chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102F throughout the day.  Physician cleared patient of ear infection, strep, or upper respiratory infections. Patient had a Febrile Seizure of 1 second in duration at 6:30 PM and about an hour later.
Patient stated she was experiencing swelling, redness, soreness and sharp pain in arm. Prescribed prednisone and Tylenol.
Itching w/o rash; insomina-could not sleep until 11pm on 10/16/07; 36 hr w/o sleep; felt like massive caffeine high.
Increased body temperature; Sweating; Headaches; GERD/acid reflux; Throat irritation/ burning in throat; Fatigue; Body aches; Pain in injection arm; Nausea; Burping; Cotton mouth; Chest pain; Underarm pain; Ear pain; Back pain; Pityriasis rosea on front and back abdomen; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 27Aug2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation syndrome with idiopathic anaphylaxis. The patient had too many allergies to name all but mainly to latex, corn, egg yolk, mold, wheat and dog. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), cromoglicate sodium (NASALCROM) and guaifenesin (MUCINEX); all for unknown indications from an unknown date and unknown if ongoing. The patient previously received pertussis vaccine (MANUFACTURER UNKNOWN) for immunisation and experienced allergy. On 27Aug2021 at 16:15, the patient experienced increased body temperature, sweating, headaches, gastroesophageal reflux disease (GERD)/ acid reflux, throat irritation, fatigue, body aches, pain in injection arm, nausea, burping, burning in throat, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event pityriasis rosea on front and back abdomen and included treatment with unspecified steroid cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased body temperature, sweating, headaches, GERD/ acid reflux, throat irritation, burning in throat, fatigue, body aches, pain in injection arm, nausea, burping, cotton mouth, chest pain, underarm pain, ear pain, back pain and pityriasis rosea on front and back abdomen was unknown at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 17Sep2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.
Normal anticipated effects for 24-48 hours post-vaccination (sore arm, low-grade fever, fatigue), followed by 24 hrs of feeling "great". By day 4 or 5, he persistently developed low-grade fever every evening, and frequently had night sweats overnight. He went for a COVID-19 test 12/21/2020, which was negative. Initial Primary Care Provider (PCP) appointment was obtained 01/05/2021. Multiple labs, imaging were obtained, showing signs of inflammation, but nothing conclusive, so no treatment. On 01/20/2021 he developed LEFT FOOT DROP, and by 02/07/2021 his RIGHT HAND developed TINGLING in his THUMB, FOREFINGER, & MIDDLE FINGER. By 02/12/2021 those fingers were NUMB.  He received referrals to Infectious Disease, Orthopedics, and eventually Neurology, Neurosurgery, Rheumatology, and Hematology. When the Infectious Disease physician ruled out any infectious source, he prescribed a prednisone taper (60 mg x 1, followed by a 10-day taper). This did appear to resolve the evening fevers and the night sweats. However, his neuropathies persisted and continued to worsen.  Patient underwent TWO EMG procedures (one by Ortho, one by Neurologist). These confirmed his neuropathies were not related to spine issues, nor carpal tunnel syndrome. His tingling and numbness had progressed by this time to include his entire right hand. Patient eventually developed TINGLING & NUMBNESS in RIGHT FOOT, and was just beginning to develop TINGLING & NUMBNESS IN LEFT PINKY & RING FINGER, when HIGH-DOSE STEROIDS were ultimately prescribed. He underwent 3 days of IV METHYLPREDNISOLONE 1000 MG/DAY, followed by PREDNISONE 80 MG/DAY X 4 WEEKS, followed by 60 MG/DAY X 2 WEEKS, then 40 MG/DAY X 2 WEEKS, then 30 MG/DAY X 2 WEEKS, currently on 20 MG/DAY X 2 WEEKS. METHOTREXATE ONCE WEEKLY WAS INITIATED 2 WEEKS AGO. Neuropathies have not resolved, but have become less painful. He is starting to regain movement in right fingers, and able to lightly grasp with R pinky & ring finger, but very little strength. He also developed a LLE DVT, discovered 04/01/2021, related to his impaired mobility since developing L foot drop & R foot numbness.
Patient received a booster COVID vaccine on 08/19/21.  He received the Moderna vaccine.  Several days later, although he was not aware of symptomatology, on the Kardia device he was noted to be in atrial fibrillation.  He has been on warfarin since that time.  He is to be scheduled for cardioversion.  He has not experienced chest pain or dyspnea.
Area under injection site painful red & warm to touch. Went to MD treated with oral abx cellulitis.
Chills, fever, vomitting, tiredness, pain, redness & swelling.
1/13 Histamine reaction: sore, itchy, red, warm, swollen. distal injection site. 3 inches wide and 4 long. including a small ring around the injection site. Also a histamine reaction on my R cheek ~ 1cm. 1/14 1000 new spot medial to original site  1inx1in red, swollen, warm. Marginal reduction in 1st reaction site and face reaction. 25mg Benadryl 1/13 2300.
Rash around injection site on left arm, currently 2 inches in diameter; also itchiness, soreness at injection site
he had pain in his arm at the injection site; lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there; he didn't feel anything right away/everything came down right away; tired; very low-grade fever; a little weak; really sick; joints and legs below the knees/  he couldn't walk for 7 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there) and FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 88D21A, 015M20H and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ), FATIGUE (tired) and PYREXIA (very low-grade fever ). On 15-Oct-2021, the patient experienced NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there). On an unknown date, the patient experienced VACCINATION SITE PAIN (he had pain in his arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL A) on 08-Sep-2021 at a dose of 1 dosage form. At the time of the report, ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/  he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away  ), FATIGUE (tired), PYREXIA (very low-grade fever ) and VACCINATION SITE PAIN (he had pain in his arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient felt really sick. He had a very low-grade fever. His joints and legs below the knees he couldn't walk for 7 hours. He was just laying down and had a bottle of Tylenol and water.  The patient adds that after the second and third dose, he had pain in his arm at the injection site. It was worse after the third dose   This case was linked to MOD-2021-356190, MOD-2021-356657 (Patient Link).
Vomiting, temperature between 101.8 and 102.8, sweating, chills, achy body. Unable to keep liquids down. Extreme fatigue. Symptoms persisting at time of reporting (1:30 PM).
Pt stated that she is now having SOB with ambulation, unable to walk a flight of stairs with out sob, Feels it is caused by the vaccine
I developed tinnitus overnight after receiving the vaccine.  I continue to have it after one week and think it may be getting worse.
Information has been received from a certified medical assistant (CMA) concerning a 10 week old female with no medical history or allergies who on 26-SEP-2008 was vaccinated PO with one pouch of the first dose of ROTATEQ (lot # 660880/0923X). There was no concomitant medication. On 26-SEP-2008, the CMA reported that the patient vomited after receiving the vaccine. It was reported that the patient had just breast fed prior to receiving the ROTATEQ. The patient was in the office when the event occurred and the doctor was called and was asked "what to do" (the physicians' response was not reported). The outcome was not reported. A product quality complaint was not involved. This is one of several cases including the same source. Additional information has been requested.
Possible myocarditis (came in with high grade fevers one week after getting vaccinated, chest pains and muscle aches, elevated troponin and white blood cell counts)
This case was reported by a pharmacist via regulatory authority and described the occurrence of fever in 2-month-old male patient who received BEXSERO. In 2015, the patient received the 1st dose of BEXSERO (intramuscular). In 2015, several hours after receiving BEXSERO, the patient experienced fever (serious criteria hospitalization). The patient was treated with paracetamol. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to BEXSERO. Additional details were provided as follows: The fever started some hours after administration of BEXSERO and lasted for approximately 1 day. The fever required hospital urgency where the infant stayed one night by precaution. The fever resolved after receiving specific treatment with paracetamol. For tolerance after the 2nd dose, see case PT2015GSK167983.
I received the flu vaccine for age 65 plus which I was told was high dose. 4 hours after the injection, I began to itch to the right of my left arm where shot was given. I noticed immeditaely that the site of the shot was black and blue. My arm began to swell and become very red and itchy. The redness and swelling increased on the following day and my entire body began to itch. I called the 24 hour nurse line at clinic who told me to use ice packs and benedryl cream. I called back a couple of hours later and and spoke to a nurse who said to go to hospital or closeby urgent care if worsens, use claritin, pill, and bendryl cream. On Sunday, I went to urgent care clinic. The swelling was less but very itchy all over arm and body. The swelling and redness went about 4 inches in length. I was given an injection of methypresidone and told I would feel better. On Monday, the 16th, I felt awfu; as I had not been able to sleep, I was dizzy and feeling unsteady. I had taken a claritin pill as the redness falred up during the Sunday night. I called the 24 hour nurse line on the 16 in the afternoon to say I felt awful, was still itching. He told me not to use claritin pill, just wait and the injection would work today, the 17th. Today, the redness is less and I am less itichy but I have felt sick all day with nausea, loose stools, dizziness, some itchiness this evening. I made an appt to go see Dr. at clinic tomorrow the 18th at 2:50.
Four to five days post vax, the pt developed a fever which rose to 102 degrees and resolved within 24 hours. The reporter indicated that 4 infants experienced this event; however, they are not presently identifiable. Additional information received from the vaccine provider stated that the infant was given a complete physical within 24 hours of the event. Concomitant vaccines included DTaP, Hib, and IPV. The pt remained recovered. The reporter stated that the office was unable to provide identifying information for the other pts.
3" x 3" circular area of erythema at site of DTaP per MD.
very sore right arm - felt like was hit with a baseball bat - started around 5 hours after injection (8pm) and lasted for 36 hours fever started around 8 hours post injection (12 midnight) and lasted for 41 hours body aches mimicked the fever started around 8 hours post injection (12 midnight) and lasted for 41 hours fatigue started within 2 hours and lasted 48 hours flush in face started 68 hours post and is ongoing at this time
Arm pain right away. Pain then slowly worked into neck muscles and would not let go, the muscles never seemed to relax even when sleeping. While driving home from work I was unable to turn my head left and right from the strain of the neck alone. I was able to get home and lie in bed where I was unable to move any limbs but could breathe normally for about 4 hours. I saw my physician whom described the muscle tension similar to meningitis symptoms so blood work was done to check for meningitis. Came back negative. I was admitted from the physicians office directly to the local hospital down the street. From there I was admitted and I claimed muscle pain and temporary paralysis possibly related to the moderna vaccine. I was there for about 4 to 6 hours for testing and monitoring. The hospital did not really do much past that point. I seemked professional help from a neurologist because the hospital was overwhelmed with covid patients at the time. I explained how the pain was unbearable and at times excruciating in the neck to shoulder area on both sides. An MRI revealed a herniated disc in my neck. This MRI was not done however until about 7 months later at the same hospital, whom assured me it seemed like a normal muscle injury. I went to physical therapy for over a year to gain back movement and strength with good success. In the meanwhile I also was admitted for an epidural injection to assist with the pain.  I then seeked pain management assistance from a specialist and she provided some relief with cortisone injections and gabapentin pain medication. To this day my neck still feels tense but has seemingly slowly gotten better over time.
AT SOI: INDURATION,PAIN,ECCHYMOSIS,REDNESS,PRURITUS.RECVD 1ST DOSE 3-5-90.NIGHT OF 3-6-90 SYMPTOMS ST OUTER ASPECT OF REDDENED AREA.GIVEN CHLOR-TRIMETON 4 MG.IMPROVED 5 HRS LATER(LESS RED AND ITCHY). ITCHING LASTED 3 DAYS.SYMPTS GONE 1 WEEK
1" x 1" red, erythematous annular area where injection given in center is slightly raised & lighter in color.  4 satellite lesions around area, 1 lesion appears to contain fluid, but less than expected with a vesicle.
4 hours diarrhea and redness today, vaccinated yesterday. Feels stiff and firm approximately 2cm of induration on (R) deltoid. With axillary tenderness. Mild Rxn.
red; Injection site redness; swelling; Pain; Itching; Tiredness; Neck pain; Lower back pain; This is a spontaneous report from a contactable consumer. A 75-year-oldnon pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right on 20Mar2021 13:15 (at the age of 75 years) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included arthritis, low thyroid. Concomitant medications included Selenium, Kelp [ASCOPHYLLUM NODOSUM) and Vitamin D Nos, Multiple Daily Vitamin. Patient had no Known allergies. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm 27Feb2021 01:15 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On 21Mar2021 13:45 the patient experienced injection site redness, swelling, pain, itching, tiredness, neck pain, lower back pain, on unspecified date patient had red (erythema). It was reported that the caller, called to say that she got both of the doses of covid 19 vaccine, and she was reporting adverse events like red, swollen and itchiness in the Injection site. She got the first dose of the covid 19 vaccine last 27Feb2021 and the second dose last 20Mar2021. Patient had no treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
CELLULITIS , FEBRILE,NOT EATING OR DRINKING, LEFT ARM PAIN.
devel petechial rash on forearms/lower extremities (dorsum); stiffness lower back & in wrist & elbow joints; bilaterally approx 2 wk post vax; seen on 30MAY95 rash almost completely resolved;
pt just felt light headed and felt nauseous; had patient lay on floor, was given an ice pack on back of neck; propped up feet, once feeling better, sat patient up and made him stay a bit longer, was monitored for a half hour before he left
Three to four years after vaccines, the first case / the second was / 5 months after the first/Suspected vaccination failure; First case was near my tail bone / second was / 5 months after the first; Second was a mere 5 months after the first, less painful, but lingered longer; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced 2nd case of shingles a mere 5 months after the 1st case of shingles and stated shingles was less painful, but lingered longer. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. For 1st outbreak of shingles refer linked case US2021AMR118138, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR118138:Same reporter, same patient, 1st shingles outbreak
"Robust Take with Lymphangitis"  Persistent 103F Fever-3 Days, Chills, Extreme Malaise, Redness throughout upper Left Forearm, Welt approximately 2" in diameter at injection site.  Unable to report for work for 7 Days.  Welt was drained approximately 19 days after injection.  Block 13: Route--multiple puncture vaccination; 3 punctures.
ALLERGIC REACTION; HEART BEAT ELEVATED; FATIGUE; GLASSY EYES; LETHARGIC; RUNNY NOSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included advanced multiple sclerosis, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced glassy eyes. On 14-MAR-2021, the subject experienced lethargic. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced heart beat elevated. On 17-MAR-2021, treatment medications included: loratadine. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, had not recovered from glassy eyes, runny nose, heart beat elevated, and allergic reaction, and the outcome of lethargic was not reported. This report was non-serious.
Information has been received from a healthcare worker referring to a male patient of unknown age. On 03-JUN-2014 the patient was vaccinated with his first dose of GARDASIL (dose, lot # and route were not reported). On 08-FEB-2016, the patient was vaccinated with his second dose of GARDASIL (dose, lot # and route were not reported). No adverse effects were reported. Additional information has been requested.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 4 months old male patient who received expired dose of vaccine, no AE PENTACEL on 10-Sep-2018 which was expired on 02-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 10-Sep-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE lot C5403AB via intramuscular route. It was case of actual medication error due to expired vaccine use. It was also reported that patient did not visit any Emergency room. No adverse event was experienced. 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. List of documents held by sender: none.