chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 vaccine for age 5-11 years with beyond use date of 1/31/2022 was administered on 2/16/2022.  Form sent to Pfizer-Biontech to assess beyond expiration date excursion of 16 days
pt recv vax & devel a flushed, red face, felt hot & vomited following vax;f/u reports pt arm began to get numb, throbbing & felt hot;pt exp pain;face felt flushed & was very hot & perspired;pt went home & slept for approx 5-6hrs;
Pt states I feel dizzy while walking to observation. Nurse assist resident to chair, nurse observed resident sweating,  warm to touch, Temp-96.9. Pt complaints of metal taste in mouth, nausea, dizziness, and back pain.   Pt self medicated with Bendaryl.  Pt sat in observation for 30 minutes. First BP-130/72, second BP-138/80  After 20 minutes pt states 'I feel better" nurse asked pt does she need a ride home, pt states "no" nurse edicated pt of safety risk of driving home alone, Pt states "I'm fine, it's only a 20 minute drive"  Nurse advised Pt to follow up with PCP.
pt recv vax & 2-7 days post vax & exp flu-like sx, nausea, h/a & gen malaise;seen by MD;tx unk;
1/11/06 Pt received extra dose of Hep B with other vaccines. Mother informed of extra dose and need to repeat at future visit. 1/12/06 Mother reported child with fever of 105. Poor appetite.  By alternating Tylenol and Motrin, slowly reduced fever during the day. 1/1306 Mother report child slept well now eating normally. Mother also reports child teething at present.
INPT STATUS 3/16/2021 AS PER EMR:  PT RECEIVED HER 2ND MODERNA COVID-19 VACCINATION ON FEB. 2ND. SHE HAD SIGNIFICANT PAIN AT INJECTION SITE FOLLOWED BY WEAKNESS, FATIGUE AND POOR APPETITE.  SHE HAD SYNCOPAL EPISODE AND FELL OFF THE TOILET AND PRESENTED TO ED ON 3/16/21.
Body/joint pain, nausea, vomiting, headache, and chills/hot flashes.
I95.9 HYPOTENSION 9/1/2022 HYDRONEPHROSIS
Immediate pain when given injection. The following morning my entire arm, neck and chest throbbed. I started the following afternoon with daily headaches that lasted for 3 months. I developed a bad bruise that lasted for 2 weeks. The arm and neck pain lasted for 3 weeks. A nurse viewing the bruise told me the shot was not given in the correct part of my arm. On sept 17 I developed sudden severe chest pain. I couldn?t talk or move. It lasted about 15 seconds. I proceeded to check my blood pressure and it was high. After 4 checks it remained high. I also had a very rapid heart beat (120 + bpm). I went to the ER. Bloodwork showed no issues nor did ekg, though my BP and heart rate stayed high for the rest of the night.
02/17/04: As per pt progress note: "I had a tetanus shot about 1.5 weeks ago and I still have pain on my left arm, shoulder and rib cage".  Pt denies swelling or redness to arm.  Meets definition Brachial Neuritis.
Sudden Sensorineural Hearing Loss in left ear within 24 hour of receiving 3rd Pfizer Vaccine; Tinnitus in left ear; received a 3rd dose of the vaccine; received a 3rd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 70-year-old), dose 3 via an unspecified route of administration, administered in arm left on 06Sep2021 11:15 (Batch/Lot number was not reported) as DOSE 3, SINGLE for COVID-19 immunisation. The vaccine was given in a pharmacy or drug store.  Medical history included osteopenia treated with prolia; breast cancer and double mastectomy in 2007. Concomitant medications included ascorbic acid (VIT C); colecalciferol (VIT D3); calcium, magnesium (CALCIUM + MAGNESIUM); lipoic acid; silybum marianum (MILK THISTLE) and multivitamins. The patient previously took codeine and experienced nausea. Historical vaccine included BNT162B2 dose 1 and dose 2 on an unspecified date for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines within four weeks prior to COVID-19 vaccine. The patient had no covid prior vaccination. She had not been tested post vaccination. The patient experienced sudden sensorineural hearing loss in left ear within 24 hour of receiving 3rd pfizer vaccine and tinnitus in left ear on 07Sep2021 07:00 with outcome of not recovered. It was reported that the patient received a 3rd dose of the vaccine on 06Sep2021 11:15. Therapeutic measures were taken as sensorineural hearing loss and tinnitus in left ear with prednisone; IT Steroids. The events resulted to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient was given epinephrine after the first dose of Pfizer COVID vaccination on 3/11/2021.
Escalating pain from time of injection, NSAIDS were taken, upon awakening next day barely able to move right arm due to pain, ice and heat applied along with NSAIDS with minimal relief; reported to physician office via phone - they "are short staffed" and a message was left for the physician and/or nurse.
:30am Donor called post vaccination, off-site, to report soreness, redness, swelling and abdominal pains and off/on fast heart beats, that started about 3 am this morning. Donor was advised to apply cool compress to area, for 10-20 minutes at a time. Put a thin cloth between the ice and her skin. Seek medical care if any of these symptoms increase or cant move arm.  Donor advised to seek urgent/ER care as soon as possible to evaluate the heart rate.  3pm Donor was called to Follow up. She stated she went to ER  at 10am and was told she was experiencing normal side effects.  Donor also reported that all symptoms had subsided by the time she got to ER.
Patient reported a 103.6 degree F fever on 10/20/16 with it lowering to 101 degree F over next few days.  However on Sunday 10/23/16 patient had chest pain and reported to emergency room.  He is in hospital now with elevated WBC and elevated cardiac enzymes.
A non-serious spontaneous report of administration of FLUMIST to a 64-year-old female was received from a health professional. Neither relevant medical history nor concomitant medications have been reported for this patient. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Left armpit, left breast discomfort after 2nd shot.  Did not incapacitate.  Just annoying! Quarter size neck lump was unsightly and uncomfortable lasted weeks.
Temp 103,.6  sever chills,achs,pains nausea dry heaving ,dizzy fell broke front tooth,cut lip . Balance off Friday Saturday headache, ichy no evenece of rash ,no appetite,
THE PATIENT WAS IN FOR A MMR VACCINE. I PULLED OUT THE DILUENT AND THE VACCINE. WHEN I RECONSTITUTED THE VACCINE I ACCIDENTALLY USED THE PFIZER BIVALENT INSTEAD OF THE DILUENT AND MIXED THEM TOGETHER. I THEN INJECTED THE PATIENT SUB-Q .  WHEN I GOT BACK TO THE VACCINE TABLE I NOTICED THE DILUENT WAS STILL CAPPED. THEREFORE I MUST HAVE MIXED THE PFIZER BIVALENT WITH THE MMR VACCINE INSTEAD OF THE DILUENT.  PATIENT COMPLAINS OF SORE ARM UP TO NECK AREA.  NO OTHER ADVERSE EFFECTS SO FAR.
Experienced Vertigo on 51/9 and 5/20 in the early am before waking up. Room was spinning very fast along with a slight migraine. Following week, had slight dizziness during the day upon looking up or down and when going to sleep.
ahead to toe hives, throat swelling; ahead to toe hives, throat swelling; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (ahead to toe hives, throat swelling) and PHARYNGEAL SWELLING (ahead to toe hives, throat swelling) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination.     No Medical History information was reported.  In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) .05 milligram once. On 02-Jun-2021, the patient experienced URTICARIA (ahead to toe hives, throat swelling) and PHARYNGEAL SWELLING (ahead to toe hives, throat swelling). On 02-Jun-2021, URTICARIA (ahead to toe hives, throat swelling) and PHARYNGEAL SWELLING (ahead to toe hives, throat swelling) was resolving.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
About six weeks after the shot I notice a slight ringing and over time it has been getting worse. High pitch ringing that just keeps getting louder. I have tried the CBD oil behind my ear and it doesn't help. I have also tried the tinnitus app on my phone and it does help a little but the ringing is still present. It has also caused headaches and difficulties sleeping. The sound gets louder the quieter it gets. The sound is like the emergency alert that comes across the TV but at a much higher pitch. Its like being at a bar/restaurant  with a bunch of people that are all talking at the same time. The sound is just in my ear and it makes me talk louder than I really want to.
At 11:30am the next day after receiving the second dose, I became extremely fatigued and felt dizzy and very nauseous. On  the morning of 1/31/21, I felt the exact same symptoms but this time the nausea led to vomiting.
Flu like symptoms:  Fever, SOB.  Was admitted to the hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim autopsy report received with the following findings:  Multilobar pneumonia (all lobes severely involved). Post mortem bacterial, fungal, acid fast and viral cultures pending.  H1N1 (-). Renal failure probably 2' to acute tubular necrosis.  10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of fever, malaise.  nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and thought to be viral, sx progressed, cough worsened and patient became dyspneic. To hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam, Cleocin, Xigris, Serum Bicarbonate. DC DX's:  Severe Multilobar Pneumonia, Respiratory failure, Renal failure, Metabolic Acidosis.  12/29/09 Autopsy report received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to Legionella, non-pneumophilia species.  Additional information abstracted: Patient developed community-acquired bilateral pneumonia causing severe hypoxia and multiorgan system failure.
Recent history of end stage renal disease. On dialysis for last 3 weeks. Discharged from hospital 10/24/06. 3-4 days ago, developed gradual increase in weakness, fatigue. Not able to get up without assistance. 11/08 intubated. 11/14 trache placed.  1/2/07 Received medical records from hospital which reveal patient admitted 3 times: 10/13/06-10/19/06 -- Final Dx: renal failure, secondary to acute tubular necrosis; hx of DVT & PE; & Wolff-Parkins-White syndrome; anemia; metabolic acidosis & hyperkalemia, resolved. Procedures during that hospitalization included: US guided percutaneous biopsy or right kidney 10/13/06; MRA of abdomen 10/17; placement of dialysis cath & initiation of dialysis 10/18/06. LABS: creatinine 7.3 (up from 2.9 2 wks prior during hospitalization for chest pain). 10/21/06-10/25/06 -- Final Dx: Abdominal & back pain; tachyarrhythmia tx w/ablation.  10/31/06-11/30/06.  Intubated on 11/8/06 due to resp muscle weakness.  Numerous episodes of plasmapheresis; numerous courses of IV immunoglobulin.  Feeding tube & trach placed 11/14/06. FINAL DX: Guillain Barre Syndrome believed to be due to flu vax; renal failure, dialysis dependent; fevers, secondary to vancomycin; profound weakness; & history of DVT & PE.  Information received from annual follow up indicates patient has not recovered. Only able to move eyes & jaw. Vent dependent. Patient died 1/26/07. Developed multiple myeloma. Had renal failure prior to this. In chronic atrial fibrillation. Per 60 day follow up: Continued to have minor improvements in neurologic function, including some neck flexion and some purposeful function of leg muscles, prior to his death due to other complications, on 1/26/07. He was a dialysis pt. who had bouts of C. difficile, dysrhythmia and ventricular tachycardia during the last days of life.
runny, loose stool specified as diarrhea; weight loss; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration in the right arm on 25Jan2021 15:30 at a single dose for covid-19 immunisation. The patient's medical history included rotator cuff surgery from 2019 and hysterectomy from 2020. The patient have no known allergies to medications, food, or other products. 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 but received any other unspecified medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced runny, loose stool specified as diarrhea on 26Jan2021. It was also reported that she did not know this would be a weight loss drug on 26Jan2021. "UGH" (pending clarification). No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Significant Fatigue and moderate stomach ache starting at about 10 am. Slight body aches and sore left arm at injection site. No fever. No redness or swelling at injection site.  Treated by laying down and drinking water. Didn?t take additional medication since I?m pregnant and there is no fever.
Itchy, burning, and swollen. If I itched it it would get worse so I avoid touching. When showered I would let my arm stay under the warm/hot water. It would look better for a day or two and it would get worse. It?s been a few days that it healed.
I63.9 CRYPTOGENIC STROKE 8/9/2021 HX OF TRANSIENT ISCHEMIA ATTACK
Night of vaccine only a sore arm. Next day woke up with a headache. Midday had a fever of 101, so took some Advil. Early afternoon felt very ill. Used the restroom and was so tired and dizzy I could not make it to a place to sit down without help. As my partner was trying to help me back to couch, I had a rush of dizziness. I remember thinking I might pass out. Instead, I vomited, and the dizziness went away after. Fever broke in PM and just felt very tired/ill for rest of day.
Patient admitted for post-op management following a pancreatoduodenectomy for pancreatic head cancer. Delayed gastric emptying required NG tube decompression and chronic malnutrition required brief TPN nutritional support. NG tube was eventually removed with improved oral intake and TPN was discontinued. This visit was within 6 weeks of receiving the COVID vaccine.
per mom arm was swollen from elbow to shoulder, reddened, warm to touch;occurred 48hr p/vax;mom gave DPH;
Started 12/4/07 tired & achy, sleepy, "weird dizziness", cold sweats, some nausea, no vomiting, some heartburn & LLQ pain, mild cough, occipital HA, lots of gas.
vaccines that were not on the ice packs melted and the temperature was warm, extended transmit time/ no symptoms reported; Initial information received on 23-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) by phone.  This case is linked to case 2019SA203083 (same reporter).  This case involves a 4 months old female patient who was vaccinated with a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number: UJ112AAC and expiry date: 21-Jun-2020) via intramuscular route in the left quad on 20-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) on an unknown date.  It was a case of Incorrect product storage.  No symptoms reported.  Documents held by the sender: none.
Bell's palsy; blood pressure increased; chest pain; breathing difficulty; weakness; tired; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (lot number: EL9262), via an unspecified route of administration, at arm left, on Jan2021 at single dose for COVID-19 immunisation. Medical history included Prediabetes from 2019 (reported as diagnosed two years ago), overweight from an unknown date, ongoing arthritis from 2017 (reported as about 4 years ago), gets worse now. There were no concomitant medications. Caller states she just has a question, states she took the test about 2 weeks ago, clarifies the Pfizer vaccine and due for next one on Sunday, caller wanted to find out if what she experienced could be due to the vaccine, states she had a reaction for almost two weeks (also reported that all the events started on 05Feb2021, pending clarification), states her blood pressure went up, she had chest pain in her chest, weakness, loss of appetite, states it lasted about 24 hours, no exact dates provided. Also experienced Bell's Palsy states it comes and goes, that when she talks the saliva comes down the side of her mouth. States her Blood pressure went really high, 145/90 or so, lasted about 24 hours. Did not know if she was having a heart attack. Does see a cardiologist because of a family history of cardiac issues. The outcome of the event Bell's Palsy was not recovered, of the other events was recovered on Jan2021 (reported as lasted for 24 hours).
Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine.  This turned bloody / dark red in color.  Over the next several days she had migraines, fever, nausea, diarrhea.  She had a very heavy period that was not normal for her.  She was treated twice for presumed UTI (once with macrobid and then with cefuroxime) in the days after the vaccine though cultures ended up negative.  She was referred to me, a hematologist, when she was noted to have a dropping hemoglobin and platelet count.  She appears to have a Coombs-negative hemolytic anemia and possibly ITP.  She is feeling a little better but her labs remain abnormal.  Please note this was reported on Pfizer website as well but I have not been contacted.  Guidance would be sincerely appreciated.  My cell phone was provided.
The patient developed shortness of breath, right-sided chest pain, fatigue and dizziness within three days after he received the third Pfizer COVID-19 vaccine. He was evaluated in our clinic and subsequently referred, whereupon he was diagnosed with a pulmonary embolism with infarction. The patient had no previous risk factors for pulmonary embolism.
cellulitis; redness of 5cm at the medial portion of the left arm; swelling of 5cm at the medial portion of the left arm; pain of 5cm at the medial portion of the left arm; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 65 years old female patient who had cellulitis (vaccination site cellulitis) with symptoms redness, swelling and pain of 5cm at the medial portion of the left arm (vaccination site erythema, vaccination site swelling and vaccination site pain) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 13-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ468AB, expiry date: 30-Jun-2021, single dose vial) once via intramuscular route in the left deltoid for prophylactic vaccination.  On 14-Oct-2020, the patient developed a non-serious cellulitis (vaccination site cellulitis) with symptoms redness, swelling and pain of 5cm at the medial portion of the left arm (vaccination site erythema, vaccination site swelling and vaccination site pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The diagnosis was reported as cellulitis.  No laboratory data was provided.   The patient was prescribed antibiotics to treat the events.  On 20-Oct-2020, the patient went back to the health care professional and it was reported that the cellulitis with symptoms vaccination site erythema, vaccination site swelling was recovering (improved) while the event vaccination site pain was not recovered.
TWO BLOOD CLOTS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient had an unspecified surgery before three weeks of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The patient received rivaroxaban (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date after vaccination, the patient developed blood clots. The patient was taking rivaroxaban (Xarelto) and went to his physician and found out that he had two blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The patient had not recovered from two blood clots. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210653162- covid-19 vaccine ad26.cov2.s- two blood clots. This event(s) is considered un-assessable. 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).
Fever 102F x 2 days, Vomiting x 1, Headache, body aches, chills, arm pain when lifting overhead.
5 days after vaccine (Tuesday 6/3/14) at 7 am T= about 102 pt developed fever and no other significant symptoms. Clinical work up was negative and pt still with temp 101.2 6/6/14 in afternoon. Pt has follow up next week.