chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning after receiving the flu shot I woke up with a tension headache. I was able to make some breakfast then I laid back down in the bed. The headache slowly became worse to unbearable. It was a migraine and I never experienced that before. A few hours into the migraine I experienced strong heart palpitations. They came in waves over the course of about 30 minutes. I was very weak and spent the rest of the day in bed. I slept a lot. Today (the day after) I am feeling better but still have a slight headache and am very tired. I've had slight angioedema for the last 24 to 48 hours.
Patient received varicella vaccine and everything seemed to be normal. However, he developed a case of shingles on right thigh and has never been exposed before to chickenpox. Doctor says chickenpox vaccine is made from chickenpox...it stays in the body and can cause shingles.
Headache radiating to left eye. refused transport. Observation complete, will take Tylenol for pain.
Pt given TDAP/ADACEL (R) deltoid IM. PNEUMOVAX R upper arm SQ on 12-2-10. Presented to urgent care 12-5 with R arm swelling, tenderness over TDAP site. Treated for cellulitis.
Warm red itchy rash  at injection site- occurred 9-10 days after injection.
4/12/04 rash on legs itching. Orapred 1 tsp QD(15/5). 4/15/04 multi target lesion clusters on knees, thigh, shin and elbows (orapred 4-5 days). 4/16/2004 Continue eruption -continued Orapred x 2days thru and 1/2 tsp qd. x 2 days. 4/19/2004 still scattered like lesions with many excoriatious from itching. Eucerin cream spray. Finish Orapred.
The patient experienced heat, redness, and swelling on the middle bicep to elbow of the left arm in which she received the vaccine. Currently the reaction measures about 5" by 3". She denied any reaction right at the injection site (left deltoid). The reaction began a few hours after receiving the vaccine, was worse the day following administration, and patient reports it has begun improving (2 days after administration). When the reaction was at its worst (5/30), the patient took acetaminophen. The patient was advised to take acetaminophen or BENADRYL as needed, and report worsening or persistence of the reaction.
After 1st vaccine shot, sore arm 2nd vaccine shot: out of work for 2 days, body aches, chills, fever   A month after 2nd shot I stopping sweating under my arms, super weird  Now 4 months after 2nd shot, have HYPERthyroid issues
My throat felt really scratchy and  sore so I took a COVID-19 Test and it was negative. I got really sick 2 days later. My ears were really hurting and painful the entire 1st day. The next day I became congested with a sore throat and fever. My fever was at 102.0. I got cough drops and other medication to treat the symptoms. I called urgent care and I went in. I was given a PCR COVID-19 Test and Flu Test. I also had a double ear infection. I was placed on antibiotics for the ear infection and I had to wear my mask the remainder of the trip. I felt really down for about a day and a half. The antibiotic kicked in and I was feeling better. I have completely recovered from all symptoms. I did call my primary care doctor on April 28th due to being stung by a wasp so I had painful swelling on my neck. My doctor thought that I was having a harder time with my immune system due to be COVID-19 positive.
Two days post vax pt developed diarrhea and vomiting all night. He was better for a few hours. Noon the next day he developed diarrhea and vomiting again that lasted several hours.
Initial report received on 15 February 2008 from a nurse.  A 17-year-old patient, with a past medical history of lactose intolerance, had received a first (route not reported) left deltoid dose of Menactra (lot number U2403AA); and a first (route not reported) right deltoid dose of Gardasil (manufacturer Merck, lot number 1060U) on 14 February 2008.  Five minutes after receiving the vaccines "simultaneous", the patient fainted.  Treatments received were not reported.  The patient was reported to have recovered spontaneously.  No other relevant medically significant information was provided.
This spontaneous report was received from a medical assistant and refers to some patients of unknown age and gender with skin cancer. The patients' medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 for prophylaxis (strength, dosage schedule, route, lot number and expiration date were not reported). The reporter stated that a physician reported to them that he read in a unspecified pilot study that some patients who were vaccinate with GARDASIL 9 experienced a decrease in their skin cancer (therapeutic response unexpected). The outcome of therapeutic response unexpected was unknown. The relatedness between the event and GARDASIL 9 was not reported.
Heart racing; This is a spontaneous report received from a contactable healthcare professional. A 59-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 59-year) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 19Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience heart racing. Heart racing onset was 5 minutes after injection. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Heart racing was briefly lasted and resolved by the time she arrived to the medical bay. Treatment for this event included water and close monitoring until end of her observation time. The follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with primary care physician (PCP). The clinical outcome of the event heart racing was resolved on 19Mar2021.   No follow-up attempts are needed. No further information is expected.
They should be like cloudy you know like off white and was completely clear; Mild pain in my shoulder; I am just like, I can't sleep its been 2 hours that I am here thinking about reading about.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on 09Sep2021 (Batch/Lot Number: BA30130) (at the age of 40-years-old) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Sep2021, the patient took the vaccine and found the appearance as like cloudy like off white and was completely clear and had mild pain in her shoulder and patient was wondering about the appearance of the vaccine and wanted to make sure that she got the thing and was done in right way that's all. It was reported that patient couldn't slept for 2 hours. The patient did not received any treatment for the events. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient had previously received monoclonal antibody treatment for COVID-19 (bamlanivimab) on 1/8/21. Patient filled out the VAR, answering yes to the question "Have you been treated with antibody therapy for COVID-19 or convalescent plasma?" Answer to this question was overlooked and the vaccine was administered on 2/9/21. Second dose has not been administered.
Was notified by administration that she should not have gotten a Quadracel, should have gotten her ADACEL for school. The immunization records that I looked at did not list a 4th IPV injection, so I administered the DTaP IPV Quadracel to bring her up to date. I did not realize that the school system will not accept this in place of an ADACEL so we called the parents and told them she needed to come back in and get her ADACEL to be able to start school on time, and that we would not charge her for this as it was our mistake. There were no reactions to the vaccines that were given, she just needed to get the ADACEL instead.
I passed out syncopal  episode  Injury to my left shoulder right wrist  My nose   Had to call fire rescue to take me to hospital  Ever since then I still have dizziness and loss of balance. Went to an ENT  all tests normal  Now I have a neurology appointment because I still experience dizziness
SWOLLEN LYMPH NODES, SWOLLEN ARM, FEVER, ERYTHEMA
The patient reported the area where the injection went in swelled up and became very red and itchy.
PATIENT STATED THAT SHE FELT THE NEEDLE WERE INJECTED TOO HIGH ON HER SHOULDER MUSCLE. SHE IS EXPERIENCING PAIN IN HER ARM AS A RESULT.
broke her left knee; More than 36 days since receiving first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOWER LIMB FRACTURE (broke her left knee) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), APIXABAN (ELIQUIS), FAMOTIDINE and METHOCARBAMOL (ROBAXIN) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced LOWER LIMB FRACTURE (broke her left knee) (seriousness criterion hospitalization). On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since receiving first dose). The patient was hospitalized from 25-Apr-2021 to 16-May-2021 due to LOWER LIMB FRACTURE. On 26-Apr-2021, PRODUCT DOSE OMISSION ISSUE (More than 36 days since receiving first dose) had resolved. On 16-May-2021, LOWER LIMB FRACTURE (broke her left knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: This report also refers to a case of product dose omission issue for mRNA-1273 (lot # 031A21A) with associated reported serious AE of lower limb fracture. Very limited information has been provided. Further information has been requested.; Sender's Comments: This report also refers to a case of product dose omission issue for mRNA-1273 (lot # 031A21A) with associated reported serious AE of lower limb fracture. Very limited information has been provided. Further information has been requested.
irritability; Fever Tmax 104; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2307092-1. The original narrative from the sender is the following:  Fever Tmax 104 and irritability.
Extreme blurry vision- eyes will not focus with our without glasses on. Can?t see far away well. Vision problem is consistent and not intermittent.
6 hours after Pneumovax 23 was given the patient had severe left leg pain, unable to walk, nausea and a temperature of 101.0. He was sent to the emergency room for testing and pain management.
30OCT97 mom noticed child unable to bend legs/shutting when walking, quiet;31OCT97 pt unable to stand up was stiff & shaky;loss of bladder control;PMD appt on 30OCt97 no tx;11NOV97 seen by MD dx w/poss GBS/adverse rxn to varicella;
Pt returned to clinic about 30 min after receiving her flu shot with a red rash on her left upper arm, left neck and chest towards her right side. Her BP was 180/110, HR 115. Pt's BP remained elevated and she started feeling some chest pressure and a lump in her throat. No wheezing or SOB. EMS was activated and transported pt to ED where she was treated with IV BENADRYL and eventually released.
Reaction with the Moderna COVID-19 vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Unknown. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information not provided.  Treatment information not provided.   Reporter did not allow further contact
A few weeks after the shot I broke out in terrible dermatitis which I'm still suffering months later. I have granuloma annulary which I've had for over a decade and it does not itch. This dermatitis is chronic and I am taking multiple medications to try to control it. There has been no relief since it began.
On 1/21/2011 - administered TDAP, MENACTRA & GARDASIL (first of 3) & pt fainted approximately 2 minutes after shots - lasted 30 seconds. Pt with dizziness & lightheaded right before event. Had pt lay down with legs elevated x 20 minutes BP normal.
MUSCLE ACHES  (LOWER BACK); TENSION HEADACHE; CHILLS; FEVER; PAIN IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and comorbidities.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced pain in the right arm. Laboratory data included: Body temperature (NR: not provided) 101 F. On 10-APR-2021, the subject experienced muscle aches (lower back). On 10-APR-2021, the subject experienced tension headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, pain in the right arm, muscle aches (lower back), and tension headache on 11-APR-2021. This report was non-serious.
Severe chest pain, shortness of breath, dizziness, sore jaw.  High d dimers with no clots on lungs. Inflammation of chest muscles. Painkillers and wait it out.
A couple days after receiving her first dose of Shingrix, pt had a shingles outbreak that radiated to one of her eye.   She has informed her PCP.
Severe throbbing pain in center of chest, jaw pain and severe pain on right side of neck through the night starting about 12 hours after the injection.
Immediate extreme migraine; Severe neuralgia flare up; Can't sleep due to muscle pain; Can't sleep due to muscle pain; Breakthrough bleeding; Cramps; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; 1st dose : 15Apr2021, 2nd dose: 15Apr2021; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 15Apr2021 09:30 (Batch/Lot Number: ER8735) as 1st dose, single, and via an unspecified route of administration, administered in right arm on 15Apr2021 (Batch/Lot Number: EW0176) as 2nd dose, single for COVID-19 immunization, in an urgent care center. Medical history included chronic migraine, occipital neuralgia, and Penicillin allergy from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL); and zonisamide, both taken for an unspecified indication. On 07May2021, the patient experienced immediate extreme migraine, severe neuralgia flare up, she can't sleep due to muscle pain, breakthrough bleeding, and cramps. The patient has not recovered from the events.
Chills, severe headache, hives on neck, chest, shoulders, back, hairline on right side of body. Mental fog, dizzy/weak feeling, no temperature, no reaction at the site.
site rash, red spot/bumps w/ itch that slowly spread (w/i 24 hours) hive like blisters formed. Took allergy medication w/i 24 hours itching stopped next day Hives disappeared and then 2 days later redness left
Woke up around 2am and was vomiting about 1-2x and hour until about 7am.  Extremely nauseous and had chills in between vomiting.
June 2003 - Developed optic neuritis and blindness in left eye with no recovery, MRI of brain clean short of ON, IV steroids provided no relief Jan 2004 - follow up MRI of brain clean Mar 2004 - feet went numb June 2004 - MRI of spine revealed leasion, subsequent spinal tap confirmed Multiple Sclerosis Aug 2004 - began drug therapy regimine with Rebif Information from Medical records states skin ulcer not new change, did develop neuropathy, retinal disease, paresthesis. msv Information from 60 day follow-up report states: Total Blindness-left eye. Typical issues associated with multiple sclerosis - numbness and fatigue being the most prevelant. I realize I will never have a definitive answer whether the MMR vaccine caused the MS, but I will always wonder.
chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Concomitant medications were not reported.  No treatment details were provided.
Information has been received from a lawyer/physician concerning a female child who was vaccinated with MMRII and within 24 hours, post vax, the pt had "seizure activity with significant impairment". Upon internal review, "seizure activity" was considered to be an "Other Medical Event". No further information is available.
Mild allergic reaction at injection site. Redness, slight swelling, itchiness area size of baseball in circumference. Noticed  7 days after injection and continuing. Itchiness and swelling responded to ibuprofen
Pt started feeling numbness around her mouth and that spread down her arm. RN administered injection of 50mg of Benadryl at 1:50pm. Pt started shaking and had chattering teeth, 911 was called and indicated that we should administer .3mg of Epi. at 2:01pm. Ambulance arrived and took over Pt. care.
Information has been received from a registered nurse concerning a male baby whose mother was vaccinated with two doses of GARDASIL on 14-JUL-2008 and 15-SEP-2008 and was pregnant. On 30-APR-2009, the infant was born with problems. He had no respiratory effort at birth and required mechanical ventilation at a couple hours of life. The infant was admitted to a neonatal intensive care unit (NICU), then was transferred to another neonatal intensive care unit (NICU) and again transferred to another neonatal intensive care unit (NICU) for additional work-up on 05-MAY-2009, a pulmonologist performed a flexible bronchoscopy on the baby which showed mild laryngomalacia with normal vocal cord function. On 31-JUL-2009, the infant had suspected pneumonia, respiratory syncytial virus (RSV) was negative, influenza was negative. Respiratory cultures were positive for Ecoli. The infant alternated between being stable on room air and requiring respiratory assistant by bi-pap or nasal cannula through August 2009, remaining in the neonatal intensive care unit. In September 2009, the baby had suspected aspiration pneumonia with migrating infiltrates on chest x-ray. The baby was ultimately diagnosed with low respiratory muscle tone, respiratory failure and congenital myopathy. The baby had been referred to a children services at this time. The mother's experienced has been captured in WAES #0901USA00343. Additional information has been requested.
Received the Tdap vaccine from my family physician, Dr., during the morning of August 31, 2007 while having my annual physical examination. The next day I noticed my legs (and later burNing feet and buttocks)becoming "heavy" and a "dulling pain" throughout my legs and back. I started also to experienced uncontrollabe "twiches/jerks" in both legs.  As the week(s) went on, I experienced severe problems sleeping during the whole night.  During the first two weeks I went to Hospital five times either to have a catheter installed (unable to void due to the pain and/or panic medication I was prescibed.  I was prescibed: Vicodin, Tramadol - HCL - Acetaminophen, Alprozolam, Predisone, Zolpidern Tar, Motrin, Ambien, Paraxetine HCL (Paxil), and Zoloft medications plus the urology drugs, Finasteride (Proscar) and Nitrofurantoin - Macro to help with an enlarged prostrate.  I had a Cystoscopy perform by Dr. on September 14th and wore a second catheter from September 14th-24th. I had allergic reactions to the Paxil, Ambien, and Zoloft medications.  I am still experiencing pain in my legs, feet, and buttocks particularly during the night; however, since I am off all the pain and panic/anixiety, and sleep medications, I usally get 4 - 6 hours of "normal" sleep. My medical doctor says that he has treated me as much as he can and has referred me to a pyschololgist, which I am seeing tomorrow for the first time (September 25th).
Felt tingling of legs that slowly progressed to weakening of her legs. By later that day patient was unable to walk. Brought to hospital and admitted with workup diagnosed as Transverse Myelitis
Headache, jaw ache, other minor body aches, chills, 99.4 F fever, mild fatigue, initial soreness of arm on day of injection
Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 13-Oct-2021 was placed in refrigerator on 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  Vial did not undergo any temperature excursion. It was reported that patient did not experience any adverse event.