chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 19 year old female with a history of fainting when receiving injections who on 15-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). On 15-JUL-2008 the patient fainted immediately after the vaccination. No treatment required. On 15-JUL-2008 the patient recovered. Additional information has been requested.
Dizziness  , Lost of balance, and  falling several times ,severe pain  lost of appitite
experienced tiredness; dizziness; nausea; Sometimes she cannot get up, feels like someone is pushing her back down; Worried about getting the second dose of the Covid 19 Vaccination; States it is really bad and strange; The inside of her head will start spinning; Caller mentions her dizziness again. States sometimes she cannot get up because it feels like someone is pushing her down; She has not been driving for 5 days now because the dizziness comes suddenly; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05Jun2021 (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included Historical Vaccine INFLUENZA VACCINES; she gets the flu shot every year with no adverse events. The patient's concomitant medications were not reported. The patient experienced dizziness and Nausea on 13Jun2021, experienced tiredness on 17Jun2021, she has not been driving for 5 days now because the dizziness comes suddenly, soreness in arm and worried about getting the second dose of the coved 19 vaccination, states it is really bad and strange and the inside of her head will start spinning on Jun2021, sometimes she cannot get up, feels like someone is pushing her back down on 13Jun2021, caller mentions her dizziness again. states sometimes she cannot get up because it feels like someone is pushing her down on Jun2021. Upon the follow-up received on 18Jun2021 reporter gave consent to contact. NDC number and expiry date of Covid 19 Vaccination were unknown. Vaccination Facility Type was Pharmacy/Drug Store. Vaccine was not Administered at admin Facility. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No AE required as visit to Emergency Room or Physician office. There was no prior vaccination within 4 weeks. There was no Family Medical History Relevant to AE and no Relevant Tests were performed. Outcome of event for the event soreness in arm was recovered on an unspecified date, Outcome of the events nausea, dizziness and sometimes she cannot get up, feels like someone is pushing her back down was not recovered and unknown other events.
got the covid booster on the 23 of october, start feeling my skin rough after two days, then red rushes in the third till fourth day, then i started itching after that. things get worse, too much itching and if i scratch, i will make the hives worse.
Bell's Palsy in the left side of my face. Onset was June 2021, which was 6 months after my second shot. I didn't have any significant side effects from the first shot. So far, Bell's Palsy has lingered on my face for 6 months as of December 2020. It affected my left eye, left cheek, and the left side of my mouth. I'm still experiencing eyelid drooping and partial paralysis of my upper lip. I repeat:  although I've had some improvement, the left side of my face is partially paralyzed, which affects my eye, my ability to eat and drink, and my ability to communicate verbally.
102.7 degree fever at its peak, vomiting, & loss of appetite, accompanied by minor chest pains (could be due to the vomiting). Started on April 10th & is still currently ongoing.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 17 years old patient who experienced was inadvertently vaccinated with third dose of MENACTRA (lot U5989AA and Exp. Date not reported) via intramuscular route in the left deltoid on an unspecified date in September of 2018. It was reported that, the first dose was in 2013, the second dose was in November of 2017. The patients medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The patient presents for fever and seizure activity that occurred at 2 o'clock this afternoon.  The patient has had no previous history of seizures.  He started having a temperature yesterday while playing outside.  Had been doing well for the entire day, but developed a temperature of 103.9.  Mother had been giving Tylenol approximately every 4 hours.  Child was febrile today, had had Tylenol last at 10 o'clock and around 2 o'clock., when he would have had the opportunity to be re-dosed, he was about to take a nap and had tonic-clonic activities of his upper and lower extremities, extended his neck, and had blanching of his lips.  Seizure-like activity lasted 1 minute.  He was not incontinent of urine, did not bite his tongue.
Arm pain; pain down her left side, rib cage and chest pains; cramping in stomach; could not lift arm, numbing behind leg, most of left side felt numb, pain up to neck/face, slight headache.
This spontaneous report was received from a registered nurse concerning to a 3 months old female patient. The patient had no drug allergy or pertinent medical history. Nurse reported that the patient had a negative titer after receiving a series of hepatitis B vaccine (name and manufacturer unknown) on 09-JUN-1993, 13-SEP-1993 and 22-MAR-1994. On 12-NOV-2012, the patient was vaccinated with a dose of RECOMBIVAX HB (Lot # reported as 008AA/Exp date: 13-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included: AVIANE. No adverse effect reported. The patient had sought medical attention by seeing a nurse. The outcome of event was reported as not recovered. Additional information has been requested.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Pt to the ED 5/15 with c/o generalized weakness, pt reports inability to transfer from bed to wheelchair. Reports recent cough for two weeks. Upon evaluation in the ED the patient was found to be COVID-19 positive.  His twelve-lead EKG showed atrial sensed ventricular paced rhythm without ischemic changes.  Chest x-ray was unremarkable. Patient was evaluated in the ED where he was found to be resting comfortably in no acute distress denies having active chest pain or chest pressure.  During the remaining course of hospitalization, the patient had no other significant events and renal function remained relatively stable for discharge on 5/27.
I felt weak and tired. I had chills and fever. On Dec 29th, I tested positive for COVID-19.
I was awoken at 6:00am with a pain in my left armpit and extreme numbness along the outside of my upper left arm from the shoulder to the elbow. I had been sleeping on my back and my arm was not pinched or compressed in any way.  I got up and walked around while moving my arm in circular motions. The numbness turned to pain that went down the outside of my left forearm. I used a 2 lb weight to do some exercises with my left arm. After about 15 minutes I took 2 Advil and kept rotating my left arm and massaging it. After one half hour the numbness and pain went away.  Then at 8:45pm the same day while sitting upright, the same symptoms as described above began again, only this time more intense. I took 2 Advil right away and massaged my left arm and rotated it around. After 45 minutes, the pain and numbness subsided.  So far these symptoms have not returned again.
Information has been received from a physician via a company representative referring to a male patient of unknown age. On an unknown date the patient was vaccinated with his first dose of GARDASIL 9 (dose, lot # and route were unknown). On an unknown date, one week post administration of the first dose, the patient experienced multiple episodes of testicular swelling and pain. The patient was sent to an unspecified emergency department as advised by reporting physician where a computerized axial tomography scan (CAT scan) was performed to rule out testicular torsion. The reporting physician stated the results of the CAT scan were negative for testicular torsion and there were no anatomical abnormalities. There was no treatment given for the events. The event of testicular swelling was resolved on its own. The outcome of testicular pain was reported as recovering. Additional information has been requested.
Paresthesias in extremities and ataxia. Atypical Guillain-Barre Syndrome-s/p vax. Hosp 11-2-99, Disch 11-3-99. Pt now independent w/activities-daily living. Disch w/outpt phys and occupational therapy.
drowsy, hypoxemia 12/30/2022 1328, 12/31/22 0505 without pulse or respiration.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 22-OCT-2015 at 6:58pm, vaccine alarm was received from Security, then the worker came up into clinic and found freezer out of range (storage unit temperature at the time was 7.3F, room temperature at the time was 72.0F). She reported to Supervisor, and the supervisor called the reporting nurse. As LogTag also showed alarm, the supervisor and the nurse discussed whether or not to move vaccine. On the time they were on the phone, the temp reading came down to 5.9 degrees F in 10 min, so the reporter felt confident it would be back within range in a matter of minutes and told the supervisor to leave vaccine in freezer and the reporter would review and submit data next morning. Upon arrival Friday morning 23-OCT-15, freezer was within range. The reporter put X on doses for which this was the first temperature excursion, and put XX on doses that were also involved in out of range incident in October 2015. On unknown dates in 2015, the patients were vaccinated with 16 doses of these improperly stored (Oka/Merck) VARIVAX (lot # L018002, expiration 19-MAY-2017, dose, frequency and route were not reported). This is one of several cases received from the same source. Additional information has been requested.
Several days with temperature 103 F and malaise per pt. report. Employee self medicated at home. Reported to employee health with temp 99.8.
Vaccinated pt (per pt report) admitted to inpatient facility. No info on dose, brand, date, etc.
pt recv vax & devel sx w/in 3wk;a fistula devel & was draining;approx 2mo later devel lymphadenopathy in neck;sx lasted about 8mo;pt has 8cm scar on neck;
hurt my arm; arm went numb a little one burned for a while; arm went numb a little one burned for a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB INJURY (non-serious), outcome "unknown", described as "hurt my arm"; HYPOAESTHESIA (non-serious), THERMAL BURN (non-serious), outcome "unknown" and all described as "arm went numb a little one burned for a while".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from an immunization coordinator refers to multiple patients of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored VARIVAX lot # M002063 with expiration date: 12-JAN-2018 (dose and route of administration were not reported). Administered doses of VARIVAX underwent temperature excursions at -11.6 degrees Celsius for 1 hour and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Heavy cough real deep sounds like the croup. Also have what feels like fluid in my bronchial tubes
pt to clinic 22OCT97 mom states that pt woke from 2hr nap w/swollen, red rt upper arm;rt upper arm is warm to palpation w/redden elevated bumps;area appear painful to child when touched & pt scratching @ them;
Headache started approximately 30 min post vaccine. Woke up at 2am that night with severe nausea, chills and body aches. Temp 100.5 F. Took Zofran, once nausea subsided took Ibuprofen. Temp didn't break until approximately 9am. Continued severe body aches, everything hurt. Temp back up around 4pm, 100-100.5 F. Body aches and chills continued through evening. 2 days later awoke at 4:30 am with fever again, eyelids felt so hot, continued body aches and chills. Continued fever, body aches, and chills throughout 2nd day post-vaccine, fever broke mid-afternoon. 3rd day post vaccine severe dizziness, all other symptoms lessened. Fatigue continued for 6-7 days.
October 2022 pt reported Bell's Palsy after second COVID vaccine.  No issue after first vaccine or subsequent vaccines.
It started after my second shot.  I had my period when I had my 2nd shot.  I then got it two weeks later.  The following period was late and I had white pea sized nipple discharge from my right nipple only, i got my period the next day.  My nipples were insanely painful leading up to that period.  SInce that time my periods have been doubling up in. month and then running anywhere from 47-60 days.  I had no irregularities before the vaccine.  I understand I am 46 but the change came fast and furious and only after the vaccine.  My periods now are late and incredibly painful and crazy heavy which they have never been in the past.  My mother did not go into menopause until her mid 50's.
CHEST PAIN SHORTNESS OF BREATH Respiratory distress Hypoxia Suspected COVID-19 virus infection Non-ST elevation (NSTEMI) myocardial infarction
Sudden onset of tender and bleeding gums Strange sores developed inside of mouth and on the lips Swollen neck glands Swelling around eyes and rash on face Extreme fatigue
little fever; some sweating; arm was itching and pinkish/ middle finger it has some redness,redness across the nail bed; real sore up there in the arm /fingers are sore/fingers are tender; arm is itching and pinkish; In the shot area, the area was real tender and real sore; little dizzy; little aching; In the shot area, the area was real tender and real sore,and then, it started itching.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Right Arm, on 12Mar2021, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 20Feb2021, as DOSE 1, SINGLE for covid-19 immunization and her arm just got sore. On Mar2021 the patient became just a little dizzy but that went on away. The patient had a problem with a little aching but she slept that off. On 12Mar2021 patient got real sore up there in the arm and she rubbed alcohol on it. The soreness went down her arm and it was itching and pinkish. The soreness went on down to about 2 or 3 of fingers, her fingers are sore. It's her middle finger- it has some redness, like a streak across there, redness was across the nail bed of both fingers. These fingers are tender. The patient further stated that she had a little fever too and she had taken Tylenol but that went away, and she drank plenty of water. The patient clarified she had the fever on 13Mar2021 (the next day after the vaccine) and she did some sweating when she was sleeping. After that, her fever went away. In the shot area, the area was real tender and real sore, and then, it started itching. The outcome of the events dizziness, Pain in extremity, Fever was recovered, while outcome of all other events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days after injection: dizziness, nausea, pain in shoulders (not at injection site) 5 days after injection rash with open pustules on chest and left side of neck and face.... visited md's office.... told not shingles but a reaction to vaccine.... given nine day prednisone treatment.... still have itching and some redness.....other observation: area on hand where plastic surgery was performed to skin following accident: skin has become leathery and painful. No other manifestations.
Pt had vaccine (H1N1) yesterday morning. In the afternoon states had fever, red eyes, headache and sore throat. Today, he has headache and "sleepy feeling"; temp 97.0 F
Severe chills, temperature 102 degrees. Nausea, dizzy, cough, headache lasting about 8 hours. Considerable swelling and redness below the injection site, not at the site. This has not resolved.
4 months old received Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19th November 2023) for prophylaxis.   On 19th December 2022, the patient received Havrix. On 19th December 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The office manager called in to report that a Havrix dose was given to a patient under the recommended age for the Havrix vaccine.  The vaccine was administered at the same location from where it was reported. The patient's information was collected.  The vaccine administration facility was the same as primary reporter. The case was escalated to second line. The reporter consented to follow up. Additional supportive information: The patient received a dose of Havrix at inappropriate age, which led to inappropriate age at vaccine administration.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9253) and on 21Feb2021 as dose 2, single (Lot number: GL9267) at the age of 74 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Rheumatoid arthritis" (ongoing), notes: She has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia. Concomitant medication(s) included: ORENCIA taken for rheumatoid arthritis. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 16Mar2022, outcome "unknown" and all described as "COVID".  Clinical course: Caller confirmed she received 2 Pfizer vaccines in Jan and Feb of 2021 and received a Moderna booster and she does not have the date and was not given a card from Withheld and thinks received Moderna booster in Dec2021. COVID-19 third vaccine, Moderna: She has nothing on that vaccine. NDC, Lot, and expiration are unknown. She was over 65 when she received the vaccines. She said the next thing that happened she had COVID on 16Mar2022. She said is infectious and she can't control the world. he has rheumatoid arthritis (RA) and on she is on an immune suppression drug Orencia and said may have something to do with it. She was diagnosed with RA before receiving COVID-19 vaccines and about 26 years ago. Caller said she did not get the second booster. She had COVID after receiving COVID -19 vaccines. For COVID -19 third vaccine, Moderna: She has nothing on that vaccine. NDC, Lot, and expiration are unknown.  No follow-up attempts are possible. No further information is expected.
chest pain; drowsy; sore arm; headache; chills; joint pain; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired). On 19-Apr-2021, CHEST PAIN (chest pain), SOMNOLENCE (drowsy), PAIN IN EXTREMITY (sore arm), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain), PYREXIA (fever) and FATIGUE (tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2020, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.Treatment information was not provided.   This case was linked to MOD-2021-151144 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR. (Wrong ARGUS number on form)