chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed soreness, swelling and lump under left armpit 3 days after booster shot.  When left arm is in extension, there is extreme soreness down the tricep and bicep belly to the elbow.  Bicep and tricep are extremely sore to the touch.   Menstrual cycle has been altered. I have been menstruating for 11 days.
This spontaneous report as received from a nurse refers to a 2 month old male patient with no medical history and  no drug reaction/allergies. Nurse stated that the patient received a dose of oral ROTATEQ, (lot # 0283AE, 2 ml orally on 11-DEC-2013 which was expired on 24-OCT-2013. Concomitant therapy included POLY-VI-SOL. No adverse event was reported. No treatment was given. No lab diagnostics study was performed. The patient did not seek medical attention. Additional information has been requested.
Patient had an acute MI died after within 8 weeks of last vaccine patient had been complaining of dizziness and feeling different since second vaccine
patient reports that 1.5 hours after show she began to have what felt like mini seizures-, headache, and extremity pain. the symptoms had mostly resolved at time of report 5 days after event
Chills, fatigue, blisters. Fatigue/muscle weakness lasting 8 days (as of right now)
Stomach pains, diarrhea, fever, chills, swelling, numbness, tinkles.
Flu vaccine given at 11:46 am on 10/14/08. Pt. started coughing at 10:30 pm- To ER for difficulty breathing. Given IV SOLUMEDROL, BENADRYL and ATIVAN. Adm to hosp with cough and allergic Rx. D/C on 10/14.  11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: cough, allergic reaction  Records reveal patient experienced severe intractable cough & hoarseness which could not be controlled in ER w/bronchodilators & steroids.
vaccine site rt anterior thigh became welted & reddened immed p/vax remained welted approx 10min;pt was seen 3/4 tsp DPH in office & monitored for 1hr;local rxn resolved to a reddened spots;
Patient called to report raised, red, itchy skin the size of a quarter at the injection site that started 3 days after the injection. Reported to patient that this has occurred with many patients and it should resolve in 1-7 days. Reporting to VAERS as this is not included in the information about usual vaccine reactions.
Large swelling and erythema at site of Varicella injection. Area warm to touch and slightly itchy. Took po Benadryl and applied cold pack and was much improved by 09/26/2016.
new patient came in and care gap noted he was due for covid booster dose. covid bivalent booster dose given. after dose given, patient clarified that he had only received the initial covid vaccine shot and never got second shot or (non-bivalent) booster.   No adverse reaction noted.
expired Fluzone Quadrivalent was inadvertently administered to a patient/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient who received an expired dos of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261JA (Expiration Date: 30-Jun-2019).  It was of actual medication error case due to expired vaccine used  It was unknown whether adverse event was noticed or not.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
STUDENTS SHOULDER AND ARM RED/HOT TO THE TOUCH.  WENT TO THE DR AND DR STATED IT WAS JUST A LOCALIZED REACTION.
L lateral upper extremity with ~ 4 cm area of blanching erythema with smaller area firmness palpated subcutaneously directly below.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 63-year-old male patient who received BOOSTRIX (batch number 9GE5D, expiry date 30th October 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). Concomitant products included PNEUMOVAX 23. On 23rd September 2016, the patient received BOOSTRIX .5 ml and FLUARIX QUADRIVALENT .5ml. On 23rd September 2016, less than a day after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: The case was previously not reported to anyone. The age at vaccination was not reported. The patient experienced headache, runny nose, burning eyes, fever, and severe body aches after vaccination with BOOSTRIX and FLUARIX QUADRIVALENT in left deltoid. This case is 1 of the 4 cases reported by the same reporter.
I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 14Apr2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 28Apr2021, the patient expecting her period end of April and she missed having a period then and the next month. The patient had period at end of June. So, she missed her period for two month. It was also reported that highly unusual since she has been regular most of her life and does not suspect peri menopausal symptom. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month' was unknown at the time of this report.
"she was exposed to possible infection because her boyfriend was unfaithful"; she received first dose of GARDASIL QUADRIVALENT on an unspecified date in 2010/ she received the second dose of GARDASIL QUADRIVALENT on an unspecified date in 2011 /She received a third dose of GARDASIL 9 on an unspecified date in 2018; she received first dose of GARDASIL QUADRIVALENT on an unspecified date in 2010/ she received the second dose of GARDASIL QUADRIVALENT on an unspecified date in 2011 /She received a third dose of GARDASIL 9 on an unspecified date in 2018; none of the clinicians shook the vial of vaccine before administering them; This spontaneous report has been received from a female patient of unknown age. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.   On an unknown date in 2010, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2011, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (inappropriate schedule of product administration). On an unknown date in 2018, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (interchange of vaccine products).   On an unknown date the patient was exposed to possible infection because her boyfriend was unfaithful. The patient reported that none of the clinicians shook the vial of vaccine before administering them (wrong technique in product usage process). The outcome of infection was unknown. The causality assessments between infection and the suspect therapies were not reported.
NECK SWOLLEN; LEFT ARM SWOLLEN TO WRIST; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced neck swollen, and left arm swollen to wrist. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neck swollen and left arm swollen to wrist was not reported. This report was non-serious.
This case was reported by a healthcare professional and described the occurrence of rotavirus in a 13-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included 1st doses of PENTACEL (Sanofi Pasteur) and PREVNAR 7 (Wyeth) both given on 3 November 2009, the same day as the 1st dose of ROTARIX. Second doses of PENTACEL (Sanofi Pasteur) and PREVNAR 7 (Wyeth) were administered on 5 January 2010 along with a 2nd dose of ROTARIX. There were no concurrent medications. On 3 November 2009 at 09:00, at 2 months of age, the subject received 1st oral dose of ROTARIX at 1.0 ml. A little over a year following administration of the 1st dose of ROTARIX, on 14 November 2010, the subject was diagnosed with rotavirus. It was reported that the subject was 13 months old when the onset of the adverse event began, however, the diagnosis date for rotavirus was not until 14 November 2010. The healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting the event was improved. The healthcare professional considered the event was unrelated to vaccination with ROTARIX. A 2nd dose of ROTARIX was administered on 05 January 2010. No additional details were provided concerning the 2nd dosing with ROTARIX.
Pt was admitted on 8/12/21 unresponsive with altered mental status and a possible seizure. She tested positive for covid- 19. chest x ray showed b/l infiltrates. she was started on remdesivir, oxygen and dexamethasone on day #3. Her condition worsened requiring heated high flow for respiratory failure requiring 45L of high flow oxygen at 45% fio2. pt had a protracted hospital course and became deconditioned requiring rehab on discharge. She continues to require 3L oxygen on discharge
Initial information received on 24-Sep-2018 regarding an unsolicited valid serious case received from a nurse. This case is linked to case 2018SA268918. This case involves a 5 years old male patient who experienced cellulitis, while he received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Sep-2018, the patient received a fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5171AA in the left deltoid. On an unknown date, patient developed a serious cellulitis the muscle following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE within days of the vaccine being given. This event was assessed as medically significant. On an unknown date, patient developed a serious swelling and redness following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was cellulitis. An unknown corrective treatment was received. The patient outcome is reported as Unknown for swelling and redness and as Unknown for cellulitis. Sender's Comments: Case concerns a 5-year-old male patient who experienced cellulitis with inflammation after vaccination. Time to onset is not known. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, safety of the vaccination procedure, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
I just had a scratchy sore throat with a ticking kind of cough and I thought it was just allergies but a number of people at my daughter's wedding was positive and I did a home test and tested positive and called my primary care doctor and I came in the office to do a PCR test that was also positive. I had symptoms for 6 to 7 days.
Patient received a very early dose of Hepatitis B vaccination. Patient's first and second dose of Hep B vaccine were given on 4/25/2022 and 5/25/2022 at his doctor's office. Patient came to pharmacy wanting his first Hep A and we asked if he wanted A and B together. We did not know that he had previous Hep B vaccinations due to lack of access to Dr's office records. He agreed and received Twinrix (Hep A and B) on 6/11/2022. Patient was not due for his Hepatitis B vaccine until 10/25/22. Adverse event is incorrect administration in Hep B schedule, but no signs or symptoms were observed  at pharmacy and patient left pharmacy without issue. We did not learn of misadministration until later today.
Weakness, dizziness and malaise felt by patient followed by apparent partial seizure: shaking of right arm and leg with intercedent hypertonic activity then shaking again; patient maintained consciousness. Apparent parital seizures.
Localized itching at the injection site that progressed up arm and neck causing the patient to become slightly short of breath and concerned for her safety
Pfizer-BioNTech COVID-19 Vaccine EUA.  injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
Patient experienced an injection site reaction, which included redness, swelling, hot to the touch and purple in color. She also experienced blurred vision and vomiting. She saw her primary care doctor to make sure it there was no infection. No infection occured.
Swollen left underarm; Chills beginning at 5am the following day-headache-fatigue-swollen left underarm; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 04Apr2021 at 05:00 the patient experienced chills, headache, fatigue and swollen left underarm. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event chills, headache, fatigue and axillary mass was recovering at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10 minutes after getting the shot I felt like I was going to pass out, I felt like my heart was beating slowly, I was breathing but felt like I couldn't get a good breath. It lasted about 5 minutes. I had the same reaction on methotrexate, which I quit taking.
Cervical myelopathy with progressive neurologic changes. Hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Initial and follow-up information has been received from a physician and a health professional through the Merck pregnancy registry concerning a 19 year old pregnant female (date of conception: 07-AUG-2006) with asthma and headaches with no drug allergies who on 23-AUG-2006 was vaccinated with a first dose of Gardasil (0.5 ml) (lot # "9725101"), intramuscularly. There was no concomitant medication. There was no adverse event related to this event. On 29-AUG-2006 the patient had a LEAP procedure. On 16-SEP-2006 the patient received medroxyprogesterone acetate (DEPO-PROVERA). The date of LMP was reported to be unknown. On 18-SEP-2006 the patient had a normal ultrasound. The estimated delivery date was 30-APR-2007. It was noted that the patient had one previous pregnancy. There was no birth defect in previous pregnancy. However, infant in previous pregnancy had oligohydrosis. Follow-up reported that the patient gave birth to a normal female infant was born at 39 weeks on 23-APR-2007 weighing 6 pounds 12 ounces, length was 20 inches. The apgar score was 8/9, with a head circumference of 33.7. There were no congenital anomalies, complications nor abnormalities with the infant. There were no infections or illness during the pregnancy. Other medications used during this pregnancy included daily prenatal vitamins, as needed albuterol, and daily ascorbic acid (+) cyanocobalamin (+) ferrous fumarate (+) folic acid (CHROMAGEN FORTE). On 27-APR-2007 the baby developed delay conjugate jaundice unspecified. On 30-APR-2007 during an office visit there was no significant jaundice. On approximately May 2007, the baby's umbilical cord was infected. The baby was given prescription "cream". On 07-MAY-2007 the patient was seen in the doctors office and the umbilical cord "looked better". On 21-MAY-2007 the baby was seen by a physician for abdominal pain generalized and excessive crying. The mom reported that the baby was crying "all the time" and she was "very gassy" and "acts like her belly hurts." It was reported that the symptoms were consistent with colic. At the time of the report, it was unknown the outcome of the infant. Additional information is not expected.
pt recv vax & exp a large induration & soreness @ inj site & nightshirts;
Headache, Myalgia, Diarrhea, NauseaVomiting, Fatigue, injection site soreness, back pain
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 22-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
The pt experienced residual erythematous circular rash measuring approximately 7 x 7 cm on the right dorsal thigh.
Vaccine administered at 9:58am.  Burning sensation in both left and right forearm around 2:00pm the same day.
Evening of 6-17-10 fever of 102.9 degrees F, vomiting, hallucinating (stated he was seeing spiders all over). Given ibuprofen but aunt/guardian stated it would not keep fever down for more than 2 hrs. Referred to family MD or pediatrician by Health Dept. On follow up call by Health Dept. guardian stated he was not seen by MD - fever gone after 3 days.
Severe muscle cramps, druling, constant urination,  chills, insomnia , severe leg cramps,
face was flushed, its red; face was flushed, its red; doesn't feel bad he just doesn't want to do anything; This is a spontaneous report from a contactable consumer (patient's wife). A 7-decade-old (in their 80's) male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 02Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 02Aug2021 and 03Aug2021, noticed that patient and his wife were both doing good but patient face was flushed on Aug2021. Wife was wondering if it was connected to the shot, it was red. Patient works out in the yard. Patient had not been outside or in the sun. Patient does not feel bad he just does not want to do anything. Patient otherwise were doing well with no other concerns. Patient was advised to consult with his doctor/healthcare provider about for what patient experienced, as his doctor/healthcare provider was most familiar with his medical condition, clinical history, how his treatment has been conducted and any relevant information to his specific case, his doctor/healthcare provider was in the best position to advise him about the appropriate action to take. The outcome of all the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Around injection site, 1 cm erythematous patch with additional 4-5 mm erythemic papules in the same vicinity.
Sudden onset of period after being in Menopause for one year. It was seven days but I was in Menopause. I had actually had bloodwork done three weeks prior to confirm Menopause. Thirty days later, I had a period again. I had severe PMS. Because of the three tumors, I immediately sought out the doctor because of those 4/6/2021). They did more Ultrasounds to check on the tumors. I haven't had another period since those two periods.