chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left foot (plantar) warts resolved; HPV vaccine used for left foot (plantar) warts; Literature Report:   This literature marketed report has been received from the authors of the published article, concerning a 45-year-old male patient. The patient's pertinent medical history included therapy with liquid nitrogen (LN2), salicylic acid, candida albicans, duct tape and zinc (unspecified). The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left foot (plantar) warts (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  The patient's immune status was reported as none. The patient was followed up for treatment for 6 months.  On an unspecified date, the patient's left foot (plantar warts) resolved (drug effective for unapproved indication).  The outcome of the event drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.  Follow-up information was received via telephone call on 02-APR-2020.  A request was made for patient identifiers, events experienced and causal relationships.; Sender's Comments:  US-009507513-1912USA012734: US-009507513-1912USA012735: US-009507513-1912USA012721: US-009507513-1912USA012722: US-009507513-1912USA012723: US-009507513-1912USA012724: US-009507513-1912USA012725: US-009507513-1912USA012726: US-009507513-1912USA012727: US-009507513-1912USA012728: US-009507513-1912USA012729: US-009507513-1912USA012730: US-009507513-1912USA012731: US-009507513-1912USA012732: US-009507513-1912USA012733:
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 23-DEC-2015, the patient was vaccinated with an expired dose of LIQUID PEDVAXHIB lot # J003720 and exp date on 05-MAY-2015, dose and route were not provided). No adverse effects reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 75 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 14Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: FE2588), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FJ441), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Vicodin, reaction(s): "allergies Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 23Sep2023 to 28Sep2023 as Treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300319576 same patient, different drug/event;
Gardasil 9 was inadvertently given to a 15 month old child; No other AE reported; This spontaneous report was received from a medical assistant, referring to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (product administered to patient of inappropriate age) (dose, frequency, and route of administration were not provided; lot number T027789, expiration date 27-FEB-2023). No other adverse events were reported. The outcome of product administered to patient of inappropriate age was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T027789; expirationdate: 27-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient presented with ILI symptoms and tested positive for 2009 H1N1 post immunization with FLUMIST.
loss of smell; Loss of appetite; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Mar-2021, ANOSMIA (loss of smell), DECREASED APPETITE (Loss of appetite) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 99 (Inconclusive) had a little fever at night that got to 99 but never want above. On 29-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non significant follow up received on 07 JUL 2021. reporter details were updated.
I started getting symptoms of coughing that was severe. I took 2 at home COVID-19 tests that were positive. I had a fever of 100.3 when I went to the doctor and received a positive COVID-19 test. I was prescribed benzonatate for cough that helped with sleeping. Last night was the first time I got a negative COVID-19 test. My cough is now gone and no lingering affects.
The night of the second dose the wife reports that he experienced hallucinations, amnesia and incontinence. According to the wife, an ambulance was called and he was taken to the hospital.
LYMPH NODES SWOLLEN UNDER ARM  UNDER ARM SORE AND TENDER TO TOUCH  NO TREATMENT,  1 WEEK LATER CONTINUES TO BE SORE BUT SWELLING AND PAIN  HAS DECREASED DAY BY DAY
stopped breathing; had a febrile seizure; This spontaneous report was received from a consumer referring to her daughter. The patient had no concomitant medications nor pertinent medical history. She had allergy to amoxicillin (also reported as "amoxyalclin").   On an unspecified date on 2005, the patient was vaccinated with  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (also reported as "was recommended by doctor")(formulation, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not reported; lot number and expiration date were not provided).   On an unspecified date on 2005 (reported as sometimes in 2005), experience a febrile seizure (febrile convulsion) and stopped breathing (respiratory arrest), events which required that the patient had to be taken by ambulance to the Emergency room (ER). She received treatment for the events (unspecified). On an unknown date, she recovered from the events.   The causal relationship between respiratory arrest, febrile convulsion and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) is unknown.  Upon internal review, respiratory arrest was considered as medically significant event.
Low back pain and stiffness; lethargy; fever 100.8, headache; Treatment - patient rested, drank fluids, used ibuprofen.  Symptoms started around 11 AM, continued through day; Fever broke approximately 6 PM; Patient was better following day and 100% 2 days later.
Severe rash on hand, wrist, knuckles/top of both of her hands; Shortness of breath; Heart Palpitations; Soreness; Low grade fever/temperature has been around 99.8 degrees Fahrenheit; hives; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151; Expiry date: Not reported), via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history included neck surgery from 25Jan2021, covid-19 from 2020 to 2020, ongoing Allergic to Sulfa Drugs. The patient's concomitant medications were not reported. On 16Apr2021, she developed shortness of breath, heart palpitations, and a temperature of 98.1-99.8. She also had a rash on the top of both of her hands. She states the rash has improved but she still has the other symptoms. She went to the ED and was prescribed methylprednisolone on 18Apr2021 and also tested negative for Covid. It was reported that she started having a severe rash on her hand. It is on her wrist, hand, and knuckles. She also developed shortness of breath, heart palpitations, soreness, and a low grade fever. States her temperature has been around 99.8 degrees Fahrenheit. Also reported that all of her symptoms began on 16Apr2021. States that the rash was very bright red at one point; it's not as red now but the hives are still there. States all of her symptoms are persisting. Felt like she did a year ago when she had Covid 19, Low Grade Fever, Shortness of Breath, Heart Palpitations, Soreness, and Severe rash on hand, wrist, knuckles. The patient underwent lab tests and procedures which included covid-19: negative on 18Apr2021, body temperature: 99.8 fahrenheit on. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Pulmonary embolism in her lungs; DVT in her leg; Chest pain in her right chest; Breathing was labored; Breaking out in hives; Chills; Dull Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, breathing was labored, pulmonary embolism in lungs, DVT in leg, chills, dull headache, heartbeat is up and stayed up , D-dimer levels were high and breaking out in hives, and shortness of breath.  Relevant  medical history included  cancer involving lungs . Relevant concomitant medication was not reported.  On 13 FEB 2021, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 FEB 2021, the patient experienced chills, headache, and heart rate increased.  On 27 FEB 2021, the patient experienced chest pain, dyspnea, urticaria, pulmonary embolism, deep vein thrombosis,  for which she  required hospitalization.  Relevant laboratory investigations included increased D-dimer.  Treatment for the events included Heparin and  oral blood thinner.  Action taken with mRNA-1273 in response to the events was unknown.  On 16 FEB 2021, the outcome of the event's chills, headache was considered as resolved. At the  time of this report, the outcome of the event's chest pain, dyspnoea, pulmonary embolism, deep vein thrombosis, heart rate increased, fibrin D dimer increased and urticaria were considered as unknown.; Reporter'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. However, the events Pulmonary embolism, DVT,  is Unlikely related to mRNA-1273 and a very limited information regarding these events has been provided.  Further information has been requested
arm still hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Nov-2022 Reporter's comment: The reporter was the patient, who received her dose of Shingrix in the left arm last week.  She stated that her left arm still hurts after a week. The reporter did not consent to follow-up.
This is the sixth of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was unknown. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
developed a local reaction to HPV site , no fever, shortness of breath no skin lesions. Started on topical steroid, use cool compress as needed and continue supportive measures. He is to follow up in 2-3 days.
This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 01-MAR-2019, the patient was vaccinated with one dose of improperly stored ROTATEQ (strength, dose and route were not reported, lot # R021069, expiration date 23-MAY-2020, therapy type digital data logger) and one dose of improperly stored LIQUID PEDVAXHIB (strength, dose and route were not reported, lot # R021077, expiration date 11-JUN-2021, therapy type digital data logger) for prophylaxis (product storage error). The vaccines experienced temperature excursion at 47.8 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No adverse effects were reported. A data logger was involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA002750:
Pt. had MMR, PCV 13, DAPTACEL on 7/6/12. Mom called yesterday 7/17/12 with concern about rash since 7/16/12 on chest, back and thighs. 7/19/12 Rash resolved.
Rash, redness, and warm to the touch and injection site only.  Patient was given 10 day course of prednisone and as well as benedryl. patient's reaction was much better following day
accidentally give the diluent from Pentacel to a baby, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00646006) and transmitted to Sanofi on 17-Jun-2021.  This case involves an unknown age and unknown gender patient who accidentally give the diluent from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (other dosing details unknown) (batch number and expiry date unknown) for prophylactic vaccination (product preparation issue) on an unknown date  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  Additionally laboratory tech reported: they wanted to know if it is possible to get a vial of diluent for ActHib to complete the Pentacel dose.  At the time of report, no adverse event was reported.  At the time of reporting, the event outcome was 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 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.  There will be no information available on the batch number for this case.
Felt warm prior to diaper changed at 9:30 PM when began to have whole body shaking with frothing at mouth. Lasted approx. 5 mins. Was sleepy and whimpening in ambulance then back to baseline once reached ER.
tightness in chest; wheezing; wet chest cough with phlegm; feeling of a lump in throat/throat constriction
About 6:00 PM I began to loose my strength, by 9:00 PM when I tried to go to bed, I had to ask for help to get to the bed. I had to get help two times during the night to get out of be bed to go to the bath room. I did not sleep very much that night.  By about 8:30 AM I was able to get out of bed and get dressed for breakfast.  I had a fever of 101 degrees most of the morning. I was tired all the next day and slept most of the day. I seems as though all of these side effects are gone now.  There were people that thought I had Covid the next day.
On 8/30/99, pt had febrile seizure, lasting about 15 sec.,and pt was taken to ER. Pt. had fever of 104 & was tx'd with Tylenol & sent home after 3 hrs. On 12/9/99, pt rcv'd 2nd dose of Hep A vax. On 12/31/99 pt was warm to touch & given
also had a severe case of covid at the beginning of the year; also had a severe case of covid at the beginning of the year; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID: (054550).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Grass-Pollen" (unspecified if ongoing); "Grass-Pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "also had a severe case of covid at the beginning of the year".  Additional information: Medication: Pfizer COVID Vaccine. Drug Allergies Allergic To Grass-Pollen (Xeljanz XR). Event Description: I also had a severe case of COVID at the beginning of the year.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
With 1 vaccine I felt a lot of pain and chills the same day at night I started with blurry vision and with a lot of chest pressure. For two days I had a lot of head pain. For the next few weeks, my vision in the right eye was always a little cloudier than the left eye. When I had the second dose it got worse. All the COVID symptoms. I was very weak, and my pressure was low at the pharmacy. The same thing happened with the vision. For 4 weeks I had stomach problems and vaginal infections and bladder and a lot of chest pressure, but they said it was anxiety but it's different. At 5 weeks I had a severe head pain and I suffer from cluster headache, so I thought that's what it was. I went to the hospital because the last time I had and episode of my headache was almost 3 years ago, but this time was different. They don't know the reason of my pains. I had this for almost a month and two weeks, and they said  it is because of the vaccine. I was healthy and the vaccine did something to me. My neurologist doesn't even know what I have. I only know that because I got the vaccine, my body is not the same nor can I see the same.
?COVID arm? red rash at injection site 2? in diameter slightly raised, firm, red, painful to touch
My left are is swollen like a golf ball and very painful. I felt fatigue for the 3 days,  On the 3rd day I started to feel pain under my left armpit and in my left shoulder. It  appears that my lympnodes under my left arm are swollen and today is day 4. I have been taking tylenol manage the discomfort and placing wet warm cloths on the the affected areas.
Intense pain at injection site and surrounding area, chills at bedtime, shivering, passed out in kitchen as a result. Recovered and no chills as of 2-22-19.
Was given YF vaccination on 8/25/14. 48 hours after receiving the vaccine, she developed fatigue, insomnia, headaches and "whole body" nerve pain. These symptoms are still present.
09/20/22 presents to ED for " urinary retention". PMHx of "Arthritis, Prostatitis"
Strongest and longest A-Fib episode ever experienced lasting 26 hours.  Followed by abrupt end with pause in heartrate as recorded on my Medtronic Cardiac Monitor.  Back in Afib  38 hours later lasting 28 hours with direction from electrophysiologist's office to increase dosage of Flecainide to every 6 hours until it ends . Prior to this episode had only needed to  take 1 Flecainide 3 times over a 6 month period in order to end an episode.  Otherwise the other 21 episodes in that 6 month period ended in less than an hour with no need to take any Flecainide.
Hep. A (HAVRIX) and HPV9 (GARDASIL 9 - Merck) administered at 1:10 pm. Pt. out to waiting area. Fainted at 1:15 pm and came to awareness within seconds. Bumped head on (L) side. Given apple juice and crackers. Diaphoretic, but A and O x3. BP:.
Felt lightheaded about 5 minutes after vaccination. She laid down and passed out for about 5 seconds. Rescue squad checked her over and she left with no trouble.
Area around injection site became hot, red, and itchy a week after receiving first dose. A week after noticing symptoms, they are still present.