chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first symptoms I experienced were myoclonic episodes. I would feel "twitchy". I would have involuntary twitching episodes that were violent enough to throw objects in my hand across the room. Shortly after these episodes began, I would lose consciousness for an unknown period of time, and would wake up with body aches, a headache and blood around my mouth due to biting my tongue and cheek. I would always be disoriented to the point of hardly knowing my name, year or location. The amount of blood and saliva present was quite excessive at times, and would always be scattered around me on the floor of which I fell. I was admitted to the hospital Emergency Room in March 2009 after describing these symptoms to my parents. I was admitted for approximately 4 days where all diagnostic testing proved negative. I was given a prescription for Topamax which was slowly tapered off due to intolerable side effects. I was then placed on Keppra 500mg daily. Since this time, I have had multiple seizures and have discovered that the "twitchy" sensation is the closest sign I have that resembles an aura. I have not been officially diagnosed with Epilepsy, yet I continue to have multiple seizures a year despite my medical regimen. My dose of Keppra has now reached is maximum limit of 1500mg daily and I have been seizure free for one month at this limit. I strongly feel that receiving the shot Gardasil had an adverse reaction that now causes me to have seizures. Over the past 3 years I have been unable to count the number of times I have had these seizure episodes and it has reached the point of severely interfering with my life in regards to losing driving privileges temporarily and countless doctors visits and trips to the hospital.
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE/ VACCINE ADMINISTERED 6 HOURS AND 40 MINUTES AFTER FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a pharmacist concerned a male of unspecified age. 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, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced incorrect product storage. On 11-NOV-2021, the patient experienced out of specification product use/ vaccine administered 6 hours and 40 minutes after first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use/ vaccine administered 6 hours and 40 minutes after first puncture of the vial was not reported. This report was non-serious.
Information has been received from a physician concerning a 12 month old white female with gastroesophageal reflux disease (GERD), a left ear infection, poor weight gain and failure to thrive who on 24NOV2003 at a well child visit was vaccinated intramuscularly in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccination included a fourth dose of pneumococcal vaccine. There was no other concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 30NOV2003 the patient developed full blown varicella lesions over his entire body that appeared like a "full slam natural illness". There was no fever. It was suspected that the patient had a natural exposure but there was no history of such. It was reported that the patient also being treated with amoxicillin for an ear infection. Unspecified medical attention was sought and no treatment was required. No diagnostic tests were performed. It was reported that the patient was still ill. It was also noted that all work-up "to date" for the patient's failure to thrive was negative. No product quality complaint was involved. Follow up information indicated that on 30NOV2003, the patient developed full blown varicella illness and left otitis and "no adverse events". It was reported that the scars were healing well and the patient did not develop cellulitis. No hospitalization or even repeated office visits were noted. The patient recovered in December 2003. No  further information is expected.
30 minutes after my 2nd shot my left lip, cheek to my left eye went numb, this lasted until the evening and had it minimally the next day as well. Today is 3rd day out and my outer corner of left lip has a little fuller and feels that way  compared to other side, when you look at it there doesn?t seem to be a physical change. This the original spot in which I felt it come on. I had this similar response with first dose but this didn?t come on until 5-6 hours later. I have reported this adverse effects with this site as well.
This spontaneous report as received from a registered pharmacist refers to an unknown number of patients. The patients were vaccinated subcutaneously with ZOSTAVAX (dose, lot# not reported) that was improperly stored in the pharmacy for an unknown period of time. The pharmacist was unable to provide the identities or exact number of patients at the time of report. No adverse effects reported. Additional information is not available.
Patient is 17 years old but received vaccination that is approved for 18 years and older under EUA
The patient developed rash on neck/back and breast and face. It started 10 min after rash. It worsened over 3 days.
This initial spontaneous case, was received on 13-Oct-2017 from pharmacist, concerning a 76-year-old, elderly, female patient. The patient's current conditions included UTI (urinary tract infection) infection (since an unspecified date) and fibromyalgia (on an unspecified date). The patient's concomitant medications included Divalproex, levothyroxine, hydrochlorothiazide, pravastatin, ropinirole, duloxetine, enalapril, uvathim, pantoprazole and cephalexin (for UTI infection). On 12-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, anatomical location: right deltoid, batch number: (reported as 179203), expiry date: on an unspecified date in Jun-2018, route of administration: intramuscular). On the same day, after 2 hours of vaccination, the patient experienced total body pains and at the night she had crawl to go to washroom. It was reported that the events were persistent until the next day. The patient had not experienced rash but she had systemic and massive muscle pain. It was reported that, the patient had not taken any treatment medication besides her normal medicine routine. The outcome of the event reported as recovered. The reporter assessed this case as non-serious. Follow up report received on 24-Oct-2017: The fibromyalgia was updated from historical condition to current condition. The route of administration (intramuscular) was added. The outcome of the event was updated from not recovered to recovered. It was reported that, the patient had not taken any treatment medication besides her normal medicine routine. The narrative was amended accordingly.
My daughter was born On June 22, 2003. She was vaccinated on Sept. 3, 2003. After the injection she screamed and continued to scream for 7 hours. I returned her to the physicians office after the first 2-3 hours, and was told she was having an allergic reaction to the pertussis portion of the DPT vaccination. Up to that point my daughter seemed to be developing at a normal rate. I have 2 other older children. After, she stopped trying to roll, did not walk til she was 23 months, cannot speak clearly with the exceptions of about 4 words. We have been told she might have CP, then it was just developmentally delayed, now autism. 04/27/06 Office Notes  x 9 pgs received/reviewed. Documentation of "flat nasal bridge" and "undefined inguinal folds" several months before vaccination. 10/26/06; records reviewed. C section for breech presentation. office note of 9/3/03 documents questionable flab nasal bridge and questionable undefined inguinal folds in pelvic areas. 6/26/03 visit cyanotic legs and feet. Sent to MPH ER for O2 saturation testing. Note from 9/3/06 mom called physician office c/o child having swollen left leg at injection site, persistent crying for 30 minutes. Pt seen by MD but mom to continue to monitor child and notify of findings tomorrow or report to ER this PM if condition worsens. Note of 9/10/03 no show to physician office called times 2 no answer.
few other things; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (few other things) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (few other things) (seriousness criterion death) and HEADACHE (headache). On 30-Jul-2021, HEADACHE (headache) had resolved. The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        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 relevant concomitant and treatment medications were reported  Very limited information regarding the events has been provided at this time.   This case was linked to MOD-2021-286501 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
1 day after vaccines, patient had very large area of redness and swelling extending from shoulder to elbow and onto upper chest. Also low grade temp (100).
I received the vaccine and waited the 15 minutes with no issues (just felt a little jittery).  I began the drive home and began feeling some nausea around 10 am.  I thought it was because I had not eaten, so I stopped and picked up breakfast (scrambled egg with cheese and bacon).  I got home, ate breakfast and then began logging in for work and the nausea grew.  Around 11:30 am, I felt tired and the need to lie down, which I did for a while, then around 20 minutes later, I got up to go to the bathroom, feeling like I was going to vomit and have diarrhea.  When I stood up, I felt really lightheaded, managed to only remove my pants and then got in the tub where I could lie down.  I vomited  (once) and had diarrhea for I don't know how long.  At some point I was able to sit up and use my handheld shower to rinse off and get back to bed where I slept until about 4:30 pm.  No more nausea although I am playing it safe and eating crackers and drinking ginger ale.  I feel better now.  Not sure it this was related to not eating and taking my antidepressant, food poisoning, or the vaccine.  But felt I should report.
Fever 104.0, painful swelling of lymph nodes in neck and under both arms and in chest
Fever, chills, fatigue, achy pain. Symptoms resolved around 10:30pm Tuesday evening.
Patient developed redness of the left arm with onset of swelling 1 day after vaccination.  Area became tender 3 days after vaccination
when he woke up he didn't feel well.; woke up and ears were ringing; woke up with a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (when he woke up he didn't feel well.), TINNITUS (woke up and ears were ringing) and HEADACHE (woke up with a bad headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) 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 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (when he woke up he didn't feel well.), TINNITUS (woke up and ears were ringing) and HEADACHE (woke up with a bad headache). On 05-Mar-2021, MALAISE (when he woke up he didn't feel well.) and HEADACHE (woke up with a bad headache) had resolved. At the time of the report, TINNITUS (woke up and ears were ringing) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included prednisone. Action taken with mRNA-1273 in response to the event was not applicable.
Worsening migraines with increase frequency and increase intensity than normal.  Excedrin no longer works as it did in past. MD prescribed  Nurtec ODT to trial, but this caused severe nausea, upset stomach a d dizziness.  I am also experiencing tingling and numbness in fingers which comes and goes. Increase fatigue.
Onset 8/17, rash lasting 7 days. Had between 50-500 bumps. Unk fever temp for 2 days. Tylenol on onset of fever. No complications or rx meds given.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 at 13:00 as dose 1, single (Lot number: ER8732), in left arm, on 13Apr2021 at 13:00 as dose 2, single (Lot number: EW0164), in left arm and on 25Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had not received any other medication in 2weeks. Patient had received Paxlovid from 20Jun2022 to 25Jun2022 with lot number of 1916517A for the treatment of COVID-19. It was reported that 2-3 days after Paxlovid treatment stopped, patient Covid symptoms returned (cough, congestion, fever). Patient had no known allergies.
Pt recvd 1st dose of vax on 9SEP91 & on 16SEP91 pt exp a fever 100, malaise & red, swollen painful joints; pt seen by MD & treated w/Ibuprofen;
Couldn't get out of bed. Left part of her body became paralyzed. She has bad pain if she tries to raise both arms up. Pain in the back of her neck.
did not receive his second dose yet because of this reaction; Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 21-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive his second dose yet because of this reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 21-Jan-2021, PRODUCT DOSE OMISSION ISSUE (did not receive his second dose yet because of this reaction) had resolved. In 2021, BELL'S PALSY (Bells Palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half. Patient did not receive dose 2 as patient's primary care doctor said the risk may be too much.  Company Comment: This is a spontaneous case concerning a 42-year-old, male patient with no reported medical history, who experienced the expected, serious, AESI event of Bell's palsy. The event occurred 28- 30 hours after the first dose of mRNA-1273 vaccine. The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half, so patient did not receive dose 2 as patient's primary care doctor said the risk may be too much, Product dose omission issue is also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42-year-old, male patient with no reported medical history, who experienced the expected, serious, AESI event of Bell's palsy. The event occurred 28- 30 hours after the first dose of mRNA-1273 vaccine. The patient developed Bell's Palsy after 28-30 hours of vaccination and was recovered almost after a month and a half, so patient did not receive dose 2 as patient's primary care doctor said the risk may be too much, Product dose omission issue is also noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Erythema and induration at site with itching and pain, pt seen 9/24/10 and measured 10x15 cm.
Left arm weakness, myalgias, fevers, chills, drowsiness with possible confusion, severe shoulder pain.
Patient received Pneumovax and flu shot in same arm. 1 IM 1 SQ. The SQ Pneumovax reacted with redness and swelling 8cm x 5cm Left upper arm. Some discoloration to purple also noted in this area. Area is hot to touch and very painful.
This is a spontaneous case, initially received from a pharmacist on 05-Nov-2018, concerning a female patient of unspecified age. On 01-Nov-2018, the patient was incorrectly administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left buttock, batch number: 250800, expiry date: 31-May-2019]. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
pt recvd vax;next am, awakened w/ tightness in chest, n, weakness, unable to stand;c/o body stiffness, neck & back pain;loss of energy;noted large lemon size reddened area at TD inject site 9dec94;
Information has been received from a medical assistant concerning a 12 month old male who on approximately 24-NOV-2002 was vaccinated with a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  On approximately 24-NOV-2002 the patient developed a fever of 101 degrees F that lasted for 24 hours.  On approximately 25-NOV-2002, the patient recovered.  The patient subsequently experienced cellulitis, dehydration, diarrhea, gait disturbance, hyponatremia, tachycardia, pyrexia and vaccination complication after vaccination with PNEUMOVAX 23 (MSD WAES 0611USA05643).  No further information is available.
Pt received DTaP/IPV and MMRV to left thigh. Pt developed blister at vaccination site; blister was fluid-filled, 0.5 cm x 0.3 cm in size, and 2 cm below site of vaccination.
Rash developed at the injection site on the 8th day .   The rash is itchy and 2 inches in diameter
Client was given 0.6 dose instead of 0.3 dose of vaccine- Client stayed for 15 minutes - she was notified at the time of what had occurred and was asked to call us should there have been any other or worsening side effects at time she left the clinic-  I outreached her to follow up- 2 times on 6-27 and left messages  1 time on 6-28 and left message- then called again on 6-29- client answered phone and reported she had some redness and soreness at site on 6-25-22- now is only minimally sore no other symptoms reported.
beginning 1 day post vax pt devel a sore throat & fever;MD felt pt may have had a sore throat d/t streptococcus; 5 days post vax pt devel rash described as small white spots;MD felt pt had coxsackievirus infect;chickenpox FEB97 100 lesion
Information has been received from a physician concerning a teenager patient who was vaccinated with three doses of GARDASIL on unspecified dates.  Subsequently the patient experienced weakness and went to see the doctor.  The doctor did not think this was related to GARDASIL vaccine.  The outcome was not provided at time of reporting.  This is one of several reports received from the same source.  Additional information has been requested.
Information has been received from a nurse who reported that her niece experienced pelvic pain after receiving the first dose of GARDASIL. The outcome of the event was unknown. The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of dose of GARDASIL. This is one of the several reports recieved from the same source. Follow-up information was received from a physician who reported that they did not have this patient and they were unaware of any adverse reactions from their practice. No further information is available.
Pt reports scratchy throat, denies difficulty breathing/swalling; pt further denies numbness/tingling/itching anywhere else; pt reports all symptoms started approx 1 minutes after administration and went away approx 5 minutes later; no other complaints; vitals, observe, comfort
myalgias, neuralgias, long bone pain, vascular throbbing, alterations of vascular patterns, muscle twitching, muscle cramping, extreme fatigue, jaundice, abd pain, hyperflexia joint pain; alopecia, heart palpitations;
I got the booster shot . My arm hurt bad for 2 days and then I got very sick for 4 days. I had a fever, chills, cough, stuffy congested nose.  I couldn't get out of bed for 4 days. I called my doctor's office but couldn't go in, I felt too bad to go anywhere.  This was the worst reaction I had to the vaccine.  I tested negative for Covid on 1/28/22, I didn't have it. It must have been the vaccine.
Itching at injection site Minor Rash Lesion at injection site  Swelling at injection site *All symptoms started approximately 5-6 days after injection of Dose 1 of Moderna COVID-19 vaccine
Moderna COVID-19 Vaccine EUA Tinnitus -- ringing, hissing in the ears constantly. Beginning approximately one day after the first dose of the Moderna vaccine. Symptoms have continued but not worsened. Second vaccine dose received 04/19/2021 -- tinnitus symptoms continue at the same level but have not worsened.
Sore Arm immediately after shot for several days Bell's Palsy 19 days after injection (reporting this since CDC web site specifically asked for reports of Bell's Palsy after vaccination)
Severe generalized muscle pain and tenderness, irritability, chills, hot flashes, talkativeness, abdominal pain and fatigue.