chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from the consumers' parent on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSONL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 1-2 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient take MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information received on 09 September 2011 from a health care professional. The reporter has had no further contact from the patient or parent regarding the adverse events. The patient had not been seen in the office for any reason since 27 June 2011. No information regarding the patient's recovery status was provided. Documents held by sender: None.
I tested positive for COVID-19 on 04/04/2022 with a at home test. My symptoms were slow and mild. First, I had a dry cough and it went from my stomach started hurting really bad. The pains were very severe, and it went to diarrhea. The diarrhea continued and I had a mid-grade fever. My body was very feverish, I had to turn on the air. I could still do some things, I just felt bad with the dry cough still. I didn't lose my taste or smell. I was very fatigue and a little tried. My diarrhea continued and I had to take Azithromycin for travelers' diarrhea. I went to my doctor, and she confirmed that I had COVID-19 on 04/06/2022.
Pounding headaches, Nausea, vomiting, diarrhea, chills, fever, joint pain, abdominal pain, extreme pain at injection site, hand swelling, rash all over chest area, fatigue to point unable to stand for more than 15 minutes
Shaking, fever, dizziness, tingling of legs, tachycardia. All started about 2 hours after receiving vaccine. He was taken to urgent care by mother. He was given 600 mg ibuprofen and EKG was done.
Initial unsolicited report received from a nurse on 18-Jul-2018. This case involves a 17-years-old female patient (reported as 17 years 9 month old) who was vaccinated with an incomplete dose of suspect 0.1 ml IMOVAX POLIO (batch number: N1A451M, expiration date: 09-Feb-2019, frequency: once) via subcutaneous in left forearm on 18-Jul-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine administered at inappropriate site and vaccine underdose. It was not known whether patient 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.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were Reported. No treatments were Reported.
This spontaneous report as received from a physician refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II, lot number M036543, (dose, dose number, albumin status, injection site, route of administration and expiration date were not provided) for prophylaxis. The dose of the vaccine was reconstituted with properly stored sterile diluent injection. It was also stated that the vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
After the first dose in 2018, he started with having fainting or dizzy spells every time he would get up. He had several full on blackout fainting episodes all the way up until Jan. 2019. Then he had his second dose. After the second dose, the fainting spells increased and that year I took him to his pediatrician followed by several other doctors and tests to determine the reason for the fainting.
Information has been received from a school nurse concerning a child who on an unspecified date a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Redness,swelling and itching of upper left arm one day after injection.  Benadryl, Cephalexin and Methylprednisolone
Generalized fatigue, weakness and worsening confusion over past few days. Had COVID around Christmas time. Increased shortness of breath, chills, fatigue.
PATIENT FELT CRAMPS IN LEGS AND FEET HER LIPS GOT SWOLLEN AND GOT BURNING AND DRY MOUTH ALSO NECKAND CHEST ITCHING
Vaccine given at 9:55 am At approximately 10:30 am, patient complained of a headache. Patient was given an ice pack and a snack as he had not eaten. At approximately 12:00 pm, patient returned to clinic complaining of shortness of breath, headache, nausea, vomiting, dizziness, and mouth tingling.  At that time, epipen was administered and EMS was called. Pt transported to Emergency Room.
Result Type: History and Physical   Date: August 14, 2021 2:17   Result Status: Auth (Verified)   Result Title: Admission H & P   Performed By: MD on August 14, 2021 2:21   Verified By: MD on August 14, 2021 2:21   Encounter info: Inpatient, 08/14/2021 - 08/25/2021    * Final Report *        Date of Admission  08/14/2021  Chief Complaint   for resp distress, COVID+, intubated by EMS and given 4mg versed, 20mg etomidate, 100mg ketamine, 125mg solumedrol   History of Present Illness     75-year-old female sent from secondary to respiratory distress.   Patient is intubated in the ER therefore history is taken from ER records and chart.  Patient had recent admission at hospital rib patient had been initially admitted with symptomatic anemia and abnormal vaginal bleeding.  At that time patient was found to have brainstem mass likely metastatic cancer secondary endometrial cancer.  Patient required blood transfusion.   Patient presents today with acute worsening of shortness of breath at 11:30 a.m. this evening.  patient has known covid-19.  Per EMS patient's initial O2 sats were in the 70s.  Patient started on CPAP with no improvement.  Patient intubated in the field.  Course of symptoms constant degree at onset severe degree of present severe.  No known exacerbating alleviating factors.  No known other associated symptoms.  Patient by emergency department patient started IV pressors given IV antibiotics. Pneumonia due to COVID-19 virus U07.1   Acute hypoxemic respiratory failure Respiratory failure J96.90  Severe sepsis R65.20   Recent diagnosis metastatic CA likely endometrial  History of Abnormal vaginal bleeding    CM Ongoing Assessment AH NEW   Patient:              Age:   75 years     Sex:  Female     DOB: Associated Diagnoses:   None  Author:   Professional Services  CM Contact Information:    Discharge Planner .   Discharge Planner Phone .     Assessment  Ongoing Assessment  Situation: was advised that pt expired this morning 8/25/21. contacted (ex-spouse) to inform him of this information. Pt was not under hospice services as ex-spouse only returned part of the paperwork..
fever to 101-vomiting 8-10 times daily x 3day; some diarrhea-could have been viral illness;
Mother called health department at 1:15p. 10/05/04. Had taken child to the ER: temp. Reported 103. No rash. To relieve symptoms with Tylenol or Motrin.
Pt. received Flouzone  (purchased vaccine) at 1:45 pm and reports that she started having diarrhea that started about 2:20 pm after receiving the Flu vaccine.  She then developed sore throat and pain with breathing shortly about 2:30 pm.  The next day she had a bump on bottom lip that was hard to the touch that came up and was about 5 mm in size. She had diarrhea that lasted 6 days, sore throat (swollen and tight feeling) that lasted 3 days.    She took ibuprofen, chroraceptic and kaopectate.   She is now recovered.
rapid eye movement, dizziness, hard time focusing, feeling of anxiety and panic attacks, hard time breathing, head fog.  Eye movements started the evening of vaccination... other symptoms followed and are still lingering today, March 19th.
Received PNEUMOVAX vaccine at 0942 on 11/12/09, and had thickened tongue with impaired speech and c/o feeling like something caught in throat at 1230. By 1235, severe swelling of tongue and peri-orbital edema present.
Fever started at 5 am. Chills and higher fever at 12pm. Congestion.
24 hours after receipt of first Moderna vaccine dose patient developed progressive weakness and decreased responsiveness.  She presented to the ER when was no longer able to walk independently.  She complains of pain all over and shortness of breath. Her temperature was 103F. D-dimer+ and CT scan revealed multiple pulmonary emboli.  She remains hospitalized.
Information has been received from a registered nurse concerning a 20 year old female student who on 21-DEC-2006, at 2:00PM, was vaccinated IM, into the left deltoid, with a first dose of Gardasil (Lot# 653937/0637F). There was no illness at the time of vaccination. On 21-DEC-2006, after the injection, at 2:00PM, the patient became lightheaded and nauseated, "approximately 15 minutes". The nurse also reported the injection was very painful when vaccine contents injected into muscle and the patient had a hot flash. On 23-FEB-2007, at 3:15PM, the patient was vaccinated IM, into the left deltoid, with a second dose of Gardasil (Lot# 654389/0961F). There was no illness at the time of vaccination. The nurse reported that the patient felt a hot flash immediately post injection . The second injection was also said to be very painful when vaccine contents injected into the muscle (not from needle placement), for "five minutes". No further information is expected.
Onset heart palpitations and tachycardia 110's-130's 2 days after vaccination.
Starting 9pm 11/1/2023, noticed site swelling and felt hot to touch on left thigh
FATIGUE, HEADACHE, CHILLS AND FEVER. TOOK TYLENOL
This spontaneous report as received from a health medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J004064; expiry date: 06-AUG-2014). On an unknown date after vaccination the patient experienced fatigue, fever and was achy. The patient also stated he had pain and swelling at the injection site which developed into edema "of the entire arm". The patient saw his unspecified primary care provider on an unspecified date regarding the reaction. Medical assistant stated "based on the report that patient was not recovered and had been out of work for 2 weeks. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age On 03-JUL-2012 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). The patient received second dose of GARDASIL on 28-MAY-2013 (dose, route and lot # not reported). Patient was in the office on 05-JUL-2013, and physician did not specify if patient will receive the third dose on 05-JUL-2013. Additional information has been requested.
Approximately one week from the vaccination, the injection site started reddening with itchiness.  Over the course of 8 days the redness spread and the richness increased in intensity, but eventually subsided.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), single dose, route and anatomical location not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had temperature excursion for 360 hours, the lowest recorded temperature of 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient received the monovalent covid for booster instead of the bivalent covid booster. patient already had received 2 doses of the monovalent covid.  no reaction after dose.
Rash on torso (trunk); Chills; Very cold; Nauseated; This is a spontaneous report received from a contactable consumer, the patient. A 62-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 08:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergic history.The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 09:00 as a single dose for COVID-19 immunisation Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, Concomitant medications included Trazodone 50mg (MANUFACTURER UNKNOWN) 2 tablets per day, Baby asprin (MANUFACTURER UNKNOWN), within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced chills, cold and nauseated. On 17Mar2021, the patient experienced rash on torso (trunk). Patient stated that after getting the 2nd dose, that evening patient started getting the chills and was very cold and felt like he had the flu. Patient also felt nauseated but did not throw up and took some Tylenol which helped but he did not check his temperature. Patient stated this lasted nearly 48 hours. On day 2 after getting the 2nd vaccine patient began getting a rash on his torso (trunk). It was mainly on the front side of his body but also some on back. The rash was fairly solid and looked like a sun burn. This lasted nearly a week with itching starting at about day 4 lasting about a full week from getting the 2nd dose. Patient was not feeling very well until about day 4 when he started getting energy to do things. At a week after patient pretty much back to normal. The clinical outcome of the events chills, cold, nauseated and rash on torso (trunk) was resolved on an unknown date in Mar2021.Patient has not tested positive for COVID-19 since having the vaccination.  Information about lot/batch number cannot be obtained. No further information is expected.
Physician Discharge Summary     Patient ID:  Age: 78 y.o.  Admit Date: 8/17/2022 11:14 PM  Discharge Date: 8/23/2022     Admitting Physician:    Discharge Physician: MD     Discharge Diagnosis:  Principal Problem:    Acute on chronic diastolic congestive heart failure  Active Problems:    Type 2 diabetes mellitus with peripheral neuropathy    NSTEMI (non-ST elevated myocardial infarction)    COVID-19    Acute renal failure superimposed on stage 3a chronic kidney disease    Benign essential HTN              Hospital Course: Patient is a 78 y.o. male admitted with a/c diastolic hf. Also covid + on admission. Received 5 years remdesivir. Was still undergoing diuresis. See plan below. Rehab called and accepting pt mid treatment. Dc with close f/u      * Acute on chronic diastolic congestive heart failure  ?Acute on chronic diastolic heart failure. IV Lasix 40 mg twice a day. Continue to monitor and O's and daily weights. reconsult cards. Echocardiogram ordered showing normal ejection fraction.   ?Chest pain/non-ST elevation MI: seen by cards earlier in stay. Troponins borderline elevated at 0.13-0.15. Not acute coronary syndrome pattern however. Stress normal.    ?Non sustained V tach. Cardiology reconsulted, reviewed, and cleared .    ?Covid 19:  Remdesivir completed 5 days, supplements, daily labs ordered. Monitor   ?Transient confusion likely secondary to use of benzodiazepine. Resolved. Family report recent memory changes as well. DC benzodiazepine and switched to Seroquel p.m. for insomnia. CT of the head shows chronic changes with no acute intracranial abnormality. Serum ammonia level is unremarkable. ABGs are reviewed. UA shows no evidence of UTI.    ?ATN per nephro. Creat still 1.8. Consult nephrology to assist.   ?Hypertension: Chronic. Continue home regimen. When necessary IV hydralazine ordered. Monitor   ?Diabetes: Chronic. Hold by mouth medications. Sliding scale ordered. Monitor   ?Debility. Feels. Weak, would like to consider inpatient rehab. PT/OT ordered. FOR SNF placement. SW following.    ?Hypoxia. Does not use O2 at home. 3L today.                      Physical Exam on the Date of Discharge:  Vitals: Blood pressure 140/62, pulse 52, temperature 97.7 °F (36.5 °C), temperature source Oral, resp. rate 18, height 5' 10" (177.8 cm), weight 65.1 kg (143 lb 9.6 oz), SpO2 98 %.   General Appearance: alert, NAD  Lungs:  normal effort  Heart: S1 S2 heard             Consults:    IP CONSULT TO CARDIOLOGY  IP CONSULT TO CARDIOLOGY  IP CONSULT TO SOCIAL WORK  IP CONSULT TO SOCIAL WORK  IP CONSULT TO NEPHROLOGY  IP CONSULT TO CARDIAC ELECTROPHYSIOLOGY              Disposition:  SNF     Discharge Condition:  fair
p/1st vax pt had h/a, sore arm, itching, weakness in arm, very tired, h/a;
Red swollen itchy area; Sore and stiffness in neck and shoulder; Experienced a lot of dizziness; Rash at the injection site; Hives at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), INJECTION SITE URTICARIA (Hives at the injection site), VACCINATION SITE PRURITUS (Red swollen itchy area), DIZZINESS (Experienced a lot of dizziness) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site) and INJECTION SITE URTICARIA (Hives at the injection site). On 22-Jan-2021, the patient experienced DIZZINESS (Experienced a lot of dizziness). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red swollen itchy area) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), INJECTION SITE URTICARIA (Hives at the injection site), VACCINATION SITE PRURITUS (Red swollen itchy area), DIZZINESS (Experienced a lot of dizziness) and MUSCULOSKELETAL STIFFNESS (Sore and stiffness in neck and shoulder) 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.   Treatment included Benadryl and Sertac.
bit by a deer tick; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that after the patient got her second vaccine, she was bit by a deer tick and stated that they carry Lyme disease. The patient was prescribed doxycycline and wanted to know if it was compatible with the vaccine that she received the day before. The outcome of the event was unknown.   Information about lot/batch number has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 69-year-old male patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B and the 2nd dose of ENGERIX B. In April 2014, the patient received the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B and ENGERIX B and 305 days after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details provided were as follows: This case was previously reported to the manufacturer. On unspecified dates, the patient received first two doses of ENGERIX B. In April 2014, the patient received his 3rd dose. In February 2015, unknown times after receiving the first two doses and 10 months after receiving the 3rd dose of ENGERIX B, the patient underwent test for Hepatitis B titers, which was found to be negative. This caused the patient to be a non-responder to the therapy.
I had the vaccine on 01/16/2021 and my heart stopped. I had a long period of Atrial fibrillation, my heart will stop for 8 seconds and then it will start again. I had like 3 or 4 fainting episodes. Since then, I have had a heart pacer implanted. They put a Halter monitor to check my heart behavior. I was already under treatment for the fibrillation but this was an exaggeration of this problem.  My cardiologist told me to come in because I had the monitor and they saw that my heart was stopping so I went in since it was an emergency. They kept me in the hospital for 3 days because they wanted to keep me in observation before they put the pace maker in.