chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a physician's assistant for the Merck Pregnancy registry, concerning a 17 year old white female with no medical history and a history of 0 previous pregnancies who on 30-OCT-2006 was vaccinated with the first dose of Gardasil (lot #653650/0697F) 0.5 ml intramuscularly. On 2-JAN-2007 the patient received her second dose of Gardasil (lot #654389/0961F) 0.5 ml intramuscularly. Subsequently, the patient presented with a pregnancy (pregnancy test found positive). The patient's LMP was 24-DEC-2006. The patient sought unspecified medical attention. Additional follow up information has been received: From 13-FEB-2007 to 29-JUL-2007 the patient received prenatal vitamins. On 20-MAR-2007 an ultrasound was performed, results were not reported. From 25-APR-2007 to 29-JUL-2007 the patient received nifedipine 20 mg PO Q 4 hours for preterm labor. On 03-MAY-2007 and 04-MAY-2007 she received 12 mg bethamethasone for prevention of respiratory distress syndrome. On 02-MAY-2007 she received general anesthesia for circlagic placement due to incompetent cervix. From 20-JUN-2007 to 29-JUL-2007 the patient received PREVACID 30 mg daily for gastroesophageal reflux disease (GERD). On 29-JUL-2007 the patient underwent amniocentesis for fetal lung maturity. The result indicated mature fetal lungs. On 30-JUL-2007 2 liveborn female infants were delivered at 31 weeks from LMP. Weight of twin A was 2425 g; APGAR score was 9/9. Weight of twin B was 2405 g; APGAR score was 8/9. The infants were normal; there were no congenital anomalies. However both twins had other complications/abnormalities: placentas. Twin A massive chronic villitis. Twin B focal chronic villitis. It was noted that the mother had a complication during pregnancy: gestational thrombocytopenia. She also had a complication during labor/delivery, specifically arrest of dilation resulting in c-section. Upon internal review, premature infant births at 31 weeks and arrest of dilation resulting in c-section were considered other important medical events. Additional information is not expected.
These symptoms lasted 6hrs Cold chills, fever, nausea, headache, body aches, soreness at injection site.  These symptoms lasted 12hrs Headache, soreness at injection site
My first period after my second shot was the worst period I have ever had in my entire life. 3 days of cramps (usually have one bout, maybe) Extremely painful cramps (typically they are only  mild to severe) more bleeding than usual and excessive blood clots (typically I have a few small ones) I experienced very large blood clots and many of them to the point that I contacted my doctor.
Swelling of left arm where vaccine was administered, rash where vaccine given, pain in arm, flu-like aches and symptoms.
Inflamed and red area below the vaccination site. Patient complained of pain in her limbs and a headache.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2010, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a physician for shingles.  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care 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.
Around 09:00 pm I started to feel muscle pain, hot breath, hot ears, headache and a slight fever 99 ° F. Approximately at 10:30 p.m., the fever increased to 104 ° F, muscle pain intensified all over the body, my teeth hurt, headache and chills. I took one (1) tablet of ACETAMINOPHEN 650MG, I took a cold bath and I put an ice pack on my head to lower my fever. I kept monitoring the temperature that at some point reached 104.9 ° F. Around 1:30 am I began to see that the temperature started to go down little by little. Around 2:30 am my temperature returned to 98 ° F and I no longer felt chills, no hot breath, neither hot ears, nor muscle pain was mild, I felt tired, headache was minimal. My last temperature was 97.5 ° F at 3:00 am. I got up around 10:30 am and I just felt tired and mild muscle pain.
had the vaccine on 09Feb2021 and had taken Praluent injection for her cholesterol and wants to know if it will not affect the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation And patient also received alirocumab (PRALUENT, formulation: injection), via an unspecified route of administration from unknown date at unknown dose for cholesterol. The patient medical history and concomitant medications were not reported. The patient had the vaccine on 09Feb2021 and had taken praluent injection for her cholesterol and wants to know if it will not affect the vaccine. On an unspecified date, the patient underwent lab tests and procedures which cholesterol results were Had taken Praluent injection for her cholesterol and wants to know if it will not affect the vaccine. Therapeutic measures were taken as a result of had the vaccine on 09Feb2021 and had taken praluent injection for her cholesterol and wants to know if it will not affect the vaccine. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
From correspondence received on 03/28/01, it was reported that a female patient received a Fluzone SV '01-'02 vaccination on 10/26/2001. Reportedly, that same day, the patient developed a 1.5 cm local reaction of redness, soreness and a fever. Reportedly, the patient recoved from this experience. This report is linked with case # U200101092 and U200200328
tested positive for Covid 19; If yes, date/location received/brand (Pfizer/Moderna/Janssen): Astra Zeneca; Dose 1 date: 11/19/2020 Lot # AD3322; Dose 2 date: 12/17/2020 Lot # AD3424.
pt awoke from nap on 22OCT92 t101 R had raised hives over most of body; mom called MD & appt was made for later in PM but hives had nearly faded so appt was cancelled; only a few hives remained 23OCT92;
ADEM; The patient suffered debilitating injuries including an outbreak of painful shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 12-AUG-2012, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster) in a pharmacy. Approximately in February 2013, six months after receiving zoster vaccine live (ZOSTAVAX), the pt suffered debilitating injuries including an outbreak of painful shingles and a diagnosis of acute disseminated encephalomyelitis (ADEM) as a result of the vaccine. These injuries caused severe brain injuries which incapacitated Plaintiff and caused her to be housed at an assisted living center where she received 24-hour supervision and caregiving. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Additionally, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of ADEM and shingles were considered as not recovered. The reporter considered ADEM and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of ADEM was determined to be medically significant. The reporters considered ADEM and shingles to be disabling.
Pfizer COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/20/2021, 2/10/2021 and 9/08/2021. on 1/4/2022. Presented to ED with complaints of cough and shortness of breath, admitted for acute hypoxic respiratory failure due to COVID-19 and Pseudomonas pneumonia.  She was intubated 1/5 and extubated on 1/10, treated w/steroids, vancomycin and cefepime, remained on NIV without ability to wean. Expired on 1/15.
Patient presented to the pharmacy requesting a Covid-19 vaccine and requested the booster dose.  He claimed to have left his previous Covid-19 vaccination card at home.  Upon administering the Moderna Bivalent vaccine and presenting him with his "second" vaccination card, he admitted that he had not received any previous Covid-19 vaccines, and should have been given the original Moderna vaccine.
This spontaneous report as received from a nurse refers to a 5 year old female patient. The patient's medical history was not reported. On 16-FEB-2015, the patient was vaccinated with the expired dose of PROQUAD lot # J008572, expiration date 12-JAN-2015, second dose, 0.5 ml, subcutaneously (site of vaccination was not reported). No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
There were two adverse events, loss of muscle strength in abdomen, such that rising from a sitting to a standing position and then marshaling the muscles to walk was extremely difficult and I could not fully straighten my back once on my feet. This began on March 6 and lasted three days. The second was the development of a lump in the underside of my right metatarsal arch, which remains there. It is painful to the touch. I noticed it on March 8 or 9.
Bitter Metallic Taste in my mouth.  Lasted 24 hrs, and abated completely.
The afternoon and next day of shot I had soreness in arm. Over next several months, fatigue, numbness in both hands, loss of lower body muscle strength, numbness in both feet, until unable to lift feet, finally collapsing due to leg weakness; at which time, I went to ER. Diagnosed on 4/24/14 as having CIDP / treatment has been prednisone and IVIG infusion therapy.
Pt. states that after receiving the 2nd dose of Phizer 05/14/2021, started experiencing symptoms 05/18/2021 of lack of appetite, fatigue, and headache. 06/30/2021 Blood Work, (07/16/2021) kidney biopsy,06/30/2021 diagnosed Blood Work kidney biopsy, kidney failure, acute kidney injury   kidney failure, acute kidney injury. Recommendation of change of diet, hydrate, Sodium Bicarbonate, and Potassium. States Kidney examine January was normal, as of August Primary states Stage 4 Kidney failure.
Patient received 1st dose Pfizer vaccine right deltoid @ 1034. Post vaccination pt felt dizziness, lightheaded, shortness of breath, and chest tightness. Hx anxiety & hypotension per pt. VS 130/90-98.3-103-20-99% RA. Sips of PO fluids given. Denies tongue/throat swelling, rash, redness, or wheezing.    @ 1050 HR 92, 98%.   @ 1105 BP 108/72, HR 93, 98% RA. Pt c/o ongoing dizziness and " some chest tightness".   Offered pt UC services, pt agreed. RRT notified @ 1113, RN-to-RN nurse report given. Pt v/s stable at this time. Pt transferred down to UC via wheelchair. Pt transferred from exam table to wheelchair with steady gait. Significant other at bedside.
On the onset of the adverse event (1/5/2021) I experienced full body hives and itching. At the same time of the adverse event I was experiencing a miscarriage (blighted ovum). Even after the miscarriage was completed, I continued to experience the persistent hives and itching and was diagnosed with chronic urticaria. Prior to receiving the COVID booster shot, I had never had any allergic reactions to food, vaccines, and no history of environmental allergies.
Narrative: COVID infection following COVID vaccine serious 04/01, MODERNA, dose #1 05/01, MODERNA, dose #2 12/27 COVID swab, result: detected 12/23 pt cc: chills, cough, fatigue, fever, headache, myalgias, rhinorrhea, dyspnea, sore throat exposure: unknown
Heart problems,fatigue,blood clots from nose, resting heart rate increased by 20 beats
Received MMR and Hepatitis B vaccines. Later developed fever and rash - following day "throat closed up". Went to ER and placed on steroids - prednisone 20 mg BID x 5 days. Was on BACTRIM x 4 days at time of vaccination.
11DEC97 pt exp fever 103, weakness, chills, noc sweats, loose stools, nausea & anorexia;17DEC pt exp abrupt change in mental status, non-voluntary speech, non-responsiveness & dec alertness;pt being worked up to r/o herpes simplex;
Our patient received a Pfizer monovalent COVID vaccine on 9/3  as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Did not feel well at all; Joint aches; Chills; Muscle aches; Slight fever/98.9°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel well at all), ARTHRALGIA (Joint aches), CHILLS (Chills), MYALGIA (Muscle aches) and PYREXIA (Slight fever/98.9°F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 011A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced FEELING ABNORMAL (Did not feel well at all), ARTHRALGIA (Joint aches), CHILLS (Chills), MYALGIA (Muscle aches) and PYREXIA (Slight fever/98.9°F). At the time of the report, FEELING ABNORMAL (Did not feel well at all), ARTHRALGIA (Joint aches), CHILLS (Chills), MYALGIA (Muscle aches) and PYREXIA (Slight fever/98.9°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Body temperature: high (High) 98.9°F.         No concomitant medications reported by reporter No treatment medications provided by the reporter.
Patient received vaccine, observed for 15, ambulated to the car. Husband came back to the clinic stating patient had severe vertigo. RN, LVN, and MA responded. Clear distress, eyes closed, pulse 82. States severe vertigo, no other symptoms. 911 call and EMS responded. Transported via ambulance to ED.
This spontaneous report was received from a back office lead and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Blood pressure - Lisinopril 20mg; Cholesterol - Simvastatin 40mg; Depression - Venlafaxine HCl 37.5 mg; Pain - Naproxen 550 mg.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 18-AUG-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-NOV-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) and hydrocodone bitartrate and acetaminophen (NORCO) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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.
Approximately 6 hours after receiving influenza and pneumococcal vaccine; patient became severaly nauseated with chilling and increased heart rate.  Later in evening, chills alternated with burning up.  Appetite decreased and remains poor.  Symptoms lasted 3 days.
Swelling at injection site. Bump the size of a quarter and 1/2 high.
Patient c/o tongue swelling 10 minutes after 2nd vaccine.  No difficulty breath or throat swelling.  Did not appear in acute distressed. Assessed by EMS, BP 126/80, P 95.  Given 75mg of liquid Benedryl.  Declined transport.  Patient not driving, being driven by spouse.  Pt stated that tongue swelling improved 30 minutes after Benedryl administration.
Reported pain at injection site on right deltoid for 1 week began after Tdap shot also drainage occurred from injection site in the morning of 4/18/2016.
Twinrix was administered on march 18, 2020; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAB (Twinrix) (batch number LG325, expiry date 15-MAR-2020) for prophylaxis.   On 18-MAR-2020, the patient received Twinrix. On 18-MAR-2020, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix was administered on march 18, 2020). The outcome of the expired vaccine used was 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: 13-JUL-2023 The reporter did not reported any reaction. The patient received a Twinrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up via email
Information has been received from a physician concerning two female patients who were vaccinated with their second dose of GARDASIL (lot number unspecified) and developed urticaria. The patients are not patients of the reporting physician and no patient specific information was provided. The physician asked not to be contacted. No other information to report.
Had typical/reported headache, pain in arm, some mild nausea, tired feeling. Had not reported diarrhea, very liquid. Started about 24 hrs after injection, lasted at least 20 hrs so far - seems to be easing.
Muscle pain through out body. (mild to moderate). Moderate to severe in arms from shoulder down to hand.
Information has been received from a registered nurse referring to a 23 year old female patient with no historical conditions or allergies. On 08-JUN-2015 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (0.5 ml, lot # K006139, expiration date 29-APR-2016, subcutaneous) for routine vaccination. There was no concomitant therapy. On 09-JUN-2015, the patient developed a "bulls eye area" at the injection site that was itchy, reddened and warm to the touch. The nurse stated that the bulls eye area was an one inch diameter ring around the injection site. The patient was in the office at the time of the call. There were no lad diagnostics studies performed. BENADRYL cream was given for the events as a treatment. The outcome of the events was reported as not recovered. Additional information is not expected since the reporter was not consent to be contacted.
This case was reported by a physician and described the occurrence of anaphylaxis in a 1-year-old subject of unspecified gender who was vaccinated with HEPATITIS A vaccine. Concurrent medical conditions included egg allergy and peanut allergy. Concurrent vaccinations given on the same day (unspecified) as the Hepatitis A vaccine included three unspecified vaccines; manufacturer unspecified; unknown. On an unknown date, the subject received an unspecified dose of Hepatitis A (unknown) vaccine, the subject experienced anaphylaxis. A physician reported that a subject with egg and peanut allergies experienced an anaphylactic reaction on the same day that the subject was administered a Hepatitis A vaccine, followed by exposure to peanuts one hour after receiving the Hepatitis A dose. The physician contacted GSK to inquire if eggs were used in the manufacturing of, or were ingredient in HAVRIX. This case was assessed as medically serious by GSK. The reporting physician considered the event to be unrelated to vaccination with Hepatitis A vaccine. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 18 September 2008 via a physician, who stated that he did not need to report this due to the subject being allergic to peanuts, which she received after the Hepatitis A vaccination.
Information has been received from a NP concerning a 35 year old female who one week ago (on approx 12/5/05) was vaccinated IM with 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine. On approx 12/5/05 the pt experienced severe cellulitis. The NP reported that the pt is presently recovering. No product quality complaint was involved. Additional information is not expected.
pt recvd vax & mildly fussy between 430-730PM @ 740PM started w/sudden high pitched unusual, unconsolable screaming & crying & thrashing; could not be calm down even mildly; unconsolable screaming & crying persisted until 915PM; vomiting;
4 y.o. male inadvertently administered pfizer 5-11 y.o. covid vaccine when he was to young to receive it.