chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Date of Admission  01/11/2022   Date of Discharge  01/18/2022   Reason for Hospitalization   Pt states legs are swollen.   NH reports decrease in mental status.  COVID+. was crawling on floor at NH  Hospital Course   The patient is a 79-year-old female with a medical history of vascular dementia, A. fib, hypertension, hyperlipidemia, and chronic kidney disease stage 3B who was admitted to MICU on 1/12 due to acute hypoxic respiratory failure 2/2 COVID.  She was intubated in the ED on 1/12.  Extubated on 1/15.  Since extubation she was profoundly delirious.  Transferred from MICU service to general floor on 1/16 with a sitter.  However prior to transfer, patient developed Afib RVR with hypotension.  Given 500cc fluid and started on amiodarone bolus and gtt.  Showed evidence of acute renal failure and shock liver, and continued to be profoundly encephalopathic with labored breathing.  Lactic acidosis of 17.  In consultation with palliative care, discussed goals of care and agreed to transition to comfort care measures.  Patient died at 0546 on 1/18/22.  Discharge Diagnoses      1. Acute hypoxemic respiratory failure due to COVID-19     2. Acute encephalopathy     3. Acute renal failure     4. Shock liver     5. Atrial fibrillation with rapid ventricular response     Orders:   Culture Blood  Other Diagnoses   Ongoing  A-fib  Historical  No qualifying data  Consultants  Supportive/Palliative Care   Discharge Disposition  Deceased  Physical Exam at Discharge  Vitals & Measurements  T: 36.4 °C  HR: 102  RR: 18  BP: 101/62  SpO2: 84%  WT: 63 kg  WT: 66.9 kg (Dosing)  WT: 66.9 kg (Dosing)  BMI: 23.1  BMI: 23.1      Physical exam performed by Dr (Privacy).   Called to bedside to assess patient.  No Response to verbal, tactile, or painful stimuli.  No spontaneous breath sounds, pulses, or movements.  Pupils were fixed.  Time Spent  More than 35 minutes spent in the discharge of this patient.     Addendum by (Privacy) MD, on January 19, 2022 15:25:38 (Verified)    Attestation by (Privacy) MD, on January 19, 2022 15:25 I personally saw and evaluated the patient on the result date found in the header of this document.  I independently performed the critical/key portions of the Evaluation and Management service and discussed the management with the author of this document.  I agree with everything documented above.    Called to bedside to assess patient.  No Response to verbal, tactile, or painful stimuli.  No spontaneous breath sounds, pulses, or movements.  Pupils were fixed.   Date: 1/18/2022  Time: 05:46 am  Next of kin, including husband and children are not at bedside.  Called to son to inform  They have refused autopsy. Did not notify on-call pathology resident.   Addendum by (Privacy) NSS, on January 20, 2022 11:17:30 (Verified) Result type corrected from Death Summary to Progress Note per request of (Privacy)/Note corrections inbox.
Case number PHEH2014US024699, is an initial spontaneous report received from a nurse on 05 Dec 2014. This report refers to a patient of unknown age and gender. Nurse reported that patient received expired FLUVIRIN (batch number: unknown) intramuscular on 05 Dec 2014. No adverse reaction was reported. No further information was provided.
Patient developed a local reaction at site of Anthrax #1 vaccination 24 hours after vaccination.  Erythematous ring warm and measured approximately 3 inches by 3 inches.  Resolved over next 48-72 hours.
Pt started with redness and itching at injection site. Then developed anaphylactic symptoms, Pt was given Diphenhydramine and SOLU-MEDROL inj.
Started having flu like symptoms, low grade fever, and aches.  He then developed diarrhea.  This lasted for 5 days.
Rash, annular, appearing over upper extremities and trunk.  Vasculitis appearing on pictures.  Fading by 2 weeks post onset.
pt complaining about arm pain- says too high in shoulder- felt tingling sensation as if she hit funny bone and states is in too much pain. it was explained that it has not been 24 hours yet, but wants her side effect reported
One week after vaccination the injection site became extremely red, itchy, swollen, hard, and warm to the touch, expanding to roughly 4 inches in diameter. There was bubbling under the skin at injection site.  Pain radiated to the underarm and lymph node of left arm. Hydrocortisone cream did not help. Mupirocin ointment, Benadryl cream, and oral antihistamines (Benadryl and Zyrtec) for the following 3 days helped clear much of the redness, itch, and warmth, Some redness, swelling, and minor bubbling are still present.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is an initial report of an AE, received on 10Feb2016, with additional information received on 12Feb2016 for Protein Sciences FLUBLOK. Subject, a 38 year-old female teacher, received FLUBLOK Intramuscular on 10Oct2015. The subject reported that, on or around 31Jan2016, she contacted a strain of Influenza and FLUBLOK is a possible relationship in light of the safety profile information that individuals with immunocompromised may not respond to the vaccine. In summary, this case report does not change the known safety profile of FLUBLOK.
Following 2nd dose COVID vaccine, the patient complained of itching in torso and arms, diaphoresis also noted. The nurse monitored the patient and administered 50 mg of Benedryl by mouth at 10:34 am. Symptoms resolved around 10:45 am.
Patient presented with active singles within 2 days of receiving ZOSTAVAX infection. Patient seen in urgent care center and given Acyclovir complaint of shooting pain from outbreak site.
Intense chills, fever of 99.1-101.1 for slightly over 48 hours. Dizzyness, fatigue, lack of apetite.
stomachache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2022, the patient received the 1st dose of Shingrix. On 3rd June 2022, less than a day after receiving Shingrix, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was not recovered/not resolved.   It was unknown if the reporter considered the stomach pain to be related to Shingrix.     Additional Information: GSK receipt date: 08-JUN-2022 Reporter's comment: Consumer wished to remain anonymous.  The patient experienced an on going stomachache. The reporter did not consent to follow-up.
This spontaneous report as received from a registered nurse refers to a male patient (age when first adverse event occurred was not reported currently at the time of the report patient had 17 years) with no drug allergies and no pertinent medical history. On 21-NOV-1995 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, first dose 0.5 ml, intramuscular (lot number was not reported). On 10-JAN-1996 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, second dose 0.5 ml, intramuscular (lot number was not reported). On 02-JUL-1996 the patient was vaccinated with RECOMBIVAX HB, 5 mcg/0.5 ml, third dose 0.5 ml, intramuscular (lot number was not reported). No history of concomitant medication. On an unknown date the patient had titers drawn at an unspecified site and results showed he failed to seroconvert. The patient sought medical attention by parent, who called physician's office. The patient outcome of failed to seroconvert was not reported. The relatedness between event and RECOMBIVAX HB was not reported. Additional information has been requested.
Nausea - 12 hours Dizziness and brief loss of consciousness - 1 hour Fever - 100 to 102 degrees - 12 hours Hot red rash at injection site - 48 hours
Child was "jerking"  lasted for less than 30 seconds, no treatment at this time.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of PEDVAXHIB (lot#, expiration date, dose and route not reported), which were improperly stored. No adverse effects were reported. Follow up information has been received from an other reporter on 07-JUL-2015 and refers to a 3 year old patient of unknown gender. On 05-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K016965, expiration date 20-JUL-2017. This is one of several reports received from the same source. Additional information has been requested. Patient demographics, product and event details and narrative were updated.
This was NOT an Adverse Event.  The vaccine was in freezer longer than 14 days.   The patient was advised to revaccinate per CDC.   Patient got Vax 11/3/2021
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional. This case involves a 16 months old male patient who was vaccinated 0.5 ml fourth dose of ACTHIB (Batch number: UI901AA and expiration date: 25-Nov-2019) via intramuscular route in the right thigh on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 in the left thigh and DAPTACEL in right thigh for Immunisation. It was a case of actual medication error due to product preparation error because wrong diluent was used to mix ACTHIB. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
Tingling and numbness in outer extremities. Progressing to weakness, paresthesia and tachypnea with exertion. Suspected Guillain Barre, professice limb weakness and loss of deep Tendon Reflexes. Treated with IVIG 400 mg/kg x 5 days.
Anaphylaxis type reaction, stridor, treated with 02, epi pen, moved to hospitals ED
day of shot leg looked like it had water blisters; later became more scabby & looked like a burn; seen by MD 23MAR95 for fever dx of subcutaneous abscess;
18 x 17.5 cm raised red hot area site of MMR injection. Site on Right ant thigh.
2-inch round diameter lump at the injection site and is sore; 2-inch round diameter lump at the injection site and is sore; fatigue; achiness/general body/joint pains; achiness/general body/joint pains; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on 26Feb2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced achiness/general body/joint pains and fatigue a day after she received her first vaccine. There was also a 2-inch round diameter lump at the injection site (a day after the vaccination) which has not gone away and is sore for a while now. The patient reported that it still hurts up to today (02Mar2021). The clinical outcome of the achiness/general body/joint pains and fatigue was unknown. The clinical outcome of the 2-inch round diameter lump at the injection site which has not gone away and is sore was not recovered.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients; Inappropriate Age at Vaccine Administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-OCT-2023, the patient received Arexvy. On 07-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients).  The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 12-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist stated Arexvy was administered to a pregnant patient instead of the Pfizer brand RSV vaccine that is indicated for pregnant patients, which led to inappropriate age at vaccine administration. HCP gave permission for follow up but stated that she would not had any additional information as she did not see the patient
MODERNA COVID VACCINE #3 GIVEN 1/27/22, LOT #016J21A-2A; pt had a positive COVID test 1/27/22; DNR/DNI; pt passed away.
Patient received what he believes was both Pfizer covid-19 vaccines in February 2021.  He was admitted to hospital on 5/5/21 with leg edema. Found to be covid-19 positive x 2 on nasopharyngeal PCR testing.  He had no pulmonary symptoms.  Normal oxygen saturations.  He seemed to have an asymptomatic infection after covid-19 vaccination.
Sudden onset behavior changes, raging, OCD, adventitious movement, sleep issues, eating issues, unrinary frequency, dysgraphia, loss of academic skills. Treatment: two IVIGs, antibiotics, steroid burst, therapy, school accomodations.
No adverse events experienced. Flu shot may have been given SQ and shingles vaccine may have been given IM. Merck stated shingles vaccine ok and no need for re-vaccination. CDC states no need for flu shot re-vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with dialysis. On 06-MAY-2013 the dialysis patient was vaccinated inadvertently with a dose of RECOMBIVAX HB (lot # 0276AE, expired date 27-MAR-2013) (1 ml, intramuscular) dialysis formulation. No adverse effects reported. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information is not expected.
The smallpox vaccine has spread to edge of bandaid.  The vaccine hasn't spread to any where else on the body.  Patient complains of tenderness around the site.
Metallic taste that progressed to a chronic "bittersweet" taste since the vaccine. Extensive work up undertaken without cause. Consults for 2 ENTS and 1 allergist. It is still present 18 months later.
Injection site reaction; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of injection site reaction in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported but it could be 68 years or 69 years. The reporter administered Shingrix vaccine to the patient, in the back of her left arm deltoid subcutaneously, which led to inappropriate route of vaccination. The patient experienced injection site reactions. The reporter consented to follow up. No additional details were provided.
During the daytime, I was unusually tired. Then, at midnight, I woke up with vomiting, diarrhea, abdominal pain, and weakness. My stomach still bothers me, several days later.
Left lower leg DVT- occlusion of the posterior popliteal vein; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EW0172) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at event onset and at vaccination. The patient previously received the first dose of bnt162b2 (lot number: EW0150) on an unspecified date in left arm for covid-19 immunization. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced left lower leg DVT- occlusion of the posterior popliteal vein on 06May2021 at 08:00. The event resulted in emergency room visit. The patient received treatment for the event with Xarelto 20 mg daily for at least 3 months. The outcome of the event was unknown.   Follow up attempts needed. Further information is expected.
Vaccination site swollen, red and tender (size of a quarter).  No s/s severe rxn, no fever.  Patient playful and active.  Recom cold compresses.  No treatment necessary.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-JUL-2013, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (lot #, route, and dose not provided). As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. She had her shingles outbreaks on 09-JUL-2016. She was diagnosed with neuropathic disorder causing her pain and was prescribed tramadol for the pain. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the Company's negligence, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. The outcome of the events was considered not resolved. Causality assessment was related. The lawyer considered the shingles outbreak and neuropathic disorder to be disabling. Upon internal review, neuropathic disorder causing her pain was considered to be medically significant. Additional information has been requested.
Enlarged lymph node appeared on right chest near collar bone after first injection of Pfizer BioNTech vaccination in November of 2021. After evaluation by his physician, he was advised to watch and wait through the month of December and be re-evaluated. At the second office visit he was advised to have ultrasound, as the enlarged node had not resolved. He did have the ultrasound, which was used to diagnose it as a  "reactive lymph node." It has persisted without change for 7 months and is still present.
In morning, parents noticed vesicles on knees and hands/wrists. No itching. Then rash developed on trunk & some on arms. Some sores on bottom lip & edge of tongue. Diagnosed as possible varicella vaccine reaction vs Coxsackie infection. Also with some vesicles/papules on palms & soles of feet.
fever of 104, skin looked like it had a sunburn-whole body, headache, Gave Motrin, put in cool bath, fever finally came down to 100 at 9:30 pm  will be watching for any other signs today
Mother and nanny noticed left thigh was red, swollen with hard lump 1 cm in diameter at injection site.  Site was tender to touch as demonstrated by patient moving any fingers away from the site.  The redness has disappeared except for tiny red dot at needle entry site.  Hard lump remains under the surface about 1 cm in diameter. Tenderness appears to have decreased as patient will not react immediately if the site is touched.  He will not let you examine it for a prolonged time without attempting to move your fingers away.  Induration at vaccine site (left thigh) with erythema; persistent 1 cm mass with tenderness.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not known. On 28-FEB-2019 the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002509 and expiration date 25-JAN-2020, for prophylaxis (strength, dose, frequency and route of administration were unknown). Sterile diluent used was properly stored. The patient experienced no adverse events. It was reported that the vaccine used had been at 6°F to 14°F (12.9 F) for 30 minutes. No previous excursions were reported. Data logger was involved. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1903USA009416: US-009507513-1903USA009465.