chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received COVID booster vaccine in our office without issue. He was sent home and approximately one hour after the vaccine, he developed a full body tonic-clonic seizure that lasted <5 minutes and self abated. Patient has never had a seizure before and has never had any similar effects with other seizures.
No real symptoms at time of vaccine. Pain after injection for two days. Pain in right hip for five days.  Went in for ultrasound on 4/1/21 at 9 weeks 4 days and found out that there was no fetal pole. Measured at 8 weeks 3 days with gestational sac and yolk sac but no embryo.  Considered an embryonic pregnancy, empty sac, or blighted ovum   Approximate loss 3/24/21. Still waiting to pass tissue to fully miscarry.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Sep2022 as dose 1, single (Lot number: Gtt9693) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin and Codeine" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN, start date: May2013; PROGESTERONE, start date: May2013; BUSPIRONE HCL, start date: 19Aug2023, stop date: 22Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 23Aug2023, stop date: 28Aug2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291330 same patient, different drug/event;
About 1 month after vaccination, I noticed my vision was changing and things were more blurry. I was driving my car and my passengers commented that my driving abilities have decreased and they did not feel safe with me driving anymore and that I should go get my eyes checked. I also noticed my right eye is red, blood shot, burning, irritated, and with drainage when I wake up daily.  I went to see an optometrist on 5/11/2021. I did all the routine eye exams and was told that I have cataracts in both eyes and my vision have worsened and that I would not pass a driving test.  I also have pressure build up in the right eye. I were given samples of eye drops Systane for relief. I was referred to a Opthamologist for removal of cataracts. I went to see the opthalmologist and he noted a scar on the retina on the right eye that would need removal prior to the cataracts surgery.  I was referred to another Opthamologist retina specialist surgeon for removal of the scar tissue.  I have surgery scheduled for 7/26/2021.
could not get dose two within six months from dose one due to the pandemic; This case was reported by a other health professional via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments: The pharmacy operations manager reported that a couple years ago (as reported) the patient could not get second dose of Shingrix within six months from dose one and could not get the vaccine due to COVID. The reporter clarified that it was not due to a COVID infection but due to the pandemic restrictions. The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2022093601 and US2022093603, reported by same reporter, for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093601:Same reporter. US-GLAXOSMITHKLINE-US2022093603:Same reporter.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient who received expired doses of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (also reported as 12-Sep-2018 to 13-Sep-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI869AA, expiry date- 05-May-2018 via unknown route. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for received expired doses of FLUZONE QUADRIVALENT. 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.
I took the 4 doses of VIVOTIF every other day from March 6th-March 12th. I kept the pills refrigerated and took them on an empty stomach, 1 hour before or 2 hours after a meal, as instructed. However, the night of my last dosage (March 12th), I began to notice episodes of bright red bloody stool. Because the stool was non-painful and regular (solid, brown) and I had no other symptoms, I made a mental note of the event and didn't think much of it. However, when the bloody stool episodes persisted every day from March 12th-March 20th, I decided to call Health Clinic to see if this was possibly an unlisted side effect of the pills. The nurse denied any association of the bloody stool with the VIVOTIF vaccine and suggested that I make an appointment with my primary care physician.
Pt recvd 1st dose of MMR vax on 20MAR92 & 45 min p/vax pt devel urticaria lesions on arm around the inject site & a few on legs;
Whole body aches, big red mark on arm of injection which is sore and hot to the touch, headache, fever, chills, dizziness, loss of appetite, chest pain, lymph node swollen and pain in armpit
swelling in lymph nodes of Left arm (size of golf ball), joint stiffness, tenderness
experienced shortness of breath; States his left arm at the injection site also hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer-sponsored program.  A 49-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 25Sep2021 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "experienced shortness of breath"; VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "States his left arm at the injection site also hurts". The event "experienced shortness of breath" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated his left arm at the injection site also hurts and he felt that for a couple of weeks and he thinks at this point that is resolved. Stated he did go to the doctor's office for this and they did do a breathalyzer or EKG or ECG and based on that it was fine and mostly they did it for the symptom of the shortness of breath which is why he was trying to find out the reason and they were not able to find any conclusion. States he had not started any new medications within 2 weeks prior to the reported event and stated he had just been on his regular medications; no further details provided by the caller. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. There were no additional vaccines administered on same date of the Pfizer suspect. The patient stated the shortness of breath started about 3 to 4 days later after getting the 1st dose of the vaccine and stated it was not ongoing but lasted several weeks and he started being able to take a full breath on Monday and he was not a HCP so was not able to say but he was able to take a breath and the shortness of breath used to happen when he was laying down in bed. There were no prior vaccinations, within 4 weeks of vaccination. Family Medical History Relevant to AE(s) was reported as none.   Follow-up attempts are completed. No further information is expected.
Seizure the day after vaccines, a rash that started on the right arm today.  Patient to call if worsens/does not show improvement soon.
Developed chills, nausea, headache, vomiting on 6/24/21-6/25/21, then developed palpitations 6/26/21 prompting evaluation in emergency department and hospitalization for myocarditis
Bruising and swelling at site ..... swelling of lymph nodes and bruising under arm pit... nausea and feverish.
Site: Pain at Injection Site-Severe, Additional Details: Patient stated that when she recieved her shingles vaccine she felt a "shock" go through her body. She stated that she can move her arm around, but that her arm hurts when she raises it over her head and when she moves it. She also states that it hurt while she was sleeping.
Mom describes circular rash around injection site red slightly raised with itching, mom states pt was punched in arm around/near injection site then rash appeared the next morning. On exam 10x7cm oval rash right upper arm, mild redness, per mom rash much better nearly gone.
My son is 16 years of age and was given the Moderna vaccine despite it only being approved for patients over the age of 18. He is experiencing mild fatigue post injection and some soreness at the site. My main concern is the second injection that is scheduled for April 15th at the same location. Should he continue with the course and get the 2nd shot of Moderna? I have been trying to speak to medical center regarding this because not only was his age stated at the appointment and he was found in the medical center system, but he provided id to a woman with the title of director who did not catch it.
Patient was given combined DTAP/HIB vaccine (this should not have been administered combined until 15 months).
Information has been received from a nurse concerning a 17 year old female patient who "has a history of passing out, even if you just draw blood". On 17-JUN-2009 the patient was vaccinated with a first dose of GARDASIL (lot # not reported) 0.5ml, intramuscularly. After got the vaccine on 17-JUN-2009 "the patient passed out and got stiff". On 17-JUN-2009 the patient recovered. The patient sought unspecified medical attention. There were no laboratories diagnostics studies performed. Additional information has been requested.
Red blotchy rash. Started today 04/01/2003. Swollen lymph glands groin area 03/31/2003. Temp 102-103 since 03/29/2003
Patient noticed rash about 2-3 days after Flu shot (9-2-10) that started under breasts. She noticed itching that spread to other parts, arm, face, legs, ankles. She has taken 12 BENADRYL tabs since then and used hydrocortisone cream.
a itchy red rash on the inner ...underside of myleft breast; a itchy red rash on the inner ...underside of myleft breast; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8732) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and obesity. The patient did not have any allergies to medications, food, or other products. Concomitant medications included elderberry (MANUFACTURER UNKNOWN) with zinc oxide (ZINC), ascorbic acid (VITAMINE C) and paracetamol (TYLENOL) all for an unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 day after the vaccine shot, the patient noticed a itchy red rash on the inner, underside of her left breast. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event itchy red rash on the inner, underside of her left breast was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient complains of lymph node enlargement in her breasts, armpits, and neck.  She also claims both arms and legs are swollen.
My back feels like it cracks more often after receiving the second dose. My rib cage also feels like it cracks/pops just like when one cracks their knuckles. While the aches are much less than the day after the second dose, I still feel a lot of back aches and soreness on both arms now.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, pt was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a pharmacist (lot#, expiration date, dose, and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, pt experienced and was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Had adverse reaction to vaccines in office. Hives, redness and swelling on arms and legs. Cough. Tx in office: albuterol nebulizer, 5 mL of BENADRYL in office. Sent to ER.
Patient received a dose of Kinrix a few weeks before their fourth birthday; This was patient's 3rd dose of IPV and DTaP.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 05-APR-2023, the patient received Kinrix. On 05-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix a few weeks before their fourth birthday) and inappropriate schedule of vaccine administered (Verbatim: This was patient's 3rd dose of IPV and DTaP.). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 11-MAY-2023 Medical assistant stated that a patient received a dose of Kinrix a few weeks before their fourth birthday. This was patient's 3rd dose of IPV and DTaP. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Kinrix dose as 3rd IPV and 3rd DTap before 4th birthday, which lead to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
9 x 9 cm injected and indurated area with vesicles at injection site. Area is warm to touch. Keflex 250mg 2tsp BID x 5 days.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On unknown dates the patients were vaccinated with unknown doses of improperly stored PNEUOMOVAX 23 (sdv)(lot # M006139, expiration date 13-MAY-2017) and PNEUMOVAX 23 (syr) (lot # L049744, expiration date 12-OCT-2017) (dose and route were not reported). Date logger was involved. The vaccine had been stored under temperature of 34.9 Fahrenheit for 13 hours, and then was back in range. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
On my drive home, I felt a wave of pressure extend from my left arm (where I received the shot), across my chest and neck, to my right arm. I did not have trouble breathing, but there was a heaviness on my chest. This sensation lasted about 4-5 hours after the shot. I then had swollen lymph nodes under my armpits for several days. Eventually, the swelling went away.
Patient  was   6 months pregnant.  She felt  hot  and  woozy  and  fell.  After water  she felt better.   Young pregnant female - 6 months along  no complications w/ pregnancy was very hot & woozy, didn't make it to chair & went to the ground didn't want to fall far EMS got her water & she quickly felt better
A few hours after the second dose, the patient was so fatigued that he could not walk. He fell down trying to walk. He said his entire body hurt to the point that he could not move.
Pt recved Hep B vax OCT91 & following vax pt exp a funny feeling in head;
urinary issues with urinary tract infection; her arm is bruised up from it; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NUS2022US217671_NS.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed with unknown manufacturer), for Covid-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary issues with urinary tract infection"; CONTUSION (non-serious), outcome "unknown", described as "her arm is bruised up from it". Therapeutic measures were taken as a result of urinary tract infection.  Additional information: Patient was the reporter. The patient reported that she developed urinary issues with urinary tract infection towards the end of Aug2022, she took an antibiotic treatment for this but was still having issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse concerning to her son, a male patient of unknown age. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 21-NOV-2018, the patient was vaccinated with VARIVAX (dose, lot number and expiration date were not provided) administered intramuscularly (incorrect route of product administration) as prophylaxis. No adverse effects were reported for the patient. No further information was provided.
Dtap and IPV were given in the left arm.  The mother was holding the child and another nurse assisted in restraining. The child cried but held still. The child was turned around for the other arm to be vaccinated with Hepatitis B and MMRV. The child knew what was going to happen so she was really tense and trying to move. Appeared to have held her breath while being vaccinated. After immunization the child went limp and appeared to have passed out. The child became sweaty. The mother held her up and splashed water on her face. Mother was instructed to lay the child down so the blood could return to her brain. Mother reassured and asked when the child had last eaten. Child recovered within a few minutes. Mother stated at breakfast. Mother instructed to come back for immunizations in March and make sure the child eats and drinks right before immunizations. Mother gave child a banana to eat.
PT reported left side of her face around the eye area (sinuses) was swollen the next morning and took aout 12 hours to go away.
Narrative:  Patient was not previously COVID-19 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 admitted to a facility on 3/29/21 with details unknown. He passed away there on 4/19/21. His comorbidities include PVD, RA, CAD, HTN, HLD, CKD, h/o coronary bypass
Injection site is warm to touch, knot has formed. This is still present 1 week after injection.
1 day after the 2nd shot in the Pfizer COVID vaccine series he began to develop substernal pressure like chest pain . Patient was admitted into the hospital for 2 days (4/27-4/29) for this substernal chest pain. A CTPE, EKG, and CXR were ordered that were unrevealing as to the etiology of the chest pain. Troponins were elevated on admission with a slightly decreased delta (515->479). An ECHO was ordered that showed a LVEF of 35-40% with moderate global hypokinesis of the left ventricle, right ventricles moderately dilated, and no pericardial effusion.  A Cardiac MRI was then ordered to determine etiology that showed subepicardial late gadolinium enhancement of the basal inferior and mid-inferior and inferoseptal wall consistent with acute myocarditis. Additionally, a small pericardial effusion without signs of inflammation, calcification, or cardiac tamponade physiology. Patient was then D/C on 4/29 after the cardiac MRI with no medical therapy with the recommendation to not partake in physical activity for one month. Will have follow up with cardiology clinic in 1 month and will participate in cardiac rehab.
Sore Throat, Minor Fever, Headache, General/Minor Ache  Acetaminophen
None. Patient was given live vaccine during pregnancy.  11/12/09: OB/GYN Record received for date of service 10/28/09.  Dx:  S/P uterine cervical cerclage. Assessment:  This Gravida 6, Para 1, LMP 7/13/09, 15w, 2d gestational age woman is seen s/p uterine cervical cerclage.  Voices no c/o at this time.  Cervix on exam is long and closed, no mention of AE. There was no adverse event a pregnant patient was given live virus on 10/22/09 with no after effect or problems.