chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous non-valid report as received from a nurse refers to a multiple unspecified patients. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown) that was properly stored. On unknown dates, the patients were vaccinated for prophylaxis with improperly stored doses of M-M-R II lot # N013296, expiration date 28-APR-2019, lot # N011005, expiration date 05-APR-2019, lot # reported as N045392, expiration date reported as 14-NOV-2018; LIQUID PEDVAXHIB lot # N012119, expiration date 06-FEB-2020, lot # N034005, expiration date 31-JAN-2020; GARDASIL 9 lot # N022728, expiration date 31-MAY-2020; PNEUMOVAX 23 lot # N025563, expiration date 08-APR-2019. On 09-MAR-2018, the patients were vaccinated with ROTATEQ lot # N013885, expiration date 09-DEC-2018; LIQUID PEDVAXHIB lot # reported as N026569, expiration date reported as 27-FEB-2020; GARDASIL 9 lot # N020353, expiration date 28-APR-2020. These vaccines underwent a temperature excursions of -0.44 degrees Celsius for 1.5 hours. The nurse denied any adverse events reported by patients. Lot number N026569 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate). Lot number N045392 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Follow-up information has been received from the nurse on 09-APR-2018. The expiration date for LIQUID PEDVAXHIB lot # reported as N026569, was corrected to 07-FEB-2020. Lot number N026569 is an invalid lot number for b conjugate vaccine (meningococcal protein conjugate). Follow up information has been received from the nurse on 08-JUN-2018. The nurse stated that only one patient who was 11 months old was vaccinated with improperly stored dose of LIQUID PEDVAXHIB.
BP 206/116 S/p Vaccine. Employee taken to the ER for evaluation and treatment of hypertension
Pneumovax and FluAD given around 2pm. Pneumovax was in the left arm. Patient was having a lot of pain in the left arm. Also increased blood pressure, after which patient took amlodipine 5mg. Patient experiencing chills and fever as the evening continues. Daughter takes her to the ER and patient is diagnosed with CELLULITIS. She takes an antibiotic at the ER and is discharged with an cephalexin for 10 days.
This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored PNEUMOVAX 23. All these patients experienced incorrect product storage as all of them were administered with improperly stored PNEUMOVAX 23. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to PNEUMOVAX 23. This is one of several reports received from the same source (MARRS # 1502USA002021 and MARRS # 1502USA002816). Additional information has been requested.
8/16: Mild pain began in lower left abdomen. 8/23: pain increased to a pain scale 9, went to the ER. Blood test, urine test and CT scan, nothing showed up of concern. Given pain medication and sent home. 8/24: visited primary care doctor, he didn't know what it was either so treated it as diverticulitis and given antibiotics. 8/30: pain continues - doctor now thinks it's a kidney stone - ordered a second CT scan - found nothing - ordered an ultrasound - left ovary seems larger and uterus appears bulky - refereed to OBGYN. 8/31: menstrual cycle begins, very heavy flow but pain finally goes away - OBGYN believes I had a ruptured ovarian cyst, hydrosalpinx in my fallopian tube and possibly have endometriosis - given antibiotics and instructed to begin birth control during next menstrual cycle. 9/16: light menstrual bleeding
A LITTLE BIT OF PAIN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a little bit of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little bit of pain was not reported. This report was non-serious.
Temp to 104(R) in PM down to 101 w/Tylenol; 2PM next day to 104; MD advised to continue tylenol & fluids. TD for next injection.
This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with GARDASIL, (dosage, route, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
MISSED THE THIRD DOSE; This spontaneous case (PVX2019-844) was received from a nurse on 09-Apr-2019. It describes a 19-year-old adult female consumer who "missed the third dose", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer took 2 doses of Vivotif on 04-Apr-2019 and 06-Apr-2019, respectively. After that, she left the remaining doses in a hotel's fridge. Thus, she missed her third dose, which was due on 08-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "missed the third dose" was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.
Rash, on right arm where site of injection occurred, painful, swollen veriy itchy, had lesion of chicken pox on site, head, extremities.
This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with Tdap (manufacturer unspecified), (non-gsk) MENACTRA. On an unspecified date, the subject received unspecified dose of Tdap (unknown, unknown arm) and unspecified dose of MENACTRA (unknown, unknown arm). Two seconds after vaccination with Tdap and MENACTRA in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of Tdap and MENACTRA in the same arm (see case id's A0887425A, A0887433A, A0887434A, and A0887435A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
diarrhea; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable pharmacist. A 72-year-old male patient received BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccination, the patient experienced diarrhea and loss of smell and taste. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1:15 PM, dryness in the throat, 1:30 PM, dizzy and lightheadedness, 2:00 PM, the muscle where the shot was located began to hurt, tightness in the chest, rash on the left arm; from the elbow up to where the shot was administered, hot flashes, red blotches on my face.  The reaction slowly went away after I took my allergy medicine. The allergy medicine that I take is Children's, Liquid Allegra. I took Advil Mini Gel Caps to help with the pain in the left arm, and the headache.  The pain in the arm muscle went away by Monday, March 29, 2021. The headache went away after three weeks.
Several fluid-filled vesicles on red bases appeared on 1/2/09.  VARIVAX done 12/15/08.
experienced fever and body aches after the 2nd dose of Shingrix; experienced fever  after the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of general body pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. A couple of people who experienced fever and body aches after the 2nd dose of Shingrix. The reporter did not consent to follow up.
A report has been received from a Health Professional concerning a 34 year old, Female subject, Height: 5.0 Inches; Weight: 169.0 Pounds, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 07-Oct-2013. The patient experienced administration to pregnant female which started on 07-Oct-2013. FLUMIST quadrivalent (intranasal) was continued. The outcome of the event of administration to pregnant female is unknown. The date of the patient's last menstruation was Mar-2013. The estimated date of delivery is 04-Dec-2013. The report was considered to be non-serious.
inflammation, pain, redness to lt arm on 5JUN97;pt recv vax 3JUN97;
The following 2 months after receiving my vaccine my monthly cycle changed and became much heavier with more blood clots that I have ever experienced.  Then on May 3rd (my 3rd cycle) I hemorrhaged at work, I was unable to control the bleeding.   I was taken to the ER and almost received a blood transfusion. I received multiple tests but there was no medical finding as to why that happened. It?s now almost been a year since receiving my second dose and my whole cycle has changed. I have never had problems with excessively  heavy menstrual cycles and now I have increased clotting and bleeding that never return back to normal.  I am a registered nurse and have a medical background.
About 30 minutes to N hour afterwards my face swelled and broke out in hives everywhere. Throat felt like it was closing  like it does if I am stung by a wasp. Took Benadryl that helped, but the hives remained for days. Also an avid runner/yoga. Weight 110. Height 5 ft 5 inches. Body ache and pain for three weeks afterwards. Went to the doctor and said I probably had a cold and a running injury. But no fever and X-ray did show anything wrong so they diagnosed as myalgia
Cough became productive; splitting headache; fever; diarrhea; dry cough; chills; Contracted Covid-19 after being fully vaccinated; Contracted Covid-19 after being fully vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative and regulatory authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, administration date 23Sep2021 (Lot number: 301308A) as dose 2, single and administration date 01Sep2021 (Lot number: FC3188) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19, vaccination failure all with onset 2021, outcome unknown; headache, pyrexia, diarrhea, cough and chills onset 23Dec2021; productive cough onset 24Dec2021, outcome unknown. Symptoms begin on 22Dec2021.  No follow-up attempts are possible. No further information is expected.  Additional information: description of event: contracted Covid-19 after being fully vaccinated. Symptoms began on 22Dec2021. On 23Dec2021 had splitting headache, fever, diarrhea, dry cough and chills. Cough became productive on 24Dec2021. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Information has been received from a licensed visiting nurse concerning a 6 yr old female who on 07Jul99 was vaccinated SC with a first dose of varicella virus vaccine live. On 13Apr05, the pt presented with about 30 vesicular lesions and a runny nose. Hydroxyzine hydrochloride (Atarax) was prescribed for itching. No other symptoms were noted. At the time of the report the pt was recovering. A product quality complaint was not involved. Follow up information was received from the licensed visiting nurse who reported that on 12Apr05, the pt had times 24 hrs positive itchy vesicles which were two to three mm on the scalp. The pt also had rhinorrhea. Subsequently, on an unspecified date, the pt recovered. No further information is expected.
SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 63-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". Therapeutic measures were taken as a result of sars-cov-2 test positive, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported event and suspect drug cannot be excluded.The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : DE-PFIZER INC-202200740728 Same article, other patient (1)
pt recv vax 14OCT96 & devel flushing & nausea which last 2hr;pt was not hosp;
Patient received  1st dose of Trumenba vaccine and fainted shortly after. Struck right eyebrow on chair. Doctor evaluated laceration on right eyebrow. Parent came to office and took patient to urgent care where they placed 8 sutures and then discharged home.
Heavy menstrual period, long lasting period, frequent, the period changed the after doze 1 and 2
Big red circle on arm around injections site.  Spread longer on arm and became lighter in color over time.  Cleared up after two weeks.
fever of 102.5, chills, muscle aches, vomiting (~30 minutes during febrile period) lasting about 14 hours Diarrhea and decreased appetite lasted a week First menstrual cycle after vaccine was abnormal
Meniere's disease (hearing loss and vertigo) occurring one day after the vaccine. Hearing loss present 3 weeks later.
07/01/2021- I had the usual vaccine response, like flu like symptoms. 08/07/2021 I fell down and broke my bone on my left foot and immediately after that I noticed I started to have a toothache, so severe. I did not go to the dental office because of Corona. It did not go away. In October, sometime, it got to the point the tooth ache was so severe I could not handle it. I went to the dentist's office and they took a lot of x-rays and they said that I had loss of bone and they could not save my tooth. I went to see my doctor, and they did a bone scan and they found I had severe osteoporosis. It started in a rapid mode. He saw my blood test results and said it looked pretty bad. He suggested I take injections for 2 years. I did not want to inject myself. So meanwhile I am not getting any treatments because I do not want to inject myself. My doctor sent me to an  endocrinologist, she said I had a severe bone loss. My dentist said I have no bone there and I have the risk of losing other teeth. It is kind of odd that I had a sudden bone loss after the 2nd vaccine. I am getting my 3rd booster next week, and I am kind of freaking out right now. It is just a sudden bone loss that came out of the blue, out of nowhere. Meanwhile, my doctor told me to take 1000 mg of Tums and then change vitamin D from 5000 mg to 1000 mg daily. I must emphasize, I am not really sure my symptoms came from the vaccine or something that came from me. In previous years my annual check up did not find anything, like this sudden bone loss or osteoporosis.
Information has been received from a healthcare worker (medical assistant) referring to unknown number of patients of unknown age and gender. Information about current conditions or medical history was not reported. The healthcare worker reported that on unspecified dates the patients might received doses of RECOMBIVAX HB (dose, route not reported, lot# J008227 with expiration date 07-FEB-2016, lot# J007946 with expiration date 24-MAR-2016, lot# H010050 with expiration date 31-OCT-2014, batch# J009049 with lot# 0589AE and expiration date 27-MAR-2015) that were exposed to temperatures of 0C for 4 hours and 55 minutes. This is one of several reports from the same reporter. Additional information has been requested.
Approximately 1 1/2 hrs. after receiving FLUZONE client began to feel SOB, tightness in her chest, & throat edema. Her symptoms worsened & she went to an Urgent Care clinic. She was given epinephrine, prednisone, ZYRTEC & an inhaler.
Chills; Eye pain; sore lymph nodes on right neck; Fatigue; pain of lymph node on both arms; pain of lymph node on the neck; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms), LYMPH NODE PAIN (pain of lymph node on the neck), LYMPH NODE PAIN (sore lymph nodes on right neck) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms) and LYMPH NODE PAIN (pain of lymph node on the neck). On 22-Feb-2021, the patient experienced LYMPH NODE PAIN (sore lymph nodes on right neck) and EYE PAIN (Eye pain). On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, FATIGUE (Fatigue), LYMPH NODE PAIN (pain of lymph node on both arms), LYMPH NODE PAIN (pain of lymph node on the neck), LYMPH NODE PAIN (sore lymph nodes on right neck), CHILLS (Chills) and EYE PAIN (Eye pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Patient came in for COVID bivalent booster vaccine at the office. I confirmed with patient's parents if the patient was getting booster and parent said yes. All booster vaccines were scheduled for the end of the day so the booster vaccines weren't drawn up yet. I grabbed a regular dose of Moderna 0.25mL and gave it to the patient.
This is a 21 y/o female who was 5 months post partum and received first dose of pfizer vaccine and has had abnormal heavy vaginal bleeding
continual ain-discomfort at the injection site, pain lifting the left arm including the shoulder. no visible bruising.
Severe Allergic reaction Immobility, swelling, and extreme pain of the entire arm. Transpired within 10mins of receiving the shot Rest and Ibuprofen and acetaminophen had no positive effects in resolving the adverse effects. Epipen was not administered by facility at any point in time.
a female patient received a 0.5 ml dose of Fluzone Quadrivalent which was already expired on 30Jun2019/No AE; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA263367, 2019SA263393 and 2019SA263394 (same reporter).  This case involves a 36 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled syringes which was already expired on 30-Jun-2019 lot UJ041AB via unknown route in the right deltoid on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
She got her vaccines, as soon as she got them it hurt in left arm.  Then within 2 hours she could not move her arm.  It was red from her shoulder to her elbow and completely swollen.  She talked to the pharmacist they told her to put Benadryl on it, put ice on it and push fluids.  It was better the next day, but was still very painful.  She is an independent caregiver and was not able to go to work so missed 2 shifts of work and 3 days of work.  She has been vomiting nonstop, pouring out sweat until 5:00 AM when it stopped, was taking Compazine for that.  Now she has a nonstop cough that she thinks is turning into pneumonia.  She has had these shots in the past, but never had  a reaction to these in the past.  She has had several sets of pneumonia vaccines as she has had pneumonia twice prior to COVID.   The arm has gone down quite a bit, still red and can definitely tell it's there but what the pharmacy told her to do has helped.   She believes it's related to the pneumonia vaccines and believes she now has pneumonia.  She did not have a cough prior to the vaccine.
Pt recvd 3 Hep B vax given 1AUG89, 31AUG89, & 23JAN90; Following these titer was neg; Pt given a 4th dose of Engerix-B vax on 8AUG90; Following 4th dose titer=4;