chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 23 July 2013. A female patient (age not reported) had received dose 1 of ADACEL vaccine (batch number: U4586AA, route and site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period date was 01 November 2012. The estimated date of delivery was 17 August 2013. Patient's health during pregnancy, specific risk factors and concomitant medications were not reported. Treatment for infertility was not reported. Laboratory investigations were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The was reported by patient. The age at vaccination was not reported. The patient got vaccinated a second time and got the shingles after the first shot anyway.
Information has been received from a registered nurse concerning a 30 year old white female with no known allergies and no past medical history who was vaccinated IM in the left deltoid with a first and second dose of varicella virus vaccine live (lot #636579/0086L) on 28 JUN 2001 and 30 JUL 2001 (also reported as 20 JUL 2001), respectively. There were no concomitant medications or illnesses at the time of vaccination. On 04 AUG 2001, the patient developed a vesicular rash of greater than 12 lesions. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse which indicated that the patient recovered from her experience on 20 AUG 2001. Additional information has been received from a completed questionnaire which indicated that the patient had no history of chicken pox or recent exposure to chicken pox or herpes zoster. It was noted that the patient's lesions started at her feet and legs, and then disseminated to other areas. The same source also provided information on another person's experience with varicella vaccine live (WAES01083115). No further information is available.
Patient received two flu shots. one on 9/24/23 and one on 9/11/23. Pt states he has had no adverse effects.
After flu vaccine he became flushed and diaphoretic with a spike in b/p b/p 169/101.
Information has been received from a healthcare worker referring to multiple patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were vaccinated with doses of improperly stored MMR II (lot # K024824 with expiration date of 02-DEC-2016; strength, dosage, frequency and route unspecified) or RECOMBIVAX HB (lot# K016005 with expiration date of 27-AUG-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. Additional information has been requested.
No additional AE reported; an expired GARDASIL 9 was administered to a patient; This spontaneous report has been received from a pharmacist referring to a consumer, of unknown age and gender patient.   No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were provided.  On 04-JUN-2021, the patient was vaccinated with an expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) of 0.5 milliliter for prophylaxis, lot # R021634, expiration date 08-MAY-2021. (anatomical location and route of administration were not provided). The reporter stated that the vaccine had no prior temperature excursions. No additional adverse event was reported. 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: Merck Sharp & Dohme Corp.; devicelotnumber: R021634; expirationdate: 08-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 026L20A), in left arm, on 06Feb2021 as dose 2, single (Lot number: 026L20A), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: C58521A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing); "migraines" (unspecified if ongoing); "mild IBS" (unspecified if ongoing). Concomitant medication(s) included: COQ10 [UBIDECARENONE], start date: 01Nov2015; VITAMIN D [VITAMIN D NOS], start date: 01Dec2017. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 15Jul2022, outcome "recovered with sequelae" (01Aug2022), described as "Rebound after treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive again; (unspecified date) Positive, notes: Treatment of COVID-19; (13Jul2022) Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective, disease recurrence. Clinical course: Concomitant medication Coq10 was currently from Pharmacy. Patient experienced rebound after treatment. Patient received Paxlovid from 07Jul2022 to 12Jul2022 for treatment of COVID-19. Patient felt good and tested negative on 13Jul2022. On 14Jul2022, patient was the same. 15Jul2022 patient felt tired and 16Jul2022 and 17Jul2022 patient had no energy and bad headaches and tested positive again. On 17Jul2022 patient told covering doc it was good enough for patient and asked for a second round of Paxlovid which led to improvement in 48 hrs. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness, COVID-19 and Disease recurrence cannot be ruled out.
Heavy legs, numbness in arms, reported swelling of face, tingling of tongue.  Hypertensive.  Hx of anxiety, HTN on Zanax.  Only took 1/2 dose this morning. Patient taken to emergency room.
hurt @ site of inj,pain of&on from 1st day to present;rt arm felt like it atrophied,was unaware of extent until tried to type;had physical therapy&occupational therapy;felt some results-did not cont,financial problems;
Received 3 Doses of Heplisav-B; Initial Report Received on 02-July-2021   A registered nurse reported that a 38-year-old female (race, and ethnicity not provided) received a third dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No relevant medical history was reported.  The patient was not pregnant at the time of vaccination.    No relevant concomitant medications were reported.   On 17-Nov-2020 the patient received the first dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC #43528-003-01, serial number and route were not reported) in the right deltoid.   On 12-Dec-2020 the second dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC #43528-003-01, serial number and route were not reported) in the right deltoid.  On 24-May-2021, a third dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022, NDC #43528-003-01, serial number 824687756125, route was not reported) in the right deltoid.  The patient did not report any adverse reactions or issues related to "this incident."   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Lower extremities in both left & right legs were in complete spasm immediately following the shot. This lasted approx 24 hours. Then for 48-72 hours had flu like symptoms. Then had severe lower right abdominal pain radiating to my left side. This last 36 hours.  As of this report my right leg has pain. No treatment - no physician visit.
Within one hour of vaccine - patient had severe headache (worst of life), nausea, chills, muscle aches. 20 YO M presents to ED S/P meningitis vaccine at about 11:30 this morning for C/O chills, nausea, one episode of violent vomiting, and headache about an hour after the vaccine.
Fever onset after 10pm day of booster shot. Fever hovering between 101-102F for about 30 hours. Unable to sleep due to chills. Arm pain (typical).  Bad headache for about 48 hours.
1. Since second vaccination i have had 3 UTIs. One caused by strep (and i am a carrier, so this was strange).  Second one caused by bacteria (unknown). And the third caused by E. coli. It is very uncommon for me to get a UTI. I test regularly for these due to my IC.  On average  i get one once every 2 years. I have now had three in less than 3 months. I also developed a lump in my lower, left breast. It is not cancer, or even a cyst (for now) I did have it checked via mammogram and ultrasound. This happened about 3 weeks after the second Pfizer vaccine.  Also within that first month to month and a half i developed a cold?i don?t generally get colds, in fact, i have not had a cold in 7 years as crazy as that may sound. The cold did not go away. After about 10 days, i had to take a steroid packet to help get rid of it. I strongly believe this vaccine has weakened my maternal immune system. And for that, Pfizer should be ashamed! Not only do i think it weakened my immune system, i am not sure what else it has done, as I?m only a few months out.  But i don?t think this is coincidence that?s these medical issues started happening after the vaccine. Issues that i don?t get prior to.  So figure out how to fix this and make it right, instead of defending the vaccine as if it?s A God or something! Unfortunately, that?s what medical professionals do!
Moderna COVID-19 Vaccine EUA - Itchy, red rash developed on my arm at the injection site in the middle of the night day 8 after receiving shot.  Had a similar spot for a day or two after the shot but it went away before reappearing.  The original spot was not nearly as itchy.  This one is extremely itchy and swollen.
Headache, developing on day of vaccination ("2/22/03")after being vaccinated; H/A continuous and escalated to 3/20, when described as 10 on a scale where 10 indicates worst pain ever experienced; hospitalized through Emergency Department of a local hospital on 3/21 for diagnostic studies and pain management.
Large red and swollen area around the site of injection. Patient reported it was painful and itchy.
3 1/2 year old received Flublok Quadrivalent/no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to case ID 2019SA321865 (same reporter).  This case involves three and half years old patient of unknown gender who received a dose of QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] [Product administered to patient of inappropriate age] intramuscularly in right thigh (lot number: Lot# QFAA1959 exp. 30-JUN-2020) on 15-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No treatment, no concurrent vaccines given.   It was a case of actual medication error due to inappropriate age at vaccine administration.  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 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.
Patient's husband stated patient had hives/urticaria on left arm 6 days after receiving FLUVIRIN on 10/18/12 (approximately 10/24) patient came into pharmacy on 10/30/12 & showed to pharmacist on duty. It was recommended pt see physician; however husband is a retired physician.
Within a few weeks of booster shot he started to get a rash on hands and upper thighs.  He is a teenager and did not tell me (his mother) about this until around March 2022.  Saw PCP in April and was diagnosed with "jock itch" fugus.  Treated for 3 weeks on oral meds with limited improvement. On 5/2/22 had a huge flair up that now extended further to scrotum, armpit and back hair line.  Took to dermatologist on 5/2/22.  Diagnosed with psoriasis.   Has never had any skin issues prior to these events.
From an initial report received on 01/15/2001, it was reported that a 10 year old female was given TD Adult vaccine on 01/04/2001. Reportedly "1 day after vaccination" pt "developed itching at site, swelling-2 days later site grossly swollen-size of chicken egg-seen in office treated symptomaticaly-unresolved." From additional info received on 02/20/2001, additional pt, vaccine, responsible physician and vaccine administrator information was provided.
"he died taking the vaccine"; This spontaneous report was received from a consumer who was doing a research on zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus)(ERVEBO) and refers to an infant male patient of unknown age. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with a dose of zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus)(ERVEBO) for prophylaxis (quantity dose, lot #, expiration date and route were not reported).         On an unknown date the patient died (death). The cause of death was not reported. It was unknown if autopsy was performed.  The reported related death to zaire ebolavirus (kikwit) glycoprotein recombinant vector vaccine (vesicular stomatitis virus)(ERVEBO) because the vaccine was a viral vector vaccine.; Sender Comments: Keywords : SL
NOTE: ACUTE RESP DISTRESS APPROX 15 MINUTES AFTER IMMS ADMINISTERED.  Mom noted child suddenly crying and then having difficulty breathing.  She called for nurse who then called me to see child.  I found child crying with moderate cyanosis.  Chest-poor air entry with faint insp and exp wheezes throughout and intercostal retractions.  Back to treatment room, called 911.  Initial pulse ox=88%, HR=133.  Placed immed on O2 via nasal cannuli at 3 liters with immed improvement of pulse ox to 100% after 1 minute.  Also started albuterol neb .5ml/3ml along with O2.  Suctioned oral secretions x1 with bulb syringe.  Much improved, acyanotic, swallowing secretions well with better air entry.  During neb treatment, retractions resolved, wheezes persisted.  On continuous pulse ox monitor which =99%-100%.  Ambulance arrived, child transported with O2 via nasal cannuli to ER.  Mom accompanied.  8/28/2008 MR received for DOS 7/11-12/2008 with DX: Wheezing, Choking episode. Infant developed acute onset of wheezing associated with cyanosis after 6 month vax. Mother reported choking with crying after vax. Initially treated with albuterol nebs, O2 and suctioning then transported via EMS to local hospital then transferred to higher level of care. Good response to albuterol. No rash, lip swelling, V&D initially. Observed o/n. Later that pm developed urticarial rash to face, neck, chest and back with peri-orbital edema, pruritis and 1 large emesis with upper airway congestion. Tx with Benadryl. Given epi-pen for home use and referred to allergist as outpt.
This spontaneous report as received from a pharmacist via company representative refers to a 61 year old patient. Patient's medical history was unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: unkonwn) (lot # K000995, exp date: 16-MAR-2015). On an unkonwn date, injection site of the female patient was swollen and red (also reported as "more severe reaction than the other patients"). The patient visited her unspecified physician on an unspecified date. The outcome of injection site was swollen and red was reported as recovered on an unknown date. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 vaccine administered to patient under the age of 18.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under the age of 18.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under the age of 18.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID-19 vaccine administered to patient under the age of 18.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Experienced sudden onset chest pain which presented like heart attack, moving from center of chest to back up neck to head, this was following fatigue and intense diarrhea from the previous day.  The symptoms subsided, but urgent care ran EKG which presented as normal.  Attributed to likely intense reaction due to GI side effect.
Woke up at 2am on 2/12/2021 feeling nauseated and been vomiting since.   Soreness in arm at injection site.
Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; Body aches, chills and body temperature max of 101.2 F; she should not have taken the vaccine with us; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, chills and body temperature max of 101.2 F on 22Dec2020 with outcome of recovered on 23Dec2020. On 22Dec2020 she spent the day in bed. The reporting nurse stated that the patient was part of a trial study. She was vaccinated in a blind study on 28Nov2020. The patient told the reporter on 23Dec2020 that she called the intake person the week before and they told her to take the vaccine here with Pfizer. She called them back after she experienced the events and spoke with a different person who stated she should not have taken the vaccine with Pfizer. They will not un-blind her at this point either. The reporter felt certain based on her response last week that she must have received the vaccine on 28Nov2020 and not the placebo. The patient wished to drop from the study and take the 2nd Pfizer vaccine in 3 weeks. Her PCP agreed that she should do so.  The information on the lot/batch number has been requested.
Pt felt nauseous and threw up right after vaccine administration.  EMS provided cold water and had the pt sit in the back of the ambulance for further evaluation. Monitor vitals and pt continues to feel nauseous and vomiting. Initially he refused EMS transport but changed mind and was transported to ED.
3:45 plus or minus nasal mist administered at high school flu clinic, 4:00 pt. re-entered after leaving stating, "throat feels thick, tongue, lips are tingling". Pt. sat down, no apparent distress. 4:05 took 50mg PO BENADRYL. 4:25 left feeling better with inst. to go to ER PRN.
Confirmed Shingles outbreak. First time ever having shingles. Received prescription for Valaciclovir.
Patient was inadvertantly administered the 1st dose of the moderan covid vaccine, and was under the age outlined by the EUA (17 years old). The second dose was eventually administered on 04/02/2021 based on guidance by the CDC. The Chief Nursing Officer and Pharmacy Director spoke with the patients guardian and consent was granted and the vaccine was administered as an unlabeled use per the CDC guidelines. The patient had Down Syndrome and respiratory issues in the past.
6/8/99 presented w/redness, heat, swelling, 2 small hives around inj site;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND)
Patient was fully vaccinated 3/18/21 and 4/15/21 with Moderna. Patient started having SOB which has worsened and he also has a productive cough. He was COVID 19 positive. Admitted 12/10/21 and is still admitted as of 12/16/21
itchy rash behind right knee/ delayed rash reaction; mild widespread itching; slight left arm soreness; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:30 (Lot Number: ER8727) at the age of 66-year-old as a single dose for covid-19 immunisation from hospital. Prior to the COVID vaccination the patient did not receive any other vaccines within 4 weeks and was not diagnosed with COVID-19. The patient was not tested for COVID-19 after the vaccination Medical history included ovarian cancer survivor, allergic asthma (not chronic) allergies to shingrix vaccine and sulfa drugs, all from an unknown date and unknown if ongoing. Concomitant medications included losartan, rosuvastatin, timolol, latanoprost, Alph all taken for an unspecified indication, start and stop date were not reported.  After vaccination, patient waited with emergency medical technician for 30 min with no reaction to 1st dose. On unspecified date in Mar2021 at home, patient had mild widespread itching & slight left arm soreness. On 25Mar2021, 03:30 am patient developed itchy rash behind right knee, which was confirmed as a delayed rash reaction to 1st dose by nurse on 13Apr2021.The outcome of the events was recovered with no treatment received.
Patient was admitted for subarachnoid hemorrhage and right hip fracture post unwitnessed fall, found to also be COVID positive.
At approximately 3:50 a.m. on 11/7/09, patient experienced vomiting & diarrhea. Examined by Dr on 11/7/09. Patient was afebrile, but had persistent vomiting & diarrhea, until noon on 11/8/09.