chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Attestation signed by, MD at 01/27/22 1800 Patient seen and examined independently. Case discussed with mid-level provider and agree with note. Critical part of the exam and management done by myself Heart NSR no murmurs Dr   Available on mobile heartbeat          Hide copied text  Hover for details  History and Physical   Attending Physician: DO;  Date of Admission: 1/27/2022     CC:    Chief Complaint Patient presents with ? Vascular Access Problem     clogged cath since thursday 1/20, has not have dialysis since         HPI:   This is a 59y.o. male with significant past medical history of HTN, T2DM, gout, and ESRD on hemodialysis that presented to the hospital with chief complaint of vascular access problem. Patient reports he went to his routinely scheduled hemodialysis session on January 20th; however, they were unable to run him due to a clotted fistula. He went to Facility on January 25th but was discharged home and instructed to follow up OP with vascular surgery. He was not able to make his outpatient appointment so he phoned his PCP who instructed him to come to the ED for evaluation. He admits to not taking his home medications since January 20th. Admits to fatigue. Denies any fever, chills, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, or constipation.    In the ED, patient normotensive, afebrile, stable SPO2 on room air. CXR negative for acute process. He has been admitted for further evaluation and management with nephrology and vascular surgery consultations.      ROS:   Constitutional: + fatigue, fever or chills.  Eyes:  Denies change in visual acuity, diplopia or pain. HENT:  Denies nasal congestion, sore throat or tinnitus. Respiratory:  Denies cough,difficulty in breathing or shortness of breath.  Cardiovascular:  Denies chest pain, palpitations or edema.  GI:  Denies abdominal pain, nausea, vomiting, constipation or diarrhea.  GU:  Denies dysuria, urinary frequency or hematuria. Musculoskeletal:  Denies back pain, atrophy, spasticity or joint pain.  Hematologic:  Denies anemia, bleeding, or bruising. Integument:  Denies rash or lesions. Neurologic:  Denies headache, focal weakness, seizure or stroke. Endocrine:  Denies temperature intolerance, polyuria, or polydipsia.   Psychiatric:  Denies irritability, depression or anxiety.
four miscarriage; acute HPV positive; "she can not have any children"; This spontaneous retrospective pregnancy report was received from a patient's mother and a 22-year-old female patient, referring herself. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. The patient's mother medical history included Human papilloma virus (HPV) and cervical cancer.  On an unknown dates (reported as around age 11 or 12 years or older when she first received the vaccine), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) 3 doses (lot#, expiration date, dose, frequency and route of administration not specified) for prophylaxis.  On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP), due date and Estimated date of delivery (EDD) were not provided. The patient reported that she experienced four miscarriages on an unknown date and was acute HPV positive. The pregnancy outcome was spontaneous abortion. The patient was told by an unspecified individual that "she can not have any children". The outcome of the events was not provided. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Legal issue was involved.  Upon internal review, the event miscarriages was determined to be medically significant.  This is one of four reports concerning the same patient (linked reports: 1908USA007782, 1908USA008893, 1908USA008894).; Sender's Comments:  US-009507513-1908USA008893: US-009507513-1908USA008894: US-009507513-1908USA007782:
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient had acute on chronic worsening dementia along with being admitted on 2/26/2021 for CHF exacerbation with SOB and lower leg edema. Comorbidities include CAD, atrial fibrillation, CKD, and hypertension. He was also 97. During last admission, he was desatting into the 70s and had possible aspiration pneumonia diagnosis on 3/3/2021 which lead to inpatient hospice consult before he passed away on 3/4/21
A report has been received a from a Medical Rep concerning a, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. The patient experienced TESTED POSITIVE FOR A 103F TEMPERATURE, SORE THROAT, ACHES and CONGESTION which started on 23-Sep-2014. The outcome of the event of TESTED POSITIVE FOR A, 103F TEMPERATURE, SORE THROAT, ACHES and CONGESTION is unknown. The report was considered to be non-serious.
Started itching 10 days after booster shot. Had widespread Uticaria. Pretty severe for about 4 days. Ended up in ER. Blood pressure dropped to 85/55. Started Prednisone, pepcid and Zyrtec daily. Slowly has gotten better but still dealing with transitory Uticaria.
Mother is extremely fatigued after her booster dose; Mother has a headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache). At the time of the report, FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache) outcome was unknown.            No concomitant medications were reported  No treatment information was provided. patient received her first Moderna Medical  in March 2021.
mother noticed Saturday night 4/11/2009 a red, raised area on left deltoid.  seen today 4/13/2009 PM in office with 4X4cm area with redness and mild swelling on left deltoid.Beginning to clear centrally. Nurse practitioner able to palpate firm centralized swelling.  Nurse practitioner instructed mom to apply cool cloth PRN.
Case number PHEH2017US001824, is an initial spontaneous report received from healthcare professional through email via other pharmaceutical company (Mylan) on 12 Jan 2017. This report refers to a 34 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) on an unknown date. The patient received butorphanol for the treatment of an unknown indication at an unknown dose on an unknown date. It was reported that on an unknown date, the patient experienced twitching, increased heart rate and had a drug interaction with butorphanol. The outcome of the events twitching and increased heart rate was reported as unknown and for the event drug interaction with butorphanol was not reported. The events twitching and increased heart rate were assessed as non serious by the healthcare professional and for the event drug interaction with butorphanol was not reported. The causality of the events was not reported.
blurred floaters in vision appeared a week or so after vaccination. Went to eye doctor about 3 weeks after vaccination and no cause was found and no treatment was given.
Aches and pains, slight headache, fatigue, large spike in blood sugar. Blood glucose levels reached 590 mg/dl
This is a spontaneous report by a contactable physician. This physician reports a 6 month old female infant started PREVNAR 13 dose unknown, on an unknown date for routine immunizations. Her dose at the onset of events is unknown. Relevant medical history includes the infant was hospitalized with failure to thrive and dehydration on 14Dec2009. Any relevant concomitant medications or drug history is unknown. The infant received an immunization with PREVNAR 13 on 09Jun2010. On an unknown date in Jun2009 (after she received her PREVNAR 13), she was hospitalized for a fever. During that hospitalization a blood culture and sensitivity grew "strep pneumococcal bacterimia" that was "pan-sensitive" the infant also had cerebral spinal fluid studies that were normal. The infant was treated with intravenous ceftirafzone, dose unknown, and then transitioned to AUGMENTIN for 10 days. The infant was discharged after 4 days in the hospital. On 29Jun2010, the infant had an office check up at which she weighed 6.73 kg and was 25.5 inches long, and everything was okay. At the visit on 29Jun2010, the treating physician wrote on the chart that the infant was to have another PREVNAR 13 at her 15 month check up. The infant then changed doctors and the reporter first saw the infant last week in Dec2010 for a well baby check. It is unknown if PREVNAR 13 is being continued.
Family left after immunizations and returned to clinic approx 30 minutes later.  They stated patient had looked "like he was dead, like he had OD'd".  After picking up sister they had placed them in backseat.  When mom looked back she noticed patient was limp, with a terrible color and would not respond. They tried to stimulate him to wake him up but mom said he would did not come out of it for 5 minutes. She thought he had looked "dead" for 5 minutes. They rushed back here to the clinic.  Upon arrival they let our nursing staff know what had happened, our nursing staff stated the patient was well appearing, happy and running around at the time of arrival.  I saw the patient as well and he appeared happy, playful running around exam room, active and in no distress.
Narrative:  headache started within an hour of vaccine and was gone by dinner Symptoms:  Headache Treatment:
Chills began, severe lower back pain, arm hurt like if hit with baseball bat, red mark at vax site 3 inches in diameter, fever 102.1 for 2 days. Could not get out of bed, no relief by any pain medication (Percocet) headaches. Saturday and Sunday felt chest pains and tachycardia. By 01/17/05 fever decreased to 100, condition gradually improving. Did not have any problems at 49 years last time received this vax.
1 week after injection (1/5/21), I developed hives around the injection site. They went away on their own last night and a red, swollen circle remains today.
On 09/21/2017 patient's arm was swollen from the shoulder down to the crease of her arm a few hours after getting the vaccine. Accompanied with pain. Around 7 pm. patient took TYLENOL extra strength when the pain began and every 4 to 6 hours after that. Patient also used cool compress and warm compress to help with the pain. Patient tried to move arm as much as she could however the pain was almost too bad to even lift her arm. Symptoms continued until 09/23/2017.
Red, swollen, itchy, slightly painful  area about 3 x2 "area
Calls for information about if a rash could be considered normal after he received the second dose of the Pfizer's COVID-19 vaccine; This is a spontaneous report from contactable male consumer (patient) of unknown age who reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient called for information about if a rash could be considered normal after he received the second dose of the Pfizer's COVID-19 vaccine.The event outcome was unknown.  No follow up attempts were possible. Information on lot/batch number could not be obtained.
Information has been received from a medical assistant concerning a 4 year old male patient who on 10-JAN-2002 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Child became listless, vomited, color "gray-blue" and appeared to have tremors; shallow respiration. EMS transported to ER. Exam was normal on arrival. Re-evaluation in office on 9/16/00; had no further symptoms. No sequelae.
This spontaneous report was received from a physician assistant referring to an unspecified female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. It was reported that on unknown date, the patient was taking GARDASIL or GARDASIL 9 (dosage scheduled, lot #, route of administration and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced ovarian dysfunction. At the reporting time the outcome of ovarian dysfunction was unknown. The causality between the event and GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Diffuse urticaria 3 hours after receiving Gardasil, Tdap, MMR today.  Presents to ED for care
G62.9 PERIPHERAL NEUROPATHY 9/8/2022 COVID-19 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 10/20/2022 COVID-19 PNEUMONIA G62.9 PERIPHERAL NEUROPATHY 9/8/2022 ACUTE RESPIRATORY FAILURE    HTN (HYPERTENSION) J96.00 ACUTE RESPIRATORY FAILURE 10/20/2022 ACUTE RESPIRATORY FAILURE    HTN (HYPERTENSION)
Shortness of Breath, Difficulty Breathing, Difficulty Swallowing, Extreme wait loss, Low energy level. Progress over 2 month period
SINUS DRAINAGE; COUGH FROM SINUS DRAINAGE WITH BLOOD; FELT DRUGGED/FUZZY; SORE ARM; LOW ENERGY; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid, and concurrent conditions included: penicillin allergy, drug allergy, ex-smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced sore arm, low energy, and headache. On 24-DEC-2021, the patient experienced felt drugged/fuzzy. On 28-DEC-2021, the patient experienced sinus drainage, and cough from sinus drainage with blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 25-DEC-2021, was recovering from felt drugged/fuzzy, low energy, and sore arm, and had not recovered from sinus drainage, and cough from sinus drainage with blood. This report was non-serious.
Awoke the next day, drank water, immediate lightheadedness led to syncope (likely vasovagal) and emesis, diaphoresis, followed by several hours of chills.  Local erythema, edema and pruritus distal to injection site appeared several days later (also following first injection on right arm) lasting about one week.  Treatment: bed rest, benadryl, hydrocotisone
Mild soreness and swelling at injection site plus slight itching.  No rash or discoloration.  Dissipated by the third day.  Had no noticeable reaction to the first dose.
Td and MMR given on 9/10/03 for EMT class requirement. Reports that on 9/11/03 AM developed "scratchy throat, nasal congestion, sinus pressure and pain, eyelids swollen" which has subsequently improved. On 9/16/03 PM developed "2-3" hives on breast, "a few" hives on thigh and "one" on arm, all itch.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date during 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
1 week out from vaccinations, patient developed SOB, increased WOB and weakness (previously healthy). Patient had significant neuromuscular weakness (primarily of respiratory muscles). Diagnosed with GBS variant. Treated in ICU with BiPAP, IVIG and had resolution of symptoms within 1-2 weeks. Follow up 12/06/04: Vaccine recipient did recover. From information from the CDC, the patient required outpatient physcial therapy for residual weakness at the time of hospital discharge on 02/23/04, but was mostly recovered.
6 hours after shot temp went to 104, then to 105. Cold shower 104 + 1 hour. 105. Back to shower for about 5 cycles approx 10 hours. 24 hours later severe "asthma-like" attack for about 4 hours, then cleared up.
Extensive deep venous thrombosis, with occlusive thrombus throughout the entire deep venous drainage of the left lower extremity.  Superficial thrombosis involving the superior greater saphenous vein in the thigh as well as of the profunda.  Required ileofemoral thrombectomy.
I am having bilateral muscle spasm down my lower leg. I am having my spasms and muscle locking at my ankles. At night I am having upper and lower leg spasms. I also have burning pain near my L5 and S1. I also have bilateral weakness. I have felt feverish but with no fever. I had chills at times, not severe. I wake up in the morning and my legs are burning with pain. I had intermittent on and off headaches which I did not have prior to the vaccine. This pain kicked up again after the booster shot. With each shot, symptoms got worse about 3 days after. I also experienced abdominal pain. I have been referred to a pain clinic by my doctor.
Headache, fatigue, temperature of 100.3. Lasted about 8 hours.
Information has been received from a pediatrics office and a nurse concerning a 12 month old female who on 27-JUN-2008 at 1545 was subcutaneously vaccinated into the left arm with the first dose of VARIVAX (Merck) (Lot # 659528/1907U). At the time of vaccine the patient had mild Upper respiratory tract infection symptoms. On 27-JUN-2009 (it was also reported as on 08-JUN-2008) the patient developed mild chicken pox -consisting of less than 20 poxes over back/neck/trunk and limbs. No fever, no cellulitis or other problems. On an unspecified date the patient recovered from rash of varicella. No further information is available.
slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe; slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe; This is a spontaneous report from a contactable consumer (patient). A patient received of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date were unknown), via an unspecified route of administration, on 15Jul2021 13:00, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Patient had the Pfizer Vaccine at 1 o'clock on 15Jul201 and experiencing like slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe if that make sense. Outcome of the events was not recovered.   Information about lot/batch number has been requested.
We gave 6 patients aged 12 and older COVID-19 booster vaccines using the monovalent formulation between dates of service 8/31/2022 and 9/9/2022.    Based on information we received from Health Authority we will contact these patients and offer the bivalent booster to them after two months have passed.
Had 1st shot on 4/14/21 and experienced fatigue and headache 4 hours later. Had 2nd shot 5/14/21..appt at 2:45, but shot at 3pm. Experienced fatigue only about 4 hours later. Woke up on 5/15/21 fine just a little tired. Appetite was off..around 7pm started itching..and 8pm felt bumps on inside of arm where I got the shot...half hour later full blown hives on arm and right arm and started on legs.took 2 benedryl, went to bed. Got up on 5/16/21 took 1 benedryl at 7:30am..but hives were spreading and unbearable so went to urgent care...usually go to a different site. Doc who was there gave me 40 mg of a steroid and told me to get some hydrocortisone  for the itch....going now to get that from pharmacy.
Initial unsolicited report received from a nurse on 01-Aug-2018. In this case unknown quantity of vaccines ADACEL and ADULT TENIVAC (lot number not reported via unknown route in unknown administration site for both the vaccines) were improperly stored and were administered to 5 unknown number of patients. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as potential medication error due to product storage error. It was not confirmed whether the patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Patient received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 2 dose schedule on an unknown dates).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received 3 doses of Shingrix. No symptoms reported. The consent to follow up was given via mail. The healthcare did not have the patient's date of birth or vaccination information or dates at the time of report. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered.
THREE TO FOUR MINUTES AFTER VACCINATION THE PATIENT HAD A HYPOTONIC/HYPORESPONSIVE EVENT WHILE SITTING IN A CHAIR IN THE LOBBY. THE PATIENT WAS BROUGHT GENTLY TO THE FLOOR AND WHILE STILL HYPORESPONSIVE HAD  A SHORT SEIZURE LASTING 5-10 SECONDS. THE PATIENT REMAINED ON THE GROUND FOR ANOTHER 5-7 MINUTES. BLOOD PRESSURE AND HEART RATE WERE MONITORED AND NORMAL GIVEN THE SITUATION.