chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother aclled to inform nurse that she had called pediatrician because patient had come home from school and his left arm was swollen and red, hot to touch and painful. Dr. advised her to apply cool compress elevate and Tylenol.  2 days later she took patient in to see dr and was dx with shingles and cellulitis.  Child was put on cephalexin and acyclovir.  This info per mom.  I called to check on child.
Influenza vaccine administered at 1:30 pm on 10/13/2010 to left deltoid. At 3:30 pm, she complained of 'feeling cold', 'heavy', 'nausea' without emesis, and stuffy nose. C/o 'heavy feeling to left arm. Assessment: temp 97.8 denies difficulty swallowing. No s/s resp distress. Left deltoid injection site without redness or swelling noted - gave TYLENOL 650 mg P.O. No itching noted.
Headache; face started to flush and was warm; red rash in the shape of a square or triangle on the right arm; red rash that was itching on her arm.; ringing in her ears; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that,  A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) (at the age of 72 years old), dose 2 via an unspecified route of administration, administered in arm left on 06May2021 11:00 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: ER8731), dose 1 via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. She thought that she had gained weight called as COVID fat. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine (Amlodipine) taken for blood pressure abnormal from an unspecified start date and ongoing. Patient received her second dose of vaccine on 06May 2021 and reported that on 06May2021 a few moments ago her face started to flush and was warm, had a ringing in her ears, and had a red rash in the shape of a square or triangle on the right arm (she received the vaccine in the left arm) appeared. She stated that she was starting to experience a headache on an unspecified date and also stated she was getting another rash on the back of her right arm. She was concerned she may be having a bad reaction to the vaccine and stated she was in no mood to pass away. No additional vaccines administered on same date of vaccine. There was no prior vaccination within four weeks. The outcome for the events of face started to flush and was warm, red rash that was itching on her arm and ringing in her ears was recovered on 06May2021. The outcome for the event of red rash in the shape of a square or triangle on the right arm was not recovered. The outcome for the event of headache was unknown.  Follow-up attempts completed. No further information expected.
She gets a burning tongue where it feels like it is on fire; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TONGUE DISCOMFORT (non-serious), outcome "unknown", described as "She gets a burning tongue where it feels like it is on fire".  Additional information: After receiving both primary vaccination series, patient experienced a burning tongue after she ate Salmon. She described the feeling as fire on her tongue. When she eats salmon she gets a burning tongue where it feels like it is on fire. That happened with both doses of the vaccine. It was reported that patient wants to get booster dose. patient queried for does the booster dose have the same ingredients as the others she got. and further queried for is it a full dose or half dose  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/31/06 Complain of severe headache, dizziness, muscle aches.  9/01/06 Dizziness, muscle aches, neck pain, headache, flew to state mentioned.  9/02/06 4:00 am fainted in bathroom, diarrhea, sore neck, vomiting.  9/3/06 Lethargic, complained of headache.  Seen in hospital center, emergency room.  9/04/06 headache continued, felt weak.    10/28/09:  Hospital Records and Discharge Summary received for dates of service 10/19/09 to 10/20/09.  Dx:  Migraines. Assessment:  Presented with sudden onset left-sided facial paresthesia shortly after receiving a flu shot.  Denies fever, chills, night sweats, vomiting or diarrhea.  Has chronic left leg numbness which is unchanged this episode.  No facial droop.  When numbness started pt. felt a "fluttery feeling" in her heart. A 2D echo was done, and was normal.  Stroke was ruled out.  Neurology consulted, comfortable with dx. of migraine and discharge to home.
lt arm of immun site became red & swollen & c/o fever 25JAN94;
Nausea continues since the day after (Now a week); Occasional stabbing pain on top of head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN699, Expiration Date: not reported), via an unspecified route of administration on an unspecified date in Mar2021 at 15:30 (reported as 03:30 PM) (at the age of 69 years old) as unknown, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included Small intestinal bacterial overgrowth (SIBO) and rash from some antibiotics from an unknown date. Prior to vaccine the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines in 4 weeks. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021, the patient experienced nausea continues since the day after (Now a week, as reported) and occasional stabbing pain on top of head. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; developed soreness and redness across the entire width of her arm from the injection site down her elbow; swelling; This spontaneous report was received from a pharmacist regarding a 77 year old female patient. The patient did not have any medical history or drug reactions or allergies. The patient's concomitant medications and concurrent conditions were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R012976, expiration date: 25-JAN-2020 , 0.5 milliliter once intramuscularly as routine vaccination. On the same day, the patient was vaccinated with  influenza virus whole virion 3v vaccine inactivated (FLUZONE) (flu shot) on the same arm. On an unknown date in September 2019, also reported as, with in 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient developed soreness and redness across the entire width of her arm from the injection site down to her elbow. The patient reported that the swelling started to go down on 30-SEP-2019. No treatment was given for the events and no laboratory tests were done. There was no intervention to prevent seriousness criteria. The outcome of events was reported as recovering. The relatedness between the events and suspect products was not reported. No product quality complaints were involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002818: US-009507513-1910USA002328:
On 05/06/2021 I received Moderna vaccine. The next day I lost the sense of taste in my mouth and more serious, I lost all my appetite. I have not eaten any food since 05/06/2021. I lost 50 lbs since May of this year.  I have talked to my primary doctor and all he said is give it some more time and your taste will come back. I  have NO help.
shingles triggered by the vaccine; A little more blisters appeared, made appt with dermatologist for 25Feb2022. got worse on 24Feb2021; a little more blisters appeared; eye swelling a bit; cheek swelling a bit; two small red patches/rash on left side of face; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 15Feb2021 at 11:30 am (age at vaccination was 61 years) as dose 1, single for COVID-19 immunization. The patient's medical history and allergies were unknown. The patient's concomitant medications were not reported. The patient previously received flu shot in 2020 which produced rash on face and swelling of face and eyes. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines in 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Feb2021, the patient had two small red patches/rash on left side of face. On 21Feb2021, red patches got a bit larger. On 22Feb2021, the patient had eye and cheek swelling a bit. That was the similar reaction that she had to the flu shot in Feb 2020 so it appeared to be the same progression. But also tiny water blisters appeared on red welts. On 23Feb2021, a little more blisters appeared and the patient made appointment with dermatologist for 25Feb2021. It got worse on 24Feb2021. On 25Feb2021, morning the patient went to urgent care and was diagnosed with shingles triggered by the vaccine. The patient was prescribed medication and went to opthalmologist to check her left eyeball and to dermatologist via telehealth that afternoon. The patient continued to take medications and ointments. Concern was scarring on face and long term nerve damage. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment with 3 medications (pills) and an ointment. The outcome of the event condition aggravated was unknown. The outcome of the other events was resolving.  No follow-up attempts are possible. No further information is expected.
I started having cramps Friday night and Saturday morning I started bleeding, by Saturday evening I was passing clots and tissue.  ER doctor and nurses did tests and found I was having a miscarriage.
DAPTACEL given to a patient when the product was 28 days past expiration with no reported AE; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 3 years old male patient who took Diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when the product was 28 days past expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Sep-2022, the patient received a 0.5 ml 1X dose of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine (lot number: C5765BA) (Expiry date: 28-AUG-2022) (strength, formulation not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 26-Sep-2022, the patient took Diphtheria-15/tetanus/5 AC pertussis vaccine when the product was 28 days past expiration with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
rash, swelling of hands, scaling of plaque on back, chest, arms;hyperkeratosis of elbow;onset 2-3wk p/vax;dx acute psoriasis;
Redness spread all over upper torso - rash spread from one breast up to top of head. Rash appeared on arms as raised, red bumps. VS: 144/82, 64, 20, 98.6.
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/24/21 (016B21A) Moderna Dose 2 4/21/21 (048B21A) Moderna Dose 3 11/12/21 (013F21A) COVID Positive 11/19/21  11/19/21: All history from son.  Patient has dementia and acute delirium not able to provide any significant cogent current history.  According to son patient was fine until week ago with nasal congestion mild cough, no significant dyspnea.  Ultimately had a home COVID test that was positive.  Overall doing well until he developed some delirium.  Son is mostly worried about that.  Patient says he has no dyspnea cough fever pain.  Son says he has been somewhat weak generally than he has historically been. Patient was seen in the ER.  Non hypoxic no respiratory distress but chest x-ray did show multi lobar left-sided pneumonia.  He was given Levaquin.  His troponin was some what elevated I called medical facility and spoke to the cardiologist he said with repeat being negative is okay for him to not be transferred for cardiac evaluation since he has no chest pain and his EKG is benign he can follow up with primary care provider get outpatient echocardiogram. He unfortunate developed acute renal failure.  Last creatinine 1.0 in 2015 today was around 4.4.  Thankfully the potassium was okay.  He was given IV fluids here.  He was given Decadron for the COVID.  The rest of labs are essentially unremarkable.  Mild leukopenia mild elevated ALT with normal lactate.  The repeat troponin was normal. Patient is being admitted for dehydration and acute kidney injury.  His COVID, nothing significant respiratory compromise at this time.  11/23/21: ADMITTED FOR COVID PNEUMONIA COMPLICATED BY AKI AND WEAKNESS AND CONFUSED. HE RECEIVED IV STEROIDS. HE HAS SOME ALCOHOL ABUSE DISORDER AND WAS TREATED FOR THIS. HE HAD AKI AND RECEIVED IV FLUIDS AND THIS IS ALSO BETTER. HE WILL BE DISCHARGED FOR HOME HEALTH SERVICES. HE HAD BLADDER OUTLET OBSTRUCTION AND FOLEY WAS INSERTED TO ALSO HELP WITH HIS Is AND Os. THIS HAS BEEN REMOVED. I WILL SEND HIM HOME ON ANTIBIOTICS.
Erythematous pruritic papules, nonblanchable on dorsal hands, elbows, knees. Slightly tender to the touch.
no adverse event; Improperly Stored / Administered; This spontaneous report was received from a nurse (other health professional) referred to a patient of unknown age and gender via phone call. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-JUL-2023, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter once, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The administered vaccine had twice temperature excursion (improper storage of product in use). No symptomatic adverse event was reported. Caller declined to provide full patient demographics and could only provide initials of patient. No additional details at this time. No additional AE/PQC reported.
I prepared by being well hydrated and taking 2 Ibuprofen. My left arm was extremely sore after the booster injection. I drank water and took two Tylenol 4 hours after the booster was injected. The following day, 12/28/2021, I began to feel as if I had the flu. I had chills, muscle aches and joint pain. I wore several layers of warm clothing and still felt cold. I also had chest pains. This was very concerning to me. I had a rough night. Kept hydrated and took Tylenol every 4 hours. Sleep was in one hour segments. 12/29/2021 - I feel better today, but still have aches and chills. No chest pains. Please note that I had to submit to being "vaccinated" in order to stay employed. I want to be clear that this is the last time I will field test an experimental drug for a multinational  drug company and suffer ill effects. Tell Pfizer to get more lab rats.
Patient has two records with different last names. Mom has been told Numerous times to bring legal Documentation to combine records.
Tremor in both hands happening at various times of day in all different environments; at rest and exercise.
No additional AE reported; expired VARIVAX got administered to a patient today (9/29/2022); This spontaneous report was received from the registered nurse and refers to a 13-month-old male patient. His medical history, concurrent conditions, and concomitant therapies were not provided.  On 29-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T032931, expiration date: 28-SEP-2022, for prophylaxis (strength, and route of administration were not provided). The administered vaccine was expired. No additional adverse events (AE) reported.
A report received from a healthcare professional on 10/29/2003, concerned a 57 year old female vaccinee who accidentally received a dose of Fluvirin on 10/21/2003 and a second dose on 10/29/2003. On 10/21/2003, the vaccinee received a dose of Fluvirin and a second dose was administered on 10/29/2003.  No adverse effects have occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 12 December 2003 The vaccinee was 56 years old at the time of the accidental overdose and received the first dose of Fluvirin on 20 October 2003.
This spontaneous report as received from a pharmacist refers to a 70 year old female patient. Medical history and drug reactions or allergies were not specified. On an unknown date in April 2014, reported as last week, the patient might have been vaccinated with a dose of improperly stored ZOSTAVAX lot # J002241, expiry date 21-MAY-2014 (dose, frequency and route not specified). No adverse effects were reported. Additional information is not expected.
Redness and swelling 30hrs after vaccination no significant tenderness, no induration given Motrin and Benadryl.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 18:15 as dose 1, single (Lot number: EN6206), in left arm, on 28Apr2021 at 18:00 as dose 2, single (Lot number: EW0171), in left arm and on 29Dec2021 at 10:30 as dose 3 (booster), single (Lot number: 33130BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE HCL, start date: 12Jan2022; SERTRALINE HCL, start date: 11Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Tested negative at 7th day after initial symptoms; Positive, notes: Tested positive again 2 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Anti-viral Paxlovid for started with 05Sep2022 and stopped on 09Sep2022. No known allergies. Other medication in 2weeks included Hydroxyzine HCL LLC started on 17Jan2022 and Bromphen-PSE-DM 2-30-10 mg/5 ml syrup started on 05Sep2022, Adderall XR started on 25Mar2022, Dextroamp-Amphetamine started on 25Mar2022. Tested negative at 7th day after initial symptoms and positive test. Tested positive again 2 days later. No worsening or recurrence of symptoms yet.
He bacame irritable, had a low grade fever.  The next morning he had was irritable, had a fever, and a rash and swelling at the injection site.  This continued all day.  The fever has continued, the irritable behavior has continued, his cheeks are red, he has a rash on his face, the rash and swelling at the injection site is worse.
This spontaneous report was received from a nurse practitioner regarding a female patient of unknown age. Approximately 1 month ago on 20-OCT-2012, the patient was vaccinated with dose 1 GARDASIL (lot#, expiry, dose, route not reported). No concomitant medications were reported. Approximately in October 2012, the patient experienced pain and swelling at the injection site. The patient also experienced nausea and was unable to eat because of nausea. No treatment information was reported. The Patient had sought medical attention (office visit). The outcome of unable to eat, nausea, pain and swelling at the injection site was reported as not recovered. The relatedness for pain and swelling at the injection site, unable to eat and nausea and was unknown for GARDASIL. Additional information has been requested.
BAD pain in left arm.   Feels like I was punched HARD.   Sometimes it feels like it's being squeezed tight, other times like it's being twisted & knotted inside.   Sometimes it extends into back of shoulder.   Certain movements are so painful that I've been using right arm instead.   But, pain is not present 100% of the time.   I'd estimate about 75% of the time.  Has been going on since day after shot.   I thought it'd go away, but saw doctor  3/17/2021.   Recommended heating pad & P.T.   Bought a heating pad but it's nearly impossible to keep it on that part of arm.   First P.T., for evai, will be 4/3/21.   Second shot in right arm 1/26, no problem.  Will NOT get another!
"By around 7p that evening 12/17/20, i was unable to life my arm to undress.  the next morning the injection site was a little tender but i could move the arm"
Chills with no fever, feeling very warm, severe discomfort at injection site limiting range of motion of extremity. This was all proceeded by a sensation of tremulousness starting at 8pm on 5/18/22 lasting until 4 am on 5/19/22.
Child broke out into erythematous, raised, macularpapular lesions (50-100) over entire body surface area. Child treated with Aveeno.
This patient came in for his first Moderna Covid vaccination. The injection went without incident. The family stayed and read book and played for almost 30 minutes. He did not have any reaction during that time. As the mother was securing him in the car she noticed  several raised urticaria on his arm that had not been there before. The EMS was called to evaluate the patient. After the assessment, it was decided that the patient did not require any further medical attention. The patients mother agreed and signed the refusal form.