chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with thrombocytopenia who on 09-MAY-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included tetanus toxoid, administered "on the same day, 09-MAY-2008") and vitamins (unspecified). On an unspecified date the patient had a positive urine pregnancy test. The patient's LMP was reported as 08-APR-2008. The patient sought unspecified medical attention. Patient outcome was not reported. Follow up information has been received from a completed questionnaire by a certified nurse midwife (previously reported as nurse practitioner). It was reported on the questionnaire that the patient with no concurrent medical conditions, on an unspecified date experienced Chlamydia infection (2 episodes) and thrombocytopenia (previously reported as concurrent condition) during pregnancy (diagnostic tests performed on unspecified dates). Other medications used during this pregnancy included prenatal vitamins (unspecified) and azithromycin. On 22-AUG-2008, the patient had a screening ultrasound. On 10-JAN-2009 at 39 weeks from LMP, the patient delivered a male liveborn infant. He weighed 8 lbs and 03 oz, apgar score was 8/9. Additional information is not expected.
20 YEAR OLD FEMALE FELT LIGHT HEADED AND DIZZY AND VOMITTED , ON SITE EMS RESPONDED. VITALS ARE BELOW. SHE WAS MONITORED, FELT BETTER AND RELEASE TO HOME
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 94 and presented to the hospital on 2/26/21 with a chief complaint of failure to thrive and deceased on 2/27/21. He had a PMH of CKD, CVA, dementia, CAD, and COPD.
This spontaneous report was received from a healthcare professional refers to multiple unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown date the patients were vaccinated with ROTATEQ (Lot# K013411, expiry: 19-MAR-2016, lot# K006457, expiry: 09-MAR-2016 and lot# K016275, expiry: 20-APR-2016) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
LIGHT HEADED, DIZZY, COULDN'T STAND BY HERSELF, SLEPT A LOT DURING THE DAY COULDN'T TELL WHEN SHE HAD TO GO TO THE BATHROOM, COULDN'T GET OUT OF BED BY HERSELF, SOMEONE HAD TO STAY WITH HER AROUND THE CLOCK, SHE GOT A UTI IN AUGUST 2021 PUT HER IN HOSPITAL FOR 2 WEEKS AND NOW IN A NURSING HOME FOR 2 WEEKS AND SHE STILL CAN'T WALK OR STAND WITHOUT ASSISTANCE. HER SHORT TERM MEMORY STARTED THE NEXT DAY AFTER THE SHOT, AND IT STILL HASN'T RETURNED, EVEN AFTER 4 MONTHS, SEVERAL CT SCANS MRI SCANS DURING THAT 4 MONTHS AND NOTHING THAT WOULD EVEN THINK SHE HAS ANYTHING WRONG WITH BRAIN. SHE DOESN'T EVEN KNOW HOW TO ANSWER THE PHONE NOW.
I tested positive for COVID-19 on 04/08/2023.  I had tremendous sore throat, little bit of breathing problems, body aches, fever and stuffy head.  I was prescribed Paxlovid medication which I took for five days. I have recovered from my symptoms, still have a lingering cough and tested negative on 04/12/2023.
ON 2/10/21, DEVELOPED LOOSE STOOLS, BODY ACHES, SORE THROAT, AND FATIGUE.
COVID-19 Break Though Case: Nov 26/2021 I received dose 2. Adverse event started happening on March 22/2022 around 5:00-6:00PM. I had a dry tickle in my throat which turned into cough all through night. Me and my husband went to an event this is where we caught COVID. We did home test and were confirmed we had COVID. I did tele medicine check with my doctor he then prescribed medication which was great. My symptoms lasted for couple of days after the medication. I was back to normal.
rash ight on thighs , shoulders , and back  states she feels okay today. feeling fatigue. rash is about the same and didnt take any benadryl.
Developed redness, swelling and pain at site of both DTaP #4 and HIB #4 shots that were administered. Redness went way within 48-72 hours; induration still present today without fever afterwards.
accidentally gave an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 14-JUN-2023, the patient received the 1st dose of Kinrix. On 14-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: accidentally gave an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2023 and 21-JUN-2023 The details of vaccines, patient and event were given.  The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. The reporter reported that a medical assistant accidentally gave an expired dose of Kinrix, which led to expired vaccine used.
The patient did not have an adverse event. Pfizer Bivalent booster was administered 30 days earlier than CDC suggested timeline.
another patient under age of 18 who received the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (another patient under age of 18 who received the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
pt recvd vax 315PM; 6-7PM devel dizziness when walking, near syncope, unable to maintain balance, fell and fractured rt radius; admitted to ER for tx & eval of syncoep;
Pt. received fourth Moderna dose. 15 min post administration, Pt c/o redness on L deltoid and L forearm to, MA, RN notified. Redness also noted on facial area. Pt denies difficulty breathing, pain, and itching. Pt advised to remain in observation area post 15 min wait time. V/S obtained q15 min. Initial V/S at 1035 HR 103 BP 147/88 RR 16 o2 100%. Mother present at bedside. Pt observed for 1 hour post vaccination. V/S at 1148 stable HR 82, BP 130/85 RR 16 o2 100%. Redness cleared at final assessment, no longer present on face, L deltoid, or L forearm. Pt advised to call PCP or 911 as needed if symptoms worsen. Pt discharged with mother, her ride home, present.
Pt fainted twice immediately after vaccine.  Blood pressure and heart rate both dropped.  Paramedics were called. Pt taken to hospital for evaluation. According to pt mother at 2:00 this afternoon, pt is fine.
Pt recvd vax 17JAN92 & devel redness & pain @ the inject site day following immun; 18JAn seen in office 23JAN dx cellulitis; treated w/ATB for 10 days; no cult taken; no spontaneous drainage @ time of this report;
Fever 101.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.8) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 101.8). At the time of the report, PYREXIA (Fever 101.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.8 101.8.         No concomitant medications were provided.  No treatment information provided.
Patient complained of vesicles down entire leg with erythema. Pt given Hydrocortisone cream.
COVID-19 Vaccine EUA; Exactly 1 week after receiving this first dose, the injection site became swollen, red and very itchy for about 2 days. 3 days later, it is still red and somewhat swollen but much less itchy.
gave pentacel instead of adacel with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an 11 years old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine conj (TET TOX) (ACTHIB).  On 20-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot number: UJ659AA, expiry date: 31-Jan, 2023; formulation, strength not reported) via intramuscular route in the left deltoid for immunization.  On 20-Jun-2022 the patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event (wrong product administered).  Action taken was not applicable.  Outcome: Unknown    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 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.
felt rugged; body aches; headache; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017821A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, VACCINATION COMPLICATION (felt rugged), MYALGIA (body aches), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication was provided The patient didn't had any side effects after receiving first vaccine.  On 28-Mar-2021, the Patient felt more rugged. No treatment received by the patient   This case was linked to MOD-2021-414003 (Patient Link).
rapid heart beat; headache; pain in her arm at the injection site; quivering in chest and palpitations; quivering in chest and palpitations; lightheadedness; tired; anxious; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports.   A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on 22Jan2021 at 15:30 at a single dose on left arm for COVID-19 immunisation. Medical history included triglycerides high, obesity, blood clotting issues, thyroid disorder and blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, rosuvastatin calcium, aspirin (acetylsalicylic acid) and vitamin D3. The patient experienced rapid heartbeat, headache, quivering in chest and palpitations, lightheadedness, pain in her arm at the injection site, tired on 23Jan2021 and anxious on 22Jan2021. The patient stated that on Saturday (23Jan2021), she noticed pain in her arm at the injection site, a headache, and feeling of like she was quivering in her chest. She was also experiencing palpitations, lightheadedness, and periods of rapid heartbeat. On Monday, the symptoms were a little less but yesterday and today she has had a lot of palpitations, quivery feelings in her chest and rapid strong heart beats. On Saturday, she took an aspirin for headache. On Sunday, she had just a mild headache and by Monday (25Jan2021) it was gone.  She wanted to know if these are normal reactions and if she should call the doctor, or what she should do about them. The patient underwent lab tests and procedures which included blood triglycerides: high and body mass index: high on Jan2021; heart rate: rapid on 23Jan2021. Therapeutic measures were taken as a result of headache. The outcome of the events pain in her arm at the injection site and headache was recovered on 25Jan2021, while of the rest was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116966 same reporter/drug, similar events, different patient
Can't sleep at night; A lot of discomfort; All his joints hurt; Headaches; Lymph nodes are really swollen in his armpits and his groin area; Body pains like with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches) and LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer survivor) in 2017. Concurrent medical conditions included Reactive arthritis and Immune system disorder. Concomitant products included TRAMADOL and PREGABALIN (LYRICA) for an unknown indication.   On 14-Aug-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) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose). At the time of the report, INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose) outcome was unknown.            Patient couldn't remember all the concomitant medications.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-287392 (Patient Link).
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with MMR II (dose and route of administration no provided). No concomitant therapy was reported. The physician reported that nursing students were required to have titers done for MMR II prior to working in the hospital and physician had seen may students who received this vaccine as part of their childhood vaccines, showing low titers for MMR components. The patients sought medical attention. Booster dose was administered as a treatment. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Vomiting at 2:00 am and very sore throat, painful to swallow and painful under my right jaw.
C/o tingling down arm 10 minutes after vaccine given to patient states she has numbness & tingling down Rt arm to fingertips.
Post vax, the pt developed severe swelling locally, bad headache, and fever of 104.
Approximately 20 minute episode of shaky, "wobbly" legs, to the point of having difficulty standing. Subsequent urinary incontinence.  Stated that she "could not stop" peeing.  She is potty trained, and has had no accidents in 6+ months.  Leg shakiness and weakness resolved within an hour but she said they still felt funny/achy.  Bladder control problems continued through the evening but resolved by next day.  Reported to doctor's office who advised to monitor and call back if any other developments.
In 4/2014 I noticed lack of appetite.   In 5/2014 she started complaining her stomach hurt on a daily basis.  In 6/2014 she was complaining of severe stomach pain.  We took her to emergency room.  We followed up with pediatrician and she sent us to Hospital.  They treated her with many medications.  They did a stomach biopsy on 10/31/2014.  We took her to an allergy doctor to be tested in 2/2015.  We kept going to Hospital.  Then they did a HIDA scan and detected gall bladder stopped functioning.  They took it out 7/2015.  She is still on medications to alleviate stomach pain.
Temperature Excursion; Initial Report Received on 05-Jan-2023 and 09-Jan-2023  A medical assistant and a pharmacy purchaser in the  reported that a 51-year-old male patient (race and ethnicity unknown) [Patient 1] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 23-Dec-2022, there was a power outage at 04:00 AM the health center. There was no backup generator to the vaccine refrigerator. When the medical assistants came into work, they heard the vaccine refrigerator's alarm go off. The refrigerator was warm with a temperature of 54.5°F at 06:45 AM. All the vaccines were removed and put into coolers with ice. Pharmacy Centralized Services was notified, and all the vaccines affected by the power outage were counted.   On 03-Jan-2023, 12 days later, the patient received a dose of HEPLISAV-B (Lot # 940486, expiration date 10-Nov-2024, and NDC # 43528-003-01) in the right deltoid (route not reported) by a medical assistant. It was discovered the next day on 04-Jan-2023 that a couple of boxes were missed being removed after the power outage, and the patient had received the HEPLISAV-B vaccine that had the temperature excursion of 54.5°F for 2 hours and 45 minutes.  No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient moved to observation room post Moderna vaccine due to feeling uneasy. Vitals taken at 1505 are BP 151/97, Pulse 101, RR 20, oxygen 100% saturation. Patient moved to supine lying position with slight tilt trendelenburg per doctor order. Vitals taken at 1510 BP 137/84, Pulse 85, RR 18, oxygen 99% saturation. Patient verbalized feeling better at this time. Vitals taken prior to discharge at 1515 BP 129/89, Pulse 80, RR 18, oxygen 98% saturation. Per doctor, patient's vitals normalized and is able to be discharged at 1521. Patient verbalized feeling well and walked out of clinic in good spirits.
Our infectious disease physician is reviewing notes from previous hospital stay for this patient who reports having had DRESS 2 days after receiving the MOderna COVID vaccine on 2/4/2021. MD cannot be sure if the DRESS is related to vaccine or new initiation of allopuriol as the drug was started 2 weeks prior to this reaction and is known to cause this. He wants it reported as a precaution, again cannot be sure what caused this, the vaccine or the new medication.
I had little red itchy bumps - soles of feet; palms of hands and between my fingers, elbows, ear, and they were itchy. I went to a doctor on the eight and they said it was: Contact dermatitis. No treatment. That lasted at least a week. I had a sore arm after the vaccine, as well.
Varicella rash - pox post vaccination on 8/28/10. Rash assessed at health center on 9/9/10.
Measles, Mumps-  Information has been received from a physician concerning a 35 year old femle with seasonal allergies that persist nine months of the year who in approximately July 1999 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  There were no concomitant medications.  Within ten days of vaccination, the patient experienced a measles like rash and swelling of the right submandibular area.  She was told at that time she had signs of mild measles and mumps.  The patient recovered from the symptoms.  The patient also had adverse experiences following vaccination with varicella virus vaccine live waes 00070374
Monday: Dizziness and headache. Tuesday: Fever and migraine. Wednesday: Migraine. Thursday: Dizziness and migraine. Took either Tylenol, Ibuprofen, or Excedrin without much luck from any of them.
swelling near injection site; redness near injection site left arm; Itching near injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling near injection site), VACCINATION SITE ERYTHEMA (redness near injection site left arm) and VACCINATION SITE PRURITUS (Itching near injection site left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Graves' disease, Depression, Cholesterol and Arthritis. Concurrent medical conditions included Drug allergy (penicillin) and Latex allergy (Latex). Concomitant products included MELOXICAM for Arthritis, PRAVASTATIN for Cholesterol, CELECOXIB (CELEXA [CELECOXIB]) for Depression, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Graves' disease.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling near injection site), VACCINATION SITE ERYTHEMA (redness near injection site left arm) and VACCINATION SITE PRURITUS (Itching near injection site left arm). On 14-Apr-2021, VACCINATION SITE SWELLING (swelling near injection site), VACCINATION SITE ERYTHEMA (redness near injection site left arm) and VACCINATION SITE PRURITUS (Itching near injection site left arm) had resolved.            Consumer has been taking Benedryl to help alleviate possible adverse events.   Consumer has not reached out to her physician.   This case was linked to US-MODERNATX, INC.-MOD-2021-079409 (Patient Link).