chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At-10:45 am C/O dizziness, headache, vertigo, eyes closed secondary to sensitivity to light from headache.  C/O mild SOB, has diagnosis of asthma.  Color pink, skin warm and dry.  No use of accessory muscles for breathing, no coughing.  Also diagnosed with HTN , takes Cozaar.  Has allergy to Ibuprofen, morphine, levaquin and chocolate.   11:30 am- BP 130/82, P 84, R 14 T 99.2 chest clear, alert and oriented x4 11:50 am- BP 140/82, P 80, R 16 T 98.2 chest clear, alert and oriented x4 12:15 pm- BP 138/90, P 68, R 14, T 97.5 chest clear, alert and oriented x 4 Action Taken:  Laid down on cot, cold compress to head, drank water, took her Breztei asthma medication one puff for her symptoms which she had not taken this morning as she usually takes it.  12:15 Headache was improving, dizziness gone, appeared better, sitting up in chair.  Drank water, poweraide and ate Starburst candy.  Eyes opened, conversing.  Left with daughter who drove the car home with her.
03/22/21: Patient presented and was admitted through ED for pain, redness and swelling to his left lower extremity which began 2 weeks ago. Patient had left leg ischemia with rest pain and foot ulcers. patient was on outpatient antibiotic treatment for same problem.   Per the EUA, hospitalization are to be reported irrespective of attribution to vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not known) on unspecified date 2 years ago, in August 2010. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient was "in the office now to receive 2 dose of GARDASIL which will be late." There were no symptoms reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
About 30 minutes after the shot, my face became very red and flushed. I continued driving home and took xyzal when I arrived. My face cleared up about an hour later. My left arm has been sore since the shot (3 days now). Also the next day after my shot, I was completely exhausted.
Patient called stating her arm was red, swollen, hot. Ibuprofen not helping, referred patient to doctor. On Tuesday 11/7/17, referred patient to doctor.
Raised red area below injecton site approx size 4x3 warm to touch,puritis
Received vaccine L deltoid 1040 hours. At 1041 pt c/o dif swallowing and throat tightness. Negative tongue swelling, positive smiling; stroke signs neg., grips hands, bilat LS ck ar. Neg c/o chest tightness, dif. breathing, shortness of breath. TX: BENADRYL 3 3/4 BP at 1046 hrs. Monitored 30 min's fully resolved.
something they experienced but didn't bother them; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (something they experienced but didn't bother them) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (something they experienced but didn't bother them). At the time of the report, VACCINATION COMPLICATION (something they experienced but didn't bother them) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant and no treatment were provided   Reporter did not allow further contact
Information has been received from a Nurse Practitioner (N.P) concerning a "13 or 14 year old" female patient who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL (Lot # not reported). It was reported that on an unspecified date the patient experienced hair loss after receiving GARDASIL. The patient sought unspecified medical attention. The outcome of the patient was not reported. Follow-up information was received from nurse practitioner who reported a mother and her child who refused vaccine stated she knew of someone who had suffered severe hair loss after her immunization. Attempts to verify the existence of an identifiable patient have been unsuccessful. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
caller stated he developed neurological issues a week after receiving the covid vax.  Pt became weak, confused, unable walk, hallucinating. He fell 3 times in that week.  Symptoms got worse to the point that 911 was called and he was admitted to the Hospital.  He had a MRI and CT of brain.  MRI on spine. Both had abnormal results w/ no bleeding.  Blood Work was normal.  He was treated and will be released on Hospice 2/25/2021.
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had a vasovagal reaction. He states he has had this occur previously. Orthostatic vitals: lying 176/81 HR 81, sitting 129/86 HR 82 standing BP 119/82 HR 83, Pulse OX 99%
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. From 24-AUG-2015, improperly stored ZOSTAVAX (lot# K023623 and expiry date: 20-FEB-2015 was administered to multiple different unspecified patients on unspecified dates. No adverse effects were noted. Additional information has been requested.
Dizziness, headache, felt like something caught in throat, felt feverish, swollen eyes/shortness of breath.
Information has been received from a medical assistant concerning a 17 year old female with diabetes who on 03-MAR-2008 was vaccinated with a second dose of Gardasil IM injection in the arm. On 03-MAR-2008 after receiving her second dose of Gardasil the patient cried, could not move, became stunned and was in extreme pain. It was noted that the patient had not eaten that day. At the time of the report on an unspecified date the patient had recovered with unspecified therapy. On an unspecified date the patient had received a first dose of Gardasil. Additional information is not expected.
injection site is warm to the touch, red spot is the size of a gulf ball, it itches and burns at the same time, hurts when touched, arm is sore, i am very sleepy, i am the patient filling this out
Hospitalization for abdominal pain, N/V  on dates 8/2/2022-8/12/2022.  Treated with dexamethasone.
HIGH FEVER; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. the company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced high fever, and severe headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and severe headache was not reported. This report was non-serious.
Patient presented 2 days later with swelling, redness, heat, and radiating pain down towards hands. Patient was recommended to see MD, and did see MD at Urgent Care across the street.
Patient came to workplace vaccine clinic with parents and was administered 0.25ml of moderna bivalent covid booster vaccine.  Patient was under the age of 18 at the time of event so not indicated to receive Moderna booster regardless of dosage as it had not been authorized for this age range yet. No adverse events reported.
Patient had typical injection site reaction- red swollen arm but also reported extreme back and muscle pain to the point that she is having trouble walking, reaction began within 12 hours of receiving vaccine and has not improved 72 hours post vaccine
Patient received shoulder injury.  Suspect SIRVA.  Shoulder pain developed within 48 hours of receiving vaccine.  Patient still with pain and weakness of the right arm 2 weeks later.  Patient went through drive thru flu shot clinic and shot was administered in the car through the car window.  Patient reports it was administered high up.
Flu like symptoms; This is a spontaneous report from a contactable consumer. An adult female patient of an unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced flu like symptoms. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event flu like symptoms was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 17JUL97 & 27JUL97 pt devel elevated liver enzymes, ALT was 60 & AST was 54;
After the shot was given it he had a small red knot appx. the size of a quarter.  The 2nd day the red knot was the size of a mayonaise jar lid.  One the 3rd day the red spot measured 10cm x12cm (larger then the size of my palm.  It was red, inflamed, sore to the touch accompanied by a 100.2 fever.
a 80 year old patient was administer an expired 0.5 ml dose of Fluzone Highdose on 02Oct2019/No AE; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 80 years old male patient who was administer an expired 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UI985AC, expiry date: 22-Mar-2019 via unknown route in unknown administration site on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Got a migraine 1 week after each of the first two covid vaccines. Two days after got covid booster, sever ringing in ears started and has never gone away.
Felling of heat and extreme cold at the injection site; Felling of heat and extreme cold at the injection site; Itchiness at the arm of the injection; Swelling of the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (Felling of heat and extreme cold at the injection site), VACCINATION SITE WARMTH (Felling of heat and extreme cold at the injection site), VACCINATION SITE PRURITUS (Itchiness at the arm of the injection) and VACCINATION SITE SWELLING (Swelling of the arm of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021, the patient experienced VACCINATION SITE COLDNESS (Felling of heat and extreme cold at the injection site), VACCINATION SITE WARMTH (Felling of heat and extreme cold at the injection site), VACCINATION SITE PRURITUS (Itchiness at the arm of the injection) and VACCINATION SITE SWELLING (Swelling of the arm of the injection). On 15-May-2021, VACCINATION SITE PRURITUS (Itchiness at the arm of the injection) had resolved. At the time of the report, VACCINATION SITE COLDNESS (Felling of heat and extreme cold at the injection site), VACCINATION SITE WARMTH (Felling of heat and extreme cold at the injection site) and VACCINATION SITE SWELLING (Swelling of the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was reported Treatment included Cold rags and topic anti-inflammatory balms were applied.
(All by Hx) 12/4 swelling & pain L knee 12/7 swelling & pain R knee & pain R knee & pain L shoulder. Symptoms are resolving.
First date extreme fatigue.  Muscle and joint pain since vaccination on 11/8/2023.   Pain is at 8.  Some relief with Tylenol.
headache; threw up; really sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick), HEADACHE (headache) and VOMITING (threw up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). On 04-Mar-2021, the patient experienced ILLNESS (really sick) and VOMITING (threw up). On an unknown date, the patient experienced HEADACHE (headache). On 05-Mar-2021, ILLNESS (really sick) and VOMITING (threw up) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) had not resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
This initial spontaneous report was received via an article and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The article discusses that the patient was awarded compensation by the compensation program. On 13-FEB-2013, the patient was administered measles (+) mumps (+) and rubella (reported as MMR; manufacturer not specified), haemophilus influenza type B (manufacturer not specified), PREVNAR, hepatitis A vaccine (manufacturer not specified), and varicella vaccine (manufacturer not specified). That evening following vaccination, the patient became feverish and irritable, prompting her mother to contact the doctor. The doctor advised the patient's mom to administer BENADRYL and TYLENOL for her symptoms. That fever persisted for several days and was followed by a severe seizure resulting in cardiac and respiratory arrest. The cardiac arrest and seizures caused the patient to develop encephalopathy, kidney failure, severe brain injury, low muscle tone, and cortical vision impairment. The outcome of the events were unknown. The events were considered related to M-M-R II. Causality was not specified for the other vaccines. Upon internal review, cardiac arrest, respiratory arrest, encephalopathy, seizure, kidney failure, severe brain injury, and cortical vision impairment were considered to be medically significant events.
Developed 1-5 mm darkly pigmented macules multiple in number all over face. No erythematous, non tender, no discharge, no pruritis.
So far has gone to emergency room and been diagnosed with Ethema nodosum . Has undergone a round of steroids and multiple doses of Benadryl.  Has difficulty walking due to edema in feet and has  edema in hands as well . Will be seeing Primary care doctor again for more follow up treatments.
Pt was seen in DR office by back up physician, MD stated pt has "allergic reaction' Phone number listed.
I had awful nausea, loud ringing in the ears, I fainted.  The medics provided help, gave me oxygen.  I started having convulsions.   After some time I felt like the lower part of my face went numb and it took tremendous effort to move my lips to talk.  At that point, the medical called the ambulance and sent me to ER, where I was under supervision for some time. I was very weak and nauseated. After I was released, I was very weak could not keep the vertical position.  The next day I was very nauseated, with awful tinnitus, lightheadedness, and weakness. Staying vertical for more than 15 minutes brought fainting symptoms.  I was not able to get out of the house to work.  The next day the fainting symptoms disappeared, everything else continued. Too weak to go to work.  I started moving about only on the 4th day after the shot.  During this event, I did not have any fever or muscle ache, no virus0tyle symptoms.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease (Required medication modifications during pregnancy, otherwise fine) since 2006. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 07-Jan-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021 at 5:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Ultrasound scan: normal (normal) Dating ultrasound, normal. On 03-Sep-2020, Ultrasound scan: normal (normal) Anatomy ultrasound, normal. On 17-Nov-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) Prenatal genetic screen at 11 weeks, blood test,normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had 1 previous live pregnancy.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Reporter address added, Pregnancy information added, Medical history added, Lab data added, Product dose details updated, concomitant medication added and Vaccine facility information added.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sore throat-sent for COVID testing, body aches, fever, fatigue and muscle aches
Patient was given pneumococcal vaccination on 11/07/18. Per patient, he woke up the next day (11/08/18) with pain, redness, and erythema on his left arm. Patient presented to urgent clinic later in the evening with "rash to upper arm" complaints, and was treated for cellulitis and allergic reaction by the attending physician's assistant. Patient was given clindamycin injection at the clinic. No labs were drawn. His vitals were all within normal limits, and he was afebrile with temperatures at 98.7. Patient was released the same night with prescriptions for prednisone and clindamycin. He has no known drug allergies. Patient presented to the pharmacy the next day (11/09/18) to pick up his prescriptions and discuss with pharmacist events that occurred. Pharmacists counseled the patient on all medications and received verbal consent to submit adverse event report. Per patient, redness has gone down.
Patient was given the wrong product.   She started the Meningococcal B series on 10/10/2022 at a different facility with Bexsero.  The patient was given a dose of Men B Trumenba at this visit 10/26/2023.  The products are not interchangeable.   The patient was scheduled back for another dose of Trumenba in 6 months.   There were no adverse reactions to this vaccine.
Fever 102, chills, nausea, twiching, dizzy, headache, body aches.
Severe inflammatory spondyloarthropathy, fever, hypertension, coronary vasospasm requiring hospitalizations and immunotherapy.
This spontaneous report as received from a healthcare worker, refers to multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD which had a lot # L045678 and expiration date of 09-MAY-2017 (dose, dosage number and route of administration were not provided). Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unspecified date: 5.4 F for 16 hours. Reportedly, there had been previous temperature excursion and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.