. No other vaccine in four weeks. The patient had other medications in two weeks. No COVID prior vaccination and was not tested post vaccination. On 05Mar2021, after the first injection patient noticed chest tightness and had difficulty breathing. Patient noticed fluttering and almost like an anxiety. By 06Mar2021, she had a rapid heart beat and her heart rhythm was completely off, she was admitted to ER on 15Mar2021 with extreme chest pain, difficulty breathing and rib / lung pain. She had tachycardia, high pulse, high blood pressure, her heart lbs were high, echo cardio was abnormal but was eventually discharged and stated that everyone felt it was pluerisy (ct scan and X-ray clear). However, after every shot after, this has happened (she had 3). She has avoided the hospital, because she took BENADRYL but now with the third shot it was really bad again. Events lasted 10- 14 days. The patient was hospitalized for the events for 1 day. The patient underwent lab tests and procedures which included heart beat: rapid on 06Mar2021; then on 15Mar2021, blood pressure: high, computerised tomogram (CT scan): clear, echo cardio: abnormal, pulse: high and X-ray: clear. Therapeutic measures were taken as a result of the events, treatment included prednisone, TORADOL, SOLU-MEDROL. The outcome of the events was recovered on unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Parents reported that infant had 24 hours of prolonged crying following above vaccinations (did not occur with 2 month vaccinations). Approximately 1 month following above vaccinations, infant presented with infantile spasms and has subequently developed refractory epilepsy and has been found to have cortical dysplasia. Parents concerned that vaccination triggered onset of seizures, report submitted at their request.
Fever, pain in joints, stabbing pains abdominally,  canker sores in the mouth
Tinnitus in both ears. Left arm was sore for a few days after shot. Had mild headache on day 2-3.
Narrative: Patient received two doses of COVID 19 vaccine in Feb/Mar 2021. The patient tested positive for COVID 19 on 27 Oct 21 and was hospitalized on 2 November 2021 with hypoxemia, loss of taste and smell, myalgia, and COVID pneumonia. The patient was discharged on oxygen on 7 November 2021.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). The reporter was unsure if the patient received ZOSTAVAX or not. On an unknown date the patient developed shingles. The outcome of event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Shots were given on Fri. 1/24/03 at 11am from Fri. into Sun my son started loosing his appetite. 1am Mon. morning he ran a high fever and started seizing and again at 9am. Medical records states cough, viral syndrome, rhinnitis, complex febrile seizure. msv
missed the 4th dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (1st dose received on 4th May 2020), Rabavert (2nd dose received on 7th May 2020) and Rabavert (3rd dose received on 11th May 2020).   On an unknown date, the patient received the 4th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 4th dose of RabAvert, which led to incomplete course of vaccination. The reporter consented to follow up.
Seen in employee health 12/12/03: states took flu 12/10 achy 12/11, took Motrin "off and on" 12/12.  Started "itching" upper extremities and back.  Noticed rash on neck and upper back. Complained of burning, tingling and itching.  No respiratory distress, took Benadryl 25mg per mouth earlier.  Exam-slight rash noted at deltoid region.  Red rash noted upper back.  12/15/03: Reports resolved 12/13/03 PM.
Patient received vaccine at a Pharmacy. She immediately felt itchy but did not notice a rash or hives, 3.5 hours later she reported feeling SOB and chest heaviness. She also felt/feels achy, foggy, weird and with a swollen face and eyes. SOB and swelling are improving
12 hours post injection, - shivering that lasted for two hours or so,  upon awakening felt exhausted, very sore arm,  loss of appetite (very unusual for me), slept off and on all day, slight headache, nauseous, no fever.   Unable to complete normal daily activities.   No such reaction with first dose. 24 hours post injection - no fatigue but feeling weak (not as bad as previously),  feeling a little sweaty upon exhaustion much like recovering from the flu),  no fever.   Injection site soreness significantly reduced.
Immunization was given on 10-7-08.  Pt states that her arm began getting extremely sore that evening.  Swelling in arm and bruising on the next day (10-8-08).  Extreme headache, body aches and nausea.  Evening on (10-8-08) arm bruising began filling out deltoid area, around inner arm down into inner elbow area.  Pt stopped by the office on 10-13-08 for visual of arm by Dr.
very tired, slept more than normal, achy all over, injection site sore day/night of injection,   injection site still  sore   8/22/2019  red area apx   1" x 2-1/2"   at injection site appeared 8/22/2019
Pt received her first dose of Pfizer LOT#: ER2613. Pt contacted EMT and reported that she had heart palpitations which lasted about three minutes. Pt also had shoulder pain on left side where she was vaccinated. EMT took vital signs. BP: 118/80, Pulse: 82, 02: 100%. Pt stated that she has had a history of anxiety and high cholesterol. Pt stayed an extra 15 minutes. Pt reassessed, pt stated that she was feeling better. Pt reported that she had not eaten breakfast and requested to have some water. Pt left with husband with a steady gait at 1425.
Pt. c/o facial redness, flushing, eye puffiness and facial tingling within 30 minutes to 1 hour after receiving the vaccine. States facial symptoms resolved within 1 hour after  beginning.  Pt. also states started vomiting 2 days after receiving vaccine and lasted for 36 hours. Pt. states went to the emergency room but was unable to be seen. Went to urgent care clinic and had bloodwork drawn and IV fluids were given on 12/28/2020.  States feeling much better today on 12/28/20.
This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151; Expiration Date: Jul2021), via an unspecified route of administration at left arm on 12Apr2021 at 13:15 as single dose for covid-19 immunisation. Patient had historical vaccine first dose of BNT162B2 (at 62-year-old) lot number: ER8727, Expiration date: Jul2021 at left arm on 22Mar2021 for covid-19 immunisation showed tenderness in left shoulder. There was no patient medical history. There was no family history. There were no additional vaccines administered on same date of the COVID suspect. There were no prior vaccinations (within 4 weeks). No AE following prior vaccinations. The patient did not take concomitant medications. Patient experienced his arm is a little tender now on an unspecified date and received second dose that was clear on 12Apr2021. He received the first vaccination 3 weeks ago and this morning got the second vaccination. When he arrived, there was 30 minute delay. He saw the vaccines that were administered were transparent. It seems like it is not according to COVID standards. The person giving it said when it is diluted, it becomes transparent. He took it and is worried that it is not effective. The first dose was off white a little bit. It was not transparent and was exactly as described by the company. But now, it is transparent. He said that maybe they kept it too long outside, but they said it was correct. This same transparent one was given to several people before him. He did not provide any information on any others that had it. He wanted to know if that means it is not effective. They are doing it all the time. He later stated maybe the first one wasn't effective either. He just doesn't know. He later stated with the first dose, they knew what they were doing. He said he got the vaccine at pharmacy, does not have sample and didn't take photo. He thinks pharmacy did not dilute the vial correctly that's why it was clear, or they left it out too long. The pharmacy RPh told him they did it correctly. He doesn't believe it since the product is supposed to be off white after diluting. He did not see them do the actual diluting or shaking, just saw the vial sitting there. Site and PQM aware. He stated his arm is a little tender now and his temp is 98.4, it usually runs lower than that. He said he asked the company if he should get a third vaccine, he said they could not answer that. He said if anyone should know, its the company. Advised him to discuss his concerns with his doctor. No ER or physician's office visit required. The patient underwent lab tests and procedures which included body temperature was 98.4. Report not related to a study or program. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
Less then 24 hours after injection, thigh started swelling up around injection site. By end of day 1 the redness was 4inches in diameter. Had a fever of 100.5°F. Took him to his doctor and they said it was a normal reaction. It would go back normal eventually. Day 2: still itchy, still fever and redness continued to grow.  Now 5 inches in diameter. By day 3 the redness was  6 inches in diameter and was also rock hard and itchy.  Day 4 the redness started to decrease but started to turn a purplish/grayish color.  Day 5 no more fever, continued to decrease but still purplish/grayish in color. Took 2 weeks for his leg to look normal again.
ANXIETY; FEELING HOT; FATIGUE; HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a physician concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and same has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced anxiety. On 24-MAR-2021, the subject experienced feeling hot. On 24-MAR-2021, the subject experienced fatigue. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and had not recovered from fatigue, headache, feeling hot, and injection site pain. This report was non-serious.
After 2nd Moderna shot, body chills for hours during night time. Awoke to find neck, back of ears, torso (front/back) covered in a rash.
Not sure when appeared but noticed late afternoon of 2nd day Rash on neck arms torso etc. and some hives on Inside of wrists . Lasted thru 3 rd  day following shot and then just super itchy as left my system .
Chief Complaint: COVID-positive/shortness of breath Additional Medical History:  Patient is an 85-year-old male who resides at a local nursing facility.  Patient has a history of coronary disease with prior CABG, congestive heart failure, atrial fibrillation, COPD, hypertension, hypercholesterolemia.  Patient tested positive for COVID 10 days ago.  He presents to the emergency room today by EMS secondary to increasing shortness of breath and hypoxia.  Patient was noted to have an oxygen saturation in the low 80s this morning at the nursing home.  EMS was called and he was transported to the hospital.  Patient does state he has had worsening shortness of breath over the last 3 to 5 days.  He is even short of breath when he rests.  Patient states he has memory loss and has a difficult time remembering all of his symptoms or the onset.  He is unsure if he had the COVID-vaccine in the past. Associated Symptoms: cough, memory loss, shortness of breath, weakness Denies Symptoms: no anxiety/ no appetite changes/ no chest pain/ no chills/ no depression/ no diarrhea/ no dizziness/ no fatigue/ no fever/ no focal weakness/ no headache/ no injury/ no rash/ no seizure/ no sensory changes/ no sore throat/ no speech changes/ no URI symptoms/ no vomiting/ no wheezing
A 64 year old male pt was treated with OncoTICE for bladder cancer since 5Jul04. Following his 4th instillation on 26July04, he reports he had blood in his urine which persisted for approx one day. On 29Jun04 he reports the blood in his urine was again very noticeable with urine red and with very small clots, and the bloody urine has continued through 30Jul04. He has also been experiencing some nausea, tiredness, and joint aching, especially his shoulder.
80-year-old gentleman with significant past medical history for diabetes/hypertension/sleep apnea, presented due to complaint of shortness of breath.  Pt is positive for COVID on 11/3/2021.  Started to have more progressive shortness of breath without any associated chest pain; denies any history ofblood clots or being on any anticoagulation; on  presentation, the patient required 4 L of O2, chest x-ray showed bibasilar interstitial findings; Admission dx: SOB, hypoxia, exertional dyspnea, COVID-19 virus. Treatment Vitamin D, decadron, oxygen, refused remdisivir prevered to have zithromax.  Paroxysmal a fib and first degree AV block.  treated with heparin.  Will need pacemaker. Discharged to rehab.
swelling in right hand.; headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history reported as cancer survivor. The patient's allergies to medications, food, or other products were reported as nine. 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:00 the patient experienced swelling in right hand and had headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of events swelling in right hand and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
3 days after receiving vaccines intussusception was suspected and patient was Hospital were intussusception was diagnosed and was unable to be reduced by enema and had to be done manually in the OR.  No bowel resectioning was necessary.  10/28/08 Reviewed hospital medical records of 10/9-10/13/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced intermittent crampy abdominal pain, abdominal distention & vomiting x 3 days.  Taken emergently to OR when enema administration did not reduce IS.  Open reduction performed.  Progressed well & d/c to home.
Substernal reproducible chest pressure described as aching soreness, associated with dyspnea. Self treated with Advil.
She had a reaction in about 5 minutes of receiving. She began to have hives form on both of her arms that looked like burns. I went to the nurse and they took a look. They did call a medical emergency, gave her a shot of Benadryl in her other leg and the hives did go away very quickly within about 30 minutes. She did not have any other issues that came up and her oxygen levels were fine. She did get some hives developing on her knee however they just kept her for about an hour after the vaccine. The hives have not come back since.
Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.; Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 6 (booster), single (Lot number: AH9463) at the age of 54 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid rebound. Tested positive for Covid after Paxlovid treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for Covid after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
PATIENT RECEIVED HEP B #1 IN SERIES ON 05/17/06,BUT DID NOT REPORT INCIDENT TO ANYONE UNTIL SHE RETURNED TO CLINIC FOR 2ND DOSE IN SERIES ON 7/19/06. CLIENT REPORTS THAT AS SHE LEFT THE CLINIC TO GET INTO HER CAR, HER "KNEES FELT LIKE JELLO". SHE FELT VERY WEAK, WAS PALE, HAD A HEADACHE, FELT HOT. SHE DROVE TO WORK WHERE SHE RESTED FOR 30 MINS THEN DROVE HOME. ON DAY 2, SHE WENT TO WORK BUT WAS SENT HOME WITH SAME SYMPTOMS. HER LEFT ARM AT THE INJECTION SITE WAS BRUISED WITH REDDNESS ABOUT THE SIZE OF A QUARTER AND HER ARM "HURT ALL THE WAY TO THE ELBOW". STATED THAT THE SORENESS LASTED FOR 2-3 WEEKS, THE BRUISING FOR ONE MONTH.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 37-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). On 28th September 2016, the patient received FLULAVAL QUADRIVALENT. On 28th September 2016, immediately after received FLULAVAL QUADRIVALENT, the patient experienced injection site muscle pain and fever. On an unknown date, the outcome of the injection site muscle pain and fever were unknown. It was unknown if the reporter considered the injection site muscle pain and fever to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: As soon the patient received the shot she felt like she got punched very hard in the arm and it hurt really bad for few days. The patient could not move her arm without hurting and it hurt in the muscle not on the skin. The patient also had a high temperature for about 24 to 48 hours after the injection as well. She said the pain was getting better but it was about 6 weeks and still hurts.
Fever of 101-104 from around 6pm on 2/26 till around 7am 9/27. Despite APAP, IBU, ASA, and cold showers pt. was unable to reduce fever below 102 from around 9pm until fever broke the next morning.
4/7/21 8pm-Itchy skin, rash on injection site.  4/8/21 7am-swollen throat and tongue, itchy skin.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 1:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 1:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 55.28.  Concomitant product was not provided.  On 28-Apr-2021, excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 04 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medication was not reported.
Client given MMR on 4-19-19 along with PCV 13, Influenza and Shingrix.   Client came in on 4-26-19 for Hib, Hep B and Meningococcal (did not want to get all at the same time).  It was noticed on 4-26-19 that client was inadvertently given MMR that should not have been given until 2 years post transplant.  Client denied any problems from vaccines given on 4-19-19.  Nurse attempted to contact client's physician - Dr. after realizing the MMR was given.  Physician and staff gone for the day.  Called physician this morning gave message to nurse.