chrisvoncsefalvay/vaers-outcomes huggingface dataset:
08/14/2017 approx 1000. Vaccines were given, client waited recommended 15 minutes post immunization without issue. 08/16/2017 approx 1200. Mom called "just to let us know" that child developed hives around 8PM the day of vaccination and that they remained to date. Nurse advised mom to have physician evaluate child urgently. Mom stated she would take child to private physician day of call. 08/17/2017 approx 0930. Mom called back to clinic stating that child had seen physician. He said it was an allergic reaction probably related to the shots and was given a steroid. 08/17/2017 approx 0945. RN from Health Department phoned Dr.'s office to confirm diagnosis and treatment. Per nurse, actual diagnosis at appointment on 08/17/2017 was delayed allergic reaction probably related to vaccines. ORAPRED taper and over the counter BACTROBAN were prescribed as treatment.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient received the first dose of TRUMENBA at 0.5 ml, single for immunisation and meningococcal vaccine a/c/y/w (reported as MCV4) at unknown dose, both via unspecified route of administration on an unspecified date for immunisation. The patient's medical history included allergies. Concomitant medication included loratadine for allergies. On an unspecified date, the patient experienced loss of hearing- felt like she was underwater, nausea, and blurred vision. She required support to remain standing. It was reported that the patient was an otherwise healthy patient. Outcome of the events loss of hearing- felt like she was underwater, nausea, and blurred vision was unknown. Information on batch and lot numbers has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
pt recvd vax late afternoon-t104 by early evening-cried prolonged until next day-seen by MD next afternoon-still fussy; leg was sore & swollen;
tongue swelled for 1 1/2hr the day pt given shots;mom denies any resp distress or any other problems;pt was seen by pvt MD for follow up on 9DEC97;
severe infection in right arm injection site; swelling at injection area; feels like a gunshot wound; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFECTION (severe infection in right arm injection site), VACCINATION SITE SWELLING (swelling at injection area) and VACCINATION SITE PAIN (feels like a gunshot wound) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Epilepsy. Concomitant products included IBUPROFEN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFECTION (severe infection in right arm injection site), VACCINATION SITE SWELLING (swelling at injection area) and VACCINATION SITE PAIN (feels like a gunshot wound). At the time of the report, VACCINATION SITE INFECTION (severe infection in right arm injection site), VACCINATION SITE SWELLING (swelling at injection area) and VACCINATION SITE PAIN (feels like a gunshot wound) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is on High blood pressure medication and epilepsy medication. No treatment medication information was reported.
I started with hives the first day and took Benadryl and they resolved.  I woke the next day I had a menthol sensation all over my body.  It affected my toes mostly.  I had pins and needles sensation on my leg?s arms and face.  A few days later it turned into a rug burn sensation all over my body.  I went to see my doctor he advised that I should be on some supplements for nerve damage.  He put me on Vitamin D3.  He also advised that I take B complex.  He also put me on an anti-inflammatory.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 27-JAN-2016 at 16:47, the patient was vaccinated with the first dose of GARDASIL lot # L016528, intramuscularly in the right deltoid (strength, dose and expiration date were not reported), which was improperly stored. The reporter stated that no adverse events were noted per medical doctor. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). Other case identifier: US-PFIZER INC-202101212345. A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient felt abnormal (outcome of unknown). Additional information: Patient received the shot in his arm. He felt the jab going into his arm, and felt something odd about the circumstances. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
On 8/6, the pt developed a fever. On 8/11, she broke out with a rash that covered her body-even her face. It looked like chicken pox.
Recieved shot on Monday Nov 10, 2008, Woke up Tuesday with a sore throat, Wednesday arms started itching by Thursday red Welts started showing up and covered both arms and a few red itchy welts showed up on the Abdomen. I was diagnosed with Hives due to an alergic reaction to something..........
Severe headache lasting from 5pm on 9/26 to 8am on 9/28. Constant itching, slight swelling, redness spreading approximately 2 inches from injection site.
PATIENT WALKED TO FRONT DESK APPROXIMATELY 5 MINUTES AFTER VACCINES ADMINISTERED TO SCHEDULE APPT FOR NEXT VACCINES. THE NURSE OPENED THE CHECK OUT WINDOW AND NOTICED PT FALLING DOWN AND HIT FACE ON COUNTER. BOTH DOCTOR AND NURSE IMMEDIATELY WENT AROUND TO FRONT LOBBY AND NOTICED PT PASSED OUT ON FLOOR WITH 2-3 SECONDS OF TONIC/CLONIC MOVEMENT. SHE WAS AWAKE AND ANSWERING QUESTIONS WITHIN 30 SECONDS. EMS CALLED. MD NOTICED TOOTH WAS CHIPPED. EMS TRANSPORTED PT TO HOSPITAL VIA AMBULANCE.
This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient were vaccinated with unspecified doses of MMR II (routes, lot numbers and expiration dates were not provided). On an unknown date, an unspecified number of patients received improperly stored MMR II, so there was an incorrect product storage. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status' was unknown. This is one of several reports received from the same source. Additional information has been requested.
Vomiting; Stomachache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jun2021 10:00 (Lot number: EW0191) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GUANFACINE; RITALIN; WELLBUTRIN; GEODON [ZIPRASIDONE HYDROCHLORIDE]; DULCOLAX [BISACODYL]. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=Ew0177, lot unknown=False, administration date=15May2021, administration time=09:45, dose number=1, vaccine_location=Right arm), administration date: 15May2021, when the patient was 12 years old, for Covid-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 06Jun2021, outcome "recovering", described as "Vomiting"; ABDOMINAL PAIN UPPER (non-serious) with onset 06Jun2021, outcome "recovering", described as "Stomachache". Therapeutic measures were not taken as a result of vomiting, abdominal pain upper.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No treatment for adverse event. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.                                                                                                                                              On 10th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient works in a long care facility suffered from severe reactions with Shingrix first dose (fever for 3 days). The reporter wanted to know if there was any information about receiving Shingrix second dose and Covid vaccine. The lot number and expiration date from Shingrix first dose date was in patient's doctor's office. The reporter consented to follow-up by email.
Within 5 minutes of vaccine, developed sweating and nausea, completely resolved by 30 minutes
Skin rash (red, raised) around neck, chest, face.  Red, raised and puffy, extremely itchy, tender.   The rash started in several spots which have then grown in size and merged in a couple of areas.  I had one patch of the same rash  a couple of weeks after the first vaccination .  It lasted a couple of days and wasn't as severe as this time.   My internist thinks this is due to the vaccination -- other possibilities (eg bug bite) are not at all likely.  Treating with antihistamines and topical cortisone - which are minimally effective so far.
erythematous local reaction - approx 10cm diameter of swelling and erythema - this was improving within 5-6 days
Lethargy; Sneezing; Eye floaters; Runny nose; Difficulty breathing; Dizzy; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Nov2021 at 13:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) 10 mg for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Nov2021, the patient experienced lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events which included treatment with over the counter (OTC) cold medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lethargy, sneezing, eye floaters, runny nose, difficulty breathing, dizzy and nausea was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was at home, felt dizzy and fainted, fell to the floor,  woke up a few minutes later and was fine.
A report has been received from a Health Professional concerning product exposure during pregnancy in female patient. The patient's medical history and concomitant medications were not reported. It was reported that patient took FLUMIST (intranasal) two weeks ago (Jan-2014) for flu, then she discovered after that she was pregnant. The patient available for follow up and pregnancy result was unknown. The reporter considered the event of took FLUMIST then discovered she was pregnant to be serious with seriousness criteria of Important medical event.
A 20 year old male patient received only one dose of GARDASIL 9 in 2019; No additional AE reported,; This spontaneous report as received from both pharmacy intern and pharmacist concerning a 20-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unspecified date in 2019,  the patient was vaccinated with only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Pharmacist was aware that a three-dose series was recommended and wanted to clarify if the series needed to be restarted, as patient would like to continue. No additional adverse event reported.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: Pt reported feeling hot, tired, weak. Gave water, provided fan, and patient rested. Offered to call ambulance if needed (pt refused and mom ok with refusal). Called mom on phone after patient went back home. Per mom, pt ate and drank at home and felt much better (no symptoms).
No actual adverse event occurred, however we discovered a vial where part of the cap had been broken off. This was caught before given to any patient and the vial was disposed of. We looked for evidence of tampering and found none.
Patient stated about 24 hours after receiving injection developed redness heat and pain in arm around injection site. Received shot on 1-18-13 and reported event on 1-24-13 and stated arm still sore a bit.
High fever, inconsolable >12 hours (<24) repetitive jerking movements of arms and legs.  Brief (few seconds) but continued throughout the night 09/12-09/13/02.
5 Bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (5 Bowel movement) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (5 Bowel movement). At the time of the report, FREQUENT BOWEL MOVEMENTS (5 Bowel movement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
12/28/2021:  Event occurred after 2nd vaccine 68-year-old gentleman presents to the emergency department because of heavy chest discomfort present with exertion.  It is reproducible with exertion. No shortness of breath, cough or sputum. GASTROINTESTINAL:  No anorexia, nausea, vomiting or diarrhea.
Complaining of arm pain and was given Motrin. Had 2" X 3" red, raised, warm and tenderness at injection site. Is using compresses.
I had really bad chest pains that were persistent. I took over the counter stuff but it did not change anything. I went to the ER on 10/08/2021 and they tried to rule out a heart attack. They said I was not having a heart attack but they were not sure that I did not have a blockage. I was there for 6-8 hours. On Friday I had an arterial test to check my blockage. They said I did not have anything critical but they will give me my results in 21 days. I had diarrhea, really bad stomach cramps, and fatigue. My back started to hurt. Some days I feel better than others. Tomorrow I am going to get some blood work done tomorrow.
Metallic smell in nose 15 minutes after injection.  Since then, the smell of odors are intense, and overwhelming at times.
Information has been received from a physician concerning a female who on unspecified dates several year ago, was vaccinated with the first, second and third dose of GARDASIL (lot# not reported), 0.5 ml suspension, intramuscularly, respectively at 0, 2 months, 6 months. The doctor reported that the patient recently had a pap smear that showed positive for human papillomavirus type 17 (HPV16). At the time of reporting, the patient was not recovered from the event. The patient was not given treatment for the event. It was unspecified if the patient sought medical attention. Additional information has been requested.
Patient presented to the ED for epigastric pain and was subsequently hospitalized for choledocholithiasis, acute biliary pancreatitis within 6 weeks of receiving COVID vaccination.
it was 142 days between second and third dose, 1st dose: 11/3/21, 2nd dose: 12/13/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 41-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 3rd November 2021).   On 13th December 2021, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 13th December 2021, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comment: Pharmacist called in to enquire about Twinrix dosing. Pharmacist stated it was 142 days between second and third dose, was this okay, a week early. )n 4th May 2022, patient received 3rd dose of Twinrix. Did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Twinrix within 142 days after 2nd dose, earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose, later than recommended interval, which led to lengthening of schedule.
Just not right; Sweating; Weakness; did not want to get out of bed; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed). At the time of the report, VACCINATION COMPLICATION (Just not right), MYALGIA (Achiness), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness; did not want to get out of bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient received vaccine at 01:24 PM on 09-Feb-2021 and waited for the allotted 15 minutes. At 10PM, the evening of 09-Feb2-021 the patient went to bed and woke between 1-2AM experiencing achiness, sweating, just not right. The patient experienced weakness all day on 10-Feb-2021. Her symptoms eventually subsided towards the evening. She did not expect the symptoms at that time. The patient was not 100%, but better. On 11-Feb-2021 the patient was still not herself, but planned on showering, washing hair and getting up and out. She felt like she can though. The patient did house chores, which she could care less for, she just felt weakened.
About a week or so after my second shot I started getting what I thought were tension headaches and  feelings of a crawling sensation at the top and sides of my head, as well as pressure over my eye with on-and-off dizziness. I went to my primary care MD who ordered CBC+Diff and a compete metabolic panel and CT scan. All came back normal. She referred me to neurologist who gave me methylPrednisolone  4 mg dose pack. No change. I then went to an ENT and had my ears checked for pressure and wax and hearing, all back fine. She gave me Rx for Flonase. I have been taking over-the-counter Excedrin Migraine, have gone to chiropractor as well as massage therapis. So far no relief.
Hypotonia, unresponsive, muscle stiffness, screaming, decreased appetite.
Pt c/o itching at injection site and feeling of flushing. Pt also had not eaten or had anything to drink for 3.5. After pt ate symtoms subsided and pt left.
About 15 min post vaccination she collapsed on the floor in an iste  without loosing consciousness, she was alert and oriented x3 when I approached her. She complained that she feels weak and her hands and feet feel cold and numb. Her breathing was shallow. 911 was called. While waiting about 25 minutes post vaccination, she developed utricaria around her neck and upper chest area Pt. was alert all the time untill rescue came in. Due to a developing weakness (was unable to get up off the floor without attistance)  rescue desided to follow up taking her to the hospital. She came in to the pharmacy next day. She stayed in the hospital for a few hours and was released home.
Pt was given Vaccine. 10 min later stated she had hives and itching and tingling in her hands. 10 min later said her throat was sore and voice was course. Gave 50 mg IM BENADRYL. Monitored pt for 40 min post BENADRYL and symptoms resolved. Event began at approx. 09:30 AM, resolved approx. 10:40 am.
PATIENT DEVELOPED BODY RASH 7 DAYS AFTER ADMINSTRATION--SAW MD AND GIVE STEROIDS AND ANTIHISTAmines for treatment
Slept 22 hrs after imms - no intake - decreased output. Seen at 11:30 9/30/08 - awake, alert, took 3 oz formula. Took another 3 oz about 3 hrs later and had another wet diaper - At 4:30 p 9/30/08 baby began having circumoral cyanosis and was seen in ER. Admitted to PICU.  10/16/2008 MR received for DOS 9/30-10/1/2008 with D/C DX: Gastroesophageal Reflux. Pt presented with excessive sleeping, decreased po intake, pallor and purple lips. Had 2 episode of vomiting and decreased wet diapers. Initial PE WNL but pt had a witnessed O2 sat drop to 52% with HR decrease to 90's. Pt was pale with oral cyanosis. Admitted for ALTE, hypoxia and cyanosis. Pt did well on smaller more frequent feed and meds. D/C on reflux precautions.