chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately two months after receiving the varicella vaccination my daughter broke out with a herpes infection in her right eye and continues to get break outs every year for the last 7 years. As a result she has scar tissue on her cornea and may eventually need a transplant.
fatigue, low-grade tactile fever, nasal congestion, runny nose, cough, body aches, chills, headache with COVID positive PCR on  08/04/2021
Red rash around injection site.  Area is warm to the touch, slightly elevated, firm.  Began tender to the touch, developed into slight itch.
ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 1/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of ROTATEQ, (lot # M043562, expiry date 03-JUN-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to cased #s 1708USA010054 and 1708USA010055). Additional information has been requested. Sender's Comments: US-009507513-1708USA010054: US-009507513-1708USA010055.
Patient reported start of illness in evening of 10/19/11 - received vaccination earlier in day. Complaints of possible fever (did not take temperature), soreness at injection site (left deltoid), body aches, stuffy nose, headache, nausea, lethargy. Patient had not contacted personal physician - advised to do this. Follow up call to patient early in week of 10/24/11 - symptoms persist. On 11/2/11, patient called to report left arm still sore and taking Advil for relief and has not seen physician, which was again suggested.  On 11/7/11, follow up call to patient.  No further daytime arm pain.  Arm pain hs and using Advil for relief. Has not contacted physician, but agreed to contact personal medical practice to locate new physician.
hives on neck, trunk (front and back), arms, hands, legs, feet that were constant for about three weeks, and came and went for about 6 weeks total
Swelling in soft pallet and oral mucosal membranes; Swelling in soft pallet and oral mucosal membranes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on right arm, via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), tachycardia, epilepsy, allergies to penicillin, cherry and apple. The patient was not pregnant at the time of vaccination. Concomitant medications included spironolactone (ALDACTONE), celecoxib (CELEXA) and naproxen sodium (ALEVE). The patient experienced swelling in soft pallet and oral mucosal membranes on 02Feb2021. She took 2 doses of 25 mg diphenhydramine hcl (BENADRYL). One at onset and one at recurrence a few hours later. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. Therapeutic measures were taken as a result of swelling in soft pallet and oral mucosal membranes which included self-administered diphenhydramine hcl. The outcome of the events was recovering.
Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) in a 51-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. Reporter had stated that no adverse events were reported by patient.
Redness, hot in right arm. Treated at emergency room for allergic reaction/cellulitis. Prescribed antibiotic + steroid.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about patient's concomitant medications, concurrent conditions and medical history as not reported. On 21-JAN-2016 the patient was vaccinated with a dose of (Merck) VARIVAX (dose and route not reported, lot number L032394 with expiration date 26-AUG-2017) that had been improperly stored (temperature ranges: 5.5F to 11.8F and time frame: 11 hours and 30 minutes). It was reported that there was a previous temperature excursion: 11.5 F for 14 hours. No adverse effects were reported. This is one of three reports received from the same reporter (other linked case # 1603USA010236 and 1603USA010237). Additional information is not expected because there was no consent to contact the physician for follow up.
On 4/19/01 and 5/16/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. On 6/1/01, the pt was seen in the physician's office with nausea, vomiting and fever. She was noted to have an enlarged liver; no jaundice was noted. It is unknown if viral hepatitis serologies were obtained. She was treated with prochlorperazine (Compazine). She subsequently, had a dystonic reaction which resolved (see report 2001013944-2). The nausea, vomiting and fever resolved on an unspecified date. The pt was seen by the physician on 6/6/01 and was found to be jaundiced. However, the vaccinee "looks and feels better". Repeat of 6/6/01, liver enzymes and hepatitis panel were performed; results were pending as of 6/6/01. This report is considered "Medically Serious". As of 6/6/01, the jaundice was ongoing. The outcome of the enlarged liver and elevated liver enzymes was not specified. F/U on 9/14/01, it was reported that the pt was referred to a gastroenterologist. A dx of hepatitis A was made and the pt rec'd unspecified outpatient tx. The reporter stated tat the hepatitis A infection was unrelated to Engerix-B. As of 9/14/01 the outcome of the hepatits A was unknown. Hepatitis A is considered medically serious. Per F/U, On 5/31/01, she developed arthralgias, myalgias and a fever of 103F. The gastroenterologist saw the pt on 6/8/01 and at that time, the pt reported "extreme" fatigue, decreased appetite, diffuse abdominal pain and nausea. She had juandice of skin and mild scleral icterus. Dx was a "Hepatitis of an unknown etiology" and prescribed rest. She was seen by this doctor again on 6/11/01 and was feeling better and was able to eat without nausea or vomiting but remained weak. She was much more jaundiced and had increasing scleral icterus. This same doctor saw the pt again 7/5/01 and she had gained 6lbs. The most recent information received on 10/15/01, the vaccine provider stated "The pt already had hepatitis prior to the shot (of Engerix-B)". She also stated that the Hep-A infection was "not at all related to Engerix-B". Outcome of the Hep-A infection was not specified.
On 12/7/00, pt noticed a "burning sensation" on 1st injection of Rabies. Did not mention to RN. That night she experienced numbness and tingling of right hand. The problem reoccurred, intermittently, only at night. On 12/25/00, numbness began to radiate from hand to elbow, again intermittently and only at night. Approx. on 1/5/01, it became "severe", lost ability to grip, had problem day and night for approx. 2 days. Informed supervisor on 1/6/01. On 1/9/01, numbness subsided, somewhat. Client reports has been lessening.
After receiving the vaccine within the first day I got a really bad fever up to 102 degrees. About a week or 2 later I started to experience diarrhea. In the 2nd month I started to feel like my heart wanted to explode. I went to the doctor and they told me I was just having panic attacks or anxiety. I never felt that way before until after getting the vaccine. To this day my heart still hurts and my chest hurts. I was prescribed Clonazepam or Xanax.  When I ask my doctor if they think it has something to do with the vaccine they don't talk about it or don't want to look into it to see if the vaccine caused it or not. Sometimes at night it feels like my heart is going to explode, and my heart starts racing to where it wakes me up. My chest always hurts now, and the issues with my heart wakes me up at night.
5-14-11 developed (Lt) arm swelling - red and hot over the Tdap injection site (Lt) delt. Pt. went to ER and was diagnosed with cellulitis. Treated with antibiotics.
Received ROTATEQ vaccine on 5/12/10. Fever of 101.7 ( R ) and watery mustard yellow x 4 on 5/20/10. Seen in our office on 5/20/10. Stool sample sent to Lab for Rotazyme and stool culture. /Patient also with decreased appetite cranky & sleepy.
tingling; swelling of the lips and tongue; swelling of the lips and tongue; vaccine provider refused to administer her with the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-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 PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose). At the time of the report, PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
After receiving the first GARDASIL injection 1 Aug, my son began to have bladder dysfunction "sense of urgency". After the second shot 19 Sep he now has incontinence. Prior to the shots he was perfectly healthy 17 yr. old.
Sweating; Pain  legs really bad, pain in his feet; Back pain; He had allergies before but after he took the shot are worse; sleeping more/woke up later than 5:00 or 7.00 AM; running nose; chest congestion; peeing yellow; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse) and HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Pain  legs really bad, pain in his feet), BACK PAIN (Back pain), CONDITION AGGRAVATED (He had allergies before but after he took the shot are worse), HYPERSOMNIA (sleeping more/woke up later than 5:00 or 7.00 AM), RHINORRHOEA (running nose), RESPIRATORY TRACT CONGESTION (chest congestion), CHROMATURIA (peeing yellow) and HEADACHE (headache) outcome was unknown.            Patient mentioned something about a sleeping machine. No concomitant medication was provided by the reporter. Patient took all kind of medicines - pain killer for treatment.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Patient refused to give anymore information.
Patient presented to the ED with mild chest discomfort and was found to be COVID positive.  Was admitted for rule out due to significant cardiac history.  He was discharged the next day in stable condition.
This initial literature case was received on 27-Nov-2017, from a physician, concerning an infant of unspecified age and gender. The main objective of the study was to estimate the febrile seizure risk from the time of vaccination through the following day associated with vaccines administered to children aged one through five months. This report was a cohort study in which patients (one to five months of age) prone to febrile seizure risk after vaccination were involved. In the present study, 15 febrile seizure cases were reported after 585,342 vaccination visits. The patients had received a median of four (range two to six) vaccines simultaneously. The patients were grouped from emergency department visits and inpatient admissions associated with International Classification of Diseases (ninth revision ICD-9, "convulsion" code 780.3, 780.31, 780.32, or 780.39 which included only febrile seizure and not epilepsy) from 01-Jul-2006 to 30-Jun-2011. They defined the day of vaccination as "day 0" and only included convulsion visits that occurred on days zero to one or 14 to 20 following the administration of one or more vaccines of any type. The patient's concomitant vaccination included DTaP, hepatitis B (with doses recommended at birth and at one to two months of age), Hib, IPV and rotavirus vaccine pentavalent (live attenuated) (doses recommended at two and four months of age), monovalent pandemic 2009 H1N1 inactivated influenza vaccine. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after administration of the suspect vaccine, the patient had febrile seizure (probable). The characteristics of the possible or probable febrile seizure followed by vaccination was determined by medical record abstraction. It was reported that, the vaccine was received by the patient at the age of five months, which was less than the minimum recommended age of six months (explicitly coded as inappropriate age at vaccine administration). The outcome of the event was not reported. The causality of the event febrile seizure was related (probable as reported) to the suspect vaccine. The author stated that the timing of fever and febrile seizure after vaccination depends on whether the vaccine contains a live attenuated virus, which requires several days to replicate before inducing a febrile response, or contains inactivated components, which may elicit a febrile response within the first 24 hours.
lt upper arm, erythema & swelling; 5 1/2cm vertically;no streaking, mild warm & tenderness;
HEADACHE; FEVER; MUSCLE ACHE; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1806018,: UNKNOWN) dose was not reported, administered on left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, fever, muscle ache, fatigue, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fever, muscle ache, fatigue, and chills, and the outcome of headache was not reported. This report was non-serious.
Light headed, headache, chills, body aches, tired. Five days after the vaccine I broke out in hives in my chest and it spread slowly through out my whole body. I was itchy all over my body and it burned for a whole week. The itchiness stopped 3 days ago and my whole body just feels sensitive
Narrative: Pt noted rash & pruritis persists, took OTC Benadryl scheduled for PCP appointmentn 3/3/31
pt's aunt called clinic stated pt had a sz p/receiving vax on 8DEC93; stated the pt had several more sz the following day & was taken to ER: stayed overnoc;
21 month old baby was given the quadracel with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who experienced 21 month old baby was given the quadracel with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), HEPATITIS A VACCINE (HEPATITIS A)  and HEPATITIS B VACCINE (HEPATITIS B VACCINE) all for Prophylactic vaccination.  On 22-Jun-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE once (lot C59708AA; expiry date: 02-feb-2024) via intramuscular route in the left thigh (left leg) for prophylactic vaccination.  On 22-JUN-2022 the patient reported 21 month old baby was given the quadracel with no reported adverse event (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.    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 guidelines. 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.
Patient lost consciousness for about 5 second after receiving the Second dose of Jynneos Monkeypox vaccine. Vital signs taken. first BP 94/62 , second after 5 minutes was 110/70. Other vital signs were within normal range. Patient verbalized not feeling dizzy or lightheaded and able to walk without assistance before leaving the vaccination site. Patient was observe for  half an hour.
01/07/2021 - 01/09/2021 - Soreness at injection site 01/10/2021 - Increased tiredness and headaches; progressed to include nausea and body aches on 01/11 01/12/2021 - 01/16/2021 - Extreme fatigues and body aches, headache, nausea, loss of appetite; progressed to include diarrhea on 01/17/2021. 01/18/2021 - 01/20/2021 - Symptoms slowly started to improve
Patient rec'd the shot on 11/27. When patient woke up the next morning (11/28) she complained of a swollen arm. I only noticed it around the injection shot. After school around 4pm she complained of it being itchy all day. We noticed around 6pm that her arm was swollen from her shoulder to elbow and was red. We contacted pharmacy as well as her PCP. Her PCP recommended 25mg of BENADRYL. We gave this to her then she went to bed. The morning of 11/29 the swelling was once again around the injection area. She still complained of her arm being itchy. She took another 25mg the night of 11/29. The morning of 11/30 the swelling was almost gone.
THE PHARMACIST ADMINISTER  THE VACCINE TO THE PATIENT , AFTER 10 MINUTESTHE PATIENT BECOME DIZZINES, SWETY AND WITH SHOTNESS OF BREATH. SEHE RECOVERED IN 5 MINUTES ANT THE PHARMACIST GO TO LUNCH AND TELL ME  (RPH) THET THETE WERE 2 MINUTES LEFT TO COMPLETE THE 15 MINUTES WAIT. SHE BECAME SICK AGAIN WITH THE SAME SYMPTOMS. (IMZ TECH) CALL 911 AND ALERT STORE MANAGER WITH CODE WHITE. I CHECK THE PATIENT, (IMZ TECH GAVE HER AN ALCOHOL PAD TO BREATH AND I ASK IF SHE CAN MOVE  AND SHE SAID SHE DIDNT, I PROCEDEED TO  APPLY A COLD COMPRES S TO HER WRIST. THE AMBULANCE CAME AND TOOK HER TO THE EMERGENCY ROOM (1:10pm) HER BROTHER  CALLED 5:03PM TO INDICATE THAT SHE IS FINE WITHOUT SYMPTOMS.
Day after injection had dizziness, nausea and diarrhea. Symptoms intensified and were the worst 2 days after receiving injection.  Symptoms did not resolve until 8 days later.  Not treatment was given for symptoms.
Morning after vaccine (2:30am) had fever 102.4 degrees F.  Took TYLENOL.
Petechia and bruising appeared approximately 2 days after receiving the Covid-19 Moderna vaccine. Patient was hospitalized  for excessive petechia and bruising in bilateral lower extremities with platelet count of 2,000.