chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: ADMISSION DATE: 8/13/21 DISCHARGE DATE: 8/23/21 DISCHARGE TYPE: Regular PRINCIPAL DIAGNOSIS (Reason for admission after study): Acute hypoxic respiratory failure due to Covid ADDITIONAL DIAGNOSES: A-fib, Hypertension, DM Type 2, Chronic DVT on apixaban, prostate cancer HISTORY OF PRESENT ILLNESS: 86yo M admitted from the ER to hospital for further care management for chest pain with heart jumping , COVID-19 PNA,and Myoclonic Jerks. Patient reports he has been feeling ill with bodyaches for past 5 days but the heart jumping and myoclonic jerks of the face and hands started 2 days ago. Jerking sensations were worse last night while chair. Significant PMHX: AFib, HTN, DMT2, Chronic DVT on Apixiban and Prostate Cancer. ROS: + Decrease in appetite x 5d, denies any history of seizure, syncope, CVA or muscle twitching to this severity, no numbness, +nervous feeling, + Chest pain fleeting, + HOH and degree of difficulty hearing, no visual defects, Per ER chart - in 2014 he had a report of involuntary twitching. , no n/v/d/f/c +SOB with +DOE sometimes , no dysphagia, decrease appetite over past week, moving bowels and urinating wnl, no dysuria, no headache/vertigo or dizziness, no coughing, +shakes with cold intolerence and no skin rash/lesions/swelling or pruritus. HOSPITAL COURSE: 1. Acute COVID 19 pneumonia - S/P Decadron and Remdesivir x 5 days. 2.Acute hypoxic respiratory failure -this was all due to Covid and unfortunately we were unable to wean the patient completely off so will be discharged on home oxygen 3. Bradycardia -due to Amiodarone -last Amiodarone dose on 08/16/2021 morning. 4. Atrial flutter -normal sinus rhythm this morning -continue Eliquis -Amiodarone discontinued due to bradycardia 5. Muscle twitches -resolved 6. Primary hypertension -continued Hydrochlorothiazide, Losartan and Norvasc 7. Diabetes mellitus type 2 -blood sugar uncontrolled (216-222), A1c = 8.0% -okay to resume home insulin 8. CKD, stage IIIA -creatinine remained right around patient's baseline on the inpatient setting. 9. Chronic obstructive pulmonary disease -no acute exacerbation - continued inhaled steroids, bronchodilators and oxygen suuplement 10. Dyslipidemia -continued Lipitor 11. GERD -continued Omeprazole 12. Constipation -resolved
Vaso vagal event. with loss of consciousness for several minutes, nausea and vomiting, and recovery over one and one half hours.
ABOUT 3 OR 4 DAYS POST VACCINE ADMINISTRATION, PATIENT REPORTED RED SWOLLEN WELP AT ADMINISTRATION SITE. NO ITCHING OR ANY OTHER SIDE EFFECTS. PATIENT SAYS WELP IS GETTING SMALLER AND DOES NOT BOTHER HER.
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation.  Medical history included End-Diastolic Heart Failure, osteopenia and arthritis.  Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. 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.
It's been 10 months since my 1st shot. I forgot the 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 10 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule.
Vaccine was administered more than 12 hours post puncture. THERE WAS NO ADVERSE EVENT
Patient reports experiencing tachycardia that required a hospital visit approximately 24 hours after vaccination with Flucelvex.  Provider at hospital advised patient that this may have been a reaction to the vaccination.  He was treated (specific treatment unknown) and has not experienced any complications.
This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer reporting for herself. A 64-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 16Feb2018 at single dose for immunisation, ELIQUIS, oral from/to an unspecified date at 5 mg, 2x/day for an unspecified indication, BRILINTA, via an unspecified route of administration from/to an unspecified date at unknown dose for an unspecified indication. Medical history included pulmonary embolism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient responded to an email from pneumococcal 13-val conj vac (dipht crm197 protein) regarding sharing her story of being diagnosed with pneumococcal pneumonia, but she couldn't confirm an official diagnosis of pneumococcal pneumonia. The patient experienced blood in her stool (medically significant) on an unspecified date with outcome of recovered, nosebleeds (non-serious) on an unspecified date with outcome of unknown, scraped her leg (non-serious) on an unspecified date with outcome of unknown, pulled off a scab and it is bleeding (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the events for apixaban and for ticagrelor was unknown. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/5/2023 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Teeth chattering; Fever of 103 Degree Fahrenheit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit). At the time of the report, CHILLS (Teeth chattering) and PYREXIA (Fever of 103 Degree Fahrenheit) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 Fever 103 Degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
A few minutes after the vaccine administration (0815) patient reported he was having blurred vision, was also feeling light-headed.  BP was 79/41, HR in 40's.  Supportive care provided to patient, oral fluids given.  Patient became less unresponsive, but maintained airway and respirations.  Patient was also assisted to lay down.  At 09:24, patient became more alert.   EMS was called and patient was also evaluated by our MD.  He returned to baseline and did not require transportation to the hospital.
mother stated SE started that evening post vaccination on 12/14/22.  Redness, swelling, heat at injection site with itchiness.  mom used a cream for the itchiness (couldn't remember name) but it helped. patient presented today for flu shot and showed me the reaction on the LA arm.  outline of redness with injection site noticeable in the center.  no swelling but patient stated it still itched off and on. mother did not use ice for swelling/redness/heat but just the cream for the itchiness per mother statement. advised mother to get second shot with MD and to wait for one hour post vaccination if MD decides to continue with the inoculation or not. will need note for school if not given.  advised mom on ibuprofen for children (gave kg chart) in future for localized redness/heat/swelling and/or fever.
Left arm at shot site stared having an allergic reaction, red, swollen, arm, glossy from being so swollen, turned purple lose of circulation in his arm, warm to the touch, and was itchy.
Information has been received from a pharmacist concerning an 84 year old female who on 01OCT2003 and 30OCT2003 was vaccinated with the first and second doses of pneumococcal 23v polysaccharide vaccine. The pt reported redness at the injection site after the second dose. No other information or lot numbers were available. Unspecified medical attention was sought. There were no product quality complaint. Additional information has been requested.
Severe hives that were intolerable. At urgent care on 12/8 they gave her a shot of steroids. The hives did not go away and she went to a dermatologist on 12/16 who prescribed Medrol but didn't have any insight into what caused the hives. She went to her primary care physician on 12/17 who suggested it was Dermatographic hives and that she see an immunologist. That is scheduled for next week.
The patient is not feeling unsteady and off-balance when attempting to walk.  Patient got her flu shot yesterday at around 2:00 and stated that as soon as she got home she started to feel nauseated and has been vomiting and experiencing generalized weakness. No relief with zofran. Patient states that she is unable to eat due to her vomiting.  She has not yet had a bowel movement today or yesterday.
Swelling entire upper arm, with redness and tenderness - Prescribed Benadryl, Prednisolone for 3 days, Augmentin for 5 days.
Patient received Pfizer vaccine on 4/10/21 (Lot EM0150) and 5/1/21 (Lot EW0151). Hospitalized with pneumonia due to covid-19 on 8/10/21
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP. Concomitant medication(s) included: MACLEODS DONEPEZIL, start date: Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective.  Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had no known allergies.
Information has been received from a registered nurse concerning a 43 year old female with a history of difficulty with seroconversion after therapy with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (WAES0512USA03376) who on 15-NOV-1999 was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot # 630227/0411J). A titer was taken on 15-DEC-2005 and did not show evidence of seroconversion. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
09/29/2020:  HA, Eye swelling, weeping eyes stared 03:00, chills, sinus drainage  09:00. Increased sinus symptoms since vaccination. Sudafed 10:30, Seasonal allergy drops 10:45, Benadryl  and Ventolin 10:55.  Throat started constricting after drops taken.  did not need to use epipen.  Intermittently clear from one or both throughout the day and Left facial swelling. Stopped allergy drops that day.
about half an hour after injection flushed blurry vision racing heart gasping for breath felt like I needed to crawl out of my body twitches went to urgent care received a shot of Benadryl and stayed under observation and sent home Dystonic reaction
This spontaneous report was received from a 62 year old female patient with history of allergy and drug reaction to sulfa and lidocaine. On 28-AUG-2015, at the pharmacy, the patient was vaccinated with a dose of ZOSTAVAX (lot # L011537, expiration date July 2016) (strength, dose number and route were not reported). Concomitant therapies included metformin and DIOVAN. The patient reported that on 29-AUG-2015, she had a rash beyond her elbow to her shoulders and then on an unspecified date in 2015 she experienced ulcers on her tongue as well. The patient went to her physician's office, to the pharmacy, as well as an unidentified urgent care clinic for medical attention and she was not hospitalized. No lab diagnostics studies were performed. The patient was treated with BENADRYL and prednisone. The patient stated that she was recovering from rash and tongue ulceration. The reporter did not  assess the relatedness of ZOSTAVAX. Additional information has been requested.
1st dose 04May2022, 2nd not yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose on 4th May 2021 which batch number 93FR9  and expiry date 29th April 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-Oct-2022 Reporter's comment: The nurse asked for information about the administration of Shingrix second dose to a patient. The reporter asked if they could administer the second dose or it needed to start over with the vaccination. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
headache; fever; chills; This is a spontaneous report from a contactable consumer (patient's daughter) from a Pfizer sponsored program. A female patient of an unspecified age received the second dose of (BNT162B2) (Pfizer Covid-19 Vaccine) via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of (BNT162B2) (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. On an unspecified date of Apr2021, the patient was having headache, fever and chills, after getting the second dose of the vaccine yesterday and because of that they were calling to ask if the patient could take Tylenol. The outcome of the reported events was unknown at the time of reporting.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
No adverse event; Expired Covid vaccine given. Vial opened Friday, November 18, 2022 and should have been tossed at the end of business day. Medical assistant came in Monday morning and gave a dose of the covid vaccine that was left over from Friday.
Transient Ischemic Attack on 1/13/2023 with no prior history of strokes. I am in good health and all my heart and vascular tests were normal prior to this event. My BP is normal and I have had no issues with blood clot in the past.
Baby present D.O.A. to ER 4 days after vaccine admin. Was healthy and behaving normal several hours prior to death. The autopsy report received on 1/14/04 states SIDS.
This is a spontaneous report from a contactable Medical assistant communicated with a Pfizer sales representative reported for her son. A 19-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose on 05Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. On 05Oct2017, the patient experienced high fever, pain, muscle aches, weakness, became pale, almost flu like, all with outcome of recovered on an unspecified date in Oct2017, it was severe enough that he will not get the second dose on an unspecified date. The information on the lot number has been requested.
This is a patient who presented to the ED with a cc of dyspnea and was found to have left central main pulm artery/left upper lobe/left lower lobe PE's and also has a large clot in transient in his RV. There is no provoking risk factor that I can clearly identify (no recent surgeries, trauma, immobilization, or active cancer). He does have a remote cancer hx of bladder cancer in 2015. He is a former smoker 20+ years ago. However, he is at risk for VTE events by being a ERSD patient and also there's increased risk for VTE for pts >70yo. His COVID vaccination a few months ago is a potential contributing risk factor, will report to VAERS
Information has been received from a certified medical assistant (C.M.A.) referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unknown dates after 29-OCT-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030591, expiration date 10-FEB-2017, dose and route were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the two reports from the same reporter. Additional information has been requested.
This was the 2nd and final vaccine i got on Friday afternoon.   My injection site was extremely hot on Saturday morning, a welt on my arm and itchy.  I then came down with a fever of 101.3 and with that came a headache and my body was aching.  I was feeling extremely tired. I had contacted our work number n spoke with some medical providers; they had me alternating take Tylenol and Ibuprofen  every couple hours!!  My fever hit its highest at 103.00 on Monday night with a severe headache,  body aches and I was also nauseated.
Left arm upper swelling redness & pain down to wrist. Extremely painful x 4-5 days. Slight wheezing whole arm swollen, vomiting x2 days.
Presented to the Hospital ER and transferred to Hospital with blood clots-one lung full of clots.  In hospital for one week.  Was told he had a 30% chance of survival.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of VARIVAX (dose, lot number and expiration date were unknown), which was following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
I vaccinated patient wiith a FLUAD instead of the correct vaccine, Fluarix.
a low of 1.3C out of range for 10 minutes were administrated post excursion(with no reported adverse event); Daptacel administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and it was reported that a a low of 1.3c out of range for 10 minutes were administrated post excursion(with no reported adverse event) and daptacel administrated post excursion with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot C589388, expiration date: 21-Jun-2023, via intramuscular route in the left thigh as Immunization.  On 31-AUG-2022 the daptacel administrated post excursion with no reported adverse event (poor quality product administered) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  On an unknown date there was a low of 1.3c out of range for 10 minutes were administrated post excursion(with no reported adverse event) (product storage error) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.No human error was there.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (a low of 1.3C out of range for 10 minutes were administrated post excursion(with no reported adverse event), Daptacel administrated post excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for all.  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 the 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.; Sender's Comments:  US-SA-2022SA372080:
feeling feverish; tired; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she was feeling feverish and tired the day after receiving her 2nd COVID vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.