chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was sick; It really knocked her out . She had a really bad sense; testing positive for Covid-19; Itchy throat; Light headedness; Wheezing; Coughing; Weakness; chest on fire; Itchy throat, Light headedness, Wheezing, Coughing, Weakness, chest on fire was reported as worsened.; tickle in her throat; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 02Aug2021, immediately after the receiving the covid-19 vaccine, patient felt a tickle in her throat, it became itchy, began to feel lightheaded, and was coughing and wheezing. patient stated that these symptoms became progressively worse, so was tested for Influenza and Covid-19. patient received a positive Covid-19 Viral Test Result and stated, "her lungs are killing, her right now." patient got progressively worse. On an unspecified date, it really knocked her out. patient had a really bad sense. Patient was so nervous, got tested again and got tested for the flu, and they did a rapid and PCR test for COVID. Patient was negative until yesterday. Patient got a positive for COVID test result today, was just confused and was trying to navigate what to do. Patient was coughing. Her chest was on fire., was weak and patient wasn't at home. She flew to (city) after getting her first dose. Her weight had been evaporating since she was sick on an unspecified date. She got her positive COVID result on 12Aug2021. The patient underwent lab tests and procedures which included Rapid test and PCR test: negative, She was negative until yesterday on 11Aug2021, Rapid test and PCR test: positive, she got a positive for COVID test result today. Positive Covid-19 viral test result after first dose on 12Aug2021. Outcome of events she was sick, tickle in her throat and it really knocked her out. patient had a really bad sense and tested positive for covid-19 was unknown and outcome of other events was not recovered.   Information on the Batch/Lot number has been requested.
The dates of previous (1st and 2nd) doses were given to me via telephone as we were in the field/community. The environmental and weather elements were a negative factor that day. But the dates I must of heard incorrectly and I calculated from the first dose date and not the second.
Client received FLULAVAL 3:42 P.M. 11/10/08. At 3:34 on 11/10/08-client reported feeling weak, lightheaded and was unable to walk, sitting on floor at hallway of store. I found client to be lethargic with generalized weakness. No angioedema, swollen lips, tongue and uvula. No urticaria or erythema. No wheezing, Lung CT. A Bilaterally.3:44pm ran b/p 170/110, pulse - 92, Resp - 20, Temp - 98.5. 911 called and Paramedics sent client to ER for evaluation at 3:47PM 11/10/2008.
Injection sight itchiness 7 days after vaccine. Itchiness went away. Injection site redness with onset 8 days after vaccine administration (2.5 inches in width and height). Redness decreased over the following 24 hours, but then returned 11 days after the vaccine upon exercising. Left arm.
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown demographics who experienced flu (Influenza), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient reported that the two times the patient took the shot were the only two times the patient had the flu.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Patient was vacinated with Smallpox vaccine on 21 Feb 2012.  Patient had positive pregnancy test on 06 Mar 2012.  Patient denies having sex between vacination and positive pregnancy test.  Patient reports previous sexual encounter was prior to vaccination.  Pregnancy test was performed at time of vaccination.
Somebody in my job was sick and that led me to get tested and I was positive for COVID-19. My congestion was more frequent than usual. I have an auto-immune dieses that causes me to have pain and fatigue so I really couldn't tell the difference between the COVID-19 symptoms and the regular body aches and pain. It was more like a head congestion and I did vomit once.
Citizen stated she felt warm and had a funny taste in her mouth. Citizen stated she is not being treated for any pre-existing medical conditions and that her BP is usually low. Citizen evaluated by EMT  -  monitored her BP 186/106; HR 77; SpO2 96%.  She appeared flush and diaphoretic.  She declined any additional treatment, wanted to get outside where it was cool and go home. Recommended for her to follow up with her primary care provider.
Information has been received from a nurse practitioner/certified nurse midwife concerning a female with no known drug reactions/allergies or pertinent medical history who in June 2007, was vaccinated with her second dose of GARDASIL vaccine (yeast), 0.5 ml, IM. Subsequently the patient experienced injection site pain, flu-like symptoms, drowsiness and headache after she received her second dosage of GARDASIL vaccine (yeast) sometime in June 2007. No laboratory diagnostic studies were performed. It was reported that the patient has since fully recovered from the events. It was not specified if the patient sought medical attention. Patient Quality Complaints (PQC) was not involved. Additional information has been requested.
I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 06Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, EW0162), administration date: 13Apr2021, for Covid-19 Immunization, reaction(s): "lost my sense of taste and smell"; BNT162b2 (Dose 2, EE0169), administration date: 04May2021, for Covid-19 Immunization, reaction(s): "sense of smell and taste has never returned". The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200926528 same reporter/patient, different dose, similar event;US-PFIZER INC-PV202200016058 same reporter/patient, different dose, similar event;
2PM pt cried had shaking episode while awake then became unconscious, awoke w/in 60 seconds;
Pt received both Pfizer vaccines. On August 2nd, 2021, pt tested positive for COVID-19. Presented to eD on August 5th, 2021 with complaint of cough, SOB, body aches, and was diagnosed with COVID pneumonia. Pt required supplemental oxygen. Pt completed a course of Remdesivir and was placed on a steroid taper. Discharged on August 10th, 2021.
on august 3 i realize a round circle on my arm of the covid vaccine that i had received almost 2 weeks ago and then later that night my arm began to hurt really bad and tingle from my shoulder down to my finger tips and it did not feel good. everytime i moved my arm it made it 10x worse and there were 2 more circles that showed up as well. i tried heat and ice and also took ibuprofen but nothing worked.  august 4th i woke up and went to the urgent care in my hometown because it hurt worse and the 3 circles combined into one big one kinda like a rash.
Red circular patch on right arm at site of injection a week after the vaccination.  Sore, slightly raised.  Itched for first few days(days 8-9).
Low grade fever; headaches; vomiting; diarrhea; fatigue; rash; obsessive overeating; weight gain excessive.
No adverse effects reported; The primary reporter reports expired dose of M-M-R II was administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.   On 14-MAY-2019, the nurse stated that the patient was vaccinated with a expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) rHA, lot number N014486, expiration date 10-MAY-2019 for prophylaxis (dosage, frequency, route of administration, and anatomical location were not reported). Therefore, was unknown if the sterile diluent to reconstitute de vaccine was not expired. No adverse effects were reported.
Patient had numbness/tingling to mouth/lips. Denied difficulty breathing. BP 119/74 -- > 104/71, HR 65 -- > 67, RR 18 -- > 16, O2 99% -- > 100%. Given Benadryl 50 mg IM. Patient stable, released from vaccination site. Recommended patient to vaccinate with non-mRNA vaccine for future booster dose.
pt recv vax 16OCT96 & pt exp red, swollen, tender area @ inj site which was about the size of a quarter;
Fever ACHINESS, COLD, CHILLS, ARM SORENESS Narrative:  Other Relevant History:
Moderna COVID-19 Vaccine EUA  Delayed reaction at vaccine site - hot, hard, red swelling.
Case number PHEH2014US019131, is an initial spontaneous report from a nurse received on 22 Sep 2014. This report refers to a 36-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12104) intramuscularly on 19 Sep 2014. On 22 Sep 2014 around 5:00 AM, he experienced heat and pain at the injection site, muscle aches, felling tired and nausea. He took over the counter (OTC) strengths of TYLENOL and ibuprofen for the pain. The outcome of the events was unknown. Seriousness and causality was not reported.
Janssen COVID-19 Vaccine EUA.  Chills, fever which reached 104 by midnight, racing heartbeat which lead to increased palpitations, slight dizziness, body aches all over.  I was unable to fall asleep until 2:30am.   The following day, chills and fever continued, though lower at ~99.4-100.6, along with aches, fogginess and loss of appetite.
Pt received MENACTRA vaccine and sat for a few minutes. He went shopping with his mom and came back about 10 minutes later saying he felt dizzy and said it started shortly after receiving the vaccine. Pt was suggested to sit and drink water. The mom said she wanted to take him home to rest.  I followed up with them (about 2 hours later when I could get ahold of the mom) and they said he was feeling better sligtly tired.  I followed up with them 11/6 and he said he was feeling fine just his arm was sore.
1-2 weeks, post vax 1st Anthrax, 1 year ago, pt noted onset of intermittent pain in left upper arm, followed later by similar less severe pain in right upper arm (had 3 doses Anthrax in left and 1 dose in right arm). Also, 3 month history of tingling paresthesias along ulna aspect of hands, left more than right, not always associated with upper arm pains. Problem still continues. Pt sought doctors care, 1 year after onset.
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 02-DEC-2015 at time- 13:50, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported.  No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.5 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Headache, Myalgia, HA, BODY ACHE, CHILLS
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: Grandmother called, said that patient had red streaks on arm and swelling night of 08/11/2021. today was better. was concerned because she said immunizer had hard time getting needle to go in and arm hurt. She said felt immunizer was unsure how to give vaccine.
NOTHING OCCURED TO PT, PT WAS GIVEN 0.1ML OF PFIZER
Pt recvd 1st dose of vax Recomb on 25SEP89 & on approx 9OCT89 pt devel severe aching & pain in the upper arms & hips; Seen by specialist who made dx of polymyocitis & acute cystitis; sx lasted approx 1 mo;
Rash developed at injection site, it was about the size of a standard post it note. A bit itchy, red, swollen. I did take a fluconazole an hour or 2 prior which I have never had any issues with. The rash was only at the injection site and spreading around the injection site. This sis 12 days after the vaccine administration.
8 days p/vax 25JUL94 pt had seizures, temp 104 ; seen in ER;seizures lasted approx 10-15 min.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis. No Medical History information was reported. On 20-Jul-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022 at 9:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (administer the vaccine to two patients, after leaving  it at a room temperature on the 19Jul2022).  This case contains information on 2nd of two pediatric patients as described by the reporter.  No concomitant medications were provided. HCP had a temperature excursion of 24 hours at room temperature of a vial for the 6 months to 5 years of age on 20-Jul-2022 they administer the vaccine to two patients, after leaving it at a room temperature on the 19Jul2022. It was unknown if the vial was initially stored in the refrigerator. Date and time vial was first punctured is 19Jul2022 at 9:45am. Vial did not undergo any temperature excursions. The vial was stored in Room temperature post puncture. Amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24hours. It was unknown, the vial was exposed to room temperature for more than 24 hours. No treatment information was given.
FLULAVAL .5 cc's given on 9-18-09 in R deltoid. Pt c/o R arm, shoulder and neck pain on 9-23-09. States pain increased a few days after shot given, was not immediate.
A few months after the vaccine while at work I had a sinkable event where I became light headed, passed out and vomited, but woke back up on my own.  I was taken to the ER and labs and EKG was performed but nothing imminent was shown and was referred  to F/U with my PCP.  My PCP stated my EKG looked different from my baseline so I was referred to an Cardiologist who performed an Echocardiogram and additional bloodwork but no additional findings were found.  I had a Chest X-ray but no additional findings were found on that either.  I also had SOB which increased with exertion and all symptoms self resolved after about 4-6 weeks on their own.
sore arm; arm bruised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U2B21A) for COVID-19 vaccination.     The patient's past medical history included Emphysema.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised). At the time of the report, PAIN IN EXTREMITY (sore arm) and CONTUSION (arm bruised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had her back surgery scheduled in 20-Apr-2021  Concomitant product use was not provided.  Treatment information was not provided.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 9/17/2022 Discharge Date: Sep 21, 2022 PRESENTING PROBLEM: COVID-19 [U07.1] Acute respiratory failure due to COVID-19  [U07.1, J96.00]   HOSPITAL COURSE: 89F with  HTN, GERD, and breast cancer s/p resection on letrozole. She came to the ER for URI symptoms and fevers.   2 days ago, 9/15 she began to have upper respiratory symptoms including nonproductive cough, rhinorrhea and sore throat.  She developed subjective fevers.      She is vaccinated for COVID 19 and received 2 boosters, last on 5/16/22   In the ER she was hypoxic with ambulation down 89%. She was placed on 2lpm NC. COVID 19  +. CXR showed no consolidation but with accentuated interstitial markings. She declined remdesivir and was started on decadron plan to complete 10 days.  Subsequently she has been weaned off oxygen.   She was noted to have accelerated HTN. Renal US negative for RAS. She was continued on Cozaar, change hydrochlorothiazide to on amlodipine and started on Coreg 6.25 mg BID with good response.  She was then discharged home stable
The pt's medical history reportedly included reflux treated with Zantac; intolerance to breast milk, and allergies to dairy products, rice, peanuts, barley, Baker's yeast, and "possibly" wheat. In July 1999, while still in the hospital after birth, the neonate rec'd an injection of hepatitis B vaccine(manufacturer unknown). Subsequently, she was reported "up all night, restless, crying, seemed to be in pain". the outcomes of the event were not specified.
Patient given Dtap instead of Tdap no previous record of immunization in past. Client is here for 1 month. Called state to verify possible harms to patient of need to patient vaccine. Patient has no signs/symptoms of reaction
pt recv vax 22OCT96 & 22OCT96 w/in 6 to 8hr of vax pt exp v, 8 to 10x, diarrhea twice, mild fever,soreness @ the inj site & nausea;there was no rash or hives;23OCT96 pt felt better but the nausea persisted;
Macular papillary rash on thighs, buttocks, and trunk. She took a dose of benadryl, and I advised she take Claritin and zyrtec.
Vaccine at 1145 Awoke at 0300 ( approx 15.25 hours after first jab) shaking and could not stop. No fever HR is persistently 150s.
Post vax, the pt developed local induration at injection site, hard 8mm diameter area on left thigh at site of Hib vax.
Patient reported tongue tingling/swelling after her 30 minutes timer went off. I called 911. They asked several questions about her condition and asked me to sit with her until EMS arrived and to call back if her symptoms get worse. The EMS team approximately 20 minutes later. There were no changes in her condition. The team took her to their vehicle for further treatment.
This is a retrospective pregnancy case. This 17-year-old female subject was enrolled in an open label study. The subject received MENVEO .5 ml on 23rd March 2012. Concurrent medical conditions included sebaceous cyst (not associated with pregnancy). Concomitant products included folic acid, FLUARIX, Flu Seasonal TIV Dresden, Prenatal Vitamins, GARDASIL, ZOFRAN ODT, BENADRYL and SUBLIMAZE. The subject's last menstrual period was on 13th February 2012 and estimated date of delivery was 19th November 2012. The subject received MENVEO at week 5 of the pregnancy and during the first trimester of pregnancy. On 13th September 2012, 174 days after receiving MENVEO, the subject developed gestational diabetes mellitus. Serious criteria included GSK medically significant. Additional event(s) included live birth and vaccine exposure during pregnancy. The outcome of gestational diabetes mellitus was unknown. The outcome(s) of the additional event(s) included live birth (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy resulted in a live neonate with a congenital anomaly. The neonate weighed 3260 grams (7lbs 3oz) at birth. It was unknown if the investigator considered the gestational diabetes mellitus to be related to MENVEO. Relevant Tests: On 4th June 2012, unconjugated estriol test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound (at less than 14 weeks of gestation) showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. Diagnostic results (unless otherwise stated, normal values were not provided): On 4th June 2012, Alpha 1 foetoprotein result was No congenital abnormality unknown, Human chorionic gonadotropin result was No congenital abnormality unknown and Inhibin B result was No congenital abnormality unknown. On 28th June 2012, Ultrasound abdomen result was see text unknown. See case US2017GSK173180 for details regarding the baby case. Additional details were provided as follows: The relevant family history of birth defects was none. The patient had not been exposed to tobacco, alcohol, and illicit drug use. The age at vaccination was not reported but the patient could be 16 or 17 years old. On 23rd March 2012, the patient received a dose of MENVEO (batch number 10135). On 4th June 2012, alpha 1 foetoprotein, human chorionic gonadotropin, unconjugated estriol and inhibin B test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. A singleton male live infant was born at gestational age of 40 weeks. The pregnancy resulted in a birth defect. The birth defect was shortened frenulum of tongue not noted prior to birth. The patient delivered a baby boy weighing 3.26 kg after 243 days of receiving MENVEO. The pregnancy did not result in fetal loss. The temporal relationship with the development of this defect and the timing of the exposure to vaccine could not be ruled out for a possible association. The reporter considered the gestational diabetes mellitus to be associated with pregnancy.