chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 27 year old male patient (currently 28 year old), referring to himself. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The patient informed that on an unspecified date, approximately in November 2017 (reported as "six months ago"), the patient was vaccinated with the first dose of GARDASIL 9 Injection, in the deltoid region of his arm (did not specify which one) for prophylaxis (strength, dose, route, lot # and expiration date were not reported). He was subsequently vaccinated with the second dose of GARDASIL 9 approximately in January 2018 (also reported as "two months after"), in the deltoid region of his arm (did not specify which one) for prophylaxis (strength, dose, route, lot # and expiration date were not reported). No adverse reaction was reported.
Dizziness, shortness of breath, chest pain, tachycardia x w/in a minute of vaccine administration. VS 136/82, HR 98, O2 sat 98%, Temp 98 degrees, Accucheck 86. Patient transported to Hospital for further evaluation.  1st responder arrived on site @ 3:38 pm left at 3:52 pm.
Tightness in throat, radiating to chest, coughing, high blood pressure (173/109). Symptons began at 4:20pm and continued until steroid were administered in ER at 6:15 and 6:27pm.
This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a subject of unknown age and gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.  No additional information available.
First reaction included low grade fever and widespread body aches (muscular). Second reaction caused large round rash on injection site about 10"X5" in area.
15 November 2012 I woke up on Monday the 5th of November and came in around 8 Am for 2 vaccinations that were required in order for my husband and I to PCS abroad. I had the Hepatitis A and the TDAP vaccine, both in my left arm. The person who delivered the vaccinations told me that I would have some pain associated with the TDAP vaccine and to keep my arm moving in order to reduce the pain, and I did as I was directed. I was fine the rest of the day, Tuesday the 6th, and Wednesday the 7th. On Thursday, the 8th of November, I woke up and noticed two fist sized red marks on my abdomen and low back, with irregular borders. I ignored them and continued on with my day. Around 7 PM, I started to feel very itchy and noted that I was starting to have hives appear on my abdomen, legs, arms, neck, and in my scalp.  Friday morning, I went to the drug store and bought some OTC Benadryl, which I took (approx. 2  3 capsules a day) as needed for any large outbreaks. I also used some Cam-phor cream in order to help the itching. Saturday-Monday the hives got much worse, and spread to my face. As long as I took the Benadryl, the bumps would go away. The itching was worse at night. By Tuesday, I really only required Benadryl at night and the bumps and itching was mostly on my Bilateral Upper Extremities (front and back) and Bilateral Lower Extremities, and around my lower abdomen and low back. I took a total of approx. 13 Benadryl capsules. I did not feel any shortness of breath, or life threatening symptoms that suggested anaphylaxis. I told the technician that I had an adverse reaction to a pertussis vaccination in the past when I was an infant. The technician then called the doctor (from the clinic) who informed the technician that proceeding with the vaccine was ok, due to changes in the vaccination since the 1980's.  I was examined by Dr. today, who ordered Zyrtec and anti-itch cream. I did speak to another Dr. 11/15/2012 regarding my condition and she recommended that I start some antihistamines like Zyrtec and recommend that in my personal record I include an allergy to the pertussis vaccination.
This spontaneous report was received from a medical assistant and refers to a 66 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 16-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 3/16/07 seen by MD for 2 mo physical. Given routine IMMs (DTaP, Hib, HepB, Prevnar and Rotavirus) On 3/18 at 1427 seen in U.C. for fever 101 4 (R), increased sleeping, decreased appetite. Then began passing explosive liquid stools lasting 9-10 days. Seen in MD office 4x to monitor wt loss/status
Mild swelling of tongue. Started 15 minutes after vaccination. No trouble breathing reported. Resolved on its own within a few hours without any treatment
Upset Stomach; Headache; second dose of Sihngrix late, 7 months; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 7th February 2020, refer case US2020AMR186127).   On 14th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th September 2020, the patient experienced upset stomach and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the upset stomach and headache were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the upset stomach and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 75 or 76 year. The patient received second dose of Shingrix on right arm after 7 months, which led to lengthening of vaccination schedule. One day after vaccination, the patient experienced headache and upset stomach. The patient also reports taking Tylenol to relieve headache.  The patient gives consent to follow up with doctor. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR186127:same reporter
Hospitalization: 10/6/2022 - 10/14/2022 Presentation to the ED: SHORTNESS OF BREATH, CHEST CONGESTION.  COVID + date: 10/6/22. Treatment: Remdesivir and Decadron. Discharge to: HOME W/ HEALTHCARE SERVICES.
Extreme fatigue, migraine, feeling of burning bones, feeling of burning muscles, diarrhea, extreme pain in shoulder of injection site, fever 102. The diarrhea subsided after 36 hours, all other symptoms eased after 36 hours but remained for 5 days
no adverse event; an additional dose of VARlVAX/ administered an "extra" dose of VARlVAX on 15 FEB 2021.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-FEB-2021, the patient was vaccinated with an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002848 with expiration date on 23-JAN-2022 (exact dose, route of administration were unknown) for prophylaxis. No adverse events was reported.
had administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event; Initial information was received on 17-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient who reported administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) expiry date: 02-Apr-2023 (lot number, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of had administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event (expired product administered) (same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had eczema flare. Patient' eczema is very sensitive to lactose/dairy.  Steroid cream resolves, did not need prednisone Rx he was given.
injection site soreness; chills; fever; hyperthermia; tachycardia; This is a spontaneous report from a non-contactable other HCP. A 25-year-old male patient received the first dose of BNT162b2 (lot number: ELI284), intramuscular at left arm on 04Jan2021 11:00 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced injection site soreness several hours following administration. Approximately 12 hrs later, patient experienced severe chills and fever lasting for several hours, followed by several hours of hyperthermia and tachycardia. The all events were reported from 04Jan2021 23:00. No treatment received. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient who is health center employee received Fluzone on 10/2/03 to left deltoid. He experienced some discomfort following injection (mild). Approximately 7-10 days later, he developed vesicular lesions in dermatomal distribution consistent with a shingles outbreak. Rash reported to nursing department on 10/27/03.
Sore arm, at night chills and shaking. Tiredness. Second day a fever of 99, very tired as well.
Two weeks after the first dose he was hospitalized with Covid 19; Two weeks after the first dose he was hospitalized with Covid 19; The only thing that got worse was the kidney problems after he came out of the hospital; The only thing that got worse was the kidney problems after he came out of the hospital; He cannot see too good (visual impairment); lost weight (weight decreased); This is a spontaneous report from a non-contactable consumer. A 75-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EL3302), dose 1 intramuscular, administered in Arm Left on 03Feb2021 (at the age of 72-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol, blood pressure measurement, cardiac disorder (He was taking medications for cholesterol, blood pressure and his heart) and glaucoma (They were started prior to the vaccine and he did not think they were relevant. He has issues with Glaucoma), diabetes mellitus (He checks his sugar and is diabetic), renal disorder and prostatic disorder (He has issues with Glaucoma, Prostate and Kidney). The patient's concomitant medications were not reported. The patient experienced two weeks after the first dose he was hospitalized with covid 19 (drug ineffective), (covid-19) (hospitalization, medically significant), He cannot see too good (visual impairment), lost weight (weight decreased) on an unspecified date. It was reported that his father received first one the beginning of Feb2021. By the second week in Feb2021, he got sick with COVID and was in the hospital for almost a month. He missed the second dose. He would like to know where can he get second dose. When can he get second dose and how long does he have to wait before getting after having COVID. He also wanted to know if it will still be effective after waiting this long. He is out of the hospital after going in. His father's name is (Name) He lost weight while in the hospital after he got the first COVID vaccine. After he got the first COVID vaccine, he ended up in the hospital with COVID virus. There was no prescriber. Where he lives, it is a senior housing center, and they were giving it out there. He could have been sick a week before, but when he came to see him, he immediately called the ambulance and they took him in. Since he has ben out of the hospital for a few weeks, he cannot see too good. It started a couple of days before he got out and since then he cannot see that well. Reporter has to drive him around. He was taking medications for cholesterol, blood pressure and his heart. They were started prior to the vaccine and he did not think they were relevant. He has issues with Glaucoma, Prostate and Kidney. He had all prior. The only thing that got worse was the kidney problems after he came out of the hospital. When he came out of the hospital, they said he needs to see a kidney doctor. He has blood test results and would not be able to understand them to provide at this time. He had all prior. Vaccine supplemental form. Outcome of the events Covid19 (drug ineffective) was recovered with sequel. Outcome of the other events was unknown.
This spontaneous report was received from a nurse practitioner via a company representative referring to a 14 year old male patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 1 vial (lot #, expiration date, route of administration and frequency were not reported). Concomitant medications were not reported. On an unknown date, two weeks after the vaccination with GARDASIL, the patient experienced a convulsive seizure. On an unspecified date the patient sought medical attention and was seen in office visit, no treatment was given for the adverse event but the patient underwent an Electroencephalogram (EEG) (results were not provided). It was also reported that the event did not cause hospitalization. At the time of the report, the outcome of seizure was unknown, and the relatedness of GARDASIL with seizure was not reported. Additional information has been requested.
The same day, after receiving the vaccine, my lymph nodes started to swell. I was also experiencing fatigue, headache and sinus pressure. I called my doctor and he told me what to do to bring the swelling down and to help with my other symptoms.
Red, itchy rash appearing six days after shot. Today is first day of rash. No treatment.
Xyphoid chest pain is the worst of the chest pain, but it is also present at the lower sternum, extending half way between midline chest and midclavicular line bilaterally.  Pain started this morning when he woke up.  The pain is 5/10 currently (~1230 PM), it was a 6/10 when he woke up.  No numbness or tingling of arms, taking a deep breath does not worsen the pain. No excessive sweating. Denies palpitations/irregular heart beat/tachycardia.  Pain feels like pressure.  No immediate allergic reaction (e.g. hives). NO reaction within the first 4 hours.   Since getting the shot he has not tried Tylenol or Motrin.  After the clinic visit he tried ibuprofen and found it helpful.  +Fatigued throughout the day.
Patient received Smallpox vaccine at 09:51, left arm. 15:10 patient complained of itching all over her body. Assessed by doctor and given Benadryl 50mg. At 15:18, 911 called; arrived at 15:27.
Right side of face including lips are numb starting at 11:55 a.m. Have phone call into associates PCP. In care of co workers. Associate is alert and oriented. Appointment with associates allergist at 4:00 p.m. today
got the vaccine after I had it/suspected vaccination failure; shingles behind my eye; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles behind my eye).   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 ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got vaccine after he/she had it, but not bad though, now he/she had small amount of shingles behind his/her eye.  The patient further stated that medications and eye drops were not fun. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. The follow up would not possible as no contact information was available.
Soreness in injection site; headache; fever like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old male patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN5318, via an unspecified route of administration (left arm) on 04Feb2021 15:15 at a single dose for COVID-19 immunization. Medical history included hereditary slightly higher blood pressure without medicine. No known allergies. No covid prior to vaccination. Concomitant medications included losartan and acetylsalicylic acid (ASPIRIN). The patient previously took first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 12Jan2021 04:15 PM (lot no. EL3249, left arm). No other vaccine in four weeks. On 05Feb2021 05:00 PM (as reported), the patient experienced soreness in injection site followed by headache and fever like symptoms that only lasted 12 hrs. The symptoms showed up around 24 hours after getting the second dose. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 06Feb2021 05:00.
Vaccination site swelling; Redness on the injection site; Vaccination site pain; Shoulder on the side of the injection was in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Redness on the injection site), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Shoulder on the side of the injection was in pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment and concomitant medications were not provided by reporter.
Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a little; This is the spontaneous report received from a contactable consumer(patient). A 76-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history included usually constipated, her doctor put her on magnesium and docusate sodium (COLACE). Concomitant drugs included magnesium and docusate sodium, both for constipated. She experienced tiredness, arm hurts a little bit, chills, back hurts a little. The clinical course was reported as follows: the tiredness did not start until a couple days later and eventually went away. The arm hurting did not happen the first few days, it was not as bad the second day.  She added that she could not complain about it. She did not have a fever, her temperature was 97.5. Her back hurts a little, but it hurts a lot anyways.  She did not like to sit a lot.  She liked to be active because it helps, but it was too gloomy to do anything on 12Apr2021. The seriousness of the events was unspecified.  Outcome of tiredness was resolved. Outcome of the other events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a health professional concerning a female patient who in approximately October 2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, "flu vaccine".  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent.  In approximately October 2002 the patient developed redness with swelling to inside of arm, joint aches, fever-101.2, pain rated "5" on a scale of 1-10 and was unable to raise her arm.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patient's who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES#'s:  0210USA01524, 0210USA01734, 0211USA02240, 0211USA02241, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).