chrisvoncsefalvay/vaers-outcomes huggingface dataset:
father of patient came to me shortly after giving him the vaccine and said is it normal to feel dizzy afterwards. I told him it could happen and checked on patient and told him to remain seated for a little bit.  I then checked on him about 5 minutes later he had turned green and said he felt like he was going to throw up but did not feel like he could stand and make it to the restroom. I gave him a bag but he never vomited .  in a few more minutes all color had drained from him and I offered him a bottle of water to sip on and after about 15 minutes he said he felt better and they left. I called in an hour or so and his parent said he was feeling much better
pt recvd vax 4MAR94;following day had episode described as sleepiness,pale,vomiting,limp,turning blue,dec resp,large bowel movement;@ 5mo recvd Tetramune/OPV/Hepatitis;16MAY w/o episode;26AUG MD visit following episode dx abd epilepsy
Hives and bumps around injection site in left arm, redness, itchy, and area warm too touch.  Grandmother administered Zyrtec OTC.
This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a licensed visiting nurse concerning a 14 year old female with no medical history and no known drug allergies, who on 08-Feb-2007 was vaccinated IM with a dose of Gardasil.  Concomitant therapy included Ortho Tri Cyclen Lo and Synthroid. The patient inadvertently received less than the recommended dose and experienced an injection site reaction. The nurse withdrew the vaccine from a vial and the medication leaked near the hub of the syringe while administering it to the patient. The patient complained of irration on the left deltoid about a two inch radius from the injection site. She also reported that the pain "ran down" her left arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Information has been received from a licensed vocational nurse concerning a 14 year old female with a thyroid condition and irregular periods and no known drug allergies, who on 08-FEB-2007 was vaccinated IM with a dose of GARDASIL (lot# 654741/0013U). Concomitant therapy included ORTHO TRI-CYCLEN LO and SYNTHROID. The patient inadvertently received less than the recommeded dose and experienced an injection site reaction. The nurse withdrew the vaccine from a vial and the medication leaked near the hub of the syringe while administering it to the patient. The patient complained of irration on the left deltoid about a two inch radius from the injection site. She also reported that the pain "ran down" her left arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. In follow-up, the nurs reported that the patient received a partial vaccination of GARDASIL (lot# 654741/0013U) in the left deltoid due to a defective syringe: some of the medication ran down the patient's arm. The patient complained of a burning sensation and "beesting-like" reaction later that evening on 08-FEB-2007. By the morning on 09-FEB-2007, the patient's are was much better. The immunization was discontinued. Addtitional information is not expected.
has not been urinating; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (has not been urinating) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced DYSURIA (has not been urinating). At the time of the report, DYSURIA (has not been urinating) outcome was unknown.            No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-398856 (Patient Link).
pt complained of itching, swollen tongue, and tingling lips 13 minutes after vaccine administration; 2 min later she reported chest tightening and swollen throat, reports she felt like when she had an allergic reaction in the past; epinephrine pen administered and benedryl 50mg by mouth given, pt refused EMS transfer, went to ER, was treated and released,
Big rashes over her foot, legs, front head, and her back and the rashes contain something like watery balloons and hundreds of these balloons.
pt recv vax 26SEP96 & pt devel intermittent swelling 3 times @ inj site, & devel less than 50 red dots around eyes, cheeks, & chest;pt mom reported that the red dots did not look like typical lesions;
Pt recvd MMR vax on 19JAN88 & 27FEB91 pt had t103 & sore throat; rales, vomiting, bronchospasm, erythematous maculopapular rash & Koplik's spots; dx measles;
NURSE GAVE PATIENT FLUAD INSTEAD OF REGULAR FLUSHOT. PATIENT IS 38 YEARS OLD.
Symptoms started immediately (1) joint pain, increased threefold (2) nerves raw & irritating (3) no sleep - 1st week - continued (4) acupuncture & enzymes.
This spontaneous report was received from a licensed practical nurse via a company representative referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 09-DEC-2016, the patient received an expired dose of M-M-R II (therapy type rHA, lot # K000738, expired date on 16-JAN-2016, dose was unknown) for prophylaxis. No adverse event was reported. Additional information has been requested.
mom reported fever of 105.2 on 10th day p/vax otherwise was well;
This is a spontaneous report from a contactable pharmacist, based on the information received by Merck & Co., Inc. (manufacturer control number: 00689118). A patient of unspecified age, ethnicity, and gender received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size. Therapeutic measures were taken as a result of red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size and included treatment with BENADRYL and TYLENOL. The clinical outcome of the event, red, irritated area at the injection site that was warm to the touch 5 days after vaccination and it's now growing in size, was not recovered. No follow-up attempts are possible. No further information is expected.
large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; large red swollen area at injection site, hot to touch, painful; Bodyaches; This is a spontaneous report from a contactable nurse (patient). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via an unspecified route of administration (at the age of 47-year-old), administered in left arm on 21Jan2021 at 12:45 PM at a single dose (1ST DOSE, SINGLE) for covid-19 immunisation. Not pregnant at the time of vaccination. Medical history included Thyroiditis, Migraine, Headaches and SVT (supraventricular tachycardia). Patient allergic to Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID) and topiramate (TOPAMAX) received within 2 weeks. Patient was not diagnosed with COVID-19, prior to vaccination. No any other vaccines taken within 4 weeks prior to the COVID vaccine. The patient experienced large red swollen area at injection site, hot to touch, painful, Bodyaches on 22Jan2021. Patient been not tested for COVID-19, since the vaccination. No treatment was received for the events. The most recent COVID-19 vaccine was administered in hospital. Seriousness reported as non-serious. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Breaking out with hives; Super itchy; sore arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Breaking out with hives), PRURITUS (Super itchy) and ARTHRALGIA (sore arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ARTHRALGIA (sore arm). On 21-Jan-2021, the patient experienced URTICARIA (Breaking out with hives) and PRURITUS (Super itchy). At the time of the report, URTICARIA (Breaking out with hives), PRURITUS (Super itchy) and ARTHRALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt was accidentally given the bivalent COVID booster instead of his first COVID-19 Shot. No adverse event occurred after vaccination. Patient was notified. Provider mistakenly grabbed the COVID booster bivalent instead of the monovalent vaccine.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:27 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 1:27 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The patient did not have any adverse events and did not require any medical attention after receiving the dose.
Pt felt throat closing within 5 minutes of receiving COVID-19 bivalent booster.   Assisted to reclining chair and administered 0.3mg epinephrine IM to left anterior thigh at 440p   Pt continues with coarse wheeze difficult to speak. Rapid response and 911 called.   BP 130/80 sats 95-97%   02 2l by nc,  Benadryl 50 IM given at 450p and paramedics arrived shortly after   Pt now able to speak full sentences returning to baseline breathing. Left by stretcher     Patient has experienced an adverse reaction to COVID Bivalent    Therapy used for reaction:  Epinephrine: one dose and Benadryl IM   Timing from:  Injection to onset of reaction: 0-15 min   Clinical Symptoms of Reaction: Cough, wheezing or SOB: Responding to treatment (Grade 2)   Plan:  EMS Called
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 22-MAR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 24 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Beginning on 5/13 and lasting until 5/25:  Extreme fatigue, dull headache that would begin in the afternoon and worsen but responded to OTC ibuprofen, intense muscle pain especially in shoulder and arms, loss of appetite, arms felt "heavy", increased tinitus.    Symptoms gradually alleviated beginning 5/24 but fatigue and heaviness in arms cycle back even now.
Post vax, the pt experienced a sore achy feeling at the injection site which goes away and comes back periodically. The pt noted that the feeling is not that bothersome.
high WBC/Neutrophil count; high WBC/Neutrophil count; bacterial infection; Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose; Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things."; BACTERIAL INFECTION (hospitalization) with onset 2022, outcome "unknown"; NEUTROPHIL COUNT INCREASED (hospitalization), WHITE BLOOD CELL COUNT INCREASED (hospitalization) all with onset 2022, outcome "unknown" and all described as "high WBC/Neutrophil count". The patient was hospitalized for neutrophil count increased, white blood cell count increased, bacterial infection (start date: 01May2022). The patient underwent the following laboratory tests and procedures: Neutrophil count: high, notes: high WBC/Neutrophil count; White blood cell count: high, notes: high WBC/Neutrophil count. Therapeutic measures were taken as a result of neutrophil count increased, white blood cell count increased, bacterial infection.  Clinical information: Caller was calling on behalf of her mother who took the second booster of COVID-19 vaccine last 26Apr2022. Caller mentioned that her mother used to be independent, talk intelligently, walk for an hour, go to bathroom without error. Now, her mother can't do any of those things. They observed these decline in activity and her mother was hospitalized 01May2022. Her mother already had one round of antibiotics for the high WBC/Neutrophil count. She mentioned that the antibiotics did not help with the bacterial infection. She wants to know if we have any recommendations for antibiotics or any information about bacterial infection after the booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reports fever 101.5. Left upper arm with mild swelling, mild erythema.  No drainage from injection site. Tender to palpation.  No ecchymosis or streaking noted. Diagnosed cellulitis left upper arm. Treatment includes course of abx, Keflex 500mg 1 tid x10days and Tylenol Extra Strength 500mg 1 tid prn.
48 hours after receiving vaccine patient awoke with left foot cramping sensation Withing another 24 hours her entire left leg was numb She took advil for 5 days with no relief and then began having severe lower back pain - dull, aching to sharp She was started on a medrol dose pak and she had relief from left foot cramping and leg numbness but at end of steroid pack she is still having lower back pain
Headache, Sore & Itchy Arm, Bruise on Rt Leg, Lightheaded, Nausea, Blurred Vision, Chest Pain, Cough, Difficulty Breathing, Elevated D-Dimer
Pt left us message this morning that he is feeling numbness at the injection site and that he is feeling numbness in his head as well. It appeard to be unilateral, same side as the arm where flu shot was given.
Fatigue. Started all of a sudden. Went to sleep early and took a naproxen and it resolved.
Left leg swollen and reddened 20 min after shot returned to clinic 2 days after: treated with Duricef.
Chills 3 days, upset stomach 3 days,  Itchy and hot injection site 4 days so far
Large, swollen, red rash over and around the injection site. Hot and painful to the touch. 101 fever for 24 hours.
Onset of signs/ symptoms on 05/05/2005 with scalp, neck, trunk with vesicles and DX with chicken pox in our office on 05/05/2005. Information from missing data report states: This child did not receive these vaccines here. These vaccines were given by Medical Group.
Patient was given the pediatric dose of Pfizer instead of adult dose for 12 and up.  There were no adverse outcomes.  At this time no action needs to be taken.
Increased pain during menstrual cycle. Feel nauseated and often bed ridden with pain. Bleeding is heavier than it used to be as well.
About 15-30 minutes after receiving the injection, I noticed erythema and edema in the right deltoid muscle where the injection was given.  I called a pharmacist who verified that patient received Fluarix instead of Flucelvax as I had requested. As the evening went on, patient had nausea and felt like he was going to vomit.  The erythema and edema progressed on his R arm and I had him ice his arm and administered diphenhydramine before bed.  The nausea resolved within 12 hours, however the local adverse reactions on the R arm persisted for 48 hours with intermittent ice and diphenhydramine.  There was still minor itching 72 hours post vaccination.  2 weeks prior to vaccination, patient failed a baked egg challenge.  He currently follows with a pediatric allergist for his food allergies.
14 Y old female presents to clinic with grandmother who is legal guardian. Patient reports she recieved on 09/18/23 she recieved the polio vaccine at her pediatrician office. Patient reports following the vaccine she had some soreness in her arm a couple hours after the vaccine. Reports she woke up early Tuesday 09/19/23 morning with body aches all over. Reports she was having some photosensitivity and headache yesterday as well. Reports photosensitivity resolved. Reports today the soreness has resolved "other places but her legs still feel sore and achy". Reports she still has a headache but has been taking OTC medications for the headache that have been helping. Reports she had a temperature 99.8 at home last night. Denies any changes in her skin at the site or anywhere ese. Denies beginning any new medications. Reports full ROM of of arms and legs. Reports overall fatigue. Denies numbness. Reports "my legs were tingly this morning when I first got out of bed but they are not anymore".
Injection site painful. Chills and fever first 2 days. Removed Band Aid 3 day and hardness and itching spread over entire upper arm. Itching became extreme and unbearable.
Burning of mouth, lips, difficulty breathing.  Lips swelled, cracked and peeled.  Inside of mouth no longer burning ,   Swelling in lips has gone down, they have been peeling for days.  Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine.   I think I may have to cancel the second shot.  I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same.  The only difference is my hands haven't cracked and peeled along with my lips and mouth.  I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still.  Please let me know if you have any solutions to prevent this.
Information has been received from a health professional concerning an 82 yr old female who on 28Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650649/0790P). On 28Sep05 the pt complained of redness, swelling, and warmth at the injection site and fever. The pt took over the counter medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
a itchy warm to touch rash at injection site; swelling/hardness at injection site; a itchy warm to touch rash at injection site; a itchy warm to touch rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a itchy warm to touch rash at injection site), VACCINATION SITE SWELLING (swelling/hardness at injection site), VACCINATION SITE PRURITUS (a itchy warm to touch rash at injection site) and VACCINATION SITE RASH (a itchy warm to touch rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (a itchy warm to touch rash at injection site), VACCINATION SITE SWELLING (swelling/hardness at injection site), VACCINATION SITE PRURITUS (a itchy warm to touch rash at injection site) and VACCINATION SITE RASH (a itchy warm to touch rash at injection site). At the time of the report, VACCINATION SITE WARMTH (a itchy warm to touch rash at injection site), VACCINATION SITE SWELLING (swelling/hardness at injection site), VACCINATION SITE PRURITUS (a itchy warm to touch rash at injection site) and VACCINATION SITE RASH (a itchy warm to touch rash at injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment included alcohol.  Action taken with mRNA-1273 in response to the event was not applicable.
Patient described having achy joints, an uncharacteristic headache, stomach ache, very painful/tender injection site area, feelings of being hot and cold but an unknown fever.
Vaccine vial diluted with 0.8mL normal saline and should have been diluted with 1.8mL normal saline
Right Upper Arm 8.5cmx9cm area of erythema noted, not currently hard to touch, not currently htk to touch.  No papules, no vesicles, no pustules noted.  No pain with examination.
Pt complaining of arm numbness and lack of ability to move arm after Heb B shot. She states this happens every time she gets a shot symptoms have resolved after about one week in the past like MMR vaccination in 2000.
I received the 1st dose of the Moderna vaccine on January 10, 2021 and had no reaction.  On January 18, 2021, I noticed a big red circular spot around the injection site (left arm).  It was warm, raised, and felt like a burning sensation.  Everyday after January 18, 2021, it has slowly gone down and not as red.  As of today, January 22, 2021, it has now disappeared.
Information has been received from a medical assistant via a company representative referring to a patient of  unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of VARIVAX (dose, lot number and expiration were unknown) subcutaneously. On an unknown date, the patient contracted chicken pox after receiving VARIVAX. The outcome of the event was unknown. Additional information has been requested.
Leg Rash Red rash and hot to touch on the injection site swollen around the injection site