chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. completed lab draw and 3 vaccinations. As pt. and family were walking out of the clinic, pt. became dizzy and fainted at the front entrance.  Pt.'s father caught pt. so that he did not hit the floor. RN's responded to CODE YELLOW call. Pt. was gently laid on the floor, RN checked HR=48, pt. diaphoretic, pale in color, eyes closed, normal respiratory breathing. RN elevated pt.'s feet. Pt. responded appropriately to all questions. Dr. spoke with pt. and parents. BP= 118/68. Pt. assisted to sitting position, then to standing position. Denied any dizziness. Pt. assisted to chair, given cup of water and frozen ice pop. After sitting in chair for a few minutes, pt. ambulated around the clinical area with RN without any sxs. Parents instructed to get a snack for pt. to help increase blood sugar. Parents verbalized understanding.
Vaccine expired on 8/31/2022 and was given on 9/01/2022.
Chest pain, palpitations, severe headache, chills, fatigue X33 hours, severe headache 9 days later as well on 02/03/2021 at 2300 hours.
Rash all over my body but on my hands, face and neck was the worst. the rash and bumps and burn. The rash and the dumps were very itch and were like in round circle on my body. I experienced frequently going to the restroom started on JULY 30. I was going to the restroom every 10-20 minutes urinating that ended on Sunday. I did not take any hypertension medication before my shot or after. my skin felt very itch on the inside were and sticky. i also had swallowing of my joint and shortness of breathe.
Feeling worse; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch was not reported and has been requested .No concomitant medications were reported. On an unspecified date, the subject experienced feeling worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling worse. This report was non-serious.
Soreness for 2 days, but then a red, swollen mark that the skin felt more hard in that area. Sometimes itchy but has lasted more than a week now. I don't want this to be permanent or happen in my other arm too as it says if you got the "covid rash" to get in opposite arm for 2nd vaccine
Discharge Provider: DO Primary Care Provider: MD Admission Date: 4/20/2023 Discharge Date: 04/28/2023 Presenting Problem: Fever and chills  HOSPITAL COURSE: No notes on file The patient is a 73 year old male with PMH of OHT 6/15/2020, ESRD on PD, OSA, dyslipidemia who presented on 4/20/23 from dialysis where he was found to be hypotensive, febrile and fatigued.  Patient was diagnosed with COVID at the end of March and with concurrent bacterial PNA, prompting holding of MMF (4/5/23).     On arrival, he was noted to be dehydrated and hypotensive, stating he has felt miserable for the past week with poor appetite/oral intake and severe fatigue.  He was also found to be COVID positive on 4/20/23. Other cultures and infectious studies were unremarkable. He was treated with remdesivir per ID recommendations.  An echo demonstrated preserved biventricular function.  His hospitalization was complicated by an acute GI bleed.  On 4/25, he underwent EGD/sigmoidoscopy demonstrating AVMs which were treated.  Nephrology was also consulted for dialysis management.  Patient then continued to improve with electrolyte repletion, fluid management, and 2units PRBC transfusion.  On 4/27, patient was stable and feeling improved, without indications to stay inpatient.  He expressed significant desire to return home.  Plan was discussed including follow up and changes to medications.  Patient and spouse verbalized understanding.  Questions answered.  He was discharged in stable condition.
blanching macules on trunk, extremeties and face, began on the morning of 5/26/09, worsened as day progressed.  No other cymptoms
bilateral rash on armpits; Threw-up after 2 hours of vaccine; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) in the left arm via an unspecified route on 13Mar2021 at 11:30 as a single dose (at the age of 26-years-old) for COVID-19 immunisation. The patient had no known allergies. Medical history, past drug history and concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 02:00, the patient had threw-up 2 hours after vaccine (vomiting) and bilateral rash on armpits. The patient did not receive any treatment for this event. The clinical outcome of the event bilateral rash on armpits and vomiting was recovering at the time of report.   Information about lot number cannot be obtained. No further information is expected.
Information has been received from a physician referring to a 12 month old male patient. There were no pertinent medical history or drug reaction/allergies. On 02-NOV-2015 the patient was vaccinated with MMR II (lot # K024825, expiration date 02-DEC-2016, dose and route not provided), (Oka/Merck) VARIVAX (lot# L013824, expiration date 21-APR-2017, dose and route not provided), HAVRIX (manufacture unknown, dose, lot number and route not provided) and FLUZONE (manufacture unknown, dose, lot number and route not provided). The physician stated the patient was seen in the office on 08-DEC-2015 because of a "fever of 102F" and a rash on his abdomen. The physician stated the patient was seen again on 10-NOV-2015 and "the patient still had a 102F but now the rash all over his body, his face and chest were bright red like a sunburn, and the rest of his body, back, arms and legs, had a macular, papular rash that was very measles like and his feet appeared red and swollen". The physician stated that on 10-NOV-2015 it was also noted that the patient developed otitis media in the right ear. The physician stated she prescribed amoxicillin (manufacturer unspecified) for the otitis media. There were no diagnostics lab studies performed. The physician stated the patient's mother called the office on 13-NOV-2015 to report that the patient's fever had resolved but the rash on his face was "scabbing over" (although the physician stated, "the facial rash was never open or draining when the patient was in the office"). Additional information has been requested.
Information has been received from a Registered Nurse concerning a 21 month old male who on 09-SEP-2005 was vaccinated subcutaneously with a 0.5 ml dose of Varivax. On 05-Jul-2006 it was reported that "last week" in June 2006 the patient had a breakthrough experience. The nurse reported that the patient was playing with another child who had chickenpox and he started developing lesions "shortly after". The patient had less than 50 lesions. Unspecified medical attention was sought and the pt recovered with an unspecified "therapy". There was no product quality complaint involved. Additional information has been requested.
Hoarsness, tightness in throat, coughing, rash on arms, flushing in face (occured twelve minutes after dose 0.3 epi 1mg/1cc-  taken to ER
Date of Admission: 11/28/2022   Date of Discharge: 11/29/2022   Admission Diagnosis: COVID [U07.1]   Hospital Principal Problem (Discharge Diagnoses): COVID   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: COVID o COVID-19 o Acute respiratory failure with hypoxia and hypercapnia (CMS/HCC)     Overview Note:     Patient is intubated and sedated on high-flow oxygen Will monitor the patient's blood gases closely Will continue breathing treatments as needed Will monitor the patient closely.   Will continue current ICU management Serial chest x-rays   Monitor lactic acid level closely
The patient mentioned to combating an illness; Being out of breath while walking; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (The patient mentioned to combating an illness) and DYSPNOEA EXERTIONAL (Being out of breath while walking) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The patient mentioned to combating an illness) and DYSPNOEA EXERTIONAL (Being out of breath while walking). At the time of the report, ILLNESS (The patient mentioned to combating an illness) and DYSPNOEA EXERTIONAL (Being out of breath while walking) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that was prescribed medication.  The patient mentioned to combating an illness relating potentially to a side effect from the COVID-19 vaccine and was prescribed the medication.  The patient has since begun administering the medication and mentioned to being out of breath while walking.  No treatment medications were reported.
8:15 started complaining of severe headache, body aches.  by 8:30 she was crying nonstop about how bad her body hurt, increasing headache, chills started.  By 9:00pm she was starting to run a fever around 100.7.  Gave her 325mg Tylenol.  Continues to cry throughout evening and symptoms worsened into the night.  By 1:30am 10/11/13 she was 103 degrees and more Tylenol was given.  By 4 she was 104.8 continues to cry how bad she hurts, head, stomach, anywhere to touch.  Gave her 200mg Motrin (which she doesn't usually tolerate well on her stomach).  She continued to run high fever into the morning.  More Tylenol given at 7 and called pediatrician at 8:15 to report symptoms.  Took her to drs office where she was examined.  Strep test was run and was negative.  Influenza nasal swab was checked and was negative.  Dr. thought possible virus.  Unsure of direct link between flu vaccine and illness.
dizziness/fainting within five mins; dizziness/fainting within five mins; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old [non-pregnant] adult female received the first dose of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 23Apr2021 at 10:30 (at 21-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. There were no concomitant medications reported. The patient denied any COVID prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 23Apr2021 at 10:35, within five minutes of receiving the vaccine that patient experienced dizziness and fainting. The patient has not been tested for COVID since the vaccine. The patient did not receive any treatment for the events; the events did not result in visit to Emergency Room or physician office/clinic.  The outcome of the events dizziness and fainting was recovered on 23Apr2021 at 10:45 after ten-minute duration.    Information on the Batch/Lot number has been requested.
After giving vaccine she fainted for about 5 seconds before she recovered and she was fine after.
Rapid and continuing arthritic symptoms. Swollen joints, fingers curving at knuckles. Severe pain on top of feet (arthritis). Total right knee replacement 4/16/01.  A follow up report received 6/27/2003 adds: Arthritis continues to worsen. January 2003 had injection of cortizone in left shoulder. May 2003 had cortizone injections in the top of both feet. These were to help ease the pain. I had a total right knee replacement in April 2001. My leftknee is showing signs of needing replacement within the next year. I'm very happy this product has been taken off the market.
Patient tested positive for COVID-19 on 8/12/2021. Received Pfizer vaccine, completed series on 4/1/2021.  Approximately 2 weeks prior to testing positive, he did have soreness in injection site. and developed pustule at the site.  Site continues to be scabbed over and sore.
Pt was administered a varicella vaccine that they did not need.  They had already been fully vaccinated against this vaccine preventable disease previously.
she was supposed to have received a vaccine called "PNEUMOCOCAL ADULT ". She thinks she may have received Merck's PNEUMOVAX 23 vaccine instead; she was supposed to have received a vaccine called "PNEUMOCOCAL ADULT ". She thinks she may have received Merck's PNEUMOVAX 23 vaccine instead; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-NOV-2007, the patient was supposed to have received a vaccine called "PNEUMOCOCAL ADULT " lot # reported as 0601F  but the patient thought she might have received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis due to product confusion.
within 15 minutes, inject site rxn characterized by a red, raised, circular rash measuring 2 to 3 inches in diameter.
Presented with diffuse rash, decreased sleep, pulling at ears, not eating, and fever. Symptoms lasted 4 days. Given Zyrtec liquid and Advil.
Pt reported to Outside ER for HA, subjective fever and muscle aches. Reports receiving fluids and being dx with a flu like illness and discharged with Zofran. Pt reports that night he developed a pruritic skin rash on his back and shoulders. Came to medical this following morning on 23Mar with 7 scattered 2-4mm umbilicated pustules on his back and shoulders, and a few tiny erythematous papules on his right thigh. Pt treated symptomatically with Tylenol and atarax. After conferring with the Director of immunization Healthcare Branch cultures were taken to determine if rash is 2/2 autoinoculation vs nonviral pustulosis vs generalized vaccinia. Strict precautions given to patient - given sick leave for the weekend, keep lesions covered with bandages, and wear shirt, sleep in separate bed/sheets then wife, use towels only once then wash, etc.
Persistent and ongoing generalized hives from date of onset to present, rash, facial swelling, eye swelling, lip swelling. severe itching.  Three ER visits received IM Epinephrine x2, IM SoluMedrol x2, IM DepoMedrol, oral Prednisone, IV Pepcid, oral Pepcid, IV SoluMedrol, IV Benadryl, oral Benadryl every 4 hours x 6 days, IV fluids, oral Tagamet x 7 days, Clarinex, Xyzal, Singulair, Medrol dose pack, Pulmocort nebulizer treaments. Had to see Allergist x 2 visits with follow-up scheduled.10/29/2009 records from  Allergist MD for 10/9 and 10/13/2009. Patient presents with c/o's hives, pruritis, "feels like throat swollen", chest tightness, cough, nasal drainage. Patient has stated that has had 3 ED visits for these c/o's and was tx'd with steroids, antihistamines and Tagamet but sx persist. PE noted diffuse urticaria. Tx: Solu Medrol, Prednisone. CT sinus was negative. On 10/13/2009 visit hives had cleared 85%. F/up clinic 3 weeks.
Moderna Vaccine lot #006C21A was affected due to out of temperature range. No adverse reactions from patients.  94 patient's affected.
The MMR was given on 9/29/08. On 10/17/08 mild to moderate swelling in front of the left ear down to jaw and into top part of neck. No fever, mild tenderness and itching sensation in swollen areas. No pain in the ear or throat.
Fussy- irritable-t101 intermittantly for 2 wks; Seen by MD who thinks sx were vax related;
Pain in the injection site; Fever of 37.7 °C; Malaise; This is a spontaneous report from a contactable consumer. This is one of the two reports.  A 14-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Jul2021 (reported as yesterday noon) (age at vaccination: 14 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history and concomitant medications were not reported. On 08Jul2021 at night, the patient had malaise. On 09Jul2021, the patient experienced pain in the injection site, and fever of 37.7 degree c. The patient underwent body temperature test which was 37.7 degree C. The patient was given paracetamol as treatment for the events. The outcome of the events was unknown.   Information on lot /batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868661 same reporter/ drug, different AE/patient
Information has been received from a health professional concerning a 14 month old female with a normal immune status who on 10 January 2006, was vaccinated subcutaneously in the left arm with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot #645164/0064R). Concomitant therapy that day included Hib conj vaccine (OMPC) (manufacturer unknown), measles mumps rubella vaccine (MSD) and influenza virus vaccine (unspecified). The patient's mother called to report that on 16 February 2006, her daughter developed a "line" of tiny vesicular lesions on her left side. She described the line as 2-3 inches wide and about 6 inches long. From the description the nurse felt this may be shingles. It was noted that the patient had not been in for an exam. No labs were done. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021 at 1:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 1:13 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 49.74 years for dose administered on 27-APR-2021. No concomitant medications were reported. Batch number 007C21A underwent temperature excursion 27-APR-2021 with temperature 35 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-APR-2021 and beyond use date for the vial was reported 19-MAY-2021. Product moved to clinic 27-APR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
Pain; Pain; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of PAIN (Pain) and the first episode of PAIN (Pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 22-Oct-2021, the patient experienced the first episode of PAIN (Pain). On an unknown date, the patient experienced the second episode of PAIN (Pain). At the time of the report, last episode of PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of pain after the covid vaccine and pain with Humira(adalimumab) was a reasonable possibility.  Treatment Drugs Not Reported  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
This eight-month gestational age fetus, whose mom was given flu vax in OCT93, died due to viremia in DEC93 coincident w/the mother developing a severe influenza infection;
Urinary tract infection; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 34-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, a few days after the first dose the patient began to experience symptoms of UTI (Urinary Tract Infection). The UTI was non responsive to antibiotics for almost 4 months. It finally went away. The patient went to the emergency room (ER) several times and saw several different doctors and was prescribed several different antibiotics. The patient had no history of UTIs, it was very out of the ordinary for the patient. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included antibiotics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event UTI (Urinary Tract Infection) was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed fever of 103 the never went down below 100 despite Ibuprofen 800 mg QID. Fever lasted for 4 days. Upper third of left arm red, hot to touch, swelling extended to clavicle in front and up toward neck and present for 7 days despite cold packs. Area of induration originally as big as tangerine and two weeks later still the size of walnut. No problems with shortness of breath.