chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 11 month old female with no pertinent medical history or drug allergies who on 06-APR-2007and 08-JUN-2007 was vaccinated PO with her first and second 2.0 mL doses of RotaTeq. On 04-OCT-2007, the patient was inadvertently vaccinated PO with the third 2.0 mL dose of RotaTeq (lot# 657520/0670U). Concomitant vaccinations administered that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of ActHIB, a dose of Prevnar and a dose of poliovirus vaccine inactivated (unspecified). On 05-OCT-2007, the patient also developed diarrhea and fever. The patient sought medical attention by phone and in the physician's office. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Symptoms flu like, very tired, aches,,24 hours, and my arm at injection site became very red huge area the next day.  It was very warm and itchy,  I was able to work with it. Still very red today. I read that this could happen. I took photos of it yesterday, I wasn?t worried about it, but other people said I should report it.
worsening SOB, non productive cough and chest tightness + COVID 19 test
itchy scalp / itchiness became worse / from head down to shoulders; itchiness became worse; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose on 17th June 2021, refer case US2021250207).   On 9th September 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pruritus and condition aggravated. The patient was treated with gabapentin. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the condition aggravated was unknown.   It was unknown if the reporter considered the pruritus and condition aggravated to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received dose of Shingrix and her itchiness became worse and experienced itchiness from head down to shoulders. The patient visited dermatologist and was put on Gabapentin. The patient still experienced itchiness. Medical Disclaimer was given and medical information phone number was provided. The patient was referred to the health care professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021250207:same reporter
Patient developed shortness of breath about 4:30 pm. Both she and her sister who also had the shot complained of sore throat and upset stomach about 6:30PM.  Both developed fevers by 9:PM.  Patient's reached 103 by midnight and by 4:30 her hands were numb and she was short of breath.  She then vomited and went back to sleep.  She has been sleeping with a 102 temp. since then and it is 3:40 PM 11/13/2012.  These are all reactions listed on the HPV handout.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742:
Last night at bedtime she noticed her arm was itching, thought nothing of it, went to sleep. This morning still itching so she looked in the mirror and arm was red-size was approximately 2 inches across at 6am. Itching worse now.
The patient developed an allergic reaction characterized by facial swelling and difficulty breathing that required ER care: IV treatment (steroids, benadryl)
Pain, swelling, and extreme itching distal to injection site; shoulder pain; headache; dizziness; lightheaded; chest tightness, back tightness.
Patient Maculopapular eruption torso and legs. No Koplik's spots. Suspected reaction to MMR vaccine. Pt assured not contagious. Instructed to return if sx worsen
Pt had swelling in the arm. He said hhis arems are swollen and sore
Pt developed a fever to 103-104F, 8 days, post vax. 10 days, post vax, developed an erythematous maculopapular rash on trunk then spreading to groin and then to neck and face. Finally it has spread to extremities.
Turned Covid-19 positive, stopped breathing for 30 seconds and began choking on mucus. Febrile, weak,  sharp body aches.  Being working up for possible pneumonia related to covid.  Supportive treatments in place, tylenol, Ibuprofen, Zinc, vitamin C, Chest PT
This spontaneous report was received from a physician refers to a 17 year old male patient. Information regarding the patient's concurrent conditions, pertinent medical history, drug reactions/ allergies and concomitant medications was not provided. On an unknown date, when the patient was 12 years old, he was vaccinated with GARDASIL (Lot #, expiration date, dose, anatomical location and route of administration were not provided) for prophylaxis. On an unknown date, when the patient was 17 years old, he received the second dose of the series; GARDASIL 9 (Lot #, expiration date, dose, anatomical location and route of administration were not provided) for prophylaxis. The reporting physician stated that this was longer than recommended interval (inappropriate schedule of vaccine administration). No adverse effects reported.
No additional adverse event; The office manager reports the inadvertent administration of a pediatric dose of VAQTA for a 19 year old patient; Information has been received from an office manager regarding a 19-year-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 18-MAY-2020, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis, lot number S032055 with expiration date in 09-NOV-2020 (dose, route of administration, strength and anatomical location not reported) (product administered to patient of inappropriate age).  No additional adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
24hr p/vax noticed redness in lt thigh & warm to touch which got worst as day went on;lt leg swollen from knee to groin w/redness & very warm to touch w/rash @ outer edges;dx cellulitis;
Severe pain; Uncontrolled sweating; Lethargic; Joint pain; Injection site pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Injection site pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Severe pain), HYPERHIDROSIS (Uncontrolled sweating), LETHARGY (Lethargic), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (Injection site pain), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information included paracetamol.
Sore arm; Chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On 12th October 2019, the patient received the 1st dose of Shingrix. On 12th October 2019, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced sore arm. She states he also had chills a couple hours after the injection and that they lasted a couple days.  No other information was provided. The reporter did not consented to follow up.  This case was linked with case US2020051451 (wife's case), reported  by the same reporter.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The patient fainted after administration. The physician stated that the patient was seated at the time and recovered from the syncope. No treatment was given for the adverse event. The causality is unknown. Additional information is not expected.
Developed Appendices On date of shot and had to be removed 4 days later. Probably not related but just wanted a record in-case this became an issue for others or a trend. Appendix removed.
pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement (right shoulder) in June 2018, Chemotherapy (for colon cancer) in August 2018 and Radiation therapy in January 2019. Concurrent medical conditions included Neuropathy (on right hand since shoulder replacement).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) outcome was unknown.            no concomitant medication provided. no treatment medication provided.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received Contact information updated.
Breakthrough case admission after three vaccines Moderna 1/28/21 Lot# 007M20A;  Moderna 2/25/21 Lot# 031L20A;  Moderna 12/16/21 Lot# 005C21A
Very large bruise with large hematoma center on right thigh, petechiae starting on feet but spread up legs and trunk, bleeding gums, easy bruising all over body - ITP. Also was left with hypothyroidism problems and Lupus antibodies.
Information has been received from a 29 year old female drug representative with no medical history or drug allergies, who in "November or December" of 2006 was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included LO/OVRAL. On 23-FEB-2007 she received a second dose of Gardasil. On 25-MAY-2007, the patient had a pap smear test which was reported to be positive for high risk HPV. On 11-JUN-2007, she received the results. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
This is a non-serious spontaneous case from a healthcare professional in the USA reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporters determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 34 year old male  medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in "no definitive reason" why the FluMist was responsible for "these symptoms."  HEPA filters were put into the environment and since then, nobody has gotten sick. The patient has recovered. The reporter believes army personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determine the events to be unrelated to FluMist vaccination. Further information has been requested. Additional information recevied on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05; patient name, gender and DOB, vacine lot number.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (circular blotchy skin at the injection site) and VACCINATION SITE PAIN (is in a lot of pain,The pain comes from there) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21A, 001C21A and 016B212) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE, SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), LOSARTAN, METOPROLOL and PROBIOTICS NOS for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced VACCINATION SITE PAIN (is in a lot of pain,The pain comes from there). On 04-Dec-2021, the patient experienced VACCINATION SITE DISCOLOURATION (circular blotchy skin at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (circular blotchy skin at the injection site) outcome was unknown and VACCINATION SITE PAIN (is in a lot of pain,The pain comes from there) had not resolved. The concomitant medications included unknown supplement.  No treatment was provided. No medical history was reported.
Patient reported that she had severe pain in her leg that started 6 days after the shot. She went to her doctor and received a steroid shot that did not help it at all. She then went to the emergency room after the pain was not relieved. She did not clarify what steps they took at that point. She read through the vaccine information statement and felt like her leg pain might have been a reaction. She also wanted me to add the flu shot to her list of allergies.
After first vaccine, I had a red and very itchy rash just under the injection site 12 days after receiving the shot that measured 4 inches wide by 2 inches long, that lasted about a week. After the second vaccine just 2 days ago, I now have a much larger rash that measures 4.5 inches wide by 6 inches long, and is very itchy.
Patient called to inform us that she got an infection at the site of injection 6 days after the shot and got treatment from her doctor.
12 hours after shot, I had server headache, fever and confusion.  No desire to eat. Headache and tiredness continued for 3 days. Feeling better sleeping a lot.  Drinking plenty of water.
The day after the second dose of the vaccine this person woke up with fever, chills, muscle aches, frequent urination, and facial swelling especially around eyes.
Three weeks after the second injection, my arm became very itchy at the injection site and continued down the arm.  Extreme itchiness continued for about a week.  I used a cortisone cream to calm it so that I could sleep.  It is now about 5 weeks after the injection, the itchiness is not as severe but it does continue at the injection site.   There was no rash or red  swollen area, just the itchiness.
Fully vaccinated with COVID infection breakthrough and inpatient hospital stay. Pfizer dose 1   Lot #  EN6205     Pfizer dose 2 Lot #   ER8727
Got the shingles shot but still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got the shingles shot but still got shingles.  The reporter wanted to know how long did the shot last. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
4/26/2021-04/27/2021 Initial pain began at injection site, pain prevented full mobility in arm. My arm was incapable of movement. Excessive fatigue severe headache, excessive thirstiness, impaired balance, felt very heavy and pain all over body. Fever of 101 degrees 4/29/2021 check into urgent care had a cough and sore throat. 5/2/2021 tele health visit. Sick for 10 days with fever chills and nausea. Hot flashes hormones' in disorder with back pain.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted approximately 5 minutes after administration. Did not hit floor, was caught by father. Paramedics came and toook him to hospital. Report given by mom later in the night said he was stable, vitals were fine and he was discharged to home.
The original soreness seemed normal and it lasted through Saturday and Friday. Sunday it was feeling better so I shoveled snow and exercised and it Monday and Tuesday and it felt like frozen shoulder. So I rested it and it was still hurting pretty bad, so I started doing exercises for frozen shoulder. Its hard to comfortable lying down and sleeping.
pt brought back to clinic 1 1/2 -2 hrs p/vax; c/o shaking arms, legs; upon arrival pt was alert & responsive, shaking chills & c/o feeling cold; that same evening parents took pt to hosp; t 102.5; P 108;
Dizzy and equilibrium problem upon waking up almost 40hrs after first dose. Can?t drive. Unbalanced. Slightly nauseous.
Hospitalization for acute hypoxic respiratory failure and COVID-19 pneumonia on dates 10/14/22- 10/21/22.  Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 21-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Woke in pain and shivering body temp 89.4 axillary, oral, and non-contact forehead
Expired Product Used; Extra Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose received on 14th October 2009) and Hepatitis A vaccine (2nd dose received on 5th April 2010).   On 13-JUL-2023, the patient received the 3rd dose of Havrix. On 13-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used) and extra dose administered (Verbatim: Extra Dose). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 Health administrator reported that a patient was administered a dose of Havrix (after expiration date). Afterwards it was realized that this patient had already received hepatitis a series. The reporter was unsure if the first two doses were brand name Havrix. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The patient received expired Havrix vaccine (3rd dose of hepatitis A component), which led to expired vaccine used and extra dose administered.
Facial tingling left side of face  11/15/2009 to present Drowsiness and weakness 11/18/09 to  present Intermittently off balance from 5-20 times per day from 11/18/09 to present
Pt presented to the hospital months after vaccination with abdominal pain, conjunctivitis, cough, and rash. Elevated inflammatory markers. COVID PCR negative. COVID serology to spike protein IgM and IgG positive.  COVID serology to nucleocapsid Ab pending. Treated for MIS-C. Alternative diagnoses being explored.
Pt broke out in hives after Pt went home. Mom gave BENADRYL and hives got better.
August 10  High fever  and rash on vaccine site as well as face chest and back   August 22  All over rash like hives
Counted months from previous DTaP incorrectly and gave 4th DTaP too soon. Patient follows own schedule.