chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been receiving from a registered nurse via field representative referring to several female patients that had recently given birth of unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II (dose 1, route, dose and lot# were unknown). On unknown dates, it indicated that the titer for Rubella was showing negative. So the patients had to revaccinated with M-M-R II. The hospital's protocol required that the patients who had recently given birth had to demonstrate Rubella Immunity before leaving. The patient's didn't seek medical attention for the adverse event. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
A non-serious spontaneous report of "that went into my eye" has been received from a registered nurse concerning a 13-year-old male, subsequent to FLUMIST Vaccine. The patient's past medical history and concomitant medications were not reported. The patient received FLUMIST vaccine on 10-Sep-2010. The patient backed up while receiving FLUMIST and stated that, "went into my eye." The reporter stated that the syringe was still in the patient's nose when the patient stated that it went into his eye. There was no leak or crack on the FLUMIST syringe used on the patient. The reporter has not received any report of untoward reaction experienced by the patient and the adverse event has resolved. The patient recovered from the event. Additional information was received on 23-Sep-2010 and incorporated into the narrative: no contributory factors to cause the adverse event were found.
Shot received @ 9:03 am on Wed.  Around 9:00 pm fever, chills, headache, dizziness and nausea set in.  Fever climbed to 103 and lasted through the next night.  Took Tylenol every 4 hours.  Shivering so hard - made muscles hurt.  Had to have help standing and walking to restroom. Fever broke around 3:00 am on Friday - listless & tired all day Friday and Friday night.  Sat morning felt better.
tested positive on the 12Mar2021; feeling bad; lost taste and smell; lost taste and smell; had feeling chills; body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204; expiration date: Jun2021), via an unspecified route of administration in shoulder on 05Mar2021 (at 67-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient started feeling bad on Monday 08Mar2021, 3 to 4 days later. After she was feeling bad the whole week, she tested positive on the 12Mar2021. The patient got all the symptoms what people said, it's like having the COVID and she lost taste and smell, she had feeling chills, body ache, headache and all that. So, week later she went for a test COVID test and she tested Positive and the test was on 12Mar2021. Her second shot was due on 26Mar2021. Feeling bad was reported as worsened from 09Mar2021. The outcome of event feeling bad was not recovered. The outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt stated having common side effects of chills, nausea, diarrhea on the same day for approx 7 hours but on 3/23/22, started having a racing heart rate, not being able to sleep, and had to use her home oxygen
Pneumococcal vaccine given SQ in left arm on 12/7/04. On 12/8, pt reported to nurse that he was experiencing pain, redness, and severe swelling from injection site to fingers.  Examined by MD on 12/8/04 and treated for cellulitis with Amoxicillin/Clav 500 mg bid X 10 days.  Pt reported some improvement on 12/9.  Per MD office on 12-17-04, cellulitis completely resolved.
approx-10 Minutes post vaccine, c/o new onset  tightness in her throat and epigastric burning, B/P 118/70 pulse 64 Resp 16, denies SOB. Rapid Response called when it did not resolve. They arrived, vs stable, they took her to ED per wheelchair. On the way to the ED, patient refused to go and went home. Was advised to call 911 if any breathing difficulty or return to ED if symptoms didn't resolve.
given after being out of refrigerator for 2 hours and 15 min. No adverse event. On phone with Janssen now.  Does pt need to be re-vaccinated?
Numbness in outer left thigh 2 hours later. Numbness in neck and face 4 hours later
HEIGHTENED BLOOD PRESSURE AND HEART RATE, ALTERED MENTAL STATUS. EMS REQUESTED AND AIDED TRANSPORTED TO MEDICAL CENTER.
Hives over most of my body both itchy & painful in places.  Lasted about 4 days
DID NOT COMPLETE HIS DOSES ONE WEEK PRIOR TO TRAVEL; TOOK AN UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-421) on 13-Feb-2019. The report describes a 15-year-old adolescent male consumer who "took an unrefrigerated dose" and "did not complete his doses one week prior to travel". The consumer was receiving oral Vivotif capsule (one dose every other day) (lot number: 3003239 and expiry date: Oct 2019) for typhoid prophylaxis  It was reported that the caregiver left Vivotif unrefrigerated since 24-Jan-2019 and her son took his first dose on 13-Feb-2019. He would be leaving for a mission trip on 23-Feb-2019.  The action taken with Vivotif with respect to the events "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" and "did not complete his doses one week prior to travel" was considered as not applicable.
Report 20010029491 describes antigenemia in a pt (age and gender not provided) who received an injection of hepatitis B vaccine (EngerixB). This report was received from a nurse via a company representative. Concurrent medical conditions included renal failure treated with hemodialysis. concurrent medications were not specified. The pt received an unknown number of injections of Engerix-B on unspecified dates. At some later date, the pt was determined to have a positive hepatitis B surface antigen antibody titer. At another, later date, the pt was found to have a negative hepatitis B surface antigen antibody titer. A diagnosis of antigenemia was made. The reporter indicated that four patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Blurry vision; This spontaneous case was reported by an other health care professional and describes the occurrence of VISION BLURRED (Blurry vision) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VISION BLURRED (Blurry vision). At the time of the report, VISION BLURRED (Blurry vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Patient called the morning of 11/3/2017 reported feeling tired and shaky, beginning on 11/2/2017. Said she had a temperature on 11/2/2017 of 101.6F and "feels terrible" today.
Infant cried uncontrollably and was unable to be consoled by breastfeeding, holding, nurturing, change of environment, toys, singing, etc. for 4 hours interrupted only by hyperventilating and gasps for air. This crying was followed by physical collapse and exhaustion and she fell into a deep sleep for 6 hours (normally wakes to feed every 3-4 hours). She had a fever that peaked at 101F on the same day and that wavered over the course of 72 hours. On 07/11/2012 she again had a spell of painful, inconsolable crying in the early morning that lasted 3 hours followed again by a long nap of 5 hours. She had fever that day of 100F. On the third day 07/12/2012, she had a period of high-pitched painful crying in the late afternoon that lasted 1.5 hours and was unable to be comforted. By 07/13/2012 she seemed tired and cranky and her fever was down to 99F. No treatment was sought since I (her mother) was unsure this was medically treatable since it was caused, seemingly, by the vaccine. Cool baths, light swaddling, and comforting her and nursing on demand were the only actions we took as course of treatment for this reaction. It was later reported to our Doctor at the next scheduled visit.
Pt has fine rash all over body, site of ID inject swollen & red; given DPH;
This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old patient with lupus. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not reported). On an unknown date, the patient experienced "flare-up" of lupus after receiving a dose of PNEUMOVAX23 in the past. The patient was in a remission at the time of report. Upon internal review, a "flare-up" of lupus was considered medically significant. Additional information has been requested.
Refusal to get out of bed or walk for almost 16 hours, refusal to eat for less than 24 hrs treated with Motrin (initially started with limping).
Information has been received from a physician concerning an 8 week old female with no pertinent medical history or drug allergies who on approximately 26-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# not provided).  The next day on approximately 27-MAR-2008, the patient experienced rotavirus.  The patient sought unspecified medical attention.  Lab diagnostic studies were performed, but unspecified.  No further information was provided.  There was no product quality complaint.  Follow-up information indicated that the patient had a past medical history of gastroesophogeal reflux disease (GERD) upon vaccination with the first dose of ROTATEQ (lot# 659855/1692U).  No other information is available at this time.  Additional information has been requested.  This is one of several reports from the same source.
In addition to flu-like symptoms and COVID arm, I developed a peripheral neuropathy with tingling in my arms, hands, legs, and feet. Additionally, my skin became hypersensitive to all materials such that my soft bed sheets felt like course sandpaper.
This spontaneous report was received from a registered nurse and refers to a unknown patient of unknown age and sex. On an unknown day in August 2012 the patient received the first dose of GARDASIL (lot #, expiration date, dose, frequency, route of administration were not reported) and then received second dose of GARDASIL on an unknown day in November 2013. Third dose has not been administered yet. No symptoms were reported. Additional information has been requested. This is one of several reports received from the same source.
This spontaneous prospective pregnancy report was received from a 29 year old female patient, concerning herself. The patient had no medical history, concurrent conditions or concomitant medications. On 01-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prevention of Human papillomavirus (HPV) (dose, lot number and expiration date were not provided). The patient stated that shortly after receiving GARDASIL 9, she was informed by her physician that she was pregnant (unspecified date). On an unknown date in November 2017, the patient experienced some pain in her womb area (uterine pain), but was not strong, just uncomfortable (pelvic discomfort). At the time of this report the patient was about 5 weeks pregnant, with a last menstrual period in approximately 11-OCT-2017. Estimated date of delivery was approximately 18-JUL-2018. The patient stated she had not seen her physician since she was told she was pregnant. At the reporting time, the outcome of uterine pain and pelvic discomfort was unknown. The pregnancy outcome was pending. The patient did not received any treatment for the events. She did not seek medical attention and no laboratory tests were performed. The reporter did not assess the causal relationship between therapy with GARDASIL 9, and the events pelvic discomfort and uterine pain.
PT REPORTED ON 10/5/08 THAT HE EXPERIENCED SWELLING, ITCHING, REDNESS, AND PAIN IN THE LEFT ARM ON THE DAY AFTER RECEIVING PNEUMOVAX.  HE WENT IN TO MEDICAL CENTER 10/4/08 AND WAS GIVEN RX'S FOR METHYLPREDNISOLONE, TRAMADOL/APAP, AND CLARITHROMYCIN.  ALSO WAS INSTRUCTED TO USE ICE ON ARM EVERY 20 MINUTES. ON 10/6/08 PT REPORTED HIS ARM STILL HAD SOME REDNESS AND ITCHING, BUT THE SWELLING HAD GONE DOWN AND WAS MUCH BETTER.
pt was vaxed 10AM, & by that afternoon pt became febrile to 39.9 & had 4 short (1-2mins each) shaking episodes;
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Mild, Additional Details: Sore arm and radiating pain that extends down the arm from where the shot was administered, and extends to the shoulder blade in the patient's back.
Two days after receiving the vaccine dry skin patches circled the area where the shot was given.  In the time since, the dry skin patches have spread around her body. The patches do not itches, are dry and sometimes raised.
all the side effects listed on the website; she had full blown body rash from neck to her feet for a week; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week). At the time of the report, VACCINATION COMPLICATION (all the side effects listed on the website) and RASH (she had full blown body rash from neck to her feet for a week) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2022-472021 (Patient Link).
CHIEF COMPLAINT:   presents to ED with complaints of vomiting today. diarrhea intermittently x 2wks.   HISTORY OF PRESENT ILLNESS:     Presents with: _vomiting pain, and diarrhea, not well also admits to holding urine in  Duration: _cisntnat  Onset: _acute  Course: _same  Location Pain Onset: _genral/back  Location Pain at Present: _same  Pain Radiation: _denies  Pain Quality: _achey
pt developed large painful local reaction in all three injections sites.  He recieved Tdap, MCV-4, Var.  The largest 10 x 8 cm.
This case was reported by a physician via call center representative and described the occurrence of injection site discoloration in a 18-year-old female patient who received BEXSERO for prophylaxis. On 16th May 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site discoloration and injection site swelling. On an unknown date, the outcome of the injection site discoloration and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site discoloration and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The health care professional reported that 18 year old patient received the 1st dose of BEXSERO and when they came in for their doctor visit 1 month later, the patient still had injection site skin darkening as well as injection site swelling. The doctor decided to hold the 2nd dose and to wait 1 month and see if the reaction resolves before giving the 2nd dose. The patient went to the doctor at the 1 month mark to receive the 2nd dose, they did not go because of their symptoms but the doctor decided to hold the dose and see how patient does after 1 month.
Child received shots in the am on 03/18/05. According to mother, baby started crying in the afternoon, temp 99 degrees Fahrenheit, Tylenol was given. The crying became high pitched and shrieking. Baby wouldn't calm down no matter what the mother tried. The mother then talked about how pt would go into a trance staring but would not move her eyes to look ath the mother. Mother called pediatrician, a CT Scan, EEG, and spinal tap were done at hospital. Pt has a follow up visit with neurologist in early April.  04/08/05- t/c to pt mother. Pt ws seen by a neurologist and his evaluation did not find any abnormalities according to pt mother. The neurologist told mother to have next set of shots to be given one at a time to determine if it is the Pertussis causing the problem. Told mother we would need a note from her pediatrician stating it is ok for the child to receive the DTaP, referred mother back to pediatrician for next set of shots, the pediatrician told mothe to keep baby away from children and adults with bad coughs.
Vaccine given after being drawn up more than 12 hours before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given after being drawn up more than 12 hours before) to be not applicable.    No concomitant drugs were reported . No treatment information was reported.  Per reporter the patient did not experience an adverse event just a medication error.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and does not contain new information.
Extreme Fatigue, Woken in the middle of the night with severe uterine contractions every 5 minutes for 4 +hours, Doubled over in pain.
This spontaneous report as received from a physician refers to a 21 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a first dose of M-M-R (manufacturer unknown). Subsequently, on an unknown date, the patient received the second dose of M-M-R (manufacturer unknown) (strength, frequency, route of administration, lot # and expiration date for both regiments were not reported). On 09-APR-2015, the patient experienced pyrexia and parotitis. On 15-APR-2015, the patient was presented to the health center. The outcome of pyrexia and parotitis was unknown. The relatedness between vaccination with M-M-R (manufacturer unknown) and the events was not reported. This is one of several reports received from the same reporter. Additional information is not expected because there was no contact details to the physician.
The injection site is red; The injection site is itchy; The injection site is raised; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised). At the time of the report, INJECTION SITE ERYTHEMA (The injection site is red), INJECTION SITE PRURITUS (The injection site is itchy) and INJECTION SITE SWELLING (The injection site is raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Bad headache and jaw and tooth ache (about 4 days); heavy fatigue (ongoing ever since the shot); loss of appetite; sore arm that lasted several weeks
Red, itchy swollen rash surrounding injection site measuring approximately 15cm. Rash is oblong shape down arm from site and has irregular border. Covid arm began about 60 hours post injection and is still present. Also, there is soreness at injection site.  Headache, chills, extreme exhaustion keeping me in bed for about 36 hours (from the night vaccine given and all thru the next day and night until the following morning) hardly able to keep my head up from pillow. Headache resolved with Tylenol 1000mg taken twice 12 hours apart. Exhaustion resolved by allowing myself to stay in bed and sleep (no appetite during this sleep phase).
54-year-old male with history of hypertension, hyperlipidemia, type II DM on insulin who presented secondary to chest discomfort and was found to have NSTEMI. .Tranferred from hospital for cardiac cath where he underwent DES to the OM.   Initial presentation was with chest discomfort.
every time I got the shot that year I got the flu; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves an adult patient with an unknown demographics who experienced every time he/she got the shot that year got the flu (influenza), while he/she received Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) it was reported when patient don't get the shot don't get the flu but every time patient got the shot that year got the flu (influenza), took him/her about five times to realize that shot aren't worth, following the administration of Influenza Vaccine.  Details of laboratory data were not reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
PATIENT HAS FILLED SOME ANTIBIOTICS SINCE VACCINATION FOR "CHEST STUFF". HE SAID HE THINKS IT WAS THE PREVNAR THAT CAUSED HIM TO GET SICK BECAUSE HE HAS BEEN SICK SINCE HE WAS GIVEN MEDICATION.