chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of redness and swelling at the injection site in a 4 year old patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  Initially, the reporter stated there were five to six patients who experienced redness and swelling at the injection site after receiving Infanrix; however, no patient identifiers were reported.  On an unspecified date, the patient received Infanrix.  At an unspecified time later, the patient experienced localized redness and swelling at the injection site.  As of 11/24/2004, the outcome of the events was unknown.  The reporting physician considered the events were possibly related to vaccination with Infanrix.
Shortness of breath; raised, warm, red and painful skin at injection point.  Treated with ibuprofen and cold compress.
ulcer developed on the tip of the tongue on 9/14/21 . dizziness occurred sporadically on 9/15/21.
Body aches, not constant but on and off; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 Infection) on 30-Dec-2020. Concomitant products included METOPROLOL, SIMVASTATIN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received and contain significant information: changed events outcome from unknown to recovering.
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 06-Dec-2012. The patient experienced INADVERTENTLY GAVE PATIENT EXPIRED FLUMIST which started on 06-Dec-2012, the patient received today and it expired on 03-Dec-2012. The outcome of the event of INADVERTENTLY GAVE PATIENT EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
I'm experiencing sharp pains in my right arm.  Immediately after the injection I had a stiffness for about a week.  Then it got worse for about 3 weeks.  Then it seemed to subside to just a stiffness every morning that eased by the end of the day.  Then the pain returned 6/7/2021 at its strongest.  I get shooting pains when I lift my arm over my shoulder.
Persistant digestive problems (diarrhea for first two mornings, followed by gas, bloating, pain, indigestion) peaking after about 5 days and gradually subsiding after about 18 days,  accompanying fatigue, occasional brief & mild dizziness,. Also occasional mild tingling/numbness of left fingertips for first few days.
Painful eye; Swollen eye; Body ache; Sore throat; Injection site pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 16Mar2021 at 18:30 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient medical history included possible lupus and allergies (Zithromax, Spirolactin, sulfa and wool allergy). The concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and BENADRYL, taken within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021 at 07:30 hours, the patient experienced painful, swollen eye, headache, body ache, sore throat and injection site pain (vaccination site pain). No treatment was received for the events. The clinical outcome of the all the events was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Started to break out in hives later in the evening before bedtime around 10pm on 4/14/21. Over the course of two weeks, the hives began to multiply and spread over my body.  Went to the ER on  4/29/21 to receive steroids and topical cream. Taking antihistamine to help as well.
Per mother of child, she had "bad inflammation". Asked mother to give ibuprofen for anti-inflammatory and warm compresses. The next day, per f/u phone call; inflammation improving slowly.
I have a red raised bump that looks like a pox. It is very itchy and bright red.
After vaccination, 4th dose:  Runny nose, watery eyes, minor itchiness (feels like small insects on skin)
Heart palpitations; Slight fever; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th November 2021, the patient received the 1st dose of Shingrix. On 6th November 2021, 1 days after receiving Shingrix, the patient experienced palpitation, fever and myalgia. On 7th November 2021, the outcome of the palpitation, fever and myalgia were recovered/resolved.   It was unknown if the reporter considered the palpitation, fever and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix and experienced heart palpitations, a slight fever, and myalgia the following day, starting between 4 and 5 am. The patient had not yet received the 2nd dose. The reporter did not consent to follow up.
7 hours after flu shot and PNEUMOVAX in left upper arm pt got mild left medial arm swelling/redness and burning and 2 days later she is better.
Sore arm,  4 inch diameter rash on arm, chills fatigue dizziness 15 min after.
Patient came into the clinic to receive the Moderna Bivalent but was inadvertently given the Moderna pediatric 0.5 mL dose. Agency, CDC and Moderna Helpline were notified this same day for guidance. Patient was notified same day of the  error.
w/in 4hr of vax pt report swelling, red, tender, hot, rt arm from shot;stopped by clinic;tx w/inc fluids, zyrtec, aleve;
Patient called after couple hours later since she left pharmacy, she feels swollen and warm cheek first then it goes to ear and neck area,
fever/I have a fever of 100.4-100.5 all day I got my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot). At the time of the report, PYREXIA (fever/I have a fever of 100.4-100.5 all day I got my second shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Body temperature: 100.4-100.5 increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided.   This case was linked to MOD-2021-189743 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021 and contains no new information
Pt complaints of chest pain/tightness and SOB that began yesterday. Admitted for evaluation for chest pain and further work up.
Enlargement of lymph nodes. Fatigue. Backache. Last visit to immunologist 4/6/16 symptoms persist.
Fever (Tmax 100.7), chills, myalgias, fatigue, nausea, headache. Worst symptoms lasted 12 hours. Fever broke by evening. Next day at work still fatigue and myalgias. Had to leave 3 hours early. No pregnancy complications yet.
Given 12/17 developed chills that evening. 12/18 fever of 103, pain and swelling at site. Same symptoms 12/19. 12/20 102 fever, continued pain, redness and swelling. MD appt 12/21 tx KEFLEX 500mg qid x 10 days as of 12/21 at appt. Pain and fever swelling less.
Pneumococcal 13-valent conjugate - When engaging the plunger to inject vaccine (Prevnar 13 @ 0945) into the patient's left thigh, a copious amount of the vaccine sprayed backwards out onto the exam table, visually wetting the exam table paper. Parents immediately notified. Dr. immediately consulted (patient saw in clinic moments prior for well exam). Patient vaccinated with dose of Pneumococcal 13-valent conjugate (Prevnar 13 @ 1015) without difficulty. Parents voiced understanding without additional questions/concerns.
Itching, swelling, warmth, redness that encircled the entire upper arm to the elbow
Patient received 2nd dose of Moderna COVID Vaccine 21 days after receiving 1st dose of Moderna COVID vaccine.
SHORTNESS OF BREATH; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath was not reported. This report was non-serious.
Covid vaccine Pfizer has expiration date of 5/31/22.  However, it was removed from freezer and transported to our facility on 1/20/22.  It is only good for use until 2/19/22, but was administered on 2/21/22.  The patient did not suffer any adverse reaction from vaccination.  Dr. and pharmacist notified.  We will have patient follow up with next pfizer vaccine and then draw titers if agreeable with patient and caregiver.
Patient received first dose of Covid-19 (Moderna) vaccine 04/08/21 at 10:45am; presented 04/09/21 at 5:00pm with large hematoma on right thigh measuring approximately 8-10 inches across from middle of front of thigh to middle of back of thigh, running the length  of her thigh from groin to knee; dark purple in color, tender and sore; patient did not report any accidents or hurting herself in any way, she had not changed any medications other than receiving the vaccine the previous day; patient contacted her regular pharmacist at another location after being unable to contact her PCP; PCP was finally reached and told the patient to stop taking her Xarelto and diclofenac and to report to her office on Monday 4/12/21 to follow-up; I was notified of this reaction on 04/10/21 and reported to database, VAERS and our corporate office after speaking with the patient; the patient reported the bruised area as tender, sore and had gotten larger (right past her knee on the backside of her leg as of 5:00pm 4/10/21). I advised the patient that if it got worse, she began to feel bad in any way, to contact her PCP, go to the ER and/or call me. I will follow-up again in the morning.
Chills and fever.  Raised area at the injection site.  Site warm to touch.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 07-OCT-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine ne adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2016 the patient was treated by a Physician Assistant for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, also known as shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful condition. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Rash that stayed near the site of injection, but has traveled a little inferior of the site. Just bumps - not itchy or hot to touch Nausea that has stayed since the day after the injection. But I've been able to keep food down.  Severe stiffness in left arm that made it hard to lift arm - only stayed for 2 days and then it cleared
Itchy arm; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018092 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
information has been received from a physician concerning an approximately 25 year old female who on "20-MAY-2009" was vaccinated, 0.5 ml, with the first dose of GARDASIL (route and lot number were not provided). Subsequently, the patient experienced flu like symptoms. The patient went to the emergency room for treatment however it was unknown if she was admitted into the hospital. Additional information has been requested.
Deep aching pain in muscle where shot was administered. Can't use arm for normal functions.  Pain moved to elbow.
low grade fever, chills, sweats, severe nausea, severe muscle pain all over, red dry irritated skin on my face Started the day after I got the shot and lasted a good 5 days. The first three days were horrible, like the worst flu I've ever had.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Mild, Systemic: burn feeling-Medium, Additional Details: described as chemical burn about 1 inch at exact injection site. first very painful then very red then weeping and saw Urgent Care Dr and started antibiotics. almost clear after 6 days
This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Influenza vaccine unspecified. Co-suspect products included Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine unspecified at an unknown dose and Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, several months after receiving Influenza vaccine unspecified and less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine unspecified and Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not provided. This case was previously reported to doctor. A GSK employee was notified by a physician that his wife received an unknown manufacturer's influenza vaccine for the 2013-2014 season and for the 2014-2015 season and came down with the flu. The physician did not wish to provide further information or address. This case was considered as suspected vaccination failure since the exact time to onset and laboratory confirmation of influenza was not provided.
I was fine for the most part after the vaccine. The only thing that hurt was my arm at the injection site. I started feeling nauseous about an hour later. Then at about 9:00 pm, I started to feel really sick. I felt very tired and my whole body hurt. I had a low body temperature, 95 degrees. Chills, fever, shaking, nausea. Very SEVERE symptoms. Felt very disoriented. I thought I was going to pass out and faint. Vision blurry and seen white.  Pounding headache. Ears ringing. I could hardly walk that night, I was crawling on the floor. I felt out of breath. My heart was beating very fast. My left side of my chest hurt by my ribs. When I did wake up from sleep, I woke up with blood in my mouth and dried blood on my lips.
Was informed by,CMA that wrong vaccine was given to patient. VFC Tdap was given in place of Required Dtap. Called CDC and spoke to person at CDC. Per CDC there is no contraindication for the patient to have received Tdap but that Dtap should be administer as soon as possible to patient. Verfied with CDC that patient had immunizations 10 days ago and it is ok for patient to have Dtap administered tomorrow. CDC states that patient can receive Dtap immunization as soon as possible. Called and spoke to patient's mother regarding Wrong Vaccine given to patient. Verified identification with Last name and Date of Birth. Patient's Mother was informed accidentally patient received wrong immunization 10 days ago. Mother was informed that CDC was called and that there are no issues or should not Be any problems with patient receiving Tdap and that Dtap needs to be administered as soon as possible to patient. Mother scheduled for DTap Immunization on 06/01/2018. Patient has no further questions at this time.
Shingles; Caller reports waking up in the middle of the night in a lot of pain; Having residual burning; Itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2019, 1 days after receiving Shingrix, the patient experienced shingles, pain, burning sensation and pruritus. On 20th September 2019, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the pain, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows The patient received 1st dose Shingrix in her right arm. Early the next morning, the patient was preparing for travel for vacation and noticing two areas on her chest where she broke out initially thinking they were insect bites.  The breakouts spread, and the patient reported later that evening and into the next day she was breaking out all over her chest.  On 3rd September 2019, she called a pharmacy near her vacation spot due to breakout spreading to her back extending over to her arm above the injection site.  The patient was waking up in the middle of the night in a lot of pain.  She went to an urgent care clinic and she was diagnosed with shingles.  The patient reported the breakout resolved approximately 20th November 2019, but still having residual burning, itching, but no severe pain. The reporter consented to follow up.
Per pt, 9/17 arm swelling with pain, vomiting. Pt did not inform pharmacy until 9/20 at 3pm. Stated she takes Benadryl for sleep, but that had not helped with swelling. Stated she will see doctor 9/21.
19JUN93 pt was given a vax for TD on rt arm 20JUN93 & had aching muscles & high fever; arm was swollen & red; pt taken to emergency on 20JUn93; pt was taken to preventive medicine due to face that it was already p/5PM;
Nausea the day after vaccination, which went away after a day. Starting two days after vaccination, she started experiencing what she described as severe headaches. The severity of the headaches decreased but did not completely resolve over the week after vaccination. The injection site was sore and remained swollen and painful over a week afterwards. She also said that she started wheezing starting a week after vaccination.
Information has been received from a consumer concerning her daughter, a 15 year old female patient who in "the end of August 2010", was vaccinated with a first dose of GARDASIL (Lot# not reported). The daughter's mother stated that on 26-NOV-2010 her daughter had experienced "hair loss and depressed" after receiving the second dose of GARDASIL (lot number not reported). At the time of the report the patient had not recovered. The patient did not seek medical attention. Follow-up information received on 25-JAN-2011 from a Nurse Practitioner (CRNP) and medical records noted that a 15 year old female (156 lbs) with no known drug allergies was vaccinated on 17-NOV-2010 with a second dose (previously reported as first dose) of GARDASIL (Lot# 663453/0249Y) IM in the right deltoid. First dose was given on 14-SEP-2010 (lot #663453/0249Y). The patient had also received HAVRIX at the same time. On approximately 24-NOV-2010 the patient developed fatigue and hair loss. Lab work on 20-NOV-2010 showed normal complete blood count with differential and normal comprehensive metabolic panel, other than alkaline phosphatase of 94 U/L and ALT of 37 U/L. The patient did not require any treatment or doctor's visit. The patient's mother reported that her symptoms were improved around 25-DEC-2010. The Nurse practitioner felt that the patient had recovered at the time of report. All available medical records will be provided upon request. Additional information has been requested.
A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced no adverse event - multiple vaccines received a 15 day period (MMR, Varicella, FLUMIST QUADRIVALENT) which started on 10-Oct-2014. The outcome of the event of no adverse event - multiple vaccines received in a 15 day period (MMR, Varicella, FLUMIST QUADRIVALENT) is unknown. The report was considered to be non-serious.
Erythema & edema on arm where inj. was rcv'd appx 4"x2".  Started almost immediately.  Given KEFLEX 500 QID x10 days.