chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope.  Breathing but unresponsive.   Dizziness and weakness prior to syncope event.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 07-DEC-2016, the patient received 1 dose of HAVRIX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). In approximately 24-MAY-2017 (reported as an unspecified date "two weeks before 07-JUN-2017"), the patient was vaccinated with a dose of VAQTA 50/1.0 U/ml for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter stated that the patient received the Hepatitis A vaccination series due to a requirement from the patient's nursing school and not due to low titers. No adverse effects were reported.  Additional information is not expected because there was no consent to contact the physician.
Sore arm; This is a spontaneous report from a contactable consumer (husband).   A 69-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266; Expiration Date: May2021) via an unspecified route of administration on 24Feb2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma and concomitant medications were not reported. On Feb2021, the patient experienced sore arm with outcome of unknown without treatment received.   No follow-up attempts are possible. No further information is expected.
My son was two weeks old when he received this vaccine. He began having trouble breathing, screamed in a high pitched scream, wrenched his face and body in pain, & had a high fever of 103.7. When we arrived at ER and he had a spinal tap (came back clear) but he had problems with his blood count.  The pediatrician in the NICU would not comment if it was related to the Hep B vaccine, but our pediatrician was kind enough to suggest that it could have been a reaction, and suggested that we skip future doses for my son- and any future children. We have done so, and thankfully escaped any more issues with this vaccine.
Fussy, fever, not sleeping. Fever 100.3 (oto) at 0530 am. Temp in office 98.9 (tem oral) at approximately 1045.
Developed 2 inch diameter of erythema with mild induration at injection site. Pt otherwise well. Afebrile. Treated with Clindamycin
Patient is a 96 yo female from Senior Living with a history of Alzheimer's dementia, HLD, depression, anxiety, GERD, endometrial cancer, recurrent falls, recent multiple rib and T6 compression fractures who presented to the ED complaining of syncope. Patient is unable to give further history and information was obtained via ED provider Dr., Senior Living staff member, and LAP. Reportedly, patient had a witnessed syncope at Senior Living in a standing position. She was helped to a seating position. She was in and out of consciousness intermittently. No seizure like activities, bowel/urinary confusion, prodromal symptoms. No history of seizures. I spoke to Patient's LAP 3609080895 and she states patient sees a Neurologist for dementia/Alzheimer's. Patient is a DNR per. This was witnessed with RN. She was evaluated by Cardiology. Cardiac work up unremarkable. She developed aphasia during this hospitalization, and MRI brain and MRA head and neck were unremarkable. She was evaluated by Neurology with no further recommendations. Aphasia resolved. As she was being discharged to ALF, she was tested positive for COVID on 7/23/21. She had no prior diagnosis of COVID and is s/p Pfizer vaccine x 2. She had been on RA with no infiltrates on CXR. As such, she is not a candidate for dexamethasone or remdesivir. Her encephalopathy might have been a result of COVID infection.
I tested positive for COVID-19 on 12/24/22. I had fatigue, runny nose, cough, sore throat, and not feeling well in general. This lasted for about 5 days. I was not prescribed medication because I am on Dialysis, and I am unable to take PAXLOVID. I am feeling much better now.
Patient noticed rash on scalp developed within a few days after flu shot, but could not say exactly when it had started. Rash has lasted about a month before coming back to pharmacy.
Pt was given 0.2 ml of the pediatric formulation which mean she was under-dosed. She is being recalled to repeat the booster at the correct dosage.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a first dose of Gardasil. Subsequently the patient fainted. The patient was seen by the physician. Subsequently, the patient recovered from fainted. Additional information has been requested.
Pain bilateral calves, tender 72-96 hrs. Post influenza vaccine, normal reflexes.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medications was not reported. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K020181, expiration date 24-JUN-2016, exact dose was not reported) route of administration defaulted to oral. No adverse effects reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
10 minutes after receiving the vaccine I experienced a strong metallic taste in my mouth. The metallic taste remained after eating food and did not go away until several hours later in the evening. I am fully recovered now and do not experience the metallic taste anymore as it only lasted one day.
approx 20 mins p/vax pt fainted & then had a sz/convuls lasted 5-8 mins; pt taken to police station where transported to hosp; felt tingling in top of legs & nausea; woke up incoherent & feeling very hot;
Patient described that she had diarrhea 36 hrs after receiving the vaccination or the diarrhea lasted for 36 hrs. The details aren't very clear, but she claims it was massive diarrhea.
Fever last checked 100.2 normally 94.5; Aches all over chills; Aches all over chills; chest pain; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 14:15 as dose 4 (booster), single (Lot number: Gj7277) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Selective immune deficiency" (unspecified if ongoing); "X-ray IVP dye" (unspecified if ongoing), notes: allergies: X-ray IVP dye. Concomitant medication(s) included: SHINGRIX, on 17Sep2022. Past drug history included: Nickel, reaction(s): "allergy"; Bactrim., reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), CHILLS (non-serious) all with onset 10Oct2022 at 16:00, outcome "not recovered" and all described as "Aches all over chills"; PYREXIA (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered", described as "Fever last checked 100.2 normally 94.5"; CHEST PAIN (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered"; HEADACHE (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, chest pain, headache.  Additional information: Dose received received more than 3. Patient had received other vaccine in four weeks and received other medications in two weeks. Patient not had covid prior vaccination and not had performed covid tested post vaccination.
Vaso vagal; Uveitis aggravated; Condition aggravated; Renal disease aggravated; Renal disease aggravated; sarcoidosis aggravated; sarcoidosis aggravated; This is a spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via follow-up letter.  A 46-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiration date: unknown), via intramuscular route of administration, administered in right arm on 27Feb2021 at 04:00 pm (at the age of 46-year-old) as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9809) via intramuscular route of administration administered in right arm as dose 1, single on 06Feb2021 1:00 pm for COVID-19 immunisation and patient experienced Extreme Fatigue, sarcoidosis, Uveitis, Renal disease aggravations. The patient medical history includes Covid -19 from 09July2020 till 26Jul2020 with no hospitalization and breast cancer from 12Oct2006 to 15Mar2007 (Stage 2. Treated with Lumpectomy, chemo, radiation). concomitant medications included escitalopram oxalate (LEXAPRO), orally at 30 mg for Anxiety, buspirone hydrochloride (BUSPAR) orally at 5 mg (twice a day) orally for Anxiety, prednilison and cyclopentolate Hcl ophthalmic for uveitis, levocetirizine dihydrochloride (XYZAL), oral 5mg for allergy, Potassium chloride 20 meq (twice a day) orally for kidney potassium, iron- orally 30 mg for anaemia all from an unspecified date and ongoing. The patient did not take any prior vaccinations within 4 weeks. On 04Mar2021, 4 days after the vaccination, the patient experienced Vaso vagal which resulted in hospitalisation, also patient experienced worsening of uveitis, sarcoidosis and renal disease after second dose of vaccine. Patient had sarcoidosis caused by Covid-19 (Jul2020) and then worsened/ flared by vaccine. Patient has uveitis, fatigue and renal disease. Under care of GP, Nephrologist, retina specialist and rheumatologist. Treatment was given to the patient with prednisone 60 mg. Patient lab data includes blood test with unknown result in Mar2021 and chest X-ray with normal findings in Mar2021. The outcome of the event vasovagal (presyncope) was recovered on 07Mar2021, and the outcome of uveitis and renal disease aggravated was not recovered and the outcome of sarcoidosis aggravated was unknown.  No follow-up attempts possible. No further information expected.
dizziness & prickling sensation in legs which travels into buttock, also in hands; states also has dizziness w/begining of menstrual cycle; pt was in contact w/a dog that may have had the saliva of a rabid fox on its fur;
Severe left arm soreness that developed into lymphadenopathy-significantly swollen armpit and pain into the left breast. Followed by severe abdominal pain that worsened  over 5 days with significant nausea.
Swelling from elbow to shoulder pain, bruising and warm to touch, red - MD says reaction to vaccine.
Vaccination hurts for days; The following information was received from a consumer via social media on 28 Nov 2019.  A female vaccinee received a dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) on 28 Nov 2019.   It was described that it has hurt for days after vaccination.  No further information available; Sender's Comments: Causality assessed as possible related, given the kind of events. However, time to onset for an adequate assessment is missing.
Red raised tiny scattered papules on bilateral upper legs, groin area spreading up to mid abdomen.
This spontaneous report was received from a Registered Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent and historical medication. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) lot number K12918, expiration date- 28-FEB-2016 (dose strength and route was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Low grade fever (99.9), body aches, headache, fatigue.   Took Tylenol. Symptoms lasted around 8 hours. Headache persisted all day.
Lump appeared on distal end of left clavicle approx 2 1/2 x 1 1/2. Tender to touch. Evaluated on May 2, May 4 and May 10,2016. No change.
Patient reports flu-like symptoms after injection of SHINGRIX, declines to obtain second dose.
Severe bilateral upper and lower extremity itching, ear and facial itching. no rash.  Treatment: Continued taking Benadryl 25 mg every 6 hours until 9PM on 1/12/21.  One dose of Prednisolone 15 mg @ 330 AM on 1/12/21 and Decadron 16 mg @ 300 PM on 1/12/21. Symptoms resolved at 1/12/21 around 8 PM.  Outcome: no other reactions
Red blotchy spot at injection site approx. 3 x 6 inches, hot to the touch.  Never grew larger from original sighting.  Stayed warm to the touch for several days later.  General soreness and discomfort.  Kept a photo.
stress; headache; Vomiting; Pain; Feeling unwell; Diarrhea; Burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and STRESS (stress) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (due to dental issues). Concomitant products included vitamin B12, multivitamin and NICOTINAMIDE (VITAMIN B3) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). In April 2021, the patient experienced PAIN (Pain), MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On an unknown date, the patient experienced STRESS (stress) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE;MAGNESIUM TRISILICATE]) at an unspecified dose and frequency. On 05-Apr-2021, BURNING SENSATION (Burning sensation) had resolved. In August 2021, MALAISE (Feeling unwell), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN (Pain), STRESS (stress) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Her left breast was larger than the other. She had thermography that indicated excess heat in the left underarm and left breast lymph nodes. treatment medication include cold packs. She was scheduled for her second dose on 13 Sep 2021.
administered vaccine to pediatric patient (under 18); A spontaneous report was received from a nurse, concerning a 17 year old female patient who was administered Moderna's COVID-19 vaccine and was to receive second dose of Moderna Covid vaccine (product administered to patient of inappropriate age).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   The patient went to the administering site to receive second dose of Moderna Covid vaccine. She was a pediatric patient.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, administered vaccine to pediatric patient (under 18)  was considered as resolved on 19-JAN-2021.; Reporter's Comments: This case concerns a 17 year old female who received fist dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of  product administered to patient of inappropriate age
Information has been received from a nurse practitioner and a patient's mother concerning a 15 year old male with no medical history or drug reactions/allergies who on approximately 14-JUL-2010 (two month ago) and 14-SEP-2010 was vaccinated with the first and second dose of GARDASIL (lot# not reported). There was no concomitant therapy. The patient did not experience adverse reaction with the first dose. The mother reported that on 22-SEP-2010 her son experienced adverse events as described: On 23-SEP-2010 the school nurse called and stated that her son was confused and having delayed responses. If he was asked a question he responded in a few minutes. He also had fatigue, nausea, loss of appetite and leg pains. He saw the doctor on 24-SEP-2010 and he thought "it was cold or his eyes". He saw eye doctor on 25-SEP-2010 and exam was normal and within his usual range. He then was taken to emergency room at a hospital on 26-SEP-2010. He had a CT scan, computed tomography, of the head and was transferred and admitted to another hospital. Many tests including blood, urine and EEG, Electroencephalogram, have been done. The symptoms continue and there was no diagnosis yet. The son remained in the hospital. At the time of the report, the patient had not recovered. Follow-up information was received from the nurse practitioner. She reported that neither of GARDASIL doses were administered by their office. The date of the first dose and lot# was not available. Unknown if other vaccines were given concomitantly. The patient was still confined in hospital. The patient was still undergoing testing. Results of previous tests not received. As an aside the mother said the patient's 18 year old brother received a GARDASIL on the same day and was not experiencing any problems. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination, lot numbers, and other healthcare provider names and contact information. Additional information has been requested.
After 3rd injection of Gardasil vaccine, pt fainted. There had not been any problems with 2 prior injections.
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The vaccines was stored in  freezer. They took out one to two vials and placed in fridge each day as needed. No treatment medication was provided.  No treatment information was provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted a few minutes after getting shot but regained concisousness in less than a minutes
Pt had received ZOSTAVAX on 7-13-2009.  He reported to his family physician with shingles on 7-21-2009.  Patient did not mention a current shingles outbreak at the time of vaccination.
sleepiness; was in bed for about 2 days; loss of appetite, no appetite; no urge to eat; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever). At the time of the report, SOMNOLENCE (sleepiness), MOBILITY DECREASED (was in bed for about 2 days), DECREASED APPETITE (loss of appetite, no appetite; no urge to eat), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. No treatment information was reported.
Left deltoid pain, redness, swollen treated by physician with antibiotics and analgesics.