chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea, blood in stool and diagnosed w/intussusception emergency surgery done on 9-21-07 at hospital (possibly from Rotavirus vaccine).  11/30/2007 MR received for DOS 9/21-23/2007 with discharge DX:  Ileal-Ileal Ileocolic Intussusception. Child presented with 2 day hx of fever, nausea and vomiting with blood in stool.  On PE, abdomen (+) distention and RLQ tenderness. Currant jelly stool in ER. Barium enema x 3 attempts-unable to reduce the IS so pt taken to OR for a Laparotomy with manuel reduction of Intussusception with Incidental Appendectomy. Pt did well post-op and D/cd home on POD 2.  12/10/2007 Vax record received from PC.  Info the same as VAERS form submission. Doing well s/p surgery.
Information has been received from an investigator via agency concerning a child patient with HIV infection who was enrolled in a study who was vaccinated with a dose of PNEUMOVAX 23 (Lot not reported). This report was part of a post-marketing surveillance program. Subsequently, the patient experienced erythema. The reporting investigator felt that erythema was definitively related to PNEUMOVAX 23. Erythema was considered to be an other important medical event. No further information is available.
The night after getting the flu shot, patient developed a head ache  and started getting hives. The hives went away and then came back again on Monday and lasted until Wednesday. Patient took Benadryl and is getting better.
INJECTION SITE SWOLLEN/HARD, PAINFUL, WARM TO THE TOUCH.
Pt reported feeling "different" and sat down. She reported that she has frequently passed out. She did pass out for a period of about 10 seconds, 911 was called prior to this and she was responsive while on phone and very responsive by the time paramedics arrived minutes later.
Anxiety  BP - 127/84 Per paramedic okay to d/c no interventions needed
on the way home from office p/vax pt became unresponsive, pale, then cyanotic;pt was very floppy;mom drove pt back (20-30min) & pt had nl tone, but still sleepy;
I administered Hep B Lot C44K4 1.0mL instead of a hep B pediatric 0.5mL at 6:55pm on April 12, 2023. Pt parents , Supervisor, PCP, and state notified.
Pt presented with swolen arm to elbow/erythematous and blister like lesions/Pt was treated with cephalexin.  Pt complaimned of itching and pain at site
Redness, itching, pain, warm to touch, grew from 1" to near 6" radius - red center surrounded by raised pink circle; getting larger daily.  Saw my doctor on 4/16/14 - drew blood for varicella titers & recommended Benedryl & Advil.
On 4/12/01, 05/15/01 and 10/15/01, the vaccinee received his 1st, 2nd and 3rd injections of Engerix-B, respectively. On 3/6/02, 142 days following the 3rd injection of Engerix-B, Hep-B surface antibodies were found to be "nonreactive". The reporter stated that this lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown.
LEFT ARM MUSCLE TENDERNESS STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; SORE LEFT ARM AND FEELS OVERUSED STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left upper arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced sore left arm and feels overused starting from the left wrist extending to the left shoulder. On 14-MAR-2021, the subject experienced left arm muscle tenderness starting from the left wrist extending to the left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore left arm and feels overused starting from the left wrist extending to the left shoulder, and left arm muscle tenderness starting from the left wrist extending to the left shoulder. This report was non-serious. This case, from the same reporter is linked to 20210353764.  Version(1) created to amend previously reported information on 15/Mar/2021. Upon review the following information was amended: Labeling of event (sore left arm and feels overused starting from the left wrist extending to the left shoulder) updated to unlabeled from labeled in USPI.  Additional information was received from patient on 15-Mar-2021 following information was updated and incorporated into case narrative: Link case added.
patient who received the 1st dose of the Moderna vaccine on 13May2021 and hasn't received the 2nd dose yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine on 13May2021 and hasn't received the 2nd dose yet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine on 13May2021 and hasn't received the 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine on 13May2021 and hasn't received the 2nd dose yet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications reported. No treatment information was provided.
This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 70 plus years old female with medical history unspecified who on 29-MAR-2008 was vaccinated with ZOSTER vaccine (Lot # was not provided), SC in his left arm at 11:00 AM. Concomitant therapy was unspecified. After receiving the ZOSTER vaccine, the patient experienced shingles. The patient was seen by a physician. At the time of reporting, the patient was recovering. Follow-up information was received from this registered nurse. On 08-APR-2008, after receiving the vaccine, the patient experienced rash and pain on the inside of his left thigh. He went to a "walk in clinic" and was treated with an antiviral drug for 7 days. The reporter also stated that the patient experienced great difficulty sleeping for 2 months (since approximately September 2008). The patient was treated by a physician. He went to a chiropractor and took a Tai Chi Chik Class for 8 weeks. The patient was seen by the physician. Lab and diagnostic test was unspecified. The patient recovered in July 2008. No further information is available.
Information has been received from a NP concerning an 79 year old male pt who on 10/16/03 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N). The pt presented to the MD's office on 10/17/03 with a red, swollen, and tender left arm. The pt's treatment was ice and elevate arm when needed. At the time of this report the outcome was unknown.  No product quality complaint was involved. Additional information has been requested. It was also reported from the same source that another pt had a similar experience (WAES 3
Patient received a Kinrex, however she was not 4 years old yet. Kinrex isn't licensed for under 4yrs old. Was found during a Site Audit on 01-04-2021.
On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6. On day 8 arm again was sore and now itchy with reddened area larger than injection site 3x4 inches.; Reported soreness at injection site and some soreness which was gone by day 5 or 6; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on left arm on 17Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included hypothyroid, osteoporosis, and known allergies to sulfa and tetracycline. The patient was not pregnant. The patient reported soreness at injection site and some soreness on Dec2020 which was gone by day 5 or 6. On day 8 (25Dec2020) arm again was sore and now itchy with reddened area larger than injection site 3x4 inches. No treatment was given for the events. The COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event pain was recovered and not recovered for the rest of the events.
Pt presented on 11/26/10 to office with petechial rash on back & B/L lower extremities: pt had described abdominal pain - vomiting the week prior to presentation; pt returned to office 11/30/10 with diffuse purpuric rash covering legs & upper arms back, sparing palms; (+) episode of gross hematuria (no proteinuria). No joint pain feeling well. Pt sent to rheumatology.  Of note pt has h/o HSP 12 years ago  (Henoch-Schonlein purpura).
Since her shot on 6/29, she has had nausea, upset stomach, diarrhea, and no appetite.  She has also experienced severe acid reflux after drinking or eating that she's never had a history of before.  She can't taste sweets, has no energy, and feels sluggish.  She developed a red ring around the injection site on 6/29 which prompted her to go to the hospital.
Pt was administered proquad by intramuscular injection instead of subcutaneous. no adverse effects noted.
Had a really bad nose bleed out of my right nostril, lasted about 20 minutes. Use nasal pressure and cold ice to stop the bleeding
Patient began having neuro decline.  Head CT/CTA demonstrated left MCA ischemic infarct d/t left ICA and L MCA occlusions.
injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer, Primary Immunization completed), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer, Primary Immunization completed), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster), Unknown manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Patient received the Pfizer Covid19 2nd booster this morning at 10:45 (Unspecified date), she wants to know if she can take Tylenol for injection site pain and she also wants to know if she can continue to take her muscle relaxer. Patient and her husband both got their second COVID booster at (withheld) hospital drive through. She just wanted to know if it is okay for them to take Tylenol for mild injection site pain. It is nothing serious. She doesn't want to do a report. She stated she is a doctor but not a medical doctor. She had success with both COVID vaccines and both boosters. She will get another in the fall if needed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966945 same reporter/drug, different patient, similar event;
The pt experienced dermatome, 1-3 inch wide vesicles, limping and right otitis media.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL, orally (lot number and expiration date and dosage not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022; expiration date of 01-May-2022 but doses were given today 04-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter. The vial was initially stored in the refrigerator on 01-APR-2022. The vial did not undergo any temperature excursions. It was reported that patient have not called to report any adverse events No treatment medications were reported by reporter.   This case was linked to MOD-2022-558253 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Source document contains no new information.
First day: high fever, shivers, diarrhea, nausea, felt like vomiting, near syncope episodes for hours (when trying to get out of bed and walk and when lying down in bed), heart palpitations. Second and third day: high fever, tiredness, exhaustion After the third day developed a consistent dry cough that still exists but not intensive anymore.
Rib cage Pain/Costochondritis; acid reflux disease; Doctor advised patient not to take the second dose which was due on 6th April; Slight headache 4 days after Covid-19 injection administration; This spontaneous case was reported by a consumer and describes the occurrence of COSTOCHONDRITIS (Rib cage Pain/Costochondritis), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux disease), PRODUCT DOSE OMISSION ISSUE (Doctor advised patient not to take the second dose which was due on 6th April) and HEADACHE (Slight headache 4 days after Covid-19 injection administration) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     The patient's past medical history included Depression. Concomitant products included PARACETAMOL (TYLENOL).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Slight headache 4 days after Covid-19 injection administration). On an unknown date, the patient experienced COSTOCHONDRITIS (Rib cage Pain/Costochondritis), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux disease) and PRODUCT DOSE OMISSION ISSUE (Doctor advised patient not to take the second dose which was due on 6th April). At the time of the report, COSTOCHONDRITIS (Rib cage Pain/Costochondritis), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux disease), PRODUCT DOSE OMISSION ISSUE (Doctor advised patient not to take the second dose which was due on 6th April) and HEADACHE (Slight headache 4 days after Covid-19 injection administration) 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 recvd vax; 8oct, red rash all over body x 5 days; redness gone p/ 5 days; now goose bumps all over body; no redness;
Patient was given a third dose of Zoster Recombinant. There was no adverse event.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 10:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:28 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 83.55  for dose administered on 02-Mar-2021 and 83.63 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27,29 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021 .  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-April-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fussy last night, restless in sleep. Reddened area 15mm x 11mm at injection site. Slight bruising at injection site. T 97.0
PATIENT FELT LETHARGIC, SWELLING OF THE LIPS, SHORTNESS OF BREATH, HEADACHE, ACHY JOINTS, COLD CHILLS (FLU LIKE SYMPTOMS), LEFT KIDNEY PAIN; TREATED WITH HYDRATION AND REST; HAS IMPROVED BUT STILL EXPERIENCING SOME OF THE SYMPTOMS
Large red swollen place at site of injection (about the size of a half dollar). It began as the usual post-injection side effect. Two days later I noticed it was more red and had risen. Since then it has gotten bigger. Also have burning and slight itch as well as tightness around the arm near injection site.
On the day of vaccination I started having intense dizziness and pressure in my head as well as heart palpitations. My eyes were also sensitive to light. I had some shortness of breath with exertion. I also started having muscle twitching in my calves mostly. A couple of weeks after vaccination, I noticed elevated blood pressure. I went to the doctor 3 weeks after my vaccination due to just not feeling well. She ran some tests and suggested I take Flonase but I did not use it. I received a cardiologist referral for an echocardiogram but it was mostly normal.
slurred speech and 'fog' for approximately three months. Could not hold a conversation without losing my place or forgetting what was being discussed. These symptoms were random and subsided mostly after 3 months
terribly sick for about 10 days; hard to cough up the phlegm; phlegm was dark and hard; affected the patients sleep; affected their ability to work; made the patient throw up a lot; did not get the second dose of the vaccine; dry cough/cough was horrible; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), COUGH (dry cough/cough was horrible), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm) and PRODUCTIVE COUGH (phlegm was dark and hard) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced COUGH (dry cough/cough was horrible). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine), ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine) had resolved, COUGH (dry cough/cough was horrible) was resolving and ILLNESS (terribly sick for about 10 days), SPUTUM RETENTION (hard to cough up the phlegm), PRODUCTIVE COUGH (phlegm was dark and hard), SLEEP DISORDER (affected the patients sleep), IMPAIRED WORK ABILITY (affected their ability to work) and VOMITING (made the patient throw up a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient explained the cough was better now but the patient still has a little bit of a cough.  The patient took cough medications to help with the symptoms.  The patient does not take any daily medications.
HPV administered on 3/1/07. Abdominal pain and rash started 4/27/07. Diagnosed with HSP on 5/2/07.