chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in right shoulder starting 11/12/2008.  Initial visit to orthopedic surgeon.  He felt pain was from inflammation of the shoulder and prescribed naproxen.  Pain did not go away and by 11/14/2008 a rash appeared.  I visited my Internist and he thought the rash was some type of allergic reaction.  On 11/17/2008 I went back to my internist and he confirmed a diagnosis of shingles.  He then prscribed an antiviral med.
In chart note. She states she got a PNEUMOVAX here at the clinic a week ago. The following day her left arm was quite painful. It has persisted that time. She has noted no redness of the arm. She had had no fever or chills. She has no other muscle pain. No hx of trauma. No new medications.
As per patient's daughter, her mother's blood pressure became uncontrollable 96 hours after 1st vaccine.  it lasted about 3 days and was stabilized with medication management.  Also as per daughter, her mother's memory got worse
This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (strength, route of administration, dose, frequency, lot# and expiration date were unspecified by the reporter) for prophylaxis. The reporter stated that the administered vaccines experienced two temperature excursions: the first one between 32F and 36F for 57 hours, and the other one between 46F and 77F for 24 hours. No previous temperature excursions were reported and the reported information was not registered in a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005592: US-009507513-1703USA000340.
Immune Thrombocytopenia Purpura diagnosed on 9/14/21 in pediatric office.  Referred to Medical Center for lab tests.  All WNL with exception of platelets at 4000.  Was seen by pediatric hematologist, Dr. on 9/16/21, confirming diagnosis of ITP.
they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.; they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A child patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.".  Clinical course: Vaccination Coordinator who was also a paramedic called in about the Pfizer COVID-19 Vaccine Dose. The patient was currently being booked for a 2nd dose of the Pfizer COVID-19 Vaccine. Caller wants to know if it's ok for the patient to take the 2nd dose and for them to take the booster dose. Caller did not have patient details available.  The lot number for bnt162b2 was not provided and will be requested during follow up.
First noticed significant discomfort, swelling & redness when getting dressed the morning after vaccination (about 22 hrs after shot).  She had difficulty lifting arm Thurs. & Fri (7/10 & 7/11).  Red band around arm/site of injection, warm to touch, swollen.  No itchiness, no fever.  Took 400mg ibuprofen which helped discomfort but did not help swelling.  7/14 swelling is decreasing.
Stroke; test positive for the COVID; 102 fever; This case was reported by a consumer and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) (batch number 27PAS, expiry date unknown) for prophylaxis.   In August 2021, the patient received Shingles vaccine. In August 2021, immediately after receiving Shingles vaccine, the patient experienced fever. In January 2022, the patient experienced covid-19. On an unknown date, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke, covid-19 and fever were unknown.   It was unknown if the reporter considered the stroke, covid-19 and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and started running 102 degree F fever immediately after vaccination. The patient also had stroke 4 days later. Between 4 and 6 months after receiving the vaccination, the patient was now (in January 2022) tested positive for the Covid vaccine which he/she did not had.
Muscle aches, stiffness unable to turn in bed to sleep or sometimes to sit on toilet. Pain eased up during the day with movement but still exists. Worse at night.   Advil would give some relief at night.  Also a new EKG, suddenly turned up LBB.  Currently trying low dose regimen of prednisone which helps.
Pt was given injection on 02/25/2003. Returned to clinic on 02/26/2003 with reaction to shot in left upper arm 10cm wide and 11 cm long. Erythematous, mildly tender to touch ad warm. Pt had fever so we covered him with an antibiotic. Reaction lasted 7 days.
SWOLLEN FACE, RASH ON FACE KNECK AND TORSO. HIVES AND ITCHING, UNABLE TO SLEEP DUE TO ITCHING. RASH STILL PRESENT 3 DAYS AFTER VACCINATION. LOW GRADE FEVER.  TREATED AT URGENT CARE WITH STEROID INJECTION (DECADRON), ORAL PREDNISONE RX, INSTRUCTIONS TO CONTINUE BENADRYL AROUND THE CLOCK.
Injection site redness; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and fatigue. On an unknown date, the outcome of the injection site erythema and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient had redness at the injection site and a prolonged episode of fatigue for 3 weeks after receiving his first dose of Shingrix. No additional details provided. Call notes stated that the patient did not give details at the time of the call.
blood clot --dvt---found on april  28 2021-------throbbing in leg....placed on Eliquis  5mg. as of july 10 2021 still taking eliguis ....follow up with doctor on july 21 2021
Patient passed out for 30 seconds, paramedics were called, patient taken to hospital for observation/exam for neck pain.
At 8PM pt felt itchy at vaccine site.  Pt felt multiple bumps on multiple areas on her body.  The bumps were circular.  The next day at noon; pt had fever of 102 degrees Fahrenheit.  Fever went down after 3 days.
Presumed granuloma in left thigh, developed within 24 hours of administration, still present 1 month after administration
Some red mark on left cheek, progressed to cover entire left cheek, Temp 99.3, fussy, decreased appetite. Had neonatal tooth extracted 3 weeks ago from bottom left. DX buccal cellulitis TX IV antibiotics. D/C 11/2/06 on PO Augmentin. DC DX: buccal cellulitis. Had a natal tooth extracted from left lower jaw approximately 3 weeks ago. Presents with progressively spreading erythema and warmth of left cheek.  WBC 17.0. Treated with Rocephin.
None administration error - patient was given 1 ml of Moderna COVID vaccine instead of 0.5 ml
pt recvd flu vax & later noticed was exp SOB on exertion along w/sense of soreness in trachea; dx viral pneumonia;
Nausea, Fever 100.0,  body aches, chills, headache, fatigue
Bell's palsy Right. since April 24,2021  He was seen at MEDICAL CENTER, s/p acyclovir, prednisone treatment. pt. states 50% improving  It was noted that he had J&J Covid19 vaccine. Pt. advised to report it to Vsafe. It will also be reported to VAERS.
I was very ill on Friday night after receiving the vaccination. Flu-like symptoms, high fever, shortness of breath, pain in my abdomen, horrible headache, nausea, dizziness, loss of consciousness and leg pain (both legs). The flu-like symptoms passed on Saturday, but by Tuesday, April 13 I was continuing to have a terrible headache, abdominal pain and leg pain. I saw my primary doctor on the 13th and was sent over to the hospital for an ultrasound of my leg. No clots were found and I was told to continue trying to recover at home unless it got worse. I was seen at the emergency room on April 14th for abdominal pain, leg pain, dizziness and headache. The nurse told me I was probably hysterical over the vaccination being pulled, and I told him this was not the case. They performed CT (without contrast) on my abdomen and head, then released me with instructions to return if I was worse. By the 16th I was unable to walk as my left side was completely numb. I went back to the ER. I had a CT of my abdomen and head with and without contrast. I had a lumbar puncture and several labs. I was given IV antibiotics for some infection they found in my urine. I was given fluids and pain meds, and my BP was shooting up to 145/94 (which is very high for me), when standing. My vision was blurry and I was unable to remember much of the last week. I was admitted from the 16th through the 20th and had an MRV, 2 MRIs, more lab work and medicine for my headache. I was released on the 20th and the headache was unbearable and I was still numb on my left side, going back to my doctor on the 22nd. He suggested the ER, and the ER admitted me back to the stroke unit. I was released on the 22nd with a diagnosis of a hemiplegic migraine that could cause stroke-like symptoms (ZERO history of headaches previously). I was sent home with a walker and home health services. PT visited on April 30th and ordered two visits per week for the next month. I am unable to walk without a walker. I cannot shower or use the stairs without assistance. My memory is still foggy. I am unable to concentrate for long. I often stutter and can't remember basic words. I have also stopped and forgotten where I am at a given moment. I am on Depakote nightly for the headaches, and they have lessened slightly, but when they flare up it is debilitating and I often vomit. I have instructions to follow up with my primary tomorrow morning and see what the next steps are.
having restless leg syndrome from her mid thighs down through her toes; This case was reported by a consumer via call center representative and described the occurrence of restless legs syndrome in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peripheral neuropathy and pernicious anemia.   On 8th June 2021 15:00, the patient received the 1st dose of Shingrix. In June 2021, 9 hrs after receiving Shingrix, the patient experienced restless legs syndrome. On an unknown date, the outcome of the restless legs syndrome was not recovered/not resolved.   It was unknown if the reporter considered the restless legs syndrome to be related to Shingrix.  Additional details were provided are as follows: The case was reported for patient herself. The patient received dose of Shingrix and on same day in midnight, she experienced restless leg syndrome from her mid thighs down through her toes. She had notified her doctor. She was still experiencing restless leg syndrome.  No additional information were provided. The consumer consented to follow up. The case was linked with case US2021125154 reported by same reporter. The event onset date was  kept partial to reflect precise TTO value.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125154:Same Reporter
having breathing problems/This went on for 7 months and then I got my vaccine on a Friday, and on Monday my breathing issues were gone instantly.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Lot number: EL9269) as dose 2, single for covid-19 immunisation. Relevant medical history included: "breathing problems", start date: Sep2020 (ongoing), notes: This past Sep2020, She said, This was before the vaccine. She started having some breathing problem.; "chronic eye problems" (ongoing); "Glaucoma" (ongoing); "Eye inflammation" (ongoing). Concomitant medication(s) included: BROVANA taken for dyspnoea; ALBUTEROL HFA taken for dyspnoea; PRED FORTE taken for eye inflammation; TIMOLOL [TIMOLOL MALEATE] taken for glaucoma. Vaccination history included: Bnt162b2, for COVID-19 immunisation.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "having breathing problems/This went on for 7 months and then I got my vaccine on a Friday, and on Monday my breathing issues were gone instantly.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She is consumer 49 years old and she is calling about the Pfizer covid-19 vaccine. She had her second dose of vaccine in Feb2021 and she got an antibody test done this week, And it was negative. She also said, This past Sep2020, She said, This was before the vaccine. She started having some breathing problem. The day after the Covid vaccine, She never tested positive, Then, When she got her vaccine in Feb2021. She got it on a Friday and on Monday. Her breathing issues completely gone, canceling. They were all better and this week, She said the breathing problems returned and that's why. she asked for the antibody test. She thinks her immunity has faded away. On paraphrasing: Consumer stated, "The antibody test was this week. I had the antibody test this week and Yeah, It was negative. So just this week, I started feeling the way the before it was not bad that. Definitely something. I am having some breathing difficulties but it's not like I had  before."   No follow-up attempts are possible. No further information is expected.
After the shot, no issues, late afternoon, I felt like I had the flu. The night of 13th fever; 14th, I had high fever, chill, and slept the day, and that evening at 7:45PM, I had chest pressure, and then chest pains, and increased and didn't go away. I was scared and thought it was like a heart attack. Went to ER, they hooked me up to machines. Small dose of morphine and nitro pills, because I couldn't talk till I took the pills. The doctor didn't understand and wasn't concerned about the COVID-19 vaccine. Stay in hospital. May be having artery cramps in my heart which was causing the pain, left 15 Oct 2021. I saw the cardiologist on 21 Oct 2021.
I have never had HPV or genital warts. Prior to this injection, I had a full examination and pap. Everything came back clear. Within 24 hours of taking the first vaccine I had some bumps. By 09/06/2016 my entire vulva/vagina is covered in what I can only assume is warts. It's painful, swollen, bright red and bumps everywhere leading towards the anus. I will be returning to Doctor for a further examination. After this happening, I did some research and there are proven cases where this shot has given the patient warts. I'm devastated. It's uncomfortable to wear panties. And I am not currently sexually active. Can his be fixed?? ????????
pale; limp; didn't look right; This case was reported by a physician via call center representative and described the occurrence of pallor in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 74FN7, expiry date 1st March 2021) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On an unknown date, the patient received the 1st dose of Pediarix, Rotavirus vaccine (oral), Hib vaccine at an unknown dose and PREVNAR at an unknown dose. On an unknown date, 5 min after receiving Pediarix, Rotavirus vaccine and Hib vaccine, the patient experienced pallor, limping and feeling unwell. On an unknown date, the outcome of the pallor, limping and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pallor, limping and feeling unwell to be related to Pediarix, Rotavirus vaccine and Hib vaccine.  Additional details were provided as follows: The patient received Pediarix, Rotavirus, Hib and Pneumococcal vaccine at the same time a couple of months ago and about 5 minutes later, the patient's father stuck his head out the door and asked the physician to come in. The patient was pale and did not look right. He was also limp. the patient's breathing was fine and there was no change to his heart rate but it took some time for him to come around. The reporter had concerns due to the warnings about pertussis-containing vaccines. The physician was transferred to medical information for additional assistance.
broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy). At the time of the report, RASH PRURITIC (broken out on her face on her chest, shoulders, and arms, one spot on her forehead and these are itchy) outcome was unknown.            No relevant concomitant medications were reported.  No treatment details were reported.
Runny/stuffy nose, constant sneezing, cough, tightness in throat since April.
This spontaneous report as received from a physician via a company representative refers to a 20 year old female patient. No medical history or concomitant conditions were reported. On 04-SEP-2013 the patient was vaccinated with GARDASIL dose 1. No lot number or expiration date was reported. As soon as the patient arrive home (on 04-SEP-2013), she experienced swelling and injection site pain. The injection site was also reported to be red. The pain was reported to be severe enough to "keep her up at night". The patient returned to the physician on 25-SEP-2013. The physician observed the injection site arm and reported that the arm was no longer swollen, but visibly red and still sore. Since an unspecified date, the events were treated with ADVIL. To date only the first dose of GARDASIL has been administered. The reporter did not provide a causality statement. No further information was provided. Additional information has been requested.
3.5" by 3" slightly indurated region in upper outer thigh, per clinician felt slightly warm. Dose of Benadryl given.  Follow up on 10/22/2003: "Per RN, ERROR, patient did not receive polio virus at the same time.  Last polio virus given 09/17/2002."
Patient had received Pfizer COVID -19 vaccine on 07/11/2022. Legal guardian ,brought child in and said he needed second COVID vaccine. Legal guardian said child received Moderna, but did not have his vaccination card. Gave child Moderna infant vaccine. Then clerk had looked up the vaccine on computer program (Public Health)  and patient had received Pfizer infant vaccine. Discussed with guardian. advised to take child to nearest medical facility. if any complications. Reported to Nurse Manager, RN.
Starting a few hours after vaccination, patient began to experience an unrelenting, severe non-migraine headache unresponsive to APAP/ASA/Caff, and APAP to treat with no relief.  Patient is not experiencing additional symptoms (ie aura) but complains of a general uneasiness rather than nausea.
Sore throat, felt like passing out, aching joints, high fever (4 PM), vomiting (2:45 PM), diarrhea (next morning).
Patients mother phoned stated patient developed hives on the lower right arm below the elbow. Hives spread to left arm. Patient was advised to take Benadryl p.o. as directed.
I went and got my shot. everything was clean and nice. I got home and I felt a light headache that was persistent. I got chills. they noth went away after day 2. On february 6th, around 6:30pm I felt a pinch or jab in my left arm and it was very itchy! I rolled up my sleeve and where the shot had been administered was knotted and very hot! I went and got some ice. i did NOT take any medicine. the ice helped. I went to bed at 11pm and I took a photo of the injection site and it was still very red and very hot. I applied a cold wet wash cloth to it. on Sunday morning I woke up and my arm felt hot again and the red dot and knot was still there but there was an additional red lump/circle below the injection site. I couldn't wear a long sleeve shirt. there was swelling. it was irritated and itchy. the next day my arm was red but the first knot was gone. the second knot was larger and still warm. I woke up this morning (Tues) the color is fading but its still a large lump and sore and warm.
HEADACHES; This spontaneous report received from a consumer concerned three patients. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches. This report was non-serious. This case, from the same reporter is linked to 20211004108.