chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient's mother called in today saying that the patient was nauseous and throwing up all morning. She received her second Moderna covid shot last night (6/2/21). The mother said that her husband was going out to get pedialyte for the patient, but wanted to know what else I would recommend. I told her to try to keep her hydrated with something along the lines of pedialyte or gatorade.  I told her that she should put a phone call into her family doctor as well to see what they might recommend. I said they could prescribe an antiemetic if the N/V continues. I said if it does continue and she is not able to keep anything down that they may want to have her seen at a walkin clinic or ER.
36 hrs - incredible headache, shiver, fever (feel like), nausea - vomit 2 times - 1st time 24 hrs after vaccine: 2nd time - 30 hrs after. No food eaten for 36 hrs, then small amount. At 48 hrs - headache less, stomach pain, injection site sore. Before: Feeling great and in good mood! Day 1: 3:15: Shot administered. 6pm dinner, then after dinner feel so full, no food rest of night. 11pm bed: Not feeling great, but sleep. 7am awaken with incredible headache, feel like have a fever, shiver, stomach nausea - didn't want to eat. Dysfunctional feeling.  Noon Eat a little bit. 1pm vomit. 6pm try again eat a little 9 pm - vomit. Intense condition lasts until 7am Day 2. Day 2 morning: above day's headache, fever, shiver, nausea lessens, Noon - eat a little. 3 pm - stomach.
Body aches; Chills; Headache; Arm was really, really sore - the whole arm; This is a spontaneous report from a contactable consumer (patient who is a mental health therapist). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 15Jan2021 at 16:00 (4 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccines were given the same day or 4 weeks prior. No problem with vaccines in past that she can recall from childhood. The patient received the vaccine last Friday (15Jan2021) and side effects started early evening Saturday (16Jan2021) or late afternoon. The patient had body aches, a few chills, headache, and her arm was really, really sore - the whole arm. At the time of reporting, all are way better. The patient was recovering from the events.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Patient had a stroke several years ago and is dependent on wife for mobility and caregiving needs. Patient experienced syncopal episode 20 minutes after receiving second dose of Pfizer shot. First shot was uneventful as per patient's wife. His wife also stated that he took his lisinopril about 40 minutes prior to coming in to receive vaccination. He did not take his blood pressure prior to coming. Patient was transported to local emergency department by EMS. I attempted to call patient's wife, no answer. Outcome currently unknown.
This spontaneous report was received from a pharmacist referring to a 76 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. Information about concurrent conditions and concomitant medication was not reported. On 23-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R018735 with expiration date 06-APR-2020 intramuscularly in the right arm (dose detail was not reported) for prophylaxis (reported as pneumonia) and also vaccinated with influenza virus vaccine intramuscularly in the right arm (dose detail, lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2018, the patient experienced erythema in the right arm and unspecified swelling at the elbow. The patient self medicated with topical diphenhydramine hydrochloride (BENADRYL) (reported as manufacture unknown) and topical cortisone cream (reported as manufacture unknown) without relief. On 03-DEC-2018, the patient returned to the pharmacy and pharmacist advised patient to take oral diphenhydramine hydrochloride (BENADRYL) (unspecified dose). There was no lab diagnostics/studies preformed. The outcome of events were reported as not recovered. The causality assessment between events, PNEUMOVAX 23 and influenza virus vaccine were not reported.
BODY ACHE; LEFT SHOULDER PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced left shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, and left shoulder pain. This report was non-serious.
3:00 pm:  sore arm, fatigue 6:00pm : severe muscle weakness, unable to sit, turnover in bed without assistance, joint pain, muscle aches 8:00pm : excruciating headache, chills x 2 hours 10:00pm:  temp 102.9,  SOA pulse ox 92-95% Symptoms persisted for more than 36 hours. On Sun while showering, I noticed diffuse rash on my entire arm and swelling at the site.  I had not examined the site before, due to going to bed at 6:00pm By Monday, I feel extreme fatigue
Chickenpox (mild case) in a healthy vaccinated child, aged 5.8.
pains in arms; didn't feel good; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (COVID 19 Vaccine), dose 1 via an unspecified route of administration, administered in left arm on 23Jul2021 (Lot number EW0178/ EWD178, further not clarified hence, not captured in tab) as dose 1, single at the age of 69-year-old for COVID-19 immunization. Medical history included glaucoma. Concomitant medications were not reported. No investigation assessment. 3 weeks ago the patient got the 1st Pfizer vaccine, he got pains in arms that he got them in and it didn't feel good for him, no fever nothing like that in 2021. No treatment received. The outcome of events was unknown. The lot number for bnt162b2, was not provided and will be requested during follow up.
Developed a sporadic, itchy rash over various parts of my body. Rash would show up anywhere and would show up without reason or cause. When I would feel itchy, I would scratch the area and then realize that I had a rash. The scratch marks would become very red and raised and would stay for a few hours. An allergy pill would help the symptoms subside for a few hours. At times, I would get so itchy that I felt as though I wanted to rip my skin off to relieve the itching. The itching continued to get worse. I finally got an appointment with my doctor and she diagnosed me with Dermatographism. She prescribed a 10mg allergy pill once a day and 20mg of an antacid twice a day. I also have 25 mg of Hydroxizine that I could take at night if I was too itchy and couldn't sleep (I have taken it on 2-3 separate occasions since prescribed). I did this routine for 2 weeks. Some of the symptoms subsided (no more raised bumps/lines from scratching and when I did scratch, it wasn't as bright red anymore and didn't last for hours). But I was still very itchy. My doctor increased the allergy pill to 20mg and kept the other medications the same. I tried this for 3 weeks and was still itchy. I was referred to an allergist. She told me to increase the meds again. I am now currently taking 20mg of the allergy pill in the morning and 20mg at night. I am continuing the antacid 20mg in the morning and 20mg at night. I still have the Hydroxizine incase my itching is too unbearable at night. I began the allergist's recommendations yesterday. I am extremely itchy today.
severe pain in left arm down to fingers and sore neck , extreme fatigue slept for 20 hours, Diarrhea that lasted 12hours
Patient called 9/27/2017 saying the right arm was red and inflamed. She stated yesterday she applied cold compress which seemed to reduce inflammation. Patient was counseled to seek attention from her MD to ensure there is no infection. She stated she would contact her MD.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
FELT TIRED; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total, dose 1 (first dose) administered in left arm on 25-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 25-MAR-2021, the patient experienced slight headache (Dose number in series 1). On 26-MAR-2021, the patient experienced felt tired and she rested for the day (Dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 2 (second dose) administered on 23-DEC-2021 for covid-19 prophylaxis.  No adverse events were reported following vaccination with booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight headache and felt tired was not reported. This report was non-serious.
DEATH N17.9 - Acute kidney failure, unspecified B96.4 - Proteus (mirabilis) (morganii) as the cause of diseases classified elsewhere
Localized swelling that extended about 8 x 8 cm with itching and redness, no respiratory symptoms or anaphylaxis.
Pt had vomiting, diarrhea, dehydration.  EMS was called 7 days after vaccination as pt refluxed on vomit, aspirated, and stopped breathing.  Rescue breathing was administered by mother in the home, transported to ER (01/19/07), admitted to hospital x 4 days.  09/21/2007 MR received for hospital DOS 1/19-21/2007 for DX of ALTE possibly 2' to GERD despite normal UGI.  Infant presented to ER with 3 day hx of vomiting with loose green stools.  On date of admit infant regurgitated feeding then developed blue lips, flaccidity and lethargy.   2nd episode in ambulance on way to hospital.
medical assistant provided expired MENACTRA vaccine to a patient/no AE; Initial information was received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a Physician via (Medical Information-00730396).  This case involves a 17 years 3 months old male patient who was vaccinated with expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 14-Aug-2021, the patient received 0.5 mL (total; standard) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AB and expiry date 26-Jan-2021) via an intramuscular route at the left deltoid for prophylactic vaccination.  It was reported "HCP called back to provide AE information from previous call that he had to disconnect from. Doctor reports that medical assistant provided expired MENACTRA vaccine to a patient on 14Aug2021.Doctor also asked about the most common side effects that may occur with an expired dose of MENACTRA but was unable to hold for a MIS transfer. Caller was advised on previous call that vaccine was not valid. MA got the expiration date confused and mixed up the year with the date 26-Jan-21. She thought it expired in 2026".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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.
Pt noticed red circle where ZOSTAVAX (approximately inch in diameter) was administered about 2d after administration - no pain, itching noted. No treatment was necessary per MD.
fainted, diaphoretic, became hypotensive, dizziness persisted after being in trendelenberg position >one hour, patient very sleepy following syncopal event
Patient in lobby for observation following 1st dose pfizer He fell off chair hit head , left side Unconsciousness, syncope episode at 1034, diaphoretic and pale Legs elevated with chair Patient regained consciousness within 1 minute approximately Left side of forehead and outer left eye with abrasion , covered with guaze Vitals taken continuously ( see vitals)  911 called by RN RN assisted with assessment, she applied 02 @2l nc Paramedics arrived at 1045 Verbal report provided Past Medical History reviewed, 1st dose pfizer given at 1008 NO KNOWN DRUG ALLERGIES to vaccines No nausea or vomiting No shortness of breath Patient awake, alert , clear speech Assisted to standing position from floor by paramedics
Patient received the vaccinations at the age of 11, because the mother misinformed the clinic and stated the birth date was 4/26/2009, so they would appear to be 12 and eligible for the COVID vaccine.  A school nurse brought this up to our attention. The mother admitted to the school she intentionally misrepresented her daughter's age.
A lot of severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot of severe side effects) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A lot of severe side effects). At the time of the report, VACCINATION COMPLICATION (A lot of severe side effects) outcome was unknown.            The patient had a lot of severe side effects since Monday when she had the second dose of the vaccine.   No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has no allergies to medications, foods, and other products.    On 26-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 26-Feb-2021 and second dose administered on 30-Sep-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has no acute illness at the time of vaccination and up to one month before.  No concomitant medications were provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2022-572300 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The nurse reported that a patient received first dose of GARDASIL on 22-JUL-2014 and second dose of the series on 03-JUL-2015 with GARDASIL 9 (doses and route of administration were not reported). It was also reported that on 30-JUL-2015, the patient was inadvertently administered this third dose of the series with GARDASIL 9-only 27 day interval. No adverse effects reported. Additional information has been requested.
I had a runny nose, congestion, scratchy throat, headache, sore throat, and a cough. I thought I had a minor cold, but after the eighth day I decided to go to the doctor because it just wasn't going away. I went to Urgent Care, and they told me too much time had passed to test for COVID-19 and Flu. They prescribed Benzonatate and Azithromycin. I also took Zinc and Vitamin C. I still feel a little inflammation in my throat when I am talking to people wile at work, but other than that I am feeling better.
Diarrhea for 2 weeks vomiting headaches  rash extreme fatigue  complete brainfog and forgetfulness lack of coordination and blurry vision and chest pains tightness with shortness of breath not to mention menstrual irregularities and heated feelings thru body with excruciating back and body pain
When probed if consumer contracted COVID after getting the shot, Consumer (First patient) stated, "Yes, we both got. He is with me on the phone."; When probed if consumer contracted COVID after getting the shot, Consumer (First patient) stated, "Yes, we both got. He is with me on the phone."; My penis shrunk; This is a spontaneous report from a contactable consumer (patient). This was the first case (First patient) out of the two cases. There were two patients over the call. A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 16May2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, consumer (first patient) added, so him and his colleague, who was also on the phone, we are very concerned because we are vaccinated and his penis had got smaller, considerably smaller and he dont seem to have any sort of protection from COVID he had contracted it. He had been suffering with symptoms, so he was curious, he was very angry with Pfizer. When probed if consumer contracted COVID after getting the shot, consumer (first patient) stated, yes, we both got. He was with him on the phone. When probed if both consumer and the colleague contracted COVID after taking the Pfizer Vaccine, consumer (first patient) stated, correct, exactly. Consumer (First patient) stated, he received his vaccination on 16May. Consumer hung up the call abruptly, hence, product details and other details were unknown. Limited information was available over the call. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted covid on 2021. The outcome of events was unknown.  QR comment: Reporter type was not available over the call as consumer hung up abruptly, hence reporter type was captured as consumer or non-healthcare professional by default.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Covid breakthrough.  Received 1st vaccine 01/16/2021.  Pt presented from Nursing Home with increased confusion and incontinence.  Treated with IV abx.
3 cm area of induration and erythema surrounding right thigh injection site with faint reticular non blanching erythematous rash behind ears, cheeks, trunk, arms, no vesicle, no crusting.
Chills, fever, pain all over, lethargy, cough, tired, headache, joint pain, stiffness
Had vaccine Wed. evening. Woke Thursday with headache and throbbing arm.  Went to hospital. Took BENADRYL and APAP.
Severe shaking. Admitted to ED for 180/90 blood pressure and  rapid heartbeat (>120). Screened for potential pulmonary embolism and blood clots
08/11/2004 adverse reaction to varicella -Vaers completed VFC vaccine provided to Dr by Health clinic for 08/04/2005 dose of MMR. 08/04/05 MMR vaccine given by Doctors nurse, who reported that child is reacting, wheezing, coughing, shortness of breath. Dr administered Benadryl PO and epinephrine injection, EMS called and transported child to Medical Center. Copies of vaccine record given to EMS and Dr. Doctor will most likely write a medical exemption for remaining IPV dose due to possible reaction. Child is not allergic to gelatin. 08/04/2005 2:00 received call from mom, states child doing well. Can call mom at work for additional information. 08/18/2005 3:35pm call to mother. Mother reports child is fine now. Vaers completed. Child was at ER 08/04/2005 for about 1 hour. received oral steroid (Orapred) No other treatment. Dr has given certificate of immunization with medical exemption to IPV.
Initial misuse report received on 09 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a YF VAX (lot number, route and site of vaccination was not reported) on an unspecified date. Vaccine was reconstituted with sterile water from MMR. As of 09 December 2013. Patient did not have any adverse events. List of documents held by sender: none.
A non- serious event of "we gave expired vaccine to a four-year-old patient" was received from a health professional concerning a four-year-old female patient. The patient's medical history was not provided. On 04-Feb-2010, the patient was inadvertently administered FluMist that expired on 24-Jan-2010. There was no adverse associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FluMist.