chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non- healthcare professional on 26 October 2015. This case involves a three-year-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number-UI463AA, expiry date-30 June 2016) intramuscularly on left thigh on 23 October 2015. The patient's medical history of illness at time of vaccination, birth defects, medical conditions were not reported and the patient had none known allergies. The patient's concomitant medications were not reported. On 24 October 2015, one day following the vaccination, the patient's thigh and upper leg became very swollen , " about 3 times normal size". The patient required ER/doctor visit on 26 October 2015. Laboratory data and corrective treatment were not reported. As of 26 October 2015, it was reported that the swelling was decreased but the patient was not recovered from the events. List of documents held by sender: none.
Left arm from shoulder to elbow red, swollen.  No hardness, no pain, no fever.  Given Benadryl and iced arm.  Symptoms gone 1.5 day.
Seizure. Follow up: New onset seizure; evaluated at medical center. Had CT and other work up, seen in office 1/21/05.
mom phoned & reported circumoral blueness, fever (not taken) & shaking;advised to go to ER;dx per mom severe middle ear infect;prescribed amoxicillin, APAP & analgesic ear GTTS; had been treated w/ampicillin 2 wks prev for URI;
This spontaneous report as received from a physician's office manage refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 01-JUN-2015 the patient was vaccinated with an improperly stored dose of M-M-R II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route and anatomical location were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
and a bit swollen; My arm was sore; now it's sore around my armpit area; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area) 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 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area). At the time of the report, PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   Reporter did not allow further contact
Patient woke up with significant swelling, warmth and redness on arm where vaccine was administered on shoulder. Within 48 hours of vaccine administration, swelling and redness had spread from mid-chest, down arm and extended to child's back almost reaching to spine. Site was itchy. No respiratory issues noted.
Lymph node in armpit swelled up to the point of hardness and difficulty in moving arm. I called doctor after a few days, but did not visit office.
administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours; administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours). On 03-Aug-2021, PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) had resolved.        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 reported.   No treatment information was provided.
A report has been received from a Pharmacist concerning a 60 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). Concomitant medication included METOPROLOL, FLUTICASONE, ATORVASTATIN, IBANDRONATE SODIUM and LORATADINE. FLUMIST (INTRANASAL) started on 05-Nov-2014. Patients over the age of 49 had administered FLUMIST. The outcome of the event of ADMINSITRATION TO PATIENTS OVER 49 YEARS OLD is unknown. The report was considered to be non-serious.
The first adverse event was an extremely large blood clot from the vaginal area about 7 days after the first injection. I was on my menstrual cycle that seemed to last the normal length of time except for that issue which has never happened to me before. Since the vaccine my period has not been normal. For two months it has been almost non-existent and much shorter than my normal 7 day cycle. For two other months (September) my period has lasted 14-16 days. The blood clot followed by non-normal periods and now I have started having night sweats/hot flashes in October and have had no period.
This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from a physician concerning her daughter (age not reported) who on an unspecified date was vaccinated IM with the first dose of GARDASIL vaccine (lot not reported). Her daughter became weak, dizzy and stayed in bed for two days after vaccination. The outcome was not reported. Additional information has been requested.  11/18/08 Reviewed ER medical records of 3/4/2008. FINAL DX: viral syndrome Records reveal patient experiencec felt faint x 1 day, fever, vomiting, cough, loss of appetite, abdominal pain, reduced oral intake.  Tx w/IVF & meds, improved & d/c to home, instructed not to go to school next day. Follow up information has been received from the physician concerning her 17 year old daughter who on 28-FEB-2008 was vaccinated IM with the first dose of GARDASIL vaccine. On 29-FEB-2008 the patient started feeling nauseous, had a headache and was very tired. Her mother took her to the ER. The patient stayed there for the whole day. She received IV fluids for dehydration. She had a CT scan, blood work and other tests that were all negative. She was diagnosed as having a reaction to the GARDASIL vaccine with a semi-seizure. She is not going to received the 2nd or 3rd dose. She has since recovered. The physician mentioned that her other daughter had received GARDASIL without any problems. The lot# was unknown because the patient was vaccinated at another office. Upon internal reveiw, semi-seizure was considered to be an other important medical event. Additonal information has been requested.
Covid Arm, rash on right arm 5 days after 2nd vaccine 03/23/2021 :  RUQ pain 8/10 pain scale deep, throbbing approx 8-10 weeks intermittent  09/23/2021 :Post menopausal spotting intermittent for 3-5 days, then again 10/15/2021 and 11/11/2021
Patient's wife called at 5:48pm and said patient was shaking more than the usual Parkinson's disease. He felt clammy, had no rash. Wife didn't think he had a temperature but didn't check with a thermometer. Patient was doing fine next day (10/3) and didn't' seek medical attention.
Encephalopathy Autoimmune Hemolytic Anemia  Pancytopenia  Severe ITP
Pt came to use 10/20/2014 about 1:30 pm stated had pain in Lt arm from deltoid down to elbow also had headache. Today LA has small pink area with  four vesicular pencil point size. Arm not hot to touch. Pt. states still has HA daily. Pain in Lt. arm but not as bad. T.98.5. Denies having temp.  Did receive Zostavax at pharmacy. That lot # was K006438. Pt. first said the reaction was after Zostavax then thinks it was before. Never called her PCP was on duty today. Took picture of rash and wants pt back in one week.
chills, dizziness, lightheadedness, fever, fatigue, GI distress, pain at injection site, muscle aches, joint aches, nausea, dry heves, vomiting, arm heavy at night.
Injection site hot; Cutaneous hypersensitivity at the injection site; Injection site itchy; Injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised). At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE HYPERSENSITIVITY (Cutaneous hypersensitivity at the injection site) and VACCINATION SITE SWELLING (Injection site raised) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included pain reliever and antibiotics for the symptoms
Provider summary "77-year-old male with a past medical history significant for prostate cancer status post radiation treatments in 2019 who was found after recent workup for weakness and chills, to have a sigmoid stricture.  This progressed to a partial large bowel obstruction.  Biopsies of the sigmoid colon were negative for neoplasm, but preoperative imaging did demonstrate significant retroperitoneal lymphadenopathy; PSA normal.  The patient underwent an exploratory laparotomy and Hartmann procedure for progressive bowel distension on 6/2/22; at the time of the operation, 1 L of ascites was removed and was sent for cytology.   Postoperatively, patient had ongoing sepsis and peritonitis  Repeat imaging raised suspicion for retained foreign body.  Underwent reopening of laparotomy and removal of a retained foreign body on 6/5/22.     Due to worsening tachycardia and clinical deterioration yesterday, and concern for possible perforated viscous, patient was taken back to the OR for reopening of his laparotomy.  No evidence of perforated viscous or intra-abdominal sepsis was identified.  Ascites was sent for cytology and liver biopsies x2 were performed, due to a cirrhotic-appearing liver.   On 6/8, the patient again showed evidence of clinical deterioration. Repeat COVID test was positive.  Patient started on Remdesivir (therapy completed on 6/13) and dexamethasone (to continue through 6/18).  Fluconazole added d/t peritoneal cultures (d/c'd 6/14 per ID's recommendations). The patient continued to improve clinically and diet was advanced appropriately. He will be discharged to a skilled nursing facility in stable condition. Patient discharged with prescription for beta blocker per Hospitalist recommendation given inpatient tachycardia."
On 10/11/17 patient states she started to feel shivering, body aches, fever, and some nausea/vomiting around 10:00pm. Patient then stated that on Sunday 10/15/17 symptoms began to subside but a red bump appeared on her left arm. Bump began to spread on her upper arm area. She has some difficulty moving her arm. Patient went to her primary care doctor on Monday 10/16/17 and was given clarithromycin 500mg for 10 days. Patient came to the pharmacy on 10/18/17 and notified us that she was has a reaction to the vaccine. Pharmacist recommended that she try Benadryl in case its an allergic reaction. Will continue to follow up with patient.
The patient complained 15 minutes after her injection that she had bruising starting to appear on the front of her right hand.  She said that after her first Janssen injection on 03/03/2021 she developed bruising on the same hand 4 days later.  She said that she went to the Dr two weeks after her injection for the bruising and the Dr did not worry.  On her pre-screening  form for us, she stated that she never had a reaction to an injection and she does not suffer from clotting or bruising disorders.  She became extremely anxious and she stated that she wanted to know if the Janssen injection causes bruising.  I did some research online and discovered that it could cause capillary leak syndrome in people with low platelets.  This condition affects 1  out of 300,000 people and 1 out of 10 die.  It can be fatal.  We offered to call 911, but she refused the ambulance and she signed a waiver to have her husband drive her to the ER.  She said that she was going to get her platelet levels checked and see her own Dr.
Patient suffered a 2-minute long seizure. She has a history of known seizure disorder. Her last seizure was 3 months ago. She also suffers from severe anxiety. patient was alert and oriented times 3 and refused transport to a local hospital by EMS. She left.
None Stated. On 10/19/09, the PCP stated that coroner called him and told him that he found consolidation of the lungs on autopsy. Autopsy report is not complete yet.   10/20/09 ER records received service date 10/14/09. Assessment: Cardiac arrest. CPR initiated. Pupils fixed and dilated. Apnea, pale. Rigor, lividity.  1022/09 PCP /Nursing medical records received, service dates 11/11/03 to 10/14/09. Assessment: Death. Office staff unable to contact patient's family, eventually visited patient's home. learnd that patient was found dead at home and taken to ER.  11/3/09 Additional ER records received for service date 10/14/09. Found supine on floor at home apneic and pulseless. Cardiac arrest. CPR initiated.   12/8/09 Autopsy received. Pronounced dead on 10/13/2009 Final cause of death: Pneumococcal Pneumonia. Pandemic Influenza A.  Additional Information Abstracted: Other contributing conditions - Leukopenia, history of leukemia, Down syndrome. Drug Screen Heart Blood: Dextromethorphan <0.10 ug/ml, Promethazine 0.11 ug/ml. \ksk  12/28/09 Pathology report received. Receipt date 10/23/2009. Sign out date 12/21/2009. Diagnosis: Lung - Diffuse alveolar damage and bronchopneumonia. Immunohistochemical and molecular evidence of novel influenza A H1N1. Immunohistochemical and molecular evidence of Streptococcus pneumoniae. Immunohistochemical evidence of Neisseria meningitidis without molecular confirmation. No immunohistochemical evidence of Group A Streptococcus or Haemophilus influenzae.  All follow-up attempts have been completed per company SOPs. No further information available.
CRVO per ophthalmology note:    States that she developed a headache on the right temple and right eye approximately 1 week ago.  This resolved.  This last Sunday 4/11/21 and later that day her vision in the left eye became suddenly dark and is what prompted her to be seen by an ophthalmologist. She was seen by Dr yesterday and was referred to Dr for further evaluation.  Patient states that her right eye vision has been seeing "diamond" shapes that she noticed yesterday. She currently has an intense headache that is all over her head and eyes. She reports nausea since 4/11/21.  States that she had floaters and flashes of light in the left eye on Sunday 4/11/21.  She is worried about the vein in the back of her right eye as well, Dr  told her it looked constricted.  She felt that her jaw was strained and tight yesterday.    States that she received her COVID Vaccine last week and she wonders if this caused her blood clot.
PT HAD PAIN, SWELLING, INCREASED WARMTH, ITCHING AND INDURATION OR LUMP- 4x4cm AT INJECTION SITE, PT VERY TIRED FOR 3 DAYS, DURATION OF ILLNESS 4 DAYS.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose: 12/23/20,PFIZER,Lot#EK9231 2nd dose:01/11/21,PFIZER,Lot# el3248 Diagnosed covid positive:04/01/21 Exposure:Unknown Symptoms:sob,fatigue,congestion,loss of smell,fever
She received her vaccinations on 9/25/03 and passed away on 10/13/03. The autopsy report received on 1/29/04 states SIDS.
He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination.     Patient didn't have any allergies and any medical history.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up). The patient was treated with EMPAGLIFLOZIN (JARDIANCE) for Adverse event, at an unspecified dose and frequency; FUROSEMIDE for Adverse event, at a dose of UNK,water pill; POTASSIUM for Adverse event, at an unspecified dose and frequency and Physical therapy (compression leg stockings and electric air pump machine that he wears twice a day) for Lymphoedema. At the time of the report, LYMPHOEDEMA (He came down with lymphedema/has water on the skin and stated that the doctor said that lymph nodes was plugged up) outcome was unknown.            No concomitant drug information was provided. Reporter reported that the patient was not hospitalized but was advised by his HCP to get hospitalized and stated that  was almost hospitalized and ended up receiving care at  primary care's clinic. Physical therapy and compression leg stockings and electric air pump machine that he wears twice a day. Patient did not have any COVID-19 test.
This spontaneous report was received from a Licensed Practical Nurse concerning an unknown number of patients with no known drugs reactions/allergies who on unknown dates might have received improperly stored GARDASIL (dose, route and lot # not provided) that was exposed to 30F for 12 hours. The nurse stated that this temperature excursion occurred during the 1st week of June 2012. Patients might have been exposed to GARDASIL after this time frame. There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
10 minutes post vaccination, pt developed severe swelling at the injection site. Patient's deltoid muscle swelled up to the size of a golf ball. No other adverse symptoms reported or observed.
Sore arm; Felt under the weather; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MALAISE (Felt under the weather) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011P21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 14-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and MALAISE (Felt under the weather) (seriousness criterion medically significant). On 15-Oct-2021, MALAISE (Felt under the weather) had resolved. On 17-Oct-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details were provided.  No Treatment medication details were provided.  Company comment: This case concerns a 70 year-old male patient with no medical history provided, who experienced the unexpected events of Pain in extremity and Malaise(seriousness criterion medically significant). Both events occurred on the same day the patient received the third dose of  mRNA-1273 (Moderna COVID-19 Vaccine). The following day, Malaise had resolved, with Pain in extremity resolving 2 days after. The reporter did not provide any causality assessments. The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.   This case was linked to MOD-2021-362098, MOD-2021-362028 (Patient Link).; Sender's Comments: This case concerns a 70 year-old male patient with no medical history provided, who experienced the unexpected events of Pain in extremity and Malaise(seriousness criterion medically significant). Both events occurred on the same day the patient received the third dose of  mRNA-1273 (Moderna COVID-19 Vaccine). The following day, Malaise had resolved, with Pain in extremity resolving 2 days after. The reporter did not provide any causality assessments. The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.
Nausea  Flu like symptoms- aches, chills, fatigue SEVERE RASH- all over body- red and inflamed  ITCHY- uncomfortable  ER VISIT - Hospitalized Medicine- Prednisone, Zyrtec, Pepcid
Vaccinated at 12:20pm. I noticed my my body feeling tired around 5:30pm and slowly intensified. At 9:00pm I got chills and temp was 99°F. My temperature steadily increased until about 10:30pm when it was 101.8°. I felt very fatigued and feverish. No nausea. Mild body aches. Temperature held at 101.5 until about 12:30am then fluctuated between 101 and 101.5 for a few hours. Then slowly decreased. At about 9:30am was the first time my temperature was under 100°.  It was 99.8. As my fever went down my headache increased to moderate/severe level. I took some acetaminophen at 12:00pm for my headache, my temp was 99.1°.