chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We discussed her inability to have a tracheostomy and overall goals of care/code status.  She currently meets criteria for extubation this morning. She is agreeable to removing her breathing tube at this time. When asked if she'd like to have the breathing tube re-placed if she needed it, she clearly indicated that she does not want the tube or breathing machine. She has requested to be a DNI.  At this time, she wishes to remain full code without intubation.  A  Code Blue was paged where Patient was found unresponsive, with agonal respirations and significant bradycardia upon arrival.   She became pulseless. ACLS protocol was initiated per the patients wishes. She was bagged via mask but not intubated. After approx. 2 minutes of compressions we had ROSC. Her daughter at the bedside requested that when her heart stops again, we allow her to pass peacefully.  Morphine 4 mg IVP was ordered for comfort.  Shortly after, she became apenic and pulseless. She was pronounced deceased at 1230 pm on 7/5/22. Family was present at the bedside.
10-12 cm area on right upper arm. Has redness, warm to touch, pain and swelling. Rash arose quickly and started to spontaneously resolve. Treated with prednisone 40 mg x 5 days.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. Approximately on an unknown date in 2009 (reported as about 5 years ago), the patient was vaccinated with first and the second dose of GARDASIL, (lot number, expiry date and route was not reported0. Concomitant medications were not reported. The patient was in the office to receive the third dose of GARDASIL, on 27-FEB-2013. No adverse event was reported. Additional information has been requested.
Severe rash and swelling with intense itching on right side of face (similar to reaction my husband had  6 days after his shot). Swollen gland on right side, and mammogram showing  enlarged lymph nodes on right side.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  PATIENT REPORTED ELEVATED BP 179/105 WHEN WOKE UP AT 1:30AM.  WENT TO ER WHERE THEY MONITORED BP FOR 3-4 HOURS, BLOOD WORK DONE.  FOLLOWING EVENING BP ELEVATED AGAIN 170/109.  BP ELEVATED FOR SEVERAL DAYS FOLLOWING VACCINATION AND NORMALLY CONTROLLED BY MEDICATION UNDER 120/80.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. In 2016 between 22-NOV-2016 and 14-DEC-2016, the patient was vaccinated with a dose of improperly store PEDVAXHIB, lot number M025194, expiration date 22-MAR-2019, (dose, route and anatomical location were not reported) for prophylaxis. The PEDVAXHIB was exposed to 34.8 Fahrenheit for 35 days and data logger was reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA004799: US-009507513-1701USA005345.
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Minor Rash/Itching/Shakiness on left side, followed by trouble breathing; symptoms lasted 1 day
Patient given multiple vaccines 4/3/07. Patient brought in 4/4/07 with blisters at one injection site left deltoid region
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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.
Received moderna vaccine 1/1/2021. On 1/11/2021 persistent tooth pain presented, upper and lower mouth. Pain has persisted for past 2 days (no improvement).  6-10 blister like painful and itchy bumps to head (only in areas covered by hair) presented on 1/11/2021, persistent.
She said her arm started itching about 15 minutes after the vaccine once she was in the car on the way home. A large red circle that was hot to the touch formed around the vaccine site. She said a pain going up her arm developed later that night and she woke up with a headache. The patient had used aleve to help with the headache but it did not help much. I suggested that she try alternating tylenol with the aleve and to get some benadryl to see if that would help the reaction go down. I told her I would follow-up with her tomorrow (9/13) to see how she was feeling.
It was reported that a 5 year old female received on IPOL vaccination on 3/13/00 and that same day, the pt developed a 20mm area of redness at the site of injection. From correspondence received on 3/30/00, it was reported that the pt also received DTAP Acel-Imune (Lederle) and MMR (Merck) on 3/13/00. The pt reportedly recovered from this experience. Additional pt, vaccine and responsible physician information was also provided.
My first 2 doses were Moderna 8 months prior.  About 6 or so hours later I smelled burnt chemicals when apple pies were cooking. I had diminished taste with peppermint candy. It went away with in about 3 hours
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in approximately January 2017 (reported as in or after January 2017), the patient was vaccinated with an improperly stored dose of VARIVAX lot # M006722, expiration date: 08-FEB-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion between 6 to 14 Fahrenheit degrees for 2 months. There were no previous temperature excursions reported. Data logger was not involved. The patient's concomitant therapies included sterile diluent, lot # reported as L019306, expiration date:04-MAR-2018. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Arm was sore and swollen at injection site. Patient describes firmness to the touch at the site of injection. Soreness persisted for
Child received varicella vaccine on 3/22/2005.  On 3/23/2005 came into clinic with localized cellulitis at injection site.  Child given RX for Keflex 125/5cc 1 tsp four times daily for 7 days
No signs or symptoms. No reaction. A 3 and up flu was given to a 22 month old.
Day 1 - Vision loss/change left eye, Left face numbness, Numbness through hands then through whole body, nausea, headache, vomiting.  Subsided after rest and ibuprofen Day 3 - Vision loss/change left eye, Headache left side and center back, nausea.
shingles; ill-defined disorder; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. In 2016, Plaintiff was inoculated with zoster vaccine live(ZOSTAVAX), as prescribed and/or administered by a pharmacist at Pharmacy for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, subsequent to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician, for shingles, and other zoster-related conditions.  As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Facial swelling; Facial swelling; Fever; Stomach issues; Shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th July 2019, refer case US2019187014). Concomitant products included lisinopril.   On 8th October 2019, the patient received the 2nd dose of Shingrix .5 ml. On 14th October 2019, 6 days after receiving Shingrix, the patient experienced facial swelling and lip swelling. In October 2019, the patient experienced fever, stomach discomfort and shivering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, stomach discomfort, shivering, facial swelling and lip swelling were recovered/resolved.   It was unknown if the reporter considered the fever, stomach discomfort, shivering, facial swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm on Thursday of 8th October 2019. After some days over the weekend, the patient developed a fever of 101.5, stomach issues and shivering. On 14th October 2019 morning, the caller reported her husband woke up with facial and lip swelling. He went to the doctor on 15th October 2019 and they were unsure if facial swelling was a reaction from Shingrix, from the Tylenol he took over the weekend to help with fever, or if it was from his lisinopril which he had reportedly taken for years. Caller reports this reaction was not similar at all to 1st dose where only his arm had hurt. The reporter did not consent to follow-up. This case had been linked to the case US2019187018 and US2019AMR188516, reported by the same reporter.
chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (chronic arthritis) and Headache (chronic headache).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better) outcome was unknown.            No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  It was reported that the patients chronic headache and chronic arthritis continued to get better on  19-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: follow-up received contain patient demographics that is patient initial has been updated.
Patient stated that she developed Virtigo around 06/15/21, 3 months after receiving her 2nd dose of Moderna vaccine. Patient stated that she has not seen a doctor for Adverse Reaction. Patient stated that her sister and brother-in-law received their vaccine on the same day, and they also have developed the same Adverse Event, at the same time.
Patient called on 1/21/20 to inform me she had a reaction to the Prevnar injection. She went in to the ER room over the weekend. She experienced major swelling, headache, chills, nausea, dizzy. She was prescribed Keflex.  Dr felt there was an infection going on.
Patient had a slight headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Patient had a slight headache) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Patient had a slight headache). At the time of the report, HEADACHE (Patient had a slight headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Mom noted pt shaking all over for about 15 seconds the evening following immunizations.  No post ictal phase, normal exam following day.
88 y.o. male patient of DO who presented with cough, weakness and fever and was found to have COVID-19 respiratory infection.  He had elevated creatinine and change in mental status.  His head CT showed 1 cm linear area of hypoattenuation relatively new and concerning for recent infarct.   Hospital course?   COVID-19 respiratory infection Acute hypoxic respiratory failure Pneumonia due to COVID-19 Onset of symptoms was on 12/5/2022, presented with cough and shortness of breath.  Chest x-ray showed pneumonia.  He was requiring 2 L of oxygen on presentation.  He was treated with steroids.  ID was of assistance in management.  He was on room air prior to discharge.   Acute metabolic encephalopathy Small subacute right parietal ischemic stroke with petechial hemorrhage He had head CT and MRI as noted above.  Was evaluated by neurology.  He was continued on Plavix and statin.  PT/OT followed during this admission.   Status post fall Fall precautions observed.  PT/OT continued.   AKI on CKD III His creatinine was back to baseline at 1.63 on discharge.  Nephrotoxins were avoided.   CAD/HTN There were no acute issues.  His antihypertensives were continued.     Diabetes mellitus II He was continued on Lantus and SSI as above.   HLD He was continued on statins.   He was discharged to ECF for ongoing therapy.  He was discharged in a stable condition.  He will follow-up with his PCP outpatient.
Swelling and redness to Left arm and right knee. Treatment: Benadryl and Ibuprofen were prescribed. Patient to return to clinic in 2 days if not better.
devel fever to 101 oral for 2 days starting 1 day p/vax; single lt ax node enlargement for 1 day; felt nl for next 11 days;
Subsequent to receiving varicella virus vaccine live the pt experienced multiple papules that were confluent at one site.
Pt recv vax approx 10 yr ago. At time of vax, pt arm "turned black", pt devel resp difficulty, severe nausea & vomiting. Tx w/Adrenaline,Benadryl & steroids.
blood clot/many people have gotten clots and died from it; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot/many people have gotten clots and died from it) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot/many people have gotten clots and died from it) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment information was provided by the reporter.  Company comment  This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
About 1 week after the first dose, had abdominal pain. After the 2nd dose, had more severe  abdominal pain with bilious vomiting
info recv for death certificate that pt had a resp arrest & acute bronchitis;parents refused autopsy according to funeral director
Itchy arm, lumpy, hard at the inj site, rash, inflamed, pink color. All is gone but the pink color.
Night fevers peaking at 101.4 degrees with chills; daytime fever of 99.3 while on Tylenol; incessant unproductive cough with wheezing that is worse at night; nasal congestion; body aches and stomach ache. Treated with Tylenol every 4-6 hours. Still sick as of this writing on 10/20. Missed at least 3 days kindergarten.
16 years, 7 months old patient received the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first dose) in a 16-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported. Caller consented to follow up: NO   Reporter did not allow further contact
Around midnight the night of my first vaccine, I spiked a fever of 102.0 and was shaking and chattering my teeth aggressively. I began hearing a loud whistling noise in my ears(tinnitus) and I've experienced it ever since. My anxiety and depression have become much worse and almost unbearable at times.
patient went back to work and about an hour and so after receiving shot, pt felt like her tongue was swollen and painful and had an itchy throat. Her work EMT gave her Benadryl tablets and monitored her for a while. She said this took care of the effects
Site of vaccine became Red and Swollen mildly Painful within 24 hours - Somewhat worsened 48 hours. Patient feels Lightheaded has mild H/A and sore throat.