chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a patient "between 1 and 4 years old" who was vaccinated on an unspecified date "between March and April 2010", with a dose of MMR II (Lot # 664659/0838Y) into the left thigh. The nurse reported that the patient had reactions at the injection site. The patient had a hard red and raised bump and blisters around the site as well. The patient required hospitalization for 2 days and surgery was considered, however not performed. At the time of this report, the patient had recovered on an unspecified date. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Blood pressure dropped to 78/52; body temp 92; debilitating head ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 08:00 (Lot number: EW0186) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrointestinal disorder" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Sulfa salazine, reaction(s): "Allergies: sulfa allergy"; Allergies: keflex, reaction(s): "Allergies: keflex allergy"; Allergies: doxycycline, reaction(s): "Allergies: doxycycline allergy"; Allergies: nutrasweet, reaction(s): "Allergies: nutrasweet allergy". The following information was reported: BLOOD PRESSURE DECREASED (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "Blood pressure dropped to 78/52"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "body temp 92"; HEADACHE (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "debilitating head ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure decreased, body temperature abnormal, headache.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient received bnt162b2 (BNT162B2), administration date 30Sep2021 08:00 (Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The case was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.
Information has been received from a medical assistant concerning a female "between 11 and 13 years old" who on an unspecified date was vaccinated with the "first dose" of Gardasil vaccine. Suspect vaccination included Menactra and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The medical assistant reported that after the patient was vaccinated with all the vaccines, the patient fainted. It was also reported that the patient "was afraid of needles." It was reported that the adverse effect "improved on therapy." There was no product quality complaint involved. No further information is available.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against covid 19. on date of administration of Vaccine. Also patient  did not call in to  complain of adverse event.  This is administrative error without adverse event.
Approx 5 hours follow Pfizer vac,, developed localized stiffness in the muscle.   No redness or swelling.   The following morning her arm was very sore from shoulder to elbow.  On the 3rd day her arm hurt from shoulder to elbow when she raised it, and has not resolved at this time.  The discomfort improves with use, but is sore/stiff again after a period of nonuse of that arm.
dizzy; feet and hands extremely cold; obvious issue with circulation; no color in fingers or toes; couldn't sit or stand; had to lay down; aches; fever,fever shot up to 101; chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't sit or stand), PAIN (aches), DIZZINESS (dizzy), PERIPHERAL COLDNESS (feet and hands extremely cold) and PERIPHERAL VASCULAR DISORDER (obvious issue with circulation) in a 44-year-old female 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 was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Headache, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (aches), PYREXIA (fever,fever shot up to 101) and CHILLS (chills). On 22-Apr-2021, the patient experienced GAIT DISTURBANCE (couldn't sit or stand), DIZZINESS (dizzy), PERIPHERAL COLDNESS (feet and hands extremely cold), PERIPHERAL VASCULAR DISORDER (obvious issue with circulation), PALLOR (no color in fingers or toes) and FATIGUE (had to lay down). On 23-Apr-2021, GAIT DISTURBANCE (couldn't sit or stand), PAIN (aches), DIZZINESS (dizzy), PERIPHERAL COLDNESS (feet and hands extremely cold), PERIPHERAL VASCULAR DISORDER (obvious issue with circulation), PALLOR (no color in fingers or toes), PYREXIA (fever,fever shot up to 101), CHILLS (chills) and FATIGUE (had to lay down) had resolved.            Treatment details not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090174 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090174:
Information regarding PREVNAR was received from a pharmacist regarding a 4-month-old patient who experienced rash and fever. At 4 months of age, the patient received the second dose on 06-May-2008. The patient experienced rash and fever on 06-May-2008. Treatments and outcome are unknown and no further information was available at the time of this report.
Patient developed a "massive headache" soon after he received his vaccine.  He stated his right side felt weak and numb. His blood pressure at the vaccine clinic was noted to be severely elevated (patient was on blood pressure medication in the past but was taken off of it a while ago). Patient drove himself to the ER and stroke alert was called. Patient needed nicardipine drip and labetalol pushes to bring down blood pressure, and once it was controlled patient was given alteplase.
Patient described having a severe headache about 36 hours after vaccine.  She also stated that she had a bruise appear on her left leg within 4 days of vaccine. A day after, she appeared to have a bump on her left hip that looked like a bug bite. She developed parathesia and was so severe that she went to the ER  04/14/2021. She returned for a second visit to the ER on 04/16/2021.
Fever of 104 degrees, unconsolable crying for 2 to days. Fever of 102 degrees for 2-3 days more.
Severe pain radiating throughout entire body.  Each join in her extremities.   Unable to perform normal daily functions (ie shower, walking, etc.)
Approximately 30  minutes after receiving the vaccine he develop urticaria on his right elbow. He was evaluated on 12/17/2019 and continued to have an intermittent urticarial rash that would appear on different areas of his arms
Day of vaccine: nausea, sore arm. Next day: nausea, sore arm, diarrhea, itchy skin (not near site of injection). 2 days post-vaccine: nausea, diarrhea, itchy skin (not near site of injection), hives (arms, stomach, back, shoulders, and neck).
Extreme nausea, dizziness, chills, fever and pain in shoulder as well as pain in other areas of body.  Swollen face and lips are extremely swollen
Pt felt nausea/feinting/weak/sweat. I called the ambulance and ask Pt to turn on his heart monitor on his phone device. His pulse rate was 75 and BP 110/75.
About 20 minutes after vaccine, started seeing visual auras, felt flushing. Auras got worse and filled vision and felt really disoriented. After about one hour., auras stopped and disoriented feeling subsided.
Information has been received from a registered nurse and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected. Additional information ha
on 10/08/2021 around 10PM  at the vaccine administration site, developed left arm pain, continues to have left arm pain, developed swollen area under left axilla, noticed swelling to left armpit/throbbing pain 10/08/2021, reports on 10/09/2021 left axilla lymph node swelling continued to increase in size.  Reports she also developed chills, fever, left arm nerve pain, heart palpation around 24 hours after vaccine.  Reports all other symptoms including heart palpations resolved except left arm pain and swollen lymph node to left axilla.    Reports she took ibuprofen and applied ice pack to left arm/armpit for her symptoms.
racing heart rate 80+  normal resting is 42/44 lasted 4/6 hours dropped to60/65 in morning 50/55  next morning  sweats first evening and chills not there the next morning
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional Information: Paxlovid used for treatment of COVID-19  from 27Aug2022 to 01Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
he has stopped breathing; seizures; a 3 yr. old vaccine-injured child; vaccine-injured child; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 3 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "he has stopped breathing"; SEIZURE (medically significant), outcome "unknown", described as "seizures"; OFF LABEL USE (non-serious), outcome "unknown", described as "a 3 yr. old vaccine-injured child"; INJURY (non-serious), outcome "unknown", described as "vaccine-injured child". Clinical course: I have grave concerns about the safety of a covid vaccine for children 6 months - 4 years. Children have already experienced adverse reactions to the vaccine including heart inflammation, heart attack, and death. Since children have almost a 0% chance of dying from the virus, this vaccine is totally unnecessary. I am the grandmother of a 3 yr. old vaccine-injured child who in spite of medication has frequent seizures during many of which he has stopped breathing. Please reverse this effort  The lot number for bnt162b2 was not provided and will be requested during follow up.
The vaccine did not prevent shingles; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contact a persistent strain of herpes zoster accompanied by pain. On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient developed a painful rash. In response to these symptoms, the patient presented to a physician and was diagnosed with shingles and remained under their care. The outcome of the events were unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Within  24 hours of receiving the second dose of the Pfizer vaccine I went into persistent atrial fibrillation for the first time ever despite having the condition for almost 10 years.
Patient says the next day he experienced excessive sweating and some dizziness that lasted until the following morning.
Occipital Neuralgia, irregular menses, abdominal pain, chronic pain including joints and muscles, low thyroid. Patient was hospitalized on 6/1/15 after 3rd vaccination.
Day of injection-Mild soreness in left arm Day 2-Moderate-Severe pain at site of injection that continued for 5 plus days Day 5- Leg weakness/fatigue to present day ( fatigued, deep aching pain like to the bone, pain in multiple locations including front and back of thighs in each leg, pain in calves, sharp stabbing, shooting, and pinching pains in legs. Legs hurt all day even affecting  sleep, hurts if sitting or walking but walking/ exercising appears to fatigue them exponentially. Severe pain in upper middle part of back behind heart past 2 weeks. Also having bilateral shoulder pain and arm fatigue bilaterally as well. Hip/Buttock pain since day 5.
At time vaccination was processed, database was down so could not verify what shot patient needed. Failed to recognize this note at pickup, so Prevnar20 was given. Upon going to enter immunization into database, it was discovered that that the patient had received Prevnar13 in 2019 and Pneumovax23 in 2020, so no additional vaccine was necessary.
Pt exp rash, achy, no temp;  3 days p/ tx rash cleared;
c/o  numbness/tingling on left arm and body 14 mins post vaccination, vital signs within normal, worked up at ambulance. Initially agreed to be transferred via ambulance to hospital then changed his mind and preferred to go home instead. Discharged home with instructions to call 911 if sypmtoms return or worsen.
Received flu vaccine in right arm on 9/21 in afternoon  Arm started hurting that afternoon Mom reports that night she applied a heating pad, watched a show with her mom During the show, mom observed a "systemic reaction" in her words- says it spread to her legs - unclear what that means, wasn't a rash, was more of a restlessness  The following day she described a tingling sensation in her legs  She asked to sit out jump exercises in ballet because she was concerned she might injure herself On Fri 9/23, she reported a tingling behind her knees before school Seemed improved over weekend Again complained on Monday 9/26 - said her legs felt tingly like there were pencils poking her, and had sore feet At her swim lesson, her swim coach said "her legs were not doing the same thing at the same time" No tingling the following morning, but did report "3/10" tingling that evening Wed 9/28- no tingling but legs sore at bedtime Thurs 9/29- no tingling but did have hip pain at bedtime, after doing some particular exercises in ballet class Today no tingling, seems to be feeling well At no point had weakness or numbness At no point had a limp Never spread past legs No fever  Mom reports, of note, that if patient never complained or reported these symptoms, mom would not have necessarily known anything was wrong Mom reports family h/o problems with flu vaccine - hives, or similar tingling reports Patient herself never with h/o similar symptoms with any vaccine
Pt was non-converting/not seroprotected p/3 doses of Engerix-B; 4th dose will be given to try to get Hep B protection;
Pt's mom came in for a shot and was mentioning how her daughter had received the flu shot about 2 weeks ago and that he arm was so sore upon flu shot, that it was in pain for several days and then her forearm swelled up with a large lump. Patient then subsequently called me later that day to explain further. Her arm is still tingling and weak. She decided to come in to show me her arm. Upon observation, the administration site of the flu shot was correct. Deltoid looks pretty normal. Her forearm does look slightly swollen and she complains of continual weakness and tingling feelings.
the fever of Kawasaki's synd started 6hr p/vax;dx made clinically 6 days later when pt fulfilled CBC criteria for dx;may not be r/t vax but reporter felt  needed to report as poss adverse event;
Case number PHEH2014US022265 is an initial spontaneous report received from a physician on 03 Nov 2014. This report refers to a 13 year old female patient. Her past medical history and concomitant medications were not reported. On 02 Nov 2014, she received FLUCELAX (batch number: not reported) at a dose of 0.5 ml intramuscularly. No adverse events were reported following this medication error (inappropriate age at vaccine administration).
Awoke next morning extremely fatigued.  In bed for 24 hours (flu-like symptoms).  Within 36 hours, I'd regained my energy.  I marked this up to the fact that I'm undergoing chemo.  Last infusion was February 9th.  Next infusion is March 2nd.  Scheduled for Dose #2 of the vaccine on March 10th.
Teeth-chattering, Bone-Chilling, shivering COLD, rapid heart rate, Balance issue & disoriented; Then a fever- 100.8 degrees- red face; sore arm.
1 week after my second dose of Moderna OO6MLOA on 02/23/21, I developed discomfort from site of injection down my left arm, that radiates further down into my arm. This discomfort has continued, but lessoned  with oral anti- inflammatory meds, but is still present.
Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). .
Immediately started getting rapid heart beat, difficulty breathing, dizziness.  Half an hour later got chest pain, mental confusion and slurring of speech.  Had to sit for over 30 minutes.  Is allergic to Epinephrine so not able to give Epi Pen.  Just had observation.   It lasted a little over an hour, but was still dizzy.  On 1/21/21 felt horrible, felt like he was getting sick, but has now recovered fully from the event.
Chest pain in the heart. Had a CRP test done on May 4th and it came back elevated at a 2.0 instead of under .8 Chest pain came with laying down, heavy breathing and getting going the first few hours of the day. Last for about 2 weeks.
Patient describes severe pain in the injection arm beginning a few hours after the vaccine - says she couldn't sleep. Over the next two days, the pain has not really decreased, and a very notable and sizeable rash has appeared below the injection site on the arm. Patient referred to follow-up care.