chrisvoncsefalvay/vaers-outcomes huggingface dataset:
genital warts; This spontaneous report was received from a physician via company representative and refers to a female patient who was 16-year-old at the time of reporting. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, she was diagnosed with genital warts. The reporter did not know the type of genital warts of if the patient had a history of sexually transmitted diseases (STD's). Outcome of the event was unknown.  Causality assessment was not provided.
Multiple maculo-papules along entire length of arms - forearms spared. Rash was itchy and BENADRYL given.
Patient stopped by the clinic and stated since this flu shot on 11/24/08- He has had left sided neck pain and left arm soreness. He denied any chest pain, shortness of breath no complain of headache or dizziness.
Positive COVID home test. Runny Nose, Cough, Fatigue, Congestion, Headache
gave monovalent moderna covid booster. The state had not yet issue vs the bivalent covid vaccine.
No additional AEs were reported.; Nurse reported that a patient received an expired ROTATEQ.; This spontaneous report was received from a licensed practical nurse concerning a 10-week-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not provided.   On 14-JUL-2022, the patient received orally an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1742079, expiration date 08-JUL-2022 for prophylaxis (Expired product administered) (Dose was not provided). No additional adverse events were reported (No adverse event).
Patient experienced swelling in her lower left extremity for a week after vaccination, beginning the same evening as vaccination. She also claims that her chronic migraines have ended since her vaccination. She also claims that she has not had a herpes outbreak since the vaccination and she would normally have one at least once a month.
On 4/1, pt was given the vaccine that was not diluted.  Patient and father had left the office when the mistake was noticed, physician was notified.  Physician advised to call parents and inform them of mistake and advised to watch pt. for any severe reaction to the vaccine such as nausea, vomiting, fever, headache and if he had any of these symptoms to contact our office or seek medical attention.  Father stated pt. was fine but he would watch and call if any changes.  Follow up call on Monday, 4/4, spoke to father again, he reports that pt. was fine and at school.
A physician reported via a company representative, that a 3 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a "high" fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ1480025MAR2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.
Chills, fever (102.9), diarrhea  fatigue, muscle pain in back, knee, and arm,
Foggy headed for the next day; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 16:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included minerals nos, vitamins nos (CENTRUM MULTIVITAMIN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 08:00, on the next day of vaccination, the patient felt foggy headed. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event foggy headed was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Death 04/23/2021  Causes of death listed on death certificate: 1. hypoxic respiratory failure  2. covid 19  3. diabetes mellitus  4. hypertension
Had soreness and pain in arm and shoulder up to 15 days or more after vaccine. (Believe assistant inexperience, took 4-5 attempts to get blood test).
Information has been received on 04-APR-2017 from a female pharmacist referring to a pregnant female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  The pharmacist reported that on an unspecified date, an unspecified pregnant female patient was inadvertently given a dose of GARDASIL 9 (Site of administration, route of administration, Lot number, expiration date, and indication not provided.)  No adverse effects reported. No additional information was provided. Additional information has been requested.
Stomach problems, difficulty breathing which lasted for 3 days but very bad the 1st night. Fever 1st night. Swollen area where the shot was administered. Lasted for 2 months.
My dad suffered what I believe to be a blood clot in his lung on April 6th, directly related to the second pfizer covid vaccination. Though chronically ill, he was not sick at the time, which was 4 days after the vaccine. He walked up the stairs, collapsed at the top, walked again to the chair, collapsed and then made his way into the chair where he told me "I can't breathe." and then slumped over. My mom and I lifted his limp body up and noticed he was not breathing.  We moved him to the floor and started life support measures. About 5 minutes later the paramedics arrived.  They were eventually able to get his heart and breathing going again about 14 minutes later.  He was moved to critical care.  After it became apparent he suffered irreparable brain damage, I stopped the life support measures (ventilator) and he passed away shortly after on Friday the 9th. They were continuously removing blood from his lungs while he was there. There was no indication he would die prior to this incident. Though we attempted to tell the critical care doctors about his recent vaccination, they were not receptive to the suggestion that this may have caused the incident that proceeded his passing. My mom did try the heimlich and there were indications that he had breathed in vomit, but he had stopped breathing before this and therefore his cause of death WAS NOT aspiration. He also had fallen the day after the vaccination (Saturday) and the notes indicated his broken ribs were from the CPR measures but this is in error as well as he had broken his ribs in the fall. It is my opinion the broken ribs caused a bruise in the lungs, the vaccination caused excessive clotting, and when he was coughing shortly before the incident it loosened the clots that then caused a pulmonary embolism.
EMERGENCY PHYSICIAN PROVIDER NOTE     FINAL IMPRESSION 1. Vaccine reaction, initial encounter      ED COURSE AND MEDICAL DECISION MAKING   48-year-old female with a history of diverticulitis persisting despite oral Augmentin who was admitted yesterday for IV antibiotics and received Covid 19 Johnson & Johnson vaccination presents with anxiety and shortness of breath.  She is scheduled to start IV ertapenem infusion today.  No evidence of anaphylaxis or severe reaction at this time.  She was treated with 1 g IV ertapenem as scheduled in the ER and monitored closely without evidence of serious reaction.  She was reassured and advised she can follow-up as scheduled in the infusion clinic tomorrow.   Return to ED instructions discussed and provided. Pt discharged from ED in stable condition.
Inflammation of small bowel at terminal ileum; abdominal pain, distention with vomiting.  Small bowel obstruction. Admitted to hospital; NG tube to suction X 2 days. Discharged home with follow up with GI.  Futher testing (CT-E, fecal studies and labs) ALL negative for any type of inflammatory bowel disease. No other, or  chronic, cause for sudden small bowel inflammation
Vaccine given 12/29/15. Patient called 12/30/15 to report some redness in area. We called pt today and redness spread and swollen. Saw provider, diagnosed cellulitis and antibiotics given.
Anaphylaxis or anaphylactic shock  Treatment: Epinephrine, Benadryl and steroids
given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination. Not known if patient had any chronic or long standing health conditions  No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Pt vaccinated with Influenza vaccine developed diarrhea, flu-like symptoms, rash, fatigue, nausea, fever.
pt recv vax 31JUL95 & 16JAN97 pt devel full-blown chickenpox consisting of many more than 50; at least 1000 lesions;it was reported that the pt was on no other med & is otherwise healthy;
Following covid-vaccine menstrual cycle was due following week on 04/30/2021 as normal -- period was extremely heavy unlike normal, following 2nd dose of covid (05/20/2021) vaccine was extremely heavy  on 05/24/2021.  June cycle was somewhat more normal(shorter) and July 16 started menstrual cycle somewhat more normal. Since the end of 5 day period that started July 16 I have not had a cycle since -- about 55 days ago. The only change in life has been the vaccine.
Woke up suddenly at 1am on 2/5/2021 with increasing neurological symptoms similar to a migraine aura. There was a no obvious pain, but a sense of deep heaviness/pressure/sinking/dizziness in my head and body.  Bilateral tingling/numbness, but still was able to move legs and arms.  Did not lose consciousness. My first thought was seizure or stroke. I later spoke to an infectious disease doctor that thought it may be brain vessel spasm due to inflammatory response from vaccine. I had no side effects from first COVID shot other than arm pain.
Patient is a 79 y.o. male patient of DO with history of ESRD, T2DM, myasthenia gravis, BPH, and Covid-19 presented to Hospital with worsening SOB.   Acute Hypoxic Respiratory Failure Severe sepsis due to pneumonia  Covid-19 Pneumonia Presented with four day hx of worsening SOB, cough, and intermittent chest pain Afebrile on arrival, HR 110, RR 30s, BP 160s/70, satting 94% on BiPAP Troponin negative x2 (26 => 36), D-Dimer 2.57 Initial CBC with WBC 0.83. Lactate 10.7.  CXR - multifocal pneumonia, CT Pulm arteries: multifocal airspace consolidation in all lobes. No PE. Cirrhotic morphology of the liver with findings of portal hypertension in the imaged upper abdomen Started on empiric antibiotics with vancomycin and zosyn MRSA nares pending Was empirically started on anti-fungals by eICU. ID and CC consulted, recommend holding on antifungals currently Started on decadron as COVID-19 + as well as remdesivir per ID recommendations as approx 5 days since symptom onset and already ESRD No Tocliziumab due to concern for bacterial pneumonia LA remains elevated, suspect delayed clearance in setting of possible cirrhosis, ESRD On Vapotherm, wean oxygen as able Blood cultures with 2/2 Gram positive cocci in pairs and chains, appears to be strep pneumonia Urine culture with GNB Continue antibiotics per ID, being switched to ceftriaxone Code status now updated to DNRCC after discussion with CC attending However plan is to continue antibiotics, lab draws, HD and oxygen, but to not escalate above current settings Continue vapotherm, wean as able, no bipap, no intubation, no NRB Patient moved out of ICU Patient expired morning of 12/2   New Onset A.fib with RVR Started on cardizem drip due to a.fib with RVR Cardiology consulted Appears to have converted to NSR, started on PO cardizem Echo with normal EF and questionable wall motion abnormality  Pancytopenia Chronic thormbocytopenia WBC of 0.8 on admission, Platelet count 75K (B/L 120-150) Suspect likely due to viral illness, sepsis WBC improving, no evidence of schistocytes Continue to monitor   Delirium Patient became delirious last night Was trialed on precedex but did not tolerate it Can trial seroquel   ESRD  Hyponatremia, mild  Undergoes HD MWF Nephrology consulted for HD management   T2DM Glucose 328 on admission A1c of 6.3 On NPH 15 units BID and SSI Monitor and adjust as needed   Myasthenia gravis  Continue home medication   BPH Continue home flomax
Patient presented with signs of myocarditis and pericarditis on 11/11/2021 several weeks after non-specific viral symptoms. Also with family history of cardiomyopathy and rhythm issues. He received Pfizer COVID vaccines on 5/13/21 and 6/3/21 so this is outside of reported timeframe for post-vaccine myocarditis but felt it was best to report out of caution. He is hospitalized and receiving scheduled toradol with stable symptoms, stable echo, and downtrending troponins.  Case is being discussed with cardiology at hospital.
sit reaction. swelling, and heat at site of injection, using Zyrtec for itch as well as topically cortisone
STROKE; BLOOD CLOTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient did not have high blood pressure or cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date was unknown) dose was not reported, 1 total administered on mid MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In APR-2021, patient had a stoke then blood clots. Patient was on wheel chair and her entire left side was paralyzed. Patient had been staying with her mom because her house had ramps and handicap bars. A ramp had been built at patient's house so that patient could live at our home with her husband.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blood clots was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210802862-covid-19 vaccine ad26.cov2.s -Stroke, Blood clots. This event(s) is considered unassessable. 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.
Patient received Varivax booster 4-17-07 on 4-18-07 patient had swelling, redness and warmth at site of injection per patient's mother. Gave Benadryl to treat.
Information has been received from a physician concerning a 75 year old female on 16-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported).  Concomitant therapy included losartan potassium (manufacture unknown), ibuprofen, simvastatin (manufacture unknown), aspirin, L-Thyroxin.  The patient developed monocytosis and anemia after administration of ZOSTAVAX (Merck).  On 28-FEB-2011 the patient reported to the office complaining of malaise.  A complete blood count revealed White blood count 13,200, Hemoglobin 9.8, Hematocrit 29.9, monocyte 72%, lymphocytes 18%, neutrophils 7.1%.  A preliminary diagnosis of acute myeloid leukemia was made.  The patient was given unspecified treatment.  The patient was scheduled to see an unspecified hematologist later "today", 02-MAR-2011.  As of the reporting time, the patient present status was unknown.  Upon internal review, acute myeloid leukemia considered to be an other important medical event.  Additional information has been requested.
c/o itching w/whelps all over about 5hr post vax;no other problems;
dizzy; sweats / sweating; fever of 101f; felt like she could not get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 08:30 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation; guanfacine (GUANFACINE) (Batch/Lot number: unknown). Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. Past drug history included: None known. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 17Dec2021, for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "dizzy"; HYPERHIDROSIS (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "sweats / sweating"; PYREXIA (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "fever of 101f"; MOBILITY DECREASED (non-serious) with onset 08Jan2022 07:00, outcome "recovered" (08Jan2022), described as "felt like she could not get up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, hyperhidrosis, pyrexia, mobility decreased.  Additional information: Additional information: The fever lasted for several hours. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. No other vaccine in fourweeks. No treatment taken for the adverse events. No covid prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning a patient at an elementary school of kindergarten to fourth grade, who on 11/06/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#627337/1057H).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than 50 pox and was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
About 10 minutes after vaccine administration, patient explains that she experienced numbness over her entire body.  Patient also stated  that she felt hot over her entire body.  Nurse advised patient to remove extra layers of clothing. Patient?s Initial Blood Pressure  taken was 162/100, patient drank a sports drink, vitals rechecked 10 mins later ; BP 136/90, Pulse 84. Patient reported feeling better.
Shoulder was a little sore; arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age (reported for himself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he heard that the second dose can cause more side effects and he stated he and his wife both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130328 same reporter and drug, similar events, different patient