chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother at clinic on 03/29/2019 & reported that daughter had an allergic reaction to vaccines she received 02/23/2018. She took child to ER but did not report the reaction to clinic. Child had redness and swelling at the injection site, fever off and on less than 100F. Employee signed obtained records from ER. Records indicate child had an area of erythema and induration  of the left deltoid region 4 cm. Clinical impression of cellulitis of left upper extremity and allergic reaction to drug.  Medications prescribed to child were dexamethasone 0.5 mg/5 ml exlixer take 10 ml po one time for 1 dose. Hydroxyzine HCL 10mg/5ml take 1.3 ml po 3 times daily and Trimethoprim-sulfamethoxzaole 40-200 mg/5ml take 7.5 ml po every 12 hours for 10 days. Take each dose with 6oz of water.
Patient received pediatric Pfizer vaccine instead of the adult/adolescent vaccine dose. There were not any immediate reactions to this dose.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2014, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot #: L042817, expiration date on 26-APR-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 9F during 10 hours. No previous temperature excursion was reported. It was unspecified if PROQUAD (Merck) lot # L051101, expiration date on: 17- JUN-2017 was administered to the patient. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Pale and dizzy after immunizations. Did not faint. Had pt lie down, ice pack to back of neck. BP WNL and pt reported feeling better after approx. 20min. D/c from clinic home with parents.
ITCHY EYES, FACE, CHEEK, AND HEADACHE 4/10. WAS GIVEN BENADRYL 50MG BY PROVIDER AND MONITORED FOR 45 MIN WITH NO FURTHER SYMPTOMS.
Patient received the Janssen vaccine.  Less than 1 minute after receiving the vaccine,  passed out and had seizure like activity for 10 sec.  When he fell, his hit the right side of his head.  When he came to, he knew where he was.  Ambulance was called, he refused to go to the hospital.  BP was 138/78 and pulse was in the 60's.  Leading up to passing out,  reported that he felt warm, then passed out.  After waking up and coming to, he was feeling better.
1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist.  RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
Red rash that appeared approximately eight days after the shot. It progressed for the next four days by becoming hot to the touch, and then spread out and began to itch. There still remains some discoloration on my arm.
Patient was given the monovalent vaccine vs the bivalent. no known adverse outcome. We were told to record this as a med error.
Felt numbness on bottom of left foot primarily at back of heel to fourth and fifth toes.  Slight numbness/tingling just above and below left elbow.  Symptoms lasted for approximately 2 days from onset.
My Uvula swelled within 5 minutes so that I could feel it. My throat was red. No other adverse symptoms. Swelling was gone after 5-7 hours. Throat was pink next morning. I had a similar experience with dicloxacillan in 1997.
Upper arm started swelling in a few hours. The swelling slowly moved down arm to wrist over several days with slight redness. It took a week until the swelling was going. Took Benadryl for several days
Information has been received from a physician concerning his daughter, with no unusual medical history, who has vaccinated many years ago with varicella virus vaccine live (Oka/Merck). Four weeks subsequent to the vaccination the patient developed diabetes. The patient's mother thought that the diabetes might have been caused by therapy with varicella virus vaccine live (Oka/Merck). The patient has been treated for the diabetes. There was no product quality complaint. Additional information has been requested.
It is reported that a pt who "always faints upon immunizations", rec'd a Menomune A/C/Y/W-135 vaccination, lot # U0926BA, at 7:13pm on 11/13/02. At 7:15pm, the pt's skin color turned grey and she fainted. the pt was revived with ammonia inhalants and regained consciousness and color. the pt reportedly recovered from this experience. This case is closed.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/5/2022 OROPHARYNGEAL CANCER, OVERLAPPING SITES CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/5/2022 PRESENCE OF TRACHEOSTOMY CHRONIC HYPOXEMIC RESPIRATORY FAILURE 3/5/2022 PULMONARY HEMORRHAGE
Patient's mom called clinic w/concern of rash. She states that patient had his 1st MMR vaccine on 11/01/2021 and a bright pink rash started on 11/12/2021 to patient's chest, back, buttocks, and genital area. She also notes to top of patient's back approximately 5-7 "blood red" pinpoint areas. She reports patient has not been scratchy at rash area, per mom's report rash doesn't appear painful to patient, and patient has been acting normally. She does feel that rash has been improving since it began as it is less pink. She has not given anything OTC for rash as she feels that patient has been acting normally.
5-6 vesicular lesions on truck. Treat with Benadryl. Full recovery expected.
A non-serious spontaneous report of gave H1N1 to a 63-year-old person was received from a nurse concerning a 63-year-old male. On 29-Oct-2009, the patient received Influenza A (H1N1) 2009 MONOVALENT Vaccine Live, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Friday: fatigue. Saturday: headaches. Sunday: couldn't sleep, congestion, headache, chills, soreness, upset stomach, tiredness, sore throat, dizziness, diarrhea, whining, discomfort.
I had a sudden, large, spontaneous bruise on the index finger of my left hand with no precipitating incident or injury.  It filled the space between my first and second knuckle completely and extended into the finger tip and below the second knuckle. It is only in hindsight that I thought it could be a blood clot, although I am not sure. It resolved on its own with a few days, although I unfortunately don't know exactly when.
Little severe migraine headache; I have gaining weight; Little severe migraine headache; I have gaining weight; My arm is really sore; I am not able to raise that up; My arm is really sore; I am not able to raise that up; I am not feeling really well and kind of under weather; also I am having a little cold; I am not feeling really well and kind of under weather; also I am having a little cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), WEIGHT INCREASED (non-serious), outcome "unknown" and all described as "Little severe migraine headache; I have gaining weight"; LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "My arm is really sore; I am not able to raise that up"; NASOPHARYNGITIS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "I am not feeling really well and kind of under weather; also I am having a little cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient finished COVID-19 vaccine series on 2/16/21. Patient arrived at reporting hospital with reports of weakness and cough. Other symptoms included fever and diarrhea. Patient was admitted on 9/23/21 with COVID-19 pneumonia  with acute hypoxemic respiratory failure and discharged 4 days later on 9/27/21.
Information has been received from a physician concerning a pediatric patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed cellulitis at the site of the vaccination. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. On 26-Dec-2003 the physician reported that no information was available; he "lost his name" of the patient. No further information is expected.
I was in pain felt sick on Sat. and Sun. Mon woke up with cluster of blisters on hands + feet. Tues. Chicken pox started. Legs, arm, back, saw dermatologist- prescribed Valtrex 1gm 10days 3x derma smooth for terrible itching was sick for 2 weeks - had terrible heart burn. Took Malox after each pill.
p/vax w/in 1 1/2hr pt began having chills, fever 103, lt arm where inj was became very red & edema torso;fever resolved p/3hr;pt did take advil for discomfort;no other intervention;
Headache, severe body aches, joint pain, chills, shaking to the point unable to walk, blurry vision, heart racing, insomnia,
I just want to report that shortly after I received the flu shot I came down with the shingles. Just put my report on file and maybe if you get enough of the same complaint after a while you might start to believe in some sort of connection. What I'm suggesting is the flu shot weakened my immune system causing the shingles to activate.
Patient presents with Rash, Pt allergic to eggs and peanut butter. Pt received 5 immunizations this AM at clinic. Pt broke out in a rash. The onset was abrupt. the course is increasing. The location is face, torso, extremities, upper, lower and generalized. Exacerbating factors scratching. Mitigation factors: antihistamine. Prior episodes: food allergies, Character: rash itching and Hives. Allergen exposure eggs. peanut butter. Risk factors; allergic exposure.
Patient received 2nd dose of Moderna vaccine from a vial that had more than 30 days.  Patient has not experienced symptoms and is stable.  No health concerns at this time.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: see below-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was shaking as if having a seizur no history, lasted roughly 10 seconds, snapped out of it, then just dizzy, sweaty, light headed.  Said he has severe anxiety for which he is on disability for the last 10 years
Starting at 10:30pm 5/24 experienced chills, fever, nausea, broke fever (drenched in sweat) then repeated continuously for 36 hours.  Also have softball size red welt at injection point.
She states that she is having pain in her arm at the injection site (no swelling, no redness, just a small bruise). She thinks the pain may have gotten worse since the time of administration.
Shortness of breath; COPD; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 71 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath leading to dyspnoea and COPD (chronic obstructive pulmonary disease) on Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included angiogram: his heart and arteries were in excellent shape.on Feb2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored GARDASIL (lot # K007828, expiration date: 02-MAR-2017; lot# K011562, expiration date: 08-APR-2017; lot# J006850, expiration date: 31-MAR-2016; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd vax 9FEB94 noted tenderness @ site the next day w/some redness; 11FEB94 noc noted itchiness & inc redness that progressed over the weekend; induration & hot to touch as well as itchiness; infection;
Suspected vaccination failure; got the shingles anyhow; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of suspected vaccination failure in a female 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 details were provided as follows: This case was reported by patient's sister. The age at vaccination was not reported. The patient received Shingles vaccine and experience shingles. The reporter stated Vaccine did not help her sister got the shingles anyhow. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Tested positive for COVID-19 after getting Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after getting Moderna booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19 after getting Moderna booster). At the time of the report, COVID-19 (Tested positive for COVID-19 after getting Moderna booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant medications were reported. No treatment medications were reported. Company Comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19, as he tested positive for COVID-19. The event occurred at an unknown after the booster dose of mRNA-1273 vaccine (reporter states that the patient had completed his vaccination series). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non-serious AESI COVID-19, as he tested positive for COVID-19. The event occurred at an unknown after the booster dose of mRNA-1273 vaccine (reporter states that the patient had completed his vaccination series). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt recvd 1st dose of vax 7AUG92 & w/in 15mins following vax pt devel nausea, palpitations, low BP, dizziness, numbness & tingling down the arm, hives, & burning & swelling @ inject site; seen by MD;
Information has been received from a registered nurse and a physician's office concerning a 6 year old Caucasian female with no known allergies, who on 10/06/00, was vaccinated with Hepatitis A virus vaccine inactivated. On 10/27/00, the patient experienced stomach pain and stomach cramping. Unspecified medical attention was sought. Subsequently, the patient recovered from stomach cramping.  Additional information has been requested.
OVERALL SORENESS; ARM WAS A KILLER; HEADACHE; BIT TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced overall soreness. On OCT-2021, the patient experienced arm was a killer. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced bit tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bit tired, headache, overall soreness and arm was a killer was not reported. This report was non-serious.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 47-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Comirnaty), for COVID-19 immunisation. The patient experienced dry eye(s), sinus congestion, injection site pain/pain at the injection site,  chills and myalgia/muscle aches; all with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Developed a widespread skin rash on both legs and feet, from mid shin downwards. Onset was approx 12-20 hrs after injection. Exact same thing happened after first vaccine dose, on 15 March 2021. I have multiple pics of each event to offer, upon request.
Bright erythema 6 inches long 3/4 around arm. Hot, swollen, painful (like a hive) area on arm of injection. Nauseous & faint 2 days after. Rash appeared less than 24 hours after injection. Right deltoid IM 1" needle.
Injection site cellulitis; This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5-year-old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 20 April 2005, the patient received the fifth dose of Infanrix in the left deltoid (lot AC14A009BA). On 20 April 2005, the patient also received subcutaneous injections of inactivated poliomyelitis virus vaccine (IPOL Aventis Pasteur, lot 40240) and measles, mumps and rubella  vaccine (MMR II, Merck, lot 037P). The injection sites for IPOL and MMR II were not provided. Approximately one day following the fifth dose of Infanrix on 21 April 2005, the patient experienced injection site reaction to the site of the Infanrix administration characterized as red and "warm to touch." The patient was seen at a physician's office and then was seen in the emergency room. The patient was diagnoses with injection site cellulitis and was treated with cephalexin (Keflex). The injection site cellulitis resolved on 21 April 2005. The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
Took oral Typhoid dose #2 on 12/14/10 at 10pm. On 12/15/10 developed headache. By 5pm developed earache, neck ache, sore throat. Uvula swelling. On 12/16/10 took Typhoid dose #3. On 12/17/10 in a.m developed nausea, vomiting, abdominal cramping, diarrhea, diaphoresis. Went to ER.
101 fever; body aches, stayed home from work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 28th July 2022, the patient received the 2nd dose of Shingles vaccine. On 29th July 2022, 1 days after receiving Shingles vaccine, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-Jul-2022. Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had fever and body aches, due to which he/she stayed at home from work. The patient would take this over shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
This spontaneous report as received from a pharmacist via a company representative refers to an elderly patient of unknown gender in his/her 70's. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not specified by the reporter. In approximately 2015 (reported as "about a year ago"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified). On an unknown date, the patient developed a mild case of shingles and had been on an anti-viral therapy (unspecified medications) up until approximately January 2016 (reported as about 2 months ago). It was also reported that the patient had a shingles like rash on the forehead when it was first reported to the pharmacist by the unspecified patient on an unspecified date after the vaccination was administered. It was not specified if the patient sought any medical attention. A sample for Varicella Zoster Virus Identification Program (VZVIP) was not send. The pharmacist had read through unspecified materials but they did not really apply to him in his position. He said that "in his position he will not really remove a scab or lesion and send it in." The pharmacist also stated that he originally received the information because he spoke with a company representative and told him that he had seen patients that sometimes get shingles after vaccination. The outcome of the adverse event was reported as recovered on an unspecified date. Causality assessment was not provided. Additional information is not expected.
I developed a lot of pain in my body, esp in my hands and fingers. In two fingers the pain never went away. Now over four months later, my RF factor score was 27, and 18 is the maximum normal score. I looked at the clinical trials and realized that an adverse event was defined as not being able to work. I work. But My hands are stiff and two fingers are sore every day. I have realized that the clinical trials never asked patients what they might consider to be an adverse event. That?s why the adverse event rate is low. Very unethical, since adverse events are harms by definition, and the Hippocratic Oath requires physicians to first do no harm. I have experienced an adverse event that was defined out of existence by the clinical trials protocol. Very deceptive. :(