chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prior to administering vaccine, patient became very upset and began vomiting. Father stated that this was from anxiety. Patient asked for something to eat and was given crackers. Writer asked patient to lie down during admin due to previous reaction to vaccine. Patient attempted to lie down but then refused, stating that he needed to sit for it. This MA administered TDAP vaccine to patient's right deltoid. Patient sat for approximately a minute and then experienced syncope with some convulsing. Father of patient held patient up and writer assisted in lying patient on his back and propping feet up with a pillow. Patient attempted to sit up upon regaining consciousness, but writer and father of patient encouraged him to continue lying down. Patient remained lying down for approximately 10 minutes prior to leaving.
Coughing, with tingling in hands. Progressed into severe tightness in arm, hands and face
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced joint pain (severe) on an unspecified date. Outcome was recovered in 2 days.
Information has been received from a Registered Nurse concerning a 21 year old female patient with constipation, hypercholesterlaemia and polycystic ovarian syndrome and no known drug allergies, who on 23-MAY-2007 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (unspecified lot number). On 24-JUL-2007 was vaccinated with the second dose of GARDASIL (unspecified lot number) and on 17-DEC-2007 was vaccinated with the third dose of GARDASIL (lot number 659439/1267U). Concomitant therapy included Glucophage, CELEXA, YASMIN and unspecified stool softeners. The nurse reported that the patient was tested positive for high risk HPV on 01-FEB-2010. A blood work performed on an unspecified date showed lipid levels slightly elevated. At the time of the report HPV positive persisted. It was unknown the outcome of the lipid levels slightly elevated. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse who reported that the patient completed the GARDASIL series on 17-DEC-2007 and was positive for HPV types 16 and 18. The nurse also mentioned that the first two doses of GARDASIL were given at another facility and that the results of previous PAP tests were not available. At the time of the report the patient had not recovered. Additional information is not expected.
A 49 year old female patient with allergies to BEXTRA and CARTIA and hypertension, atrial fibrillation, hyperglycemia, hyperlipidemia experienced tinnitus or "ringing in the ears" after receiving H1N1 (lot number UP053AA) on 15 December 2009. The patient was noted to have been on LIPITOR, coumadin, DIGOXIN, TOPROL XL, "ALTASE"' hydrochlorothiazide. Recovery status was unknown. List of Documents held by Sender: none.
Severe headache within 2 hours of the shot, followed by significant Tinnitus (constant high pitch ringing) in both ears. The Tinnitus was noticeable the next morning and at 2 weeks post vaccine continues to be a problem.  Tinnitus is a new condition and I have never had the problem previously.
Very whiny on day 1 and 2 after. Highly unusual. Then woke up with vomiting and diarrhea several times an hour on day 3 post vacc.  Low verbal so unsure of other issues.
MUSCLE ACHE FROM NECK TO SHOULDER A FEW DAYS AFTER VACCINE UP THROUGH TODAY
Fever, rash, myalgias, nausea, vomiting, diarrhea.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received SHINGRIX (batch number 4492P, expiry date April 2020). Concomitant products included Atorvastatin, Baby Aspirin, PAXIL, Ranitidine, glucosamine, estradiol and glipizide. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash, injection site erythema and injected limb mobility decreased were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, headache, injection site warmth, rash and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient received SHINGRIX in the right arm. Immediately after receiving SHINGRIX, the patient had headache. The patient's right arm was sore and swollen from her elbow (extensive swelling of vaccinated limb) and was red hot. The swelling was so much that she could hardly bend her elbow (injected limb mobility decreased). The patient also experienced a butterfly shaped rash. This side effects lasted 6 weeks and then resolved.
I woke up with a fast heart rate around 120 BPM and a fever of 102 degrees. I had lower oxygen which I haven't had in a while. I felt as bad as when I had Covid. In the morning I still had a fever. April 8th I went to an urgent care at the Hospital and Medical Center because my oxygen was still low around 89 or 82. The doctors listened and they heard crackling sounds. They did an X-ray and saw something on my lungs. They was scared I had a blood clot in it. I got sick and started throwing up. They transferred me to the ER at that same facility. In the ER they did a CAT scan, and it showed that I did not have a blood clot. They came to the conclusion that it was just a reaction to the vaccine.
I received the Shingrix vaccine 3 years after having shingles.  I had muscle weakness & fatigue as well as similar symptoms that I had whenI first had the virus.  My lower lip blistered and I had a rash on the left side of my face.  These symptoms lasted a week and a half.
GENERAL MALAISE; FEVER; INJECTION SITE SWELLING; INJECTION SITE REDNESS; INJECTION SITE VERY WARM TO TOUCH; INJECTION SITE HIVES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 230 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included asthma, low thyroid, pollen allergy, sesame allergy, abstain from alcohol and and non smoker. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included levothyroxine for low thyroid.  On 12-APR-2021, the subject experienced injection site very warm to touch. On 12-APR-2021, the subject experienced injection site hives. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. On 13-APR-2021, the subject experienced general malaise. On 13-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) ranging from 99 to 100 degree Fahrenheit. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, injection site swelling, injection site redness, injection site hives, general malaise, and injection site very warm to touch. This report was non-serious.
Around 5pm after getting the vaccine, I developed a fever of 101 and got chills, body aches, a migraine, and severe nausea (no vomiting). It lasted about 14 hours.
Patient received the shot on 9/13/18. That afternoon he reported that he had flu like symptoms suich as fever, shakes, sweats, temperature, that increased in intensity throughout the afternoon.  Late that evening he contacted his primary doctor to report the ongoing side effects. The PCP reported that if he felt that bad to contact the ambulance and be seen at the hospital. The patient contacted that ambulance and was seen at hospital arriving around 1130Pm on 9/13. He was discharged the following morning around 6:30am when his symptoms started to decrease.
A non-serious spontaneous report of congestion, fever, headache, sore throat and nausea has been received from a parent/non health professional concerning a seven-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications were reported. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 28-Oct-2009, after four days of vaccination, the patient experienced congestion, fever, headache, sore throat and nausea. Nasal swab was taken which tested negative for flu. The outcome of the reported events was not resolved.
13JUN96 mom c/o following 17APR96 vax given in lt leg hot, swollen immed following shot & soon p/became discolored;states it was approx 1mo a/swelling went down & cont to be tender to touch;dimpled depression now @ site mom states;
coughing; wiped out; sore throat; nasal congestion; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient in his 30's received bnt162b2 (BNT162B2), administration date 24Jan2022 (Batch/Lot number: unknown) at the age of 4 decade as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 24Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 25Jan2022, outcome "recovering", described as "wiped out"; OROPHARYNGEAL PAIN (non-serious) with onset 25Jan2022, outcome "not recovered", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "not recovered", described as "nasal congestion"; COUGH (non-serious) with onset 27Jan2022, outcome "not recovered", described as "coughing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, reporter just spoke with a male, mid-30's, at approximately 08:30 AM today (Friday, 28Jan). He reported that he received his 3rd Pfizer COVID-19 vaccine late afternoon on Monday, 24Jan. Later that evening he may have had some fever. On Tuesday morning he felt "wiped out", but that improved over the day. He also started to develop a sore throat and then some nasal congestion and coughing which was continuing through Thursday night (his time) when reporter spoke with him.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tested positive this morning 5/25/2022 after testing negative 5/23/2022 and 5/21/2022. Slight sore throat; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive this morning 5/25/2022 after testing negative 5/23/2022 and 5/21/2022. Slight sore throat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Allergic reaction was reported for an unspecified drug.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 25-May-2022 at 7:00 AM, the patient experienced COVID-19 (Tested positive this morning 5/25/2022 after testing negative 5/23/2022 and 5/21/2022. Slight sore throat). At the time of the report, COVID-19 (Tested positive this morning 5/25/2022 after testing negative 5/23/2022 and 5/21/2022. Slight sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative. On 23-May-2022, SARS-CoV-2 antibody test: negative (Negative) Negative. On 25-May-2022, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. In February 2021 at 1:15pm , the patient received Moderna vaccine. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 25-May-2022.  Company Comment: This spontaneous case reported by a patient concerns a 72-year-old female patient, with no reported medical history, who experienced unexpected, non-serious Covid19, approximately 1 year and 3 months after receiving a dose of mRNA-1273.  She was given Nirmatrelvir/Ritonavir for around 5 days, after which she tested negative for Covid19 twice.  However, around 1 week after completing Nirmatrelvir/Ritonavir, she developed slight sore throat, then tested positive for Covid19.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case reported by a patient concerns a 72-year-old female patient, with no reported medical history, who experienced unexpected, non-serious Covid19, approximately 1 year and 3 months after receiving a dose of mRNA-1273.  She was given Nirmatrelvir/Ritonavir for around 5 days, after which she tested negative for Covid19 twice.  However, around 1 week after completing Nirmatrelvir/Ritonavir, she developed slight sore throat, then tested positive for Covid19.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
This spontaneous case reported by a consumer, describes the occurrence of abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak), pain in extremity (arm was very sore) and chills (shivering for a number of minutes, pretty hard) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002A21A) for COVID-19 immunization. No medical history provided. Concomitant products included atenolol and baby aspirin (acetylsalicylic acid) for an unknown indication. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 25, 2021, patient experienced abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak) and chills (shivering for a number of minutes, pretty hard). On an unknown date, the patient experienced pain in extremity (arm was very sore). On Feb 25, 2021, abdominal discomfort (little of upset stomach), gastritis reflux, pain in extremity (legs felt weak) and chills (shivering for a number of minutes, pretty hard) resolved. At the time of the report, pain in extremity (arm was very sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment information not provided. This case linked to MOD-2021-266531 (patient link). Most recent follow-up information incorporated above includes: On May 7, 2021: Follow-up information received contains no new information. On Jul 26, 2021: Received- Added new event: Pain in arm.
Initial information received from a consumer who is the patient's parent on 03 February 2014. A 12 month old male patient was vaccinated on 16 November 2011 with FLUZONE Batch U4159BB intramuscularly, site of administration unknown. The reporter denied that the patient had any illness at the time of vaccination and pre-existing medical conditions and allergies were reported as none. The patient had received a 1 dose of FLUZONE vaccine intramuscularly on 21 September 2011, batch U4159BB, site unknown. At an unspecified time on 16 November 2011, the patient was withdrawn and zombie like after the vaccine. He was less vocal, lethargic, with no emotion and less babbling. He never "snapped out of it". The patient is speech delayed and has processing issues. He was on a delayed schedule of other vaccines, but by 21 September 2011 he had at least 3 DTaP, polio, hib, chickenpox and Hep B vaccines. He did not receive a Hep A or MMR vaccine. The patient required an ER/doctor visit on an unreported date. Concomitant medications were not reported. Further details at the time of this event were not reported. The outcome was not reported. Documents held by sender: none.
Renal cell carcinoma of right kidney metastatic to other site   ? Bone metastasis  ? Perforated bowel
Patient received a total of 3 Flu shot doses for the year 2022-2023 season. First flu shot was administered on 11/01/2022 and received second flu shot on 12/15/2022 since the flu shot given on 11/01/2022 was stored in a fridge where temperatures were not monitored. He received third dose on 01/19/2023 as a mistake.
9/16 Pt said injection site warm, red, swollen. Pt went to sleep, upon awakening noticed the warmth, redness & swelling migration down & towards  back of arm.
Gross Hematuria; This is a literature report.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IgA nephropathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: HAEMATURIA (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Gross Hematuria". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.54 mg/dl, notes: Presentation after second dose; 1.24 mg/dl, notes: Follow-up after second dose; 1/17 mg/dl, notes: baseline; Blood urine: greater than 50, notes: Presentation after second dose; 11 to 25, notes: Follow-up after second dose; 11-25, notes: baseline; Urine protein/creatinine ratio: 3.56, notes: g/g; Presentation after second dose; 2.20, notes: g/g; Follow-up after second dose; 2.40, notes: g/g; baseline.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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, and Investigators, as appropriate.
This is a spontaneous report from a contactable consumer reported for herself. This female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, muscle ache, fatigue and some joint pain with outcome of unknown. The information on the lot number has been requested.
reporting vaccine error...pt received first dose 7/14/2018 and another dose 6/18/2022 instead of the recommended every 10 years
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from an investigator in a post marketing surveillance study regarding a 10 month old male participant in a study entitled "ongoing Surveillance of Invasive Pneumococcal Disease in Original Efficacy Population and in NCKP<5 Years of Age." On 11-JUN-2001, at 6 months of age, the participant received the third dose of Prevnar, along with third doses of Hib-TITER, Infanrix, Engerix B, and IPOL. The patient experienced sudden infant death syndrome on 14-Sep-2001. The coroner's office reported that the patient expired due to sudden infant death syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. The investigator(s) and medical monitor(s) considered SIDS not related to the study product. No additional information was available at the time of this report. Follow up information received from the investigator provided the autopsy findings. Information regarding Prevnar was received from an investigator in a post marketing surveillance study regarding a 10 month old male participant in a study entitled "Ongoing Surveillance of Invasive Pneumococcal Disease in Original Efficacy Population and in NCKP <5 Years of Age." On 11JUn2001, at 6 months of age, the participant received the third dose of Prevnar, along with third doses of HiB Titer, INfanrix, Engerix and IPOL. The infant was fed oat meal about 1000 hours. At about 1100 hours, he was laid down for his noontime nap with a bottle of formula. At about 1145 hours, the infant was discovered blue in color and unresponsive. Paramedics responded to the call and initiated advanced cardiac life support measures. They then transported him to the emergency room where ACLS was continued for about 20 minutes but all efforts were to no avail. The coroner's office reported that the patient expired on 14SEP2001 due to sudden infant death syndrome. The autopsy cause of death was reported as sudden infant death syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA.   Follow up on 06/10/04 states: "Complete."
02/11/22 presents to ED for "Abdominal Pain, Nausea And Vomiting". PMHx of "GERD, abdominal pain, elevated blood pressure, vitamin D deficiency, postgastrectomy malabsorption, status post conversion of gastric sleeve for gastric bypass and hiatal hernia repair 11/21, history of appendectomy, history of cholecystectomy, history of hysterectomy"
This spontaneous report was received nurse refers to 39 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, (lot # L032396, expiry date: 26-AUG-2017 and lot # L045956, expiry date: 17-NOV-2017) (route, dose and frequency not reported). The vaccines were exposed to temperature of -14.41 degree Celsius for 9 hours 45 minutes. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No adverse effects were reported. Additional information has been requested.
Pt developed hives one week, post vax. Treated with Benadryl and Claritin with no relief. PCP started him on Prednisone. Three days later, hives are still there, itching has subsided.
when injecting vaccine needle separated from hub, partially;vaccine spilled on skin;wiped off w/dry gauze;skin became red w/in mins;mom washed w/soap & water;area of redness 2" diameter;subsided in 10mins;