chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional, for the Pregnancy registry for GARDASIL, concerning a male baby patient whose 24 year old mother with tobacco use and a history of 1 pregnancy and 1 live birth was vaccinated intramuscularly with the first, second and third 0.5 ml doses of GARDASIL on 03-DEC-2007, 04-FEB-2008 and 04-JUN-2008, respectively (lot # of the 2nd dose: 655327/1287U; lot # of 3rd dose: 655604/0052X). There was no concomitant medication. The mother was two weeks pregnant while receiving the third dose of GARDASIL. The pregnancy test was positive. On 23-SEP-2008, ultrasound was performed with normal result. On 15-OCT-2008, maternal serum alpha-fetoprotein (MSAFP) was performed with negative result. On 13-FEB-2009 (Weeks from LMP: 39), the baby was born with congenital anomaly cleft palate, weight: 8 pounds 3 oz and Apgar score 8/9. As of 01-JUL-2009, the outcome of cleft palate was unknown. Follow-up information was received from a nurse who reported that the baby was born with congenital anomaly cleft palate and cleft lip, height: 22 inch. The baby visited a cleft craniofacial center on 18-FEB-2009 and visited an audiology center on 09-JUN-2009. At the time of reporting, the outcome of cleft palate and cleft lip were unknown. Follow-up information was received from a nurse via medical records indicating that the baby's Apgar was 8 at 1 minute, 9 at 5 minutes. Birth weight was 8 pounds and 5 ounces. He failed the newborn hearing screen of the left. The baby was born with cleft lip unilateral complete and cleft palate unilateral complete. On 25-FEB-2009, the infant was 12 days old. This was a well visit. It was noted that the cleft lip and palate would be repaired when the child was 4-6 months of age. On 04-SEP-2009 the patient had cleft lip repaired and had myringotomy with tubes. On 17-NOV-2009 the patient presented for a scheduled 9 months well child visit. He had ear tubes. Physical exam showed tympanic membranes normal landmarks, no fluid or erythema bilaterally. At the time of this report, the patient's outcome regarding cleft palate was unknown. The reporting health professional considered cleft palate and cleft lip to be other important medical events and disabling. The mother's experience has been captured in WAES #0807USA03163. The baby also experienced adverse events after being vaccinated with hepatitis B vaccine (manufacturer unknown) (WAES#0912USA01491). Additional information is not expected. All available medical records will be provided upon request.
Throat itching; Trouble breathing; This is a spontaneous report from a non-contactable pharmacist. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via intramuscular route of administration in the right arm on 24Feb2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced throat itching and trouble breathing. It was reported that the patient was assessed and water was given, and the patient felt better in 20 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events throat itching and trouble breathing was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Hives on left side of face. Left eyelid and under eye swollen. 2.5 mL of BENADRYL administered by mouth.
I had racing heartbeat, SOB, and dull ache in my chest. The pain has moved up in my neck and my bottom teeth. The pain in my chest feels like a stabbing when I move now. I been to a walking in clinic twice, my doctor a few times, and a cardiologist once about this. They did 2 chest X-ray, 3 EKG, 2 blood work, and Echogram on my heart, all came back normal. I am wearing a heart monitor right now.
This spontaneous report was received from a physician, via a company representative, referring to an unknown number of child patients between 5-6 years old, of unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients developed pertussis. At the reporting time, the outcome of pertussis was unknown. The causality assessment was not provided. Upon internal review, pertussis was considered a medically significant event. Sender's Comments: US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1905USA004179: US-009507513-1905USA004178: US-009507513-1904USA013391: US-009507513-1905USA004177.
About 12 hrs after the vaccine I developed a excruciating headache, loss of appetite, fever, body aches and extreme fatigue which lasted for about 48 hrs and by the 3rd day I developed diarreah which lasted about 12 hrs. On 6/29 I felt a small lump in my right breast. Reached to my Gynecologist who advised I have a biopsy done.  A monography was done and biopsy on 7/1 and 7/7 the results came back that I have Invasive Ductal Carcinoma.  I had a bone density scan done d/t the meds taken and that revealed I have bad Osteoporosis.  I have to see an Endocrinologist to see if I have any underlying condition that could have resulted in me having Osteoporosis.  7/20 I had a lumpectomy to remove the lump in the breast.  21 days of radiation has been performed on my right breast and now I am currently taking Arimidex, a hormone blocker as part of the treatment for the breast cancer and have to take IV infusions of Zometa for the osteoporosis
Numbness of right arm down to the fingers; Slight swelling of the right arm down to the fingers; Facial swelling around the mouth and cheeks; Accelerated heart rate; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 14:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient previously took ciprofloxacin and experienced drug allergy. The patient was allergic to sulfa drugs and ciprofloxacin. 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 vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 09Apr2021 at 15:00, the patient experienced numbness and slight swelling of the right arm down to the fingers within first 30 minutes and continued for several hours then reduced to light swelling without numbness into the next day and then "tapered off". On 09Apr2021 first night of vaccine, patient noticed that facial swelling around the mouth and cheeks with slight numbness which disappeared during the day then returned again next night with less noticeable swelling around the mouth. On 09Apr2021 and 10Apr2021, during the first and second night of vaccine patient noticed an accelerated heart rate which kept patient up for a few hours but patient felt asleep and awoke fine. Patient was told that she was breathing "funny" like a dog on the first night of vaccine which prompted her fiance to woke up and make sure she was fine.  Patient felt fine when she was awakened. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the events numbness and slight swelling of the right arm down to the fingers was recovered on 10Apr2021 after the duration of 1 day. The outcome of the event accelerated heart rate was recovered on 11Apr2021 after the duration of 2 days. while the event of facial swelling around the mouth and cheeks was recovered on unspecified date Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SHOULDER PAIN; BODY WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shoulder pain. On 12-APR-2021, the subject experienced body weakness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 13-APR-2021, had not recovered from nausea, and the outcome of shoulder pain and body weakness was not reported. This report was non-serious.
pt recvd vax & given apap after vax; 6pm turned blue; pale; limp & cold; to er, all test nl;
Dizziness, palpitations and not feeling well followed by confusion/altered mental status, chills and weakness 4 days later. Presented to medical center with bacteremia & hypotension on 4/26 PM.  Transferred to same medical center on 4/29 with concerns for myasthenia crisis.
Chills, fever, severe whole body aches that are ongoing after three days. Concerned that this may be Guillain-Barré Syndrome as I have never had this reaction to the flu vaccine before. Also the steroid QVAR may be impacting my body's ability to manage its immune response.
Exacerbation of oral lichen planus immediately after receiving Pfizer-BioNTech; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "oral and cutaneous lichen planus" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Steroids for oral and cutaneous lichen planus, notes: topical. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: LICHEN PLANUS (medically significant), 24 hrs after the suspect product(s) administration, outcome "recovering", described as "Exacerbation of oral lichen planus immediately after receiving Pfizer-BioNTech". The patient underwent the following laboratory tests and procedures: Sialometry: 0.3 mg/3 min, notes: resting; 2.1 mg/3 min, notes: was reduced stimulated. Therapeutic measures were taken as a result of lichen planus.  Clinical course: The history of oral and cutaneous lichen planus managed with topical steroids received the Pfizer-BioNTech vaccine in February and March 2021. Twenty-four hours following the second dose, she reported a feeling of "mouth on fire" which continued for 2 weeks. She was seen in July 2021; she had gingival erythema and striations extending into vestibular mucosa Saliva production was reduced (resting 0.3 mg/3 min and stimulated 2.1 mg/3 min). She has prescribed topical clobetasol and bethanechol for dry mouth. At one month follow-up, a significant reduction in erythema was seen.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200111251 Same article/ drug/event and different patient:;
Donor stated having circular raised areas reddish in color fading and coming back, painful on both left and right wrists.
Left arm swollen, red, hot, itchy, fever of 100.4, 1 day, generally felt bad. The redness, swelling, itchy, and feeling bad lasted 2 weeks. Treated with benadryl and ibuprohin.
Patient is fully vaccinated and boosed on 10/27/2021.  COVID + 1/25/2022 on admission to hospital. This patient was admitted through the emergency room because of sudden onset of the atrial fibrillation with RVR. Recently diagnosed with DVT.  The patient has been started initially on IV drip of Cardizem and she switched short-acting Cardizem for 6 hours. The patient did remain in normal sinus rhythm.  Cardiology consultation was made.  The patient had 2D echo without any abnormality with ejection fraction over 50%. ON Eliquis. CT chest:  No evidence of acute pulmonary embolism. 2. No acute process. Discharged home.
2 days post vaccine, woke up with a rash to bilateral palms and arms that stop at the shoulder.  small  maculopap bumbsular from palms to shoulder, skin is sensitive to hot and cold, rash is "itchy and painful," denies skin peeling, took zytrtec with no relief, also complains of low energy/fatigue, appetite is ok, denies fever, approximately 12 hours later noticed rash to abdominal region, same maculopapular bumbs across  bilateral upper abdoment, denies shortness of breath
3RD DOSE PFIZER COVID VACCINE GIVEN 10/26/21, #FE3592; Pt had a positive COVID test on 6/27/22; pt had pneumonia, COPD exacerbation, AHRF; was dc'd to nursing home; in nursing home was found without life signes; EMS called; pt taken to Medical Center and pronounced deceased
Arm pain at sign of vaccination began 2 hour after injection. No redness, no induration, no fever. Symptoms resolved after 2 days.
Information has been received from a physician concerning an approximately 25 month old female patient who on 05-JUN-2008, 29-JUL-2008 and 30-SEP-2008 was vaccinated with a first, second and third dose of ROTATEQ. Subsequently on an unspecified date the patient experienced rotavirus infection after receiving ROTATEQ. The patient was hospitalized. Subsequently, the patient recovered on an unspecified date and released after treatment. Additional information has been requested.
a leg cist or cancer tumor; a leg cist or cancer tumor; loss of nerve damage; diabetes drops real low; I can die at any time, my functions are all out of walk.; This is a spontaneous report from a contactable Other health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Jan2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Booster dose was administered. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced a leg cyst or cancer tumor, loss of nerve damage with, diabetes drops real low and he can die at any time, his functions were all out of walk. Patient mentioned that, he need serious help. He lives in a nursing home and was having serious health issues after getting the 2 doses of the Pfizer covid vaccine. He said that approximately 2 months ago he received the second dose and about the same time a leg cyst or cancer tumor started growing on him. He was going to pursuit a lawsuit against Pfizer and he was looking for legal counsel. He said he had photos to send to prove this. Patient reported that, he was going through serious symptoms after he got his second shot. he now had to see a surgeon, loss of nerve damage and diabetes drops real low. Patient said, I felt like I can die at any time, my functions are all out of walk. Outcome of the leg cyst or cancer tumor was not recovered whereas outcome of the loss of nerve damage, diabetes drops real low and i can die at any time, my functions are all out of walk were unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.; Sender's Comments: Based on limited information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Received second vaccine, and 3 days later developed left chest pain, with occasional fluttering in her chest. Symptoms come and go. She has been to Urgent Care twice, and PCP once, and ER once. Wore a 48 hour Holter Monitor with results pending.
mom called on 13SEP93 stating during previous noc, pt was sleeping & observed jerking of rt side-rt arm & rt leg that lasted 35 mins; pt difficult to arouse p/episode;
Lightheaded, nausea, headache, diarrhea, tingling sensation in legs, feet, and fingers. Flushing hot and cold chills. Low grade fever.
Was feeling well up until 4 days ago.  Since then, he has developed progressive shortness of air and generalized weakness.  He does endorse cough productive of greenish sputum.  He has been taking his temperature at home and reports temp of 99-100, which are high per him.  He is also having generalized weakness, to the point where he cannot walk more than a few steps without feeling extremely fatigued.
This is a spontaneous report from a contactable physician. A patient of unknown age and gender received TRUMENBA single dose on unknown date. The patient experienced wheezing 24  hours post vaccination. No history of asthma or ever having wheezing. The patient also experienced a slight fever on unknown date. The patient received albuterol and QVAR as treatment for the event wheezing. Chest X-ray was clear and full blood count was unremarkable. The outcome of the events was unknown. Follow-up (08MAY2015): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 07-FEB-2017, the patient was vaccinated with a dose of VARIVAX, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
THE PATIENT RECEIVED THE 11 YEAR SHOTS, TDAP IN THIS CASE BOOSTRIX BY GSK AND MCV, MENVEO ALSO FOM GSK. EACH ONE IN EACH ARM. SHE STATED THAT SHE FELT DIZZY AT THE ELEVATOR OF THE OFFICE'S BUILDING. TWO HOURS LATER SHE FELT SICK VOMITING AND WITH HIGH FEVERS. HER MOM TOOK HER TO THE HOSPITAL LATE AT NIGHT BECAUSE THE FEVER WON'T LOWER AND THE VOMIT DID NOT STOP. THEY RUN SOME LAB TEST AND HER BLOOD PLATELET SEEM LOW. THEY GAVE HER ANTIACIDS AND AN IV. HER MOM TOOK TO HER PEDIATRICIAN AND RUN SOME LABS AGAIN AND EVERYTHING SHOWS NORMAL. BUT THE PATIENT STILL FEELS WEAK AND STIFFNESS IN HER NECK. SOUNDS AND LIGHT SEEMS UPSET HER TOO. THEY WILL TAKE HER AGAIN TO HER PEDIATRICIAN NEXT WEEK.
Itching that started few minutes after the vaccine was given. Pt. reoprted it was very itchy and is bothering her. There was localized redness around the injection site. Itching was decreased substantially.
Tenderness pain swelling on left deltoid. Txd with Keflex 500mg 2x a day x 5 days.
24 hours of hypotonia; limp, staring blankly or sleeping, not crying, not reacting, nursing very little (sxs c/w HHE).
Approximately 7 minutes into observation, patient had a blank stare and became unconscious: sternal rub and awoke within a few seconds. Brought via wheelchair to a stretcher. Vitals taken. Patient C/O numbness and tingling in hands and feet and being hot. Ice packs to head and neck.  Rested for a few minutes. Reported high anxiety around getting the vaccine and had been awake all night on call shift.  Patient rested for about 20 minutes.  Vitals signs taken. Was able to walk.  Instructed to follow up with PCP if symptoms continued.
Pt states stomach cramps lower abd. and full body aches. Pt states fever-but has not checked temp with thermometer. Symptoms started on 06/21/2002 late afternoon around 4pm.
I had an EKG done on Monday, 26 July and when I saw my primary care physician today, July 28  for pre-op for a shoulder surgery scheduled for August 10th, the doctor told me my EKG was abnormal and it shows signs of myocarditis (enlargement of heart)
Day of vaccine site was the size of a quarter, the next day 1/2 dollar size, 8/19/10 almost the size of a baseball. Red and tender to touch. Puffy.
Patient developed chest pain starting 3 PM on 5/17. Presented to a local ED for this on 5/18 and was found to have elevated troponin level. Transferred to a hospital with pediatric floor and was seen by a pediatric cardiologist. Echocardiogram notable for evidence of pericarditis but normal cardiac function. Given concern for development of arrhytmia, transferred to a hospital PICU. Chest pain was mild to moderate, stabbing, and was somewhat relieved by antinflammatory therapy.  He never had fever, chills, vomiting, diarrhea or rash. He had no ill contacts. He had no history of prior COVID nor did his family
Approx 24 hours after bee sting in upper left, arm became red and slightly swollen , mostly below (toward the elbow) the sting location.  Swelling progressed toward the elbow and about halfway around the arm.  Total area was slightly larger than my palm.  Area was slightly sore.  (It had not been sore about 6 hours after the sting, and had only a small, dime-sized swelling after the sting.)  Approx 48 hours after the sting, an egg-like swelling occurred below the elbow, without discoloration.  Slightly sore, mostly stiff.  Then the discolored area began to itch.  Swelling gradually subsiding 72 hrs after sting, but itching continues.  I have never had this kind of reaction to a bee sting.  The sting reaction itself appeared to have subsided in the first 4-6 hours, leaving just a tiny red spot with a dark center dot.