chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of hives in a 5-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 27 August 2008 the subject received 1st dose of HAVRIX (unknown).  In September 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced hives.  The subject was treated with BENADRYL on 11 September 2008.  The subject consulted a health care professional regarding the event.  At the time of reporting the outcome of the event was resolved.  On 19 October 2009, a physician reported that a subject experienced hives after receiving HAVRIX.  The subject was not allergic to eggs.  He was given BENADRYL on 11 September 2008.  His hives lasted for one month.  In 2009, the subject received FLUZONE and broke out in hives two days after receiving via a prefilled syringe.  Follow up information was received on 30 October 2009.  The physician did not have any details to add to this case and requested that the case be closed.  Follow up information was received on 16 November 2009 via the reporting physician.  The physician had "nothing else to add".
I had no initial reaction, however on January 28th, the site of the injection was red, raised and itchy. The next day it became a hardened mass and larger in area. On the third day the rash elongated. Today, the top part of the rash is fading, however, the rash appears to continue to elongate.
Mid May, I was extremely constipated. I went to an urgent care and the employee suggested that I take some Magnesium citrate. It did not work. My Gastroenterologist friend suggested fiber capsules, that worked. It lasted about three weeks long. This was extremely painful, I am not used to that happening. It took months for me to get back to normal. I awake and still feel ill in the stomach from time to time.
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 27 year old female with cephalexin allergy and no relevant medical history and no history of prior pregnancies who on an unspecified dates received the first and second doses of GARDASIL and on 22-JUL-2008, was vaccinated with a third dose of GARDASIL (lot number, injection site and route not reported). Concomitant therapy included LEXAPRO and ACIPHEX. On 26-JUL-2008 the patient was found out to be pregnant by urine pregnancy test. Date of last menstrual period 18-JUN-2008, estimated date of delivery 25-MAR-2009. Unspecified medical attention was sought. Follow-up information was received from a physician who reported that patient was on LEXAPRO throughout pregnancy, 10 mg daily for depression. Complications during pregnancy included gestational hypertension. On 09-MAR-2009, patient delivered an 8 pound and 1 ounce male baby, 21 inches tall, 38 weeks from LMP. Apgar score 8-9-10. Complication during labor/delivery included failure to progress. Baby was born with congenital anomaly: no left nipple. No other complications or abnormalities. No further information is available.
Legally blind; Neuropathy; Lymphedema in legs; Arm had swelling; Arm had / itching; Arm had / burning; This case was reported by a consumer via other manufacturer and described the occurrence of blind in a adult 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 blind (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant), lymphedema, swelling arm, itchy upper limbs and burning sensation. On an unknown date, the outcome of the blind, neuropathy, lymphedema, swelling arm, itchy upper limbs and burning sensation were unknown.   The reporter considered the blind, neuropathy, lymphedema, swelling arm, itchy upper limbs and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient received shingrix and experienced blind, neuropathy, lymphedema, swelling arm, itchy upper limbs and burning sensation. The reporter wanted to know about  ingredients of covid vaccine. The reporter did not consented to follow up.
Developed hives, urticaria all over body. Did not develop respiratory symptoms responded to Benadryl 50mg after minimal relief with Loratadine 10mg.
I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 2021. I injured my face badly as well as my eye. I had to go to the Emergency room here on 3/16/21. I had a second seizure at the entrance to event on Saturday March 27, 2021 . It was a grand mal, clonic-tonic seizure. I was life flighted to Medical center on March 27, 2021 I was not discharged until 3/31/21.
Redness (not rash) at injection site, body aches, chills, headache for 2 days post injection.
Patient received the first dose earlier this year. And she gave a dose today(1stMay2021); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)) in a 31-year-old patient of an unknown gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)). On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)) had resolved.        For mRNA-1273 (Unknown Route), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Prolonged pain in shoulder, in the area of the left side of clavicle.  Pain lasted for approximately 2 weeks.
After reviewing patient's  VAR (vaccine administration record) (verifying patient's NO answers on all allergy and seizure history questions and currently taking no medication), pharmacy intern administered the Covid-19 Pfizer second dose of the primary series to the patient around 3: 33 PM on 9/11/22. Right after the shot, the intern called my attention since the patient loss consciousness and jerky (seemed to be having seizure). One of the store personnel called 911 for medical assistance. We did not move the patient and we just provided support to prevent him from falling off the chair. After like 1 to 2 minutes he regained consciousness and was asked to stay for 30 minutes for observation. We  interviewed the patient if anything like this happened before, and he said similar thing happened around last year when he got bitten or stung by a scorpion. The paramedics came in around 3:46pm and they had him checked. Based on their conversation, he was given the option to go with them to the hospital or he can go to hospital on his own. Patient decided that he will go to the hospital on his own (together with his older brother). Patient left the store around 4PM. I called the patient for follow up around 3:40PM on 9/13/22. He said he is doing okay, and he said he went to the ER on 9/11/22, everything is okay with his tests and evaluation in the ER and he was given a diagnosis of vasovagal syncope. Upon further questioning he said that he was not referred for further follow up and he currently has no primary care physician.
I had an ischemic anterior neuropathy in my left eye which created a grey cloud over most of my sight.  Diagnosed w/full testing by 2 opthalmologists, 1 optomotrist; and internal medicine doctor; no known treatment.
soon p/vax pt devel severe & chronic gastrointestinal problems;this was followed by devel of mult food & environment allergies, loss of motor functioning, severe sensory dysfunction hypersensitivity & finally devel autistic like sx;
Fever Avg 100.5 Deg with chills and general malaise. Duration: 22 days. Quarter-sized red-raised plaques appeared on both arms.  Final diagnosis by multiple specialists: Cutaneous Lupus
Employee's first influenza vaccine to date. CDC info sheet on influenza inactivated vaccine given and discussed. Employee denied sulfate allergy. Vaccine administered accordingly. Onset of tachycardia (130), increased BP, dizziness, and pale within 5-10 minutes of administration. Employee monitored on floor by co-workers. No medication given. Employee did not notify provider until 11/28/05 at 09:45. Advised employee not to take flu vaccine again.
Medical Assistant inadvertently pulled the wrong product from the freezer and administered the Moderna Pediatric dose 6m-11yrs old 0.25ml to patient instead of the Adult dose of 12 years and older (0.5ml). We reported it to our organization, Moderna and VAERS as well as called the CDC to get guidance on how to proceed with ensuring that patient should receive the full dose recommended.  Patient's father also notified.  After speaking with CDC, they stated to revaccinate the child with another dose of 0.25ml (6m-11yrs old) with no waiting period. Dose can be administered immediately.  We will contact parent back and schedule an appointment for revaccination.
dementia; Delusions; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient (not pregnant) received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9269), via an unspecified route of administration (left arm) on 06Feb2021 10:45, (at the age of vaccination70 -years-old) single dose for COVID-19 immunisation.  Medical history included Early-onset Alzheimer's, high blood pressure, allergies: fire ants. Concomitant medications included memantine hydrochloride (NAMENDA), amlodipine, clopidogrel, atorvastatin. The patient previously had first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 16Jan2021 at 70 years old for covid-19 immunisation and experienced delusions and dementia. The patient experienced Delusions. Believing that people are trying to get into home. Belief that people on TV are in her home and speaking with her. Frequency and severity has increased since second dose. Also wandering (attempting to leave the home with no purpose). No COVID prior vaccination,no COVID tested post vaccination. No treatment for the events. The patient had not recovered from the events.
Chronic nausea, dizziness, headaches, migraines, food/smell aversion (not pregnant)
A nurse reported that the patient inadvertently received an injection of Acel-Imune on 5/30/00. He experienced pain at the injection site on 5/31/00. He recovered.
This spontaneous report was received from a medical assistant and refers to 61 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-MAR-2016, the patient received dose of improperly stored ZOSTAVAX lot number L035283, expiry date: 15-DEC-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 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.
Pt. described "hard to swallow" Lump in throat.  Denies any SOB, Lungs clear, Bilateral, 10:28 AM Benadryl given IM 50 mg.  10:45 AM Observed scratching neck, raised area, hives noted. 10:55 Hives remains, no enlargement. No further complaints, 10:58 to Physician office per school staff.  Alert & orientated X3 during entier episodes.  11:35 Returned from MD office, MD did not exam patient. PC. from RN, discussed with Dr. that patient was fine, just sleepy.  No distress noted, no further swelling noted, Advised per Dr. to have teacher stay with an adult for a couple of hours to make sure no further complications. No adult at home so teacher stayed with school nurse.  After a couple of hours no further problems and teacher went home.
Stomach Pain; worse reaction with terrible chills; Temp of 102 degrees; Vomiting; Bad pain in hip; Pain in left knee; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Pain), CHILLS (worse reaction with terrible chills), PYREXIA (Temp of 102 degrees), VOMITING (Vomiting) and ARTHRALGIA (Bad pain in hip) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach Pain), CHILLS (worse reaction with terrible chills), PYREXIA (Temp of 102 degrees), VOMITING (Vomiting), ARTHRALGIA (Bad pain in hip) and ARTHRALGIA (Pain in left knee). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Pain), CHILLS (worse reaction with terrible chills), PYREXIA (Temp of 102 degrees) and VOMITING (Vomiting) outcome was unknown, ARTHRALGIA (Bad pain in hip) had resolved and ARTHRALGIA (Pain in left knee) had not resolved.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-019517, MOD-2021-019517 (Patient Link).
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt stated she was nervous getting shot before shot was given due to side effects. while being observed,she said she felt hot and dizzy. gave apple juice and told her to sit and be observed as long as she felt comfortable. left after feeling better. tried calling to follow up but # not valid.
No symptomatic Adverse events; expired dose of VAQTA was administered to a patient inadvertently; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergy, pertinent medical history and concomitant therapy were not reported.  On 23-MAY-2022, inadvertently, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # T033304, expiration date 02-APR-2022 (dose and route were not reported)  for prophylaxis (expired product administered).  Neither symptomatic adverse events and nor product quality were reported.
pt recvd DTP/OPV/MMR/TB Tine; parents stated pt was fine p/vax; pt stiffened up, threw head back; vomited;
RASH ON BACK, ARMS AND LEGS; ITCHY; This spontaneous report received from a patient concerned a 59 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced rash on back, arms and legs. On an unspecified date, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on back, arms and legs, and the outcome of itchy was not reported. This report was non-serious.
Pain and swelling under left arm next to breast.; Pain and swelling under left arm next to breast.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Lot number: Gh9694) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN; MCT OIL [COCOS NUCIFERA OIL]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ff2593, Location of injection: Arm Left), administration date: 28Nov2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: 30155ba, Location of injection: Arm Right), administration date: 06Nov2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 2022, outcome "recovering" and all described as "Pain and swelling under left arm next to breast.". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: Known allergies reported as no. Other vaccine in fourweeks reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility type vaccine reported as doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.
Within 2 minutes, patient felt lightheaded and warm. She was very flush, reported abnormal taste in mouth, chest tightness, SOB, lightheadedness. Administered 0.3ml epinephrine immediately. SpO2 98%, pulse 123 bpm, BP 50s systolic. Pt AAOx3, conversive. HEENT: EOMI. Lungs CTAB. CV: tachycardia, RRR, normal S1/S2, no MRG. Oropharynx patent.    Pt was moved to wheelchair and escorted to ED.  Per patient "I got the shot and immediately felt hot I went out and sat down in the hallway and started seeing black dots like I was going to pass out, I could taste the vaccine, then my throat started to get tight and I couldn't breathe" In ED patient had flushed red rash that starts at her injection site and has spread across her chest over her face and down her left arm.
Fever, chills, feeling overheated, weak, nauseous, dizzy, extreme fatigue
She received a flu vaccine in her right deltoid on 10/19/2022, when she established care.  Since that time she has had pain, decreased range of motion, swelling in her right shoulder.  She has been unable to lift her right arm to get dressed, perform ADL's.  She initially thought pain was due to getting the vaccine.  She has tried ice, heat and taken acetaminophen and ibuprofen without relief of pain.
Experienced pain in her armpit area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "Experienced pain in her armpit area".  Additional information: The reporter stated that the patient received the first dose of Pfizer COVID-19 Vaccine on 22APR2021 and reported that the patient experienced pain in her armpit area. The reporter also stated that the Patient's second dose was schedule for 3 weeks after the first dose which is correct but she would like to know if she could take it later like 4 weeks after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT STATED BEING NAUSEATED AT 4AM. HAD EMESIS, DIARRHEA, BODY ACHE, FEELING WEAK, HOT & COLD FLUSHES. PATIENT SAID THAT SHE REPORTED SYMPTOMS TO HER PRIMARY PHYSICIAN. NO MEDICATIONS TAKEN. AS OF TODAY, 2/12/2010, PATIENT STATES THAT SHE NO LONGER HAS EMESIS AND THAT STOOL IS NOW SEMI-FORMED. SHE IS CURRENTLY AT HOME RESTING.
Information has been received from a pharmacist and a 25 year old female patient with sulfonamide allergy reporting that on 18 Dec 2006 the patient was vaccinated IM with a first dose of Gardasil. Concomitant therapy included Lexapro. Four days later, on approximately 22 Dec 2006, the patient developed painful genital warts. The patient's painful genital warts persisted and she sought unspecified medical attention. Additional information has been requested.
By 8 PM same day of vaccinations, whole body in extreme pain and could not lift or use left arm. Muscle and/or pain primarily in hips, shoulder and sharp pains in abdomen. Saturday arm very painful and still could not lift. Swollen and red at injection site, moving into armpit by evening. Took ibuprofen and BENADRYL at advice of on call Dr. Sunday urgent care nurse practitioner diagnosed as infected and prescribed cephalexin and diclofenac. Within 3-4 hrs. pain greatly reduced and mobility improved. Slightly better on Monday, but still red, warm, swollen on shoulder and in armpit.
Headache over the front of the head; This is a spontaneous report from a contactable unspecified healthcare professional reporting for herself. This 60-year-old female patient received on 22Dec2020 11:15 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EH9899) at single dose intramuscular in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. She denied any history of previous adverse reactions to vaccines. On 22Dec2020, during her 15 minutes waiting period after the injection, the patient began to experience headache over the front of the head. The event required an emergency room visit. Outcome was unknown. Neurogical examination was positive on an unknown date.  No follow-up attempts are possible. No further information is expected.
cyst on his back that is draining; This spontaneous case was reported by a consumer and describes the occurrence of CYST DRAINAGE (cyst on his back that is draining) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, FLUDROCORTISONE, ATORVASTATIN CALCIUM, CENTRUM SILVER +50, ACETYLSALICYLIC ACID (BABY ASPIRIN) and PLANTAGO OVATA (METAMUCIL CITRON).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CYST DRAINAGE (cyst on his back that is draining). At the time of the report, CYST DRAINAGE (cyst on his back that is draining) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
11APR97 3PM mom called pt has had a swollen neck gland & was on Cefzel;p/shots started w/severe vomiting & diarrhea;t103-referred to MD called 15APR97 MD said give clear liquids;pt OK;
shortness of breath Narrative:  Patient received first dost of Moderna COVID19 vaccine on 1/23/21. On 2/5/21, called clinic to report that day after (1/24) noted rash near injection site, which spread to right arm, down right forearm, up his neck, then to his right groin and right knee. Described as raised and itching. Was improved with use of OTC anti-itch cream and resolved with out further treatment after 2-3 days. Then on 2/2 (10 days after dose) developed cold/flu symptoms, including cough, greenish mucous, feeling heavy in the lung area per him "like you do when you can't get a deep breath because you have a cold" He denies fever, denies chest pain, denies diff swallowing, denies swelling. He has been taking Alka seltzer Plus cold/flu and using normal saline sinus spray, and taking hot showers. Per subsequent PCP notes, patient tested for COVID19 and flu, both negative, and possibly treated with steroid injection and antibiotics by outside provider (records not available).