chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED FROM THE INTERACTION OF THE TWO PRODUCTS RISPERDAL AND COVID VACCINE; This spontaneous report received from a consumer who had heard that two people who took Risperdal and got a COVID vaccine died from the interaction of the two products. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received risperidone (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, consumer heard that a few people who took Risperdal and got a COVID vaccine died from the interaction of the two products. The action taken with covid-19 vaccine ad26.cov2.s, and risperidone was not applicable. This report was serious (Death).; Sender's Comments: A report received from a consumer who had heard that "a few people who took Risperdal and got a COVID vaccine died from the interaction of the two products." The patients past medical history, concomitant medications were not reported. COVID-19 vaccine ad26.cov2.s date and dose administered were not reported. Risperidone dose, frequency, therapy dates and indication were not reported. There is insufficient information provided in this case to make a meaningful medical assessment.
Can't get warm after the 2nd dose; Gets lightheaded when she gets up after the 2nd dose; Achy all night after the 2nd dose/ Severe body aches after the 2nd dose; Severe chills after the 2nd dose; Temperature from 99.8 F - 100.8 F after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Can't get warm after the 2nd dose), DIZZINESS (Gets lightheaded when she gets up after the 2nd dose), MYALGIA (Achy all night after the 2nd dose/ Severe body aches after the 2nd dose), CHILLS (Severe chills after the 2nd dose) and PYREXIA (Temperature from 99.8 F - 100.8 F after the 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036821a) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Can't get warm after the 2nd dose), DIZZINESS (Gets lightheaded when she gets up after the 2nd dose), MYALGIA (Achy all night after the 2nd dose/ Severe body aches after the 2nd dose), CHILLS (Severe chills after the 2nd dose) and PYREXIA (Temperature from 99.8 F - 100.8 F after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING COLD (Can't get warm after the 2nd dose), DIZZINESS (Gets lightheaded when she gets up after the 2nd dose), MYALGIA (Achy all night after the 2nd dose/ Severe body aches after the 2nd dose), CHILLS (Severe chills after the 2nd dose) and PYREXIA (Temperature from 99.8 F - 100.8 F after the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 - 100.8 (High) High.         Concomitant medication was not provided Action taken with mRNA-1273 in response to the events were Not Applicable   This case was linked to MOD-2021-095534, MOD-2021-095534 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow Up document was attached on 28-May-2021 which contains no new information
Information has been received from a pharmacist and nurse in a pediatrician's office concerning a 6 month old male with Down's syndrome, reflux, trial septal defect, recurrent pulmonary infections and congenital heart defect (type unknown no corrective surgery) and no drug allergies who on 18-SEP-2007, 29-NOV-2007 and 26-FEB-2008 was vaccinated PO with a dose of Rotateq (lot# 657670/0901U, 657672/0903U, 657989/1838U).  Concomitant drug therapy included PREVACID.  In February 2008, a few weeks ago, the patient had a previous hospital admission for aspiration.  The nurse mentioned that the patient had aspirated before, but not after the first and second doses of Rotateq.  The nurse did not have specifics on interventions, but said that the pediatrician would have the information.  On 16-FEB-2008 a chest X-ray revealed interstitial infiltrates and cardiomegaly.  On 17-FEB-2008 the chest X-ray showed persistent infiltrates.  On 26-FEB-2008 from the nurse's understanding, he "just aspirated on the Rotateq and it was not necessarily an allergic reaction.  On 27-FEB-2008 another chest X-ray showed left lower base infiltrates and cardiomegaly.  On 29-FEB-2008 early in the morning the patient was admitted to the hospital with a diagnosis of pneumonia.  Prior to admission the chest X-ray that was performed at 02:30 showed cardiomegaly, severe and persistent bilateral infiltrates.  At the time of this report, the patient remained hospitalized according to the pharmacist and pediatrician's and pulmonologist's offices.  The patient was recovering noted to be doing better but still had a lot of infiltrates.  There was no product quality complaint.  Additional information has been requested.  3/19/08 Reviewed hospital medical records of 2/29-3/7/2008. FINAL DX: Down's syndrome; aspiration pneumonia; bronchomalacia; atrioseptal defect; GERD; dysfunctional swallow. Records reveal patient experienced gag, cough & choking s/p rotavirus vax.  That night was febrile & had decreased O2 sats.  Seen by pcp.  Tx w/oral antibiotics.  Worsened & taken to ER where noted to have severely decreased O2 sats.  Admitted to PICU.  Tx w/IV antibiotics.  Improved very slowly.  Feedings changed from oral to transpyloric to minimize further risk of aspiration.   Developed bilateral interstitial infiltrates.  Tx w/diuretics.  Bronchoscopy done 3/7/08 revealed bilaterally large airway bronchomalacia & thick mucuous plugs.  Improved to room air by d/c & was able to tolerate thickened formula.
A non-serious spontaneous report of expired FLUMIST given to this child was received from a certified medical assistant in a physician's office concerning a 48-month-old male. Neither medical history nor concomitant medications were reported. On 26-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 25-Dec-2008. There was no adverse event 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 a post-marketing commitment on accelerated reporting for the newly population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Additional information was received on 03-Feb-2009: The reporter confirmed there were no delayed occurring adverse events. Follow-up information received on 24-Mar-2009 included Product Complaint Investigation results.
Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day  Lasted over a period of 2 days
Pruiritic rash on arm on 5/23 Hives and purpura-like rash on bilateral arms, legs and chest on 5/24 Hives on neck and face; SOB, difficulty swallowing on 5/25
Heat, Redness, Swelling of injection site. will see MD on 10-28-16 if no better.
This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a "nurse" via a company representative and follow up information has been received from a licensed practical nurse concerning an 18 year old female student who on 26-OCT-2006, was vaccinated in the arm with a first dose of GARDASIL (Lot# 653735/0688F). The nurse reported that the patient experienced nausea and dizziness the same day as the vaccination. Follow up information from the nurse also indicated that the patient had experienced nausea, shaking and a "stoned feeling" on 26-OCT-2006. The patient returned to the office and was stable with no urticaria, no erythema, no swelling. Her blood pressure was 118/62, pulse 92 and respiration 20. It was reported that the patient had "blood work" done (results not reported). It was not known whether the patient recovered. The patient sought unspecified medical attention. Subsequently, on the same day, 26-OCT-2006, the patient recovered. Additional information is not expected.
Erythema and induration at site of injection about 5cm in size with redness moving down the arm almost to elbow with width 4cm or so. Tender at indurated area.
On 05/20/22 I had diarrhea. I am prone to it because I have no gallbladder and certain foods I eat. At first I didn't think anything about it but then thought why was it happening. Nothing I had eaten should have given me problems. It was severe diarrhea. I almost didn't make it to the restroom. The next day I was fine until after dinner. I took Imodium and it helped. It was one episode of diarrhea every day after the afternoon time for about 3 days. I did eat desert on the days I had a diarrhea and stopped because I thought it was the pie crust in the the desert. I have not had diarrhea since Sunday 05/22/2022.
Infected tooth nerve 12 days after first pfizer vaccine. No history of tooth issues.  UTI 14 days after 2nd pfizer vaccine. No history of UTI or infection.
Bilateral knee pain with effusions requiring injections of steroids. No prior history of joint effusions.  After approximately 3 months,  Recurrent knee L knee effusion treated conservatively
Fever, chills, nausea, headache, and arm soreness. Teeth chattering from chills.
Approximately 4 hours after receiving my second vaccine of Shingrix, I experienced extreme sweating, fever, dizziness, nausea, chills, loss of balance. I could not stand or walk. I was disoriented and fell. I could not stand and had to crawl to get back to bed. I could not eat for 48 hours. I drank only water and one Sprite.
Nearly 3 months after receiving the shot, and quite suddenly, I developed severe pain in my entire right arm. The shot was given quite high up on my arm, close to the shoulder. I commented about the height of the shot, and was told, "that is how we do it". The pain was in the muscles of my arm and the tissues that make up the shoulder. The pain was debilitating, making it difficult to put a shirt or coat on, drive a car, push a door open, etc. The pain, after 9 days has lessened and will hopefully go away so I don't need to see a doctor for treatment.
Low-grade fever observed on 18JUL2021.; This is a spontaneous report from a contactable Pfizer colleague reported for a 15-year-old male patient that, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 17Jul2021 (at the age of 15-year-old) as single dose for covid-19 immunization. There were no concomitant medications. Known allergies and other medical history was reported as no. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 26Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 15-year-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low-grade fever observed on 18Jul2021. Seriousness was reported as non-serious. Patient did not receive treatment for adverse event. The outcome of the event was resolved on unknown date in Jul2021.  Information about lot/batch number has been requested.
101.5 Fever, Nausea, joint pain, muscle aches all over body, severe fatigue, headache, severe injection site soreness
Delayed allergic reaction on day 8, following vaccine #1. Sudden onset of HUGE induration (thick, hard, hive-like plaque) measuring 5cm x 10cm with additional fingerlike projections, hot,  red, swelling with itching. Treated at home with diphenhydramine.
Severe Puritic Body Rash that started as Pustules and progress to full blown Cellulite to Boils.  Rash over upper 1/3 of body and arms as well as buttock lesions and Left foot.  No Sleep from 5-6-2021 to today 5-24-2021.  Atarax and Steroids and Antibiotics have not helped.
Pt encountered difficulty speaking, this episode lasted 5-7 minutes. Pt currently being evaluated in the ER and getting a work up for TIA
On 4/10 I got the J&J shot at Medical Center at 8am.  12 hours later at 8pm I experienced the normal side effects - body aches, tired, arm pain.  I slept it off and the next day felt better - took a nap, but no problems.  8 days later on Sunday (4/18) I started to get a headache, on the top of my head (where a hat would go) and the back of my head.  It was on / off, but it's out of character as I don't normally get headaches.  On Monday, it continued on/off so I wrote my doctor...on Tuesday it continued more "on" then off - she recommended I go get bloodwork for low platelets and I did (at medical center). They came back normal.   On Wednesday (4/21), the headache became a migrane and was screaming at me - all day with no relief.  I've never had a migrane in my life and needed to be in low light - screen time became hard to deal with.  I did get a Covid Test to rule out that and it came back negative Thursday morning.  Thursday morning - same....screaming headache.    Friday, less screaming but still not great - I met with my doctor on telehealth and she recommended I go to the ER to get evaluated.   I went to another hospital on Friday afternoon to get evaluated.   Since my bloodwork from Tuesday was all clear - they believe the migrane was inflammation from my immune response to the vaccine - especially because i never had a migrane before.  They gave me anti-inflammatory meds via IV to mellow out the pain.  They said if the pain came back or if I had other symptoms in the coming week to check back and likely need imaging.    Today is Saturday (4/24) - the anti-inflammatory meds have helped but not 100%.  I do still have some throb on/off and had a few dizzy feelings earlier.
PATIENTS STATES  SHE FEELS FUNNY WITH MILD ABILITY TO TAKE A DEEP BREATH. PATIENT HEART RATE IS 70 AND REGULAR WITH RESPIRATIONS OF 20. TIMER RESET FOR ADDITIONAL 15 MINS WITH INSTRUCTIONS TO HONK HORN OR BLINK LIGHTS IF IN ANY DISTRESS. PATIENT STATES FEELS BETTER WITH BLOOD PRESSSURE OF 137/79  HEART RATE OF 70, RESPIRATIONS OF 20 AND O2 SAT AT 97%. PATIENT AGREED TO REMAIN FOR 15 ADDITIONAL MINUTES. PATIENT STATES FEELS FINE WITH NO OBVIOUS DISTRESS AND WILL GO TO EMERGENCY DEPARTMENT IF SYMPTOMS RE-OCCUR.
Pt came to ER c/o URI and nasal drainage onset 3 weeks prior.
Pt recvd vax & w/in a wk of immun pt devel hyperglycemia;
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Angina, chills, shaking, sweating, vertigo, tinnitus, double vision, difficulty walking, , swelling in hands and feet, fatigue Narrative: Still feeling dizzy, with headache and mild nausea and taking Tylenol and Zofran. The vertigo has persisted despite meclizine treatment. Loss of balance head is moved quickly. Does not drive to vertigo. Still feels ill. Tinnitus, headache and utter exhaustion every day.
Extreme dizziness and vertigo and headache, blurred vision, nausea, vomitting, fatigue. Headache and pressure on the sides of my head for two days.  Trouble with balance while ambulating through the next day after the shot.
72-year-old female with past medical history of non-insulin-dependent diabetes, hypertension, hyperlipidemia arrived to ED complaining of shortness of breath.  She tested positive for COVID-19 and had increasing oxygenation requirements in the emergency department requiring BiPAP 40%.  She was transferred to our facility for further care.  ---------- Hospital course:   1/18: Patient appeared comfortable on BIPAP this AM. Transitioned to HHF but unable to tolerate due to tachypnea. Likely a COPD component more than oxygenation.
Nausea, swollen and sore glands, diarrhea, vomiting, fever
Approximately 2-1/2" x 4" rash at injection site, 8 days post injection.  Itchy, tender, red, raised.
Began having trouble swallowing about a month later until present. Also had pain behind the right eye and blurring vision. The pain has subsided but the blurry vision persists.
Patient experienced adverse events such as fever, vomiting, rash and went to the ER 2 days after receiving the vaccine
Reaction began around 7pm (3 hrs after shot) with numbness spreading from injection site through neck and left side of face. Numbness in arm and neck faded but numbness in face remains. Can move it, but it is persistently numb and sometimes tingly.
Pneumococcal vaccine uptake in pregnant individuals; Information has been received from the authors in a published literature article, entitled as stated below, referring to a retrospective cohort study on pregnant woman, to evaluate the pre and post-guideline cohorts to determine if Tdap vaccine uptake and timing improved after the new Tdap guidelines. Additionally the cohort examined influenza and pneumococcal vaccine uptake before and after guidelines.  The authors found that nearly one-third (N = 675, 29.5%) of individuals were eligible for the pneumococcal vaccine.  No information was provided regarding the patients' medical history, concurrent conditions, past drug history or concomitant medications. Frequency of receiving the pneumococcal vaccine during pregnancy was low throughout the study period, with only 3.8% (N = 8) of eligible individuals in the pre-guideline cohort and 7.3% (N = 32) of eligible individuals in the post-guideline cohort receiving the pneumococcal vaccine (manufacturer unknown) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).  Also the authors observed that there was no significant difference in uptake of the pneumococcal vaccine during pregnancy among eligible individuals in the post-guideline cohort compared to the pre-guideline cohort.  The authors stated that among their study cohort, pneumococcal vaccine uptake was low throughout the study period, consistent with prior reports of poor obstetric provider knowledge about the pneumococcal vaccine. The also stated that a 2020 survey assessing resident knowledge on pneumococcal vaccine during pregnancy found that obstetrics and gynecology residents expressed a comfort level of 3.8/10 in regards to understanding potential candidates for the vaccine.  Another study on a nationally representative sample of residents found that the majority of residents demonstrated low or moderate knowledge of the indications for pneumococcal vaccine during pregnancy.   The authors pointed out that areas for future work include examining whether improving provider knowledge of pneumococcal vaccine eligibility criteria results in improved patient receipt of indicated vaccines  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report: Association of Tdap vaccine guidelines with vaccine uptake during pregnancy.  2021-07-01. 16: 1-12.
A report was received from a health care professional on 11/19/03 concerning a 32 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report was received from nurse practitioner referring to patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 22-JUL-2014 patient received improperly stored MMR II [LOT # J009382/ exp. date 08/08/2015], exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with cases 1407USA012136, 1407USA104425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000012, 1408USA000013, 1408USA000015, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, 12 hours after receiving SHINGRIX, the patient experienced shivering, fever, headache and myalgia. On 10th April 2018, the patient experienced nausea, light headedness and welts. On 14th April 2018, the patient experienced tiredness. In April 2018, the outcome of the shivering, fiver, tiredness, nausea, light headedness and welts were recovered/resolved. On an unknown date, the outcome of the headache and myalgia were not recovered/not resolved. It was unknown if the reporter considered the shivering, fever, headache, tiredness, nausea, light headedness, myalgia and welts to be related to SHINGRIX. Additional details were provide as follows: The reporting nurse practitioner was the patient. The patient received SHINGRIX on an unknown arm. One day after vaccination, the patient experienced nausea, lightheadedness, dizziness and welts on arms. Five days after vaccination, the patient experienced tiredness. Only partial information was provided by the sales representative from the nurse practitioner.
Patient received vaccine.  Proceeded to observation area and 10 minutes into wait period of 15 she started complaining of pressure in her neck and head and in middle of her chest.  Vital signs taken, pt states normal blood pressure is 120/70, current B/P 166/82, O2 sat 100 HR 66, 10 minutes later B/P 181/79, Team Alert called and patient taken to the Emergency Deparment via gurney, alert and oriented.
In addition to pain at the injection site, I developed headache and muscle pain on Oct 12, 2023.  I slept only fitfully that night.  When I got up on Oct 13, I felt as though my head was pounding.  I took my blood pressure before breakfast at 6:30 am.  It was elevated: 147/67 and my heart rate was 105.