chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLURRED VISION KEEPS GETTING WORSE; UNSPECIFIED ABNORMAL HEART RATE; BODY ACHES; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced blurred vision keeps getting worse. On MAY-2021, the subject experienced unspecified abnormal heart rate. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) Abnormal (values unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurred vision keeps getting worse, and unspecified abnormal heart rate, and the outcome of body aches and weakness was not reported. This report was non-serious.
difficulty breathing when laying down; Constant "fluttering" in chest for 2 - 3 hours; difficulty taking medication in large capsules; This is a spontaneous report received from a contactable consumer (patient). This 75-year-old female patient, did not Pregnant at the time of vaccination, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot EL9269) on 06FEB2021 at single dose on Right arm for COVID-19 immunization. Medical history included ARVD, Breast Cancer, Carcinoid Syndrome, Autoimmune Problems, Asthma. Allergies included Several meds and seasonal respiratory. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Concomitant medications were not reported. Event started on 06Feb2021 07:45 PM, several hours after vaccination, constant "fluttering" in chest for 2 - 3 hours, difficulty breathing when laying down, difficulty taking medication in large capsules. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was Recovered.   Information on Lot/Batch number was available. Additional information has been requested.
p/vax pt unable to open mouth completely; this has come & gone; it has recently happened again and has lasted longer; 3 days; no fever or pain at inj site;
This is a 75-year-old male with a past medical history of coronary artery disease, anxiety, bipolar 2 disorder, dementia, GERD, hypertension, type 2 diabetes mellitus, mixed hyperlipidemia, schizoaffective disorder presenting to the ED today via EMS with chief complaint of fatigue and weakness.  Patient is unable to provide HPI or ROS given the acuity of his condition.  History was provided by EMS as well as by patient's family members via telephone.  Patient reportedly has had poor and increasingly worsening neurocognitive decline recently.  He recently tested positive for COVID and was found to be lethargic and poorly responsive at the nursing home earlier today.  Upon his arrival here to the ED he has tachypneic breathing with pale cool skin and overall ill-appearing.  2+ radial pulses bilaterally.  No signs of trauma.  Paperwork at bedside indicates that patient is DNR CC.  No further information available.  This is a 75-year-old male with a past medical history of coronary artery disease, anxiety, bipolar 2 disorder, dementia, GERD, hypertension, type 2 diabetes mellitus, mixed hyperlipidemia, schizoaffective disorder presenting to the ED today via EMS with chief complaint of fatigue and weakness.  Vital signs show a rectal temperature of 92.7 °F with a blood pressure of 94/77 and heart rate of 85 bpm.  Patient is ill-appearing with pale skin.  He has tachypneic breathing.  Cardiac sounds normal rate and rhythm.  Abdomen soft and compressible.  No bilateral lower extremity edema.  2+ radial pulse bilaterally.  Unable to assess neurological function given the acuity of his condition.  He does open his eyes to sternal rub and withdraws from painful stimuli.  His differential diagnosis includes, but is not limited to septic shock, acute respiratory failure, palliative hospitalization.  Paperwork at bedside initially indicated that patient was a DNR CC.  Attending physician did speak with patient's power of attorney and updated POA on the acuity of patient's condition.  Initially POA would like to proceed with DNR CCA.  Patient was then given IV fluids as well as bicarb as his initial VBG showed a pH of 6.97, PCO2 23.5 and PO2 of 31.  Initial lactic acid of 18.0.  We did obtain blood cultures and started patient on broad-spectrum antibiotics.  When POA arrived to the hospital, my attending physician Dr. had a discussion regarding how critically ill patient is.  Goals of care were discussed and it was decided from the family that the best interest for patient was to make him a DNR CC.  IV fluids were subsequently discontinued.  Pressors were discontinued as well.  Orders were placed for comfort care measures in addition to Ativan, morphine as needed  Was called to the bedside by RN.  Patient asystole on the monitor.  Patient without spontaneous respirations.  No pulse.  Bedside ultrasound shows no cardiac activity.   Time of death 238.  Comfort provided to family at bedside
I have asked the parents to take the original of this form for Doctor to complete 7, 12, 11. By history, the child had a temperature of 105 and redness all over the body No treatment was necessary.
Pt experienced fever. Two days later the pt experienced chickenpox with 20 lesions on the trunk.
Patient works late evening shift, worked until 2am, went home, came back to hospital for vaccine at 6am. Received vax and went home, slept 7 hours, got up and had an extremely strenuous workout including deadlifts (pyramid to heavy weight, 275lb x 5 reps in HIIT sets with kettlebell swings, and boxing in garage gym. Was 45 dF at the time. Patient was finishing workout with last 2 minutes boxing on a 100lb heavy bag and suddenly felt violent "pop" in right medial gastrocnemius muscle. Pt stopped workout and could barely put weight on right leg and reported back to work for shift within 45 minutes of event. Pt iced 4x per day for next 2 days (current), walking better by 2nd day but still very painful and unable to put much weight on forefoot. This has never occurred to patient. Possibly related to vaccine? Worth reporting
She took her second dose and she died five days after; This is a spontaneous report from a contactable consumer. This female patient of unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient took her second dose and she died five days after on 24Aug2021. No prior health issues (further not clarified). The reporting consumer had coffee with patient that morning and she died hour and a half later. In moment reporting consumer find her on ground because of the vaccine. The reporting consumer asked how you guys can give a vaccine that kills people. Like it killed patient two days back (further not clarified) when she took it. Covid was not even that serious. The reporting consumer was going to file a huge lawsuit against you guys, a huge law site. But patient didn't have to die if you guys didn't fear among her and taking your stupid vaccine. She only died because she took up the vaccine. You know that right! because she took Pfizer. There's more than 11 thousand deaths (not clarified) because of that shit. The very system was wrong, they are probably knowing that people are dying because of your stupid vaccine. There's no way that could be approved if it is killing over 11 thousand people. The outcome of the event was fatal. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: She took her second dose and she died five days after
First shot on 4/20, knee joint pain, on knee that has never had any issues, still have the pain.   Second shot 5/18, shoulder joint/rotator cuff pain in shoulder that didn?t get the shot.  Not able to lift shoulder without pain.
It made me gay; This is a spontaneous report from a non-contactable consumer (patient) for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included COVID-19 (If covid prior vaccination: yes). Concomitant medications were not reported. The patient experienced it made him gay on an unspecified date with outcome of recovering. AE resulted in disability or permanent damage. No treatment for AE. No COVID tested post vaccination.  No follow-up attempts are possible; Information on lot/batch number cannot be obtained. No further information is expected.
Patient received flu shot on 10/30/20 at 4:52 pm and experienced itching, raised area, and slight pain at injection site. On 10/31/20 at 10 a.m. itching and redness that is spreading down her arm mid way. Today on 11/1/20 the redness has spread further down and onto her inner arm area. Patient feels fine but just worried about it spreading and continuing to be red.
Immediately post vaccination pt reported feeling dizzy.  Pt reports she has a hx of this issue w/ injections.  Pt reports taking Klonopin before vaccination @11:45 Vitals: 106/73, 72, 20, 100% Pt stable and released from the vaccination site.
11-27-12 - Developed rash 2 days post vaccination also c/o fever at that time - rash worsened covering trunk, arms, legs, back - seen in E.R. 12-6-12 - acute urticaria trunk & arms not hands or feet.
The patient shopped for an hour and a half after receiving the vaccine.  She then fainted in the store.  She hadn't had anything to eat or drink that day.  She was slurring her speech and agreed to allow the ambulance to take her to the hospital.
1st dose - moderate site injection pain lasting ~2 days, mild fatigue, mild headache 2nd dose - major site injection pain lasting ~3 days, moderate fatigue, moderate headache, mod Body/joint aches,  low grade fever, insomnia
POST VAC. SHOT C/O OF THROAT TINGLING, TONGUE FEELING HEAVY AND NUMB.   EMS PRESENT. 1427:  VS:  BP:  143/91,  O2 SAT R.A.:  98%; P:  78. 1435:  VS:  144/88;  02 SAT R.A.:  98%; P:  78;  1440:  LEFT SITE, NO OTHER COMPLAINTS.
Pt recvd Engerix-B on 15JUL92, 19AUG91 & 25JAN91 & 31MAr92 titers levels revealed pt had not seroconverted;
Extreme back pain with headache. Hospital visit with multiple medications given including pain medication and Benedryl
Had vaccine on 8/19/21. On the 22nd and 23rd I had very, very bad muscle, joint, body aches. On 8/22 I started to have a hard time breathing whenever I was active, not sitting. I was given an Albuterol inhaler which had no effect after 1 week of use. On 8/27 I was given a 5 day dose of prednisone. This was helpful on day 3 but all help went away and my chest started to hurt after each breathing episode. On 10/01/21 I was started on an Alvesco inhaler and on Omeprozal.  From 8/31 to 10/08 my symptoms have been; shortness of breath whenever active (walking, standing, sitting at a computer), and whenever I have a breathing episode I also have chest pain that can last up to 3 hours. The only changes I have had during this time is that now I can be active a bit longer ? 3 to 15 minutes- before breathing is difficult and chest pain starts at all times not just after a breathing episode.
Per Mother: Patient complained of discomfort and had been limping 6-25-6/26. On the evening of 6/26 mother noticed large area of redness, warmth to touch, and swelling to the right knee and took him to Urgent Care. Urgent Care referred patient to the ER. Patient diagnosed with right knee effusion, cellulitis, and given oral clindamycin. Today patient is no longer limping and warmth to ouch has decreased per mother.
Dizziness, Headache, Myalgia, NauseaVomiting, CHILLS Narrative:
Developed a rash similar to Herpes Zoster.  No spreading, painful or blistering, no treatment to date, monitoring
a four month old patient was received an expired dose of Pentacel today, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who was vaccinated with a second dose of 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C5553AC, expiry date: 18-Oct-2019, via intramuscular route in the left thigh on 24-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.   A the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Narrative:  COVID INFECTION FOLLOWING COMPLETION OF COVID-19 VACCINE SERIES 02/26 COVID vaccine dose #1 03/19 COVID vaccine dose #2 04/16 tested for COVID due to planned travel, no symptoms related to COVID, COVID PCR test positive 04/17 test for COVID at facility and received negative Ag results Advised to quarantine and postponed travel to 5/10
Extreme soreness  and stiffening  to left shoulder, which continues as of now.  Nausea lasting only hours later that evening.
My symptoms began about 48 hours after exposure as a low-grade fever. I had a mild cough and congestion. I contacted the on the day I tested positive for COVID-19, Friday, February 24, 2023. I took PAXLOVID and I began to feel better after a couple of days. I still have an issue with my lungs and will see a doctor about this soon.
pt reported fever and chills starting about 6 hours after vaccination. also reported tingling and numbness on left side starting at the same time frame. pt stated her jaw was also sore and tight starting 9pm and is now getting better. Sharp
Just the slight headache and sore arm, it went away after a couple of days. Very, very bad headache; I was not hungry for the longest time and was tired all the time and I did not go to the doctor.
Information has been received on 12-JUL-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M039453 expiration 19-DEC-2017, subcutaneous for prophylaxis on 11-JUL-2017. No adverse effects reported. The vaccines were stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for the time frame of 4 hours and at 15 degrees Fahrenheit to 46 degrees Fahrenheit for the time frame of 1 hour. There were no previous temperature excursions. The call was made because of a data logger. No further information was provided. Additional information has been requested.
Day of shot about 2 hours later developed welt on arm the size of a tennis ball, sore arm, sinus headache, chills.  These lasted about 12 hours.  About 48 hours from the shot developed tinnitus.
Injection was extremely painful.  about 3-4 minutes after injection got very dizzy and flushed. Red face and pressure behind eyes.  Heart rate jumped to 150 and stayed above 125 for several minutes. I could barely walk back to  vaccination area where pharmacist waited with epipen.  I was given water and after a few minutes HR went below 100.  I stayed another 30 minutes and left however I did still feel a bit dizzy.  At about 8 hours post injection got chills and fever of 101.5 and HR remained high (above 102) for at least 6 hours after onset of fever.   Resting HR usually 59 and still remains above 90 at 48 hours.
This spontaneous report was received from a medical assistant and refers to two patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017, dose and route of administration were not reported) which were improperly stored. Administered doses of vaccine experienced the temperature excursion of 74 degrees Fahrenheit for 164 hours. No adverse effects were reported. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Evening of Nov 11 beginning at approximately 10 pm, low grade fever: 99-100 [duration of approx 5-8 hours], generalized muscle aches beginning at approximately 10 pm [duration approximately 24-30 hours]. Injection site pain (left arm) beginning 5-6 hours after injection and continuing as of the date of this report Nov 14.  On Nov 14, at approximately 2:30 pm 1st noticed mild whole body rash covering neck, torso, shoulders, legs. Fever and generalized muscle aches resolved by morning of Nov 13. Injection site pain continues. Whole body rash continues.
On Feb 2, 2019 (9 days after vaccines administered) pt developed a reddish-purple area of swelling at the right deltoid "where the vaccines were given" (FLUZONE QUAD and varicella w/i 1" from the flu vaccine injection), noting injection site at lower quarter of red annular reddish-purple area. Today, this area measured 3.5cm but the reddened area appeared more vascular rather than looking like a bruise. Mother reports that the size of the area has become a bit smaller than 2 days ago when originally noticed. Area itched a little (no signs of excoriation noted today).
Had temp of 99.7 body aches, small red circle that increased to a rectangle then to a big circle, felt bad for a t least five days. Pharmacist told her she was not suppose to have these symptoms until the second shot.
Fatigue, Muscle or body aches, and Congestion or runny nose,diarrhea , cough
NUMBNESS TO TONGUE 10-15 MINUTES AFTER VACCINE, FEW HOURS LATER MOUTH NOT CLOSING ALL THE WAY FELT NUMB, THEN STARTED WITH LEFT EYE NOT BLINKING AND LEFT EYE TEARING
Patient received booster today only 3 ½ months after 3rd dose of Pfizer. Patient received his 3rd dose at another facility on 10/04/2022. Patient was fine after booster. We will follow-up with PCP.
I am reporting that I was diagnosed with  shingles after 2 wks of getting my 1st dose of Covid vaccine shot in my upper left arm.  My arm starting hurting & a few days later, I broke out with tiny dark red spots inside a red swollen circle.  Arm remained with a burning aching pain. My dermatologist said it was definately shingles & prescribed a 10 day treatment of antiviral medication.  She didn't know if it was caused by the vaccine but  should report this.   The shingles are just below the shot area.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 16-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903:
Patient said she had extreme pain in the arm that she received her flu shot. After talking to her she is allergic to mercury. She said that the pain in her arms lasted approximately 1 week. Pt did not go to the dr office. Fully recovered.
Pt recvd 3 doses of Hep B vax & 24 hrs p/vax pt devel urticaria; skin testing was neg for Hep B vax & pos for HIBTITER;
Facial numbness, pruritis, aching lower limbs, malaise, edema, induration redness and warmth at site, fever blisters on lips.
Injection site was red and swollen for 1.5 weeks post vaccination; muscle pain is still prominent 12/1/18.