chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After five years of being post-menopausal, I made an appointment with my OB/GYN. She did a biopsy right there in the office that came back cancerous. She referred me to oncologist, who scheduled me for surgery to remove me the cancerous area, we decided to do a total hysterectomy. I do not have to go through chemotherapy and radiation as everything was contained to the uterine area. I do have a few more weeks of some restrictions for lifting and water submission but I have been released to do most everything else.
Information has been received from a physician concerning an approximately 12 month old patient who on approximately 1/17/03 was vaccinated with a dose of MMR (second generation) (lot # not reported). Concomitant therapy included varicella virus vaccine live. On approximately 1/26/03 the patient developed a rash and runny nose. A few days later, the patient developed conjunctivitis, dry mucus membranes, lethargy, and it was noted that the rash was expanding. The patient was admitted to the hospital and the patient is suspected to have the measles. As of 1/31/03 the patient remains hospitalized. Additional information has been requested.  Reported on 04/04/2003: "On 01/15/2003 the patient was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 643497/0770M).  Additional therapy also included vaccination on 01/15/2003 with a dose of varicella virus vaccine live (Lot #643121/0548M).  On follow up it was reported by the nurse that the patient was seen in the office on 01/19/2003 with cold-like symptoms, nasal congestion, poor food intake and vimiting.  On 01/22/2003 the cold-like symptoms had moved into the child's chest.  Initial report by the physician had also noted a runny nose.  The nurse reported that on 01/25/2003 the child was seen in the physician's office for a rash and an upper respiratory infection.  Initial information reported by the physician had noted that on aproxinately 02/29/2003 that the child had developed a rash that was expanding, dry mucus membranes, lethargy, conjunctivitis and the child was admitted to the hospital and was suspected to have the measles.  Follow up information reported by the nurse indicated that on 01/28/2003 the child developed lethargy and was seen by "infectious disease" at the hospital.  The child was admitted to the on hospital on 01/28/2003 and was diagnosed with viral encephalitis.  The nurse reported that she did not think that the child was treated with any specific medication and she reported that treatment might possibly have been intravenous fluids and observation.  On 02/02/2003 the child was discharged from the hospital.  The nurse reported that on 02/08/2003 the child's mother called the physician office and reported that the rash was better but not completely gone, as a pinpoint rash was still present.  The mother also reported that her daughter's lethargy was better, but that she was not back to normal yet.  the nurse also reported that on 02/18/2003 the child was seen in the physician's office with a cough, clear runny nose and poor appetite.  Upon examination an inspiratory stridor with crying was noted.  A questionable diagnosis of early croup was noted.  The nurse reported that the child was stil recovering from the viral encephalitis.  Additional information has been requested.  On follow up, the nurse reported that the patient's sibling had an adverse event of otitis media following vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and varicella virus vaccine live (WAES# 0303USA02028).
Severe acute migraine lasting 24 hours. Sudden severe joint and muscle burning/pain dizziness and weakness.
Became dizzy about 10-15 minutes after her received the flu vaccine, came to University Health Services. Vital signs P72, R20, B/P 134/84.
Arm soreness, moderate fatigue, achy muscles and/ or joints, headache, skin sensitive and a little sore to the touch- all over body, not just injection site.
UTI; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). The patient was treated with METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) on 16-Apr-2021 for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.            Concomitant products also include Zyrtec.
Fully vaccinated, not boosted.   Asymptomatic COVID breakthrough infection and inpatient hospital stay for non COVID reason.
Received vaccines 4/2, on 4/9 developed fevers, sore throat - unresponsiveness and encephalitis with brain edema by 4/11. Suspect viral encephalitis - multiple studies pending.  4/23/09 Received hospital medical records of 4/12-4/21/2009. FINAL DX: encephalitis Records reveal patient experienced fever, chills, HA, sore throat on 4/8/09.  Seen in student health 4/9 where strep neg.  Tx w/antipyretics.  Later on 4/9, developed altered mental status, unintelligible speech, vomiting x 1 & shaking.  Admitted to local hospital.  LP done.  Admitted to ICU, tx w/IV antibiotics/antivirals, intracranial bolt place to reduce ICP.  Condition deterorated, remained febrile, intubated & transferred to higher level of care.  Neuro, ID, Optho consults done.  Tx w/antibiotics, antivirals, IVIG x 3.  Improved slowly but febrile throughout, failed extubation, trached, feeding tube placement & transferred to rehab.  At d/c pt could open eyes & tracks but unable to follow commands.  6/10/09 Hospital records and DC summary received DOS 4/10/09 to 4/12/09. ASSESSMENT: Encephalitis, unknown etiology. Post vaccination sore throat, headaches, fever, irritable, confused. Not very responsive. Shaking rigors. On ventilator. Pupils assymmetric.  Spontaneous eye movements, posturing of upper extremities on stimulation, hiccups, diffuse erythema. Withdrawal response of lower extremities to painful stimulation. Transferred to another facility. ICD-9 Codes: 780.97 Altered Mental Status. 323.9 UNSP Causes of Encephalitis, Myelitis & Encephalitis. 348.5 Cerebral Edema. 780.60 Fever unspecified. 573.3 Hepatitis NOS. 305.1 Tobacco use disorder.
Immediate flushing of face. Itchy hands and arms. Ears and face red/hot. C/O hives on back. Hypertensive
1pm - shots given. 5 pm - tired, jittery, pupils dilated, heart pounding, chest pressure, (L) arm rash next day - still jittery & chest pressure.
patient received seasonal flu vaccine on 10/25/21, on 10/26/21 signs and symptoms  started, which included poor appetite, increase weakness, general fatigue, Dizzy and fall without injury. SpO2 decreased and patient came to the hospital
Feeling arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CARBAMAZEPINE, GABAPENTIN, LAMOTRIGINE, METOPROLOL, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Feeling arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (Feeling arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient consented for a followup from the safety team and preferred method of contact was telephone.   This case was linked to MOD-2021-272923 (Patient Link).
Information had been received from a healthcare worker who reported that a 57 year old female with allergies to sulfa drugs and naproxen received a dose of PNEUMOVAX 23 (lot# K007826, expiration date 03-FEB-2016) in an unspecified arm on 01-DEC-2014. Concomitant medications included CALTRATE, unspecified multivitamins, fluticasone, vitamin D3, simvastatin, omeprazole, REGLAN, atenolol, VALIUM, ginger root, metformin and unspecified probiotics. Later that same day (01-DEC-2014), the patient reported that she had a swollen arm that was hot to the touch and described difficulty lifting the affected arm. Patient called into the physician's office on 02-DEC-2014 to report her symptoms but was not seen in the office. Patient was treated with BENADRYL and an unspecified topical ointment. There are two more AE reports involving this same PNEUMOVAX 23 lot; Lot# K007826 exp. 03-FEB-2016 (See SR#'s 1-12956467246 and 1-12956447580). A lot check has been requested with results to be reported to the physician. No further information provided. Additional information has been requested.
A report was received from a health care professional on 25Nov03, concerning a 21 month old female vaccinee who inadvertently received Fluvirin on 19Nov03. On 19Nov03 the vaccinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporters causality assessment. Update 1, 11March04: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400047, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037,PJP200400036.
AWAKE ALL NIGHT; EXTREME HEART PALPITATION / RAPID HEART RATE; FEVER 102; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The batch number was not reported and has been requested. The patient's concurrent conditions included corn allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 07-APR-2021 18:00, the subject experienced fever 102. On an unspecified date, the subject experienced insomnia, and extreme heart palpitation / rapid heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, insomnia and extreme heart palpitation / rapid heart rate was not reported. This report was non-serious.
Deceased 02/05/2022  presented to ER with CPR ongoing.  Had GI bleed.
Information has been received from a 60 year old nurse practitioner with no pertinent medical history reported and no drug reaction/allergies, reporting that she received ZOSTAVAX (Oka/Merck) on 03-DEC-2008 subcutaneously. Concomitant therapy included vitamin D (unspecified) and calcium (unspecified). On 11-DEC-2008 she had dental surgery. By 14-DEC-2008, she noticed that there were a cluster of vesicles on the roof of her mouth on her hard palate. She went back to the dentist who thought that it might be herpes simplex-1. The nurse practitioner was prescribed an unspecified pain pill. She also mentioned that she developed a small lump at the injection site. By 25-DEC-2008, the patient recovered from the event. Additional information has been requested.
This spontaneous report was received from a 59-year-old female consumer regarding herself. The patient's current conditions included asthma and hyperparathyroidism. The patient is allergic to citrates. The patient used to donate platelets. The patient's medical history included hives. The patient was first vaccinated with PREVENAR 13 on 24-MAY-2012. On 06-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 in the left arm (dosing details were not reported) instead of PREVENAR 13 for prophylaxis. On 07-JUN-2018, the patient experienced redness and pain that extended to whole upper arm and to the biceps. It was warm and super tender. The patient reported it was not really swollen. The outcome of the events was reported as recovered/resolved on 11-JUN-2018 (also reported as lasted for about 4 days'). Causality assessment was not reported.
4.18.11 woke up with congestion, given inhaler at home. Got worse, went to hospital. Dx with croup. Rest of week very fussy & some wheezing. 4.23.11 neck swollen also right cheeks swollen and hard to touch. Seen that day at ER. Per mom dx with mumps. Seen by doctor 4.25.11 dx with Parotitis.
5 weeks Pregnant and Received Heplisav-B; Initial Report Received on 04-Oct-2022  This is a spontaneous report, received from a pregnant female patient aged 21 years, who received HEPLISAV-B for hepatitis B immunisation.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 30-Sep-2022, dose 1 of HEPLISAV B (Lot #937228, expiration date 30-Aug-2023, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.   On 30-Sep-202, the patient was 5 weeks pregnant. No adverse reactions were reported by the patient.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a health care worker concerning a patient who on 01-FEB-2008, was inadvertently given a 0.5mL. subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 658587/1520U) instead of zoster vaccine live (Oka/Merck). The reporter indicated that the event was not product confusion. No adverse event was reported. The patient was seen in the physicians office. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Lt arm was swollen, hot and very painful. Pt also had a fever of 100.4. Pt c/o chills and diarrhea x 1 day.
Vaginal spotting began two days after with increased volume each day (no reason for spotting and have never spotted).  Neck pain started on day three.  Took ibuprofen to reduce pain.  Pain returned after medication wore off.
This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 05Feb2021 or 08Feb2021 as single dose to help prevent and make the caller immune (COVID-19 immunization). Medical history included blood pressure high diagnosed 15 years ago, high cholesterol diagnosed 10 years ago. The patient's concomitant medications were none. Historical vaccine included BNT162B2, first dose, received 2 weeks prior to the second dose. The patient has developed a skin condition since she has had her second dose of the vaccine, it came up about 3-4 days after it. She had the skin condition in her hairline and eye, it is improved but when she comes off of the cream it comes back, it is starting to get red again, flake and itch. She received the second dose of the vaccine on 05Feb2021 or 08Feb2021 the skin condition showed up in the following week. She applied a cortisone cream before contacting her doctor and the skin condition was still there, unknown lot or expiration date as she finished the tube and threw it out. The patient thought she had eczema and her doctor thought it may be dermatitis. She has been doing and antibiotic ointment and cortisone cream and the skin condition is still there and irritating. She has never had any skin conditions before. The caller's doctor recommended another cortisone cream but he didn't want her to use it more than a week or a week and a half. She discontinued it yesterday because she has been on it so long. Hydrocortisone cream 1% over the counter- lot 9736488T1, expiration date Jan 2022. The antibiotic cream the caller's doctor prescribed is Ketoconazole 2% cream, lot REVA9-2018, expiration date Oct 2022. Treatment received. Outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
For 2 days after receiving vaccine area was very swollen and itchy - to point where he did not go to school. No respiratory distress. Had a similar reaction to HPV vaccine a few years prior, but physical reaction was stronger and mother will not get any additional HPV vaccines. I am not sure if these are just exaggerated responses or (due to itching) allergic reaction to a component. Will refer to allergy as well.
Patient sat in room for 5 minutes - then was checking out and felt faint dizzy - resolved. Laid down for 5-10 minutes felt better - on her way home. Told to call with any questions.
briefy blacked out w/resp absent for 30seconds; became pale w/blue lips; began breathing on own 911 called & taken to ER; pt sent home from ER:
On 1/19/01, pt noticed 1st pox but by 1/20/01, covered in pox with fever of 103F. Temperature was 100F-101F on 1/21/01. Denies contact with infected individuals. Chickenpox covered body. (Vesicular lesions scabbing over in 3-4 days).
TESTED POSITIVE FOR COVID; This spontaneous report received from a pharmacist concerned a 47 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 12-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Booster) (Dose number in series: 2) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 21-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On 23-DEC-2021, the patient tested positive for covid (Dose number in series: 2). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 13 year old female who was vaccinated with a first dose of Gardasil. Subsequently the patient complained of headaches when she came in for the second dose. On an unspecified date the headaches resolved. Additional information has been requested.
ABDOMINAL PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced flu-like symptoms. On 28-JUN-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and the outcome of abdominal pain was not reported. This report was non-serious.
Information has been received for the Pregnancy Registry of GARDASIL from a Registered Nurse (R.N.) concerning an 18 year old female patient who on 10-MAY-2007 was vaccinated with a dose of GARDASIL (lot # 654389/0961F). In follow up information from the doctor's office it was reported that on 02-OCT-2007 patient had ultrasound (19 weekd pregnancy) for bleeding and result was within normal limit. On 22-OCT-2007 she had a amniocenticsis (at 21weeks pregnancy) and the result was within normal limit. On 23-JAN-2008 she was treated for gastric esophageal reflux disease (GERD) with PRILOSEC twice a day and with KEFLEX twice a day for urinary tract infection. On an unspecified day patient was started with prenatal vitamins. The office learnt about the pregnancy when patient went to the office on 26-JUL-2007. In a follow up telephone call and from the follow up information from the doctor's office it was reported that patient's last menstrual period (LMP) was on 27-MAY-2007 and she delivered a normal male baby on 21-FEB-2008. The apgar score for the baby was 9/9. The baby weighed 7 lb 8 oz. The nurse stated that the baby was "fine". No other information was provided. Additional information is not expected.
Mother called office at 8:30 am on 7-15-09 reported that her daughter had fever of 104 F that morning (approx 24 hours after vaccines).  Mother gave tylenol and temp came down to 102 F. Mother advised to call pt's PCP or go to ER ASAP.  Mother unable to reach PCP.  Mother took child to local ER and was told that she probably had a reaction to vaccines.  Pt was discharged to home. At 4:00pm child developed fever of 105 F.  No other s/s reported.  Mother took child back to ER and had infection ruled out.  Child had lab drawn, chest x-ray, throat culture, etc.  Called mom this afternoon (7-16-09) she reports that pt feeling better and work-up on pt came back negative.
Sore upper arm, muscle soreness developed within 2 hours and persists still mildly 4 weeks later
Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's left eye was dialated, had some blurred vision
Child experienced seizure-like activity for a few seconds & fell to floor hitting forehead on desk; ice applied, child observed, 911 summoned; family refused ER evaluation at that time; child was seen later that day in ER after c/o persistent headache & dizziness (work-up negative per family report).
No reaction on Friday, date of vaccination. Saturday 11-8-14 site slightly red rash size of quarter. Sunday 11-9-14-rash larger, redder and warm to touch. Monday rash 1 1/2" x 3" red, warm to touch, some arm pain but very tolerable. Rash 3 x 5 cm by provider.
26 hours after 2nd covid dose: fatigue, body aches and mild fever lasting until 72 hours after shot.   72 hours after shot: body aches gradually progressed into low back pain.  1.5 weeks aftershot and ongoing: low back pain continues and which is now excruciating
RED AREA APPROX 2X2 INCHES STARTS ABOUT 4 INCHES BELOW INJECTION SITE; PAIN AND DISCOMFORT IN ARM. RECOMMENDED ICE PACK AND BENADRYL.
Case number PHEH2015US017660, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 54 year old male patient. Medical history and concomitant medications were not reported. Vaccination history included administration of FLUVIRIN (batch numbers: not reported) in the past which was well tolerated. He was vaccinated with FLUVIRIN (batch number: 157103) prefilled syringe (PFS) intramuscularly at a dose of 0.5 ml in right deltoid on 08 Sep 2015 at 10:20 hour. The nurse stated that the vaccine administered was out of temperature range at 33.2 degree Fahrenheit. The event was reported as non-serious. No adverse events were reported following the maladministration. Follow up report received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history and vaccination details.