chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered mental status, hemoglobin of 4.6 with creatinine of 2.53, patient has lactic acidosis, anion gap metabolic acidosis.  Stool Hemoccult is positive, platelet count of 23,000 noted.  Patient is awake but confused, patient's son is by the bedside.Patient has diffuse oozing from multiple skin wounds,Patient has received 2 units of blood along with 2 units of platelets and 2 units of FFP.  Fibrinogin of 209. Hematology service recommended starting dexamethasone for suspected ITP.  Patient is a PMH of  spontaneous subdural > 20 years ago, surgically evacuated, HTN, Hypothyroidism ,pre-diabetes who presented to the ED with CC of AMS and slurred speech x 1 day.  History obtained from son at bedside and chart review. At baseline patient is reportedly very independent and able to ambulate in the home without assistive devices. He handles his own ADLs. Patient reportedly received his 2nd dose of the COVID vaccine on Monday and since then has been experiencing fatigue and generalized weakness, in addition to decreased appetite.  AMS started yesterday.  He reportedly fell out of bed last night around 2 AM and family found him at 7 AM on the floor. Denied loss of consciousness. He was evaluated by Stroke team, CT of the head was un-revealing for an acute process and stable chronic changes, and CTA revealed some mild intracranial stenoses, Stroke team felt was unlikely to be an acute stroke. He was found to have Hb 4.6 on admission. Platelets were 23, He was transfused 1 unit of blood and 1 unit of platelets. Hematology was consulted and recommended dexamethasone 20 mg daily for 3 days. Rectal exam was done and he was found to be Guaiac positive was started on Protonix 40 BID.
Patient vaccinated for COVID 4/30/21. Admitted 8/22/2021, tested positive for COVID 8/22/21. Discharged 9/1/2021 to Rehabilitation Hospital.  History of present illness: This is an 86 year old female who presents to ED with left hip and pelvic pain s/p mechanical fall. Pt. was making herself breakfast when her legs gave out. She denies hitting her head or LOC. No preceding chest pain, palpitations, shortness of air, dizziness. Pt. had immediate pain after fall, but was able to get up and call family. Pt. reports chronic pain making mobility an ADLS difficult. She has fallen in the past but not recently. She denies any recent fever/chills, dysuria, cough, nausea/vomting/diarrhea.   XR PELVIS 1 OR 2 VIEWS, XR CHEST 1 VIEW IMPRESSION: No acute traumatic findings in the chest or pelvis. Chronic findings as above. Bilateral hip hardware without evidence of hardware complication.  #Leukocytosis - Pt. afebrile with WBC (11.8). No obvious source of infection. Elevation likely 2/2 stress response. - continue to monitor   Chief Concern, Brief History of Present Illness, and Hospital Course   Patient is a legally blind 86yoF with a PMHx significant HTN, scoliosis, anxiety, osteoporosis, right THA, left femoral ORIF who presented to ED with left hip and pelvic pain s/p a mechanical fall after her legs gave out at her kitchen sink. Patient denied hitting her head or LOC. Xray of her pelvis showed no acute traumatic findings in the chest or pelvis with bilateral hip hardware and no hardware complications. CT C/L/T spine w/o IVCON and CT bony pelvis showed no acute fracture of the c/t/l spine with malalignment and chronic deformity noted; acute mildly displaced fractures of the left superior and inferior pubic rami. Ortho fracture was consulted and noted non-operative management. Weight bearing as tolerated and will follow up with patient on September 21st as outpatient. PT/OT evaluated patient and recommended acute rehabilitation.  While admitted, patient initially Covid positive, however patient clinically asymptomatic and states that she had not been away from her house nor around other persons for approximately the last year. Repeat covid testing on 8/23 negative and 8/24 negative as well. Patient also agreeable to weaning benzodiazepines during hospitalization as could potentiate risk for falls while at home and can also increase risk for delirium in conjunction with her being blind at baseline. Patient is now appropriate for discharge to acute rehabilitation.
Patients arm started to hurt in afternoon, by the evening dizziness to where should could not walk. On the following day, could barely walk, her speech was low and hoarse and her vision was not good.  Given Tylenol by family members with additional food and water. The following day taken to PCP for blood work and a CT Scan w/wo contrast of the brain with lacunar stroke resulted.
Received SP vaccine 3/7/2002; on 03/15/02 Developed erythema, lymphangites, body aches, increased drainage @ site, pain  left arm 2 degree swelling. Treated with Ceftin 250mg BID X 5d; 3/18/02 Reevaluated - cellulitis lymphadenopathy resolving
Developed +PCR for rotavirus; developed symptoms (it is unknown to reporter what the symptoms were); This spontaneous report was received from a physician via company representative and refers to a 6-month-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On an unknown date, at the age of 2 month-old the patient was received first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and on an unknown date in 2021, at the age of 4 months old, the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered, both orally as vaccine (exact dose, lot number and expiration date were not provided), and the patient tolerated those doses without any side effects.  On-09-APR-2021, the patient received the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot number and expiration date were not provided) and developed symptoms (it was unknown to reporter what the symptoms were). The patient sought for medical attention. On 15-APR-2021, the patient was seen at urgent care and in the emergency room (ER) on 17-APR-2021, and the patient had a positive the polymerase chain reaction (PCR) for rotavirus in ER.  The outcome of gastroenteritis rotavirus and ill-defined disorder was unknown. The causality assessement was not provided.  Upon internal review, the event of gastroenteritis rotavirus was determined to be medically significant.
Information has been received from a registered nurse concerning her 12-year-old daughter with a history of chickenpox (2 vesicles at 6 weeks of age) who at age 9 or 10 (in approximately 2003) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In the "spring of 2006", a few years after vaccination, the patient developed zoster on the right side with a T1 distribution. She was seen in the physician's office and was treated with acyclovir. It was reported that the zoster went down then up her right arm and lasted for several weeks. The sensitivity at the area of the zoster lasted 6 months and the daughter presently has scars at the zoster site. Subsequently, the patient recovered from zoster. No product quality complaint was involved. Additional information has been received from a woman from a physician's office stating that the patient is no longer a member of their practice (since 01-JUL-2004). She confirmed her date of birth to be 14-JUN-1994. A response was received by a physician indicating that she was never notified of this by any patient. Additional information is not expected.
Pt devel measles following vax w/measles vax; No further details were provided;
pt recvd vax;  swollen, red, hard & itchy; sauve & pills for itching; seen at hosp; clear up 7jul94;
Patient was given the first dose from a vial that was expired, from 30 days of date it was received. The Moderna Vaccine dose was  inadvertently administration past the 30-day.
Rash, bumps at injection site. Nausea. According to patient, reaction persisted for 14 days.
DTaP lot expired on 5/17/17 and was administered after the expiration date on 5/23/2017. No signs, symptoms, or issues resulted in vaccine being administered after the expiration date. Patient tolerated the vaccines.
2nd day redness. Tired on second day. Sore, tender to touch, warm. 1 week aches all over and chills. IBU for treatment.
Pt received multiple vaccines during one visit. Received MMR, HepA, and Pneumococcal vaccination.  VAQTA was the only vaccine that listed latex as an ingredient and due to the pt's report of allergy to Latex, it is assumed that the reaction was to the Hep A vaccine. However, since multiple vaccines were administered in one arm, it is not possible to definitively determine which was the offending agent.
Legs are bloody and stuff; Legs are bloody and stuff; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff). At the time of the report, SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) outcome was unknown.            The Concomitant medications and Treatment information was not provided.
Low blood pressure 2 days ago 96/54.    Very light headed. Also I have a lump on my right arm 3? hurts, red and itches.. in width and hot to touch. It has been present for 5 days
Fever (101) 2 week Aches 4 weeks Chills 2 week Nausea 2 week Sleep paralysis 2 nights Chilblains ongoing Breathlessness ongoing Tremors/ticks 2 weeks Psychosis 3 weeks Visual and auditory hallucinations 2 weeks Delirium 3 weeks Confusion 3 weeks Unable to track time 3 weeks Lethargy 4 weeks Weakness 4 weeks Nightmares 3 weeks
Extremely high fever (103), sore throat, muscle aches, nausea, dizziness, arm red and swollen.
Fever up to 104, night sweats, malaise, fatigue, joint pain, mild gum bleeding after brushing teeth, decreased appetite, sore throat, mild global headache, and mild menstral cramps with increased bleeding.
began itching @ the back of neck;devel hives;8MAY97 d/c allerg rxn to HBV;had swelling of eyes & red blotchy on elbow, back & feet;resolved now x/for some itching;
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
5/20/08 GARDASIL & ADACEL.  6/11/08 - Nausea, abd pain, fatigue, purpura hands to forearms, axilla soles feet to ankles.  9/23/08 Reviewed PCP medical records of 5/20-6/13/08. FINAL DX: Henoch-Schonlein purpura Records reveal patient experienced good health on day of vaccination.  RTC 6/11 w/rash on hands, nausea, fever, fatigue, malaise, sore throat x 1 day.  Tx w/lotion.   10/28/08 Reviewed hospital medical records of 6/11-6/12/2008. FINAL DX: none provided.  H&P states likely viral illness Records reveal patient experienced fever, spreading petechial rash, sleepiness, mouth pain, difficulty eating, nausea, diarrhea, nosebleed, chills.  Tx w/IV antibiotics & d/c to home on continued oral antibiotics.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patient were vaccinated orally with unknown doses of ROTATEQ (lot # L022447 with expiry date 26-FEB-2017 and lot # L010837 with expiry date 16-FEB-2017), which were exposed to the temperature of 1.5 degrees Celsius for 265 hours and 19 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. was administered H1N1 flu vaccine intranasal instead of intravascular, no symptoms noted as of 12/16/09 - Thinking that there is no protocol no MD order in place.
Patient was brought in with rash all over body, swollen and red feet. Patient diagnosed with Urticaria and prescribed Orapred Solution, 15 MG/5ML, 7 ml PO QD x 3 days, then 3 ml QD x 2 days, Orally, Once a day, 5 days and Syp benadryl 5 ml every 6 hrs x 2 days. Patient told to use Calamine lotion.
Achilles tendonitis left leg with black and red bruises. Treated with stretch exercise initially. Treated with Voltaren started03/31/21
Ringing in my ear; felt pretty lousy/not as bad as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) and TINNITUS (Ringing in my ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose). On an unknown date, the patient experienced TINNITUS (Ringing in my ear). At the time of the report, FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) and TINNITUS (Ringing in my ear) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-433346 (Patient Link).
After patient reeived her 1st dose of Moderna and stayed for her waiting pencil she did go home and start "feeling itchy all over". No difficulty breathing or swelling. Benadryl taken by patient. Patient to go to clinic.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 16-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On 17-SEP-2015 (reported as within the last two days of receiving ZOSTAVAX, the patient developed a red welt (1-1.5 inches) at the injection site (injection site erythema), which was painful (injection site pain). The patient sought medical attention by calling the pharmacist. Ice to the site was reported as treatment for the patient. At the time of the report, the outcome of the patient developed a red welt (1-1.5 inches) at the injection site which was painful was reported as not recovered. Additional information has been requested.
Confusion, Dizziness, Diarrhea, NauseaVomiting, MUSCEL PAIN, AND FATIGUE Narrative:
Client called and reported, "having a Lupus flare up." Client reported feeling feverish and body feels like it is on fire. Client reported experiencing migraines, nausea, and weakness. Client reported having the same thing happen after the first dose for ten days, three weeks after the second dose, and still having symptoms up to date after the third dose. Client has had a follow up with doctor. No treatments at this time.
Pt mother had given at the vaccination site not at our facility. Our staff administered at the site. Pt developed hives and itching to face only. Denies any s/s of respiratory distress. Only symptom was rash/hives to face.
Initial and follow-up information has been received from a physician concerning a 4 month old male who on 17-SEP-2007 was vaccinated in the right thigh with a dose of PNEUMOVAX (Lot # 656233/0200U).  Concomitant vaccination on the same day included PREVNAR.  Other concomitant vaccination included ACTHIB (Lot #UF160AA).  Other concomitant therapies included DTPA (unspecified) (Lot #C2651AA) and tetanus toxoid and poliovirus vaccine and poliovirus vaccine inactivated (unspecified) (Lot #20547-2).  The physician also called Poison Control.  The baby waited in the office for 2 hours and no adverse symptoms were noted.  At the time of the report the patient's outcome was unknown.  On 26-SEP-2007 the physician reported that the boy was doing well and he had been calling daily to follow-up.  He also reported that the nurse had mistakenly given the child PNEUMOVAX instead of PREVNAR.  He reported that both vaccines were stored in the same refrigerator; however, they are clearly labeled and located on different shelves.  Additional information has been requested.
Information has been received from a health professional concerning a 10 year old male who on 18-APR-2007 was vaccinated with 0.5ml of varicella virus vaccine live (Oka/Merck) (lot# 656287/1508F). On 19-APR-2007 the patient developed swelling, heat, and redness in the arm in which he was vaccinated. The area affected was 2 to 3 inches in diameter. At the time of this report, the patient had not recovered. The reporter requested a lot check. Unspecified medical attention was sought. No other details were provided. No product quality complaint was involved. This is one of several reports received from the same source. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, 15 days after receiving SHINGRIX, the patient experienced shingles (serious criteria other: as per reporter) and pain. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: After receiving 1st dose of SHINGRIX, the patient developed full blown shingles. The patient went to the doctor on the day of reporting and was diagnosed with shingles. The healthcare professional stated that it was very painful for the patient and it was painful for her when clothes touch that area. The physician started her on shingles treatment. The healthcare professional believed that this was very coincidental since she received the vaccine 2 weeks ago. The healthcare professional did not have lot number or expiration date because the vaccine was administered at another location.
Lightheaded headaches. Chest discomfort and felt my heart rate pounding fast. There have been times when my pulse is unrealistic and irregular. My vision has been blurry. I have had several headaches and have been to the hospital on May 30 where they did blood work, X-ray and urine tests. They placed me on a beta blocker and have been improving. I get a heart monitor tomorrow and a stress test in a few weeks since they don't know what is wrong with me.
12 hours after her 2nd shot, patient complained of pain in her right arm near where she received the vaccine. 15 minutes later she woke up violently shaking. They appeared to be seizures but have since been identified by doctors as severe muscle spasms. These have continued for 2 days. She has been admitted to the hospital. The episodes seem to occurs 1-2 times per hour and remain fairly significant even after being administered Ativan.
He is having chest pain.; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0167), via an unspecified route of administration on 17May2021 (at the age of 17 years) as dose 2, single for covid-19 immunization. The patient's medical history included asthma. The patient had not taken Asthma medication for probably 3 years. The patients concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8736), via an unspecified route of administration on 26Apr2021 (at the age of 17 years) as dose 1, single for covid-19 immunization. There were no other products. The reporter stated that his son got the second round of Covid vaccination (Hence captured as covid vaccine) on the day before reporting and he had a side effect that was not listed on any of the information, so he did not know if it was a serious side effect or not. Reporter said he was having chest pain. No laboratory tests performed. The outcome of event was unknown.  No follow up attempts were possible. No further information was expected.