chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Radiating pain throughout my left arm which eventually went to left pec muscle. Sustained pain for 3 days and an inflamed lymph node under my armpit. After that subsided, my left eye started hurting and I started losing color in my eye. This got worse for a week before I went to hospital. After 3 MRIs, it was found that I had a lot of inflammation in the nerve behind my eye and I was diagnosed with optic neuritis. I can no longer see out of my left eye. Vision has not improved.
Information has been received from a physician concerning a female patient who in February 2008, was vaccinated with the first dose of GARDASIL. In May 2008, was vaccinated with the second dose of GARDASIL. In February 2008, since the first dose was given the patient experienced rash. In May, 2008, after the second dose was given the patient's rash got worse. The patient's rash persisted. The patient spoke to the physician for medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning a female child with no allergies or medical history who on 07-AUG-1990, who at 18 months of age, was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. "Later," on an unspecified date, the patient had a seizure. Unspecified medical attention was sought. The nurse believed that the seizure was unrelated to the vaccine and may have been years after vaccination. The child never had a specific diagnosis but has been seizure free since the initial seizure. The patient was considered recovered. Her second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live was never given due to the seizure. A product quality complaint was not involved. Upon internal review, seizure was determined to be an other important medical event (OMIC).  Additional information has been requested.
This spontaneous report concerning a patient of unknown gender and age was received from a physician. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot and expiration date were not provided), by intramuscular route. There were no concomitant medications reported. On an unknown date, the patient fainted (syncope). No product quality complain was involved. At the time of reporting, the outcome of the event of syncope was unknown. The causality between GARDASIL and the event of syncope was not assessed. Additional information is not expected as the reporter did no consent for follow-up attempts.
Extreme hardness, redness, hot, itching and swelling at injection area.  As of today this has now spread to an area larger than my hand can cover and is still spreading.  Mild headaches and dizziness.  I am thinking about seeking emergency room care today.
During injection notes shoulder joint pressure. After noted severe and worsening shoulder joint pain with significant swelling and inability to utilize arm functionally. Catching intense pain with small movement.
Bubble of blood at injection site; Yellow crystalline precipitate (potentially be vaccine, did not receive full dose); A regulatory authority report was received from a consumer concerning a 69-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced bubble of blood at injection site and yellow crystalline precipitate.  There were no medical history and concomitant medications reported.  On an unreported date, the patient experienced COVID-19 with a positive COVID-19 test. No symptoms were reported. On 18 Feb 2021, approximately 1 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced bubble of blood at injection site, yellow crystalline precipitate. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, bubble of blood at injection site, yellow crystalline precipitate (Vaccination site discharge) was considered as resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Stroke; Dose Number 1 on 08Jan2021/Dose Number 2 on 25Jan2021; This is a spontaneous report from a contactable nurse. A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249 and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Patient has no medical history. Concomitant medication included tamsulosin hydrochloride (FLOMAX). Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on 08Jan2021 on the left arm. The most recent COVID-19 vaccine was administered at the hospital. On 18Jan2021 06:00, the patient experienced right foot drop. Spine MRI on 18Jan2021 was negative. Stroke confirmed on brain MRI on 28Jan2021. Patient was sent to the ED at the hospital immediately after and was admitted from the ED to the hospital. Number of days of hospitalization was 2. Adverse event result: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient has not recovered from the event stroke. Event was reported as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has been tested for COVID-19 with test type: nasal swab on 28Jan2021 with result negative. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based on current information available, the event stroke mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Vomiting, Shaking violently, muscle contractions throughout body, joint pain, headache
RED SPOTS ARE ITCHING AND BURNING; RED SPOTS ON LEFT KNEE LEFT ANKLE AND LEFT ARM; SLIGHT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced red spots are itching and burning. On 18-JUN-2021, the subject experienced red spots on left knee left ankle and left arm. On 18-JUN-2021, the subject experienced slight fever. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, red spots on left knee left ankle and left arm, and red spots are itching and burning. This report was non-serious.
PATIENT COMPLAINED OF DIZZINESS.  10:20 BP 138/88, HR 80, RR 18, O2 SAT 97% 10:35 BP 140/86, HR 80, RR 18, O2 SAT 97%  PATIENT DID NOT WANT TO WAIT FOR NEXT VITAL SIGN MEASUREMENTS AND LEFT IN STABLE CONDITION WITH DIZZINESS RESOLVED.
Patient reports nausea and dizziness following vaccination. Patient states she thinks its psychological reaction. Took patient vitals to find them stable. Patient refused transport to ED
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, 1 total administered to left arm on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient tested positive for covid-19 infection using rapid SARS covid antigen test (suspected covid-19 infection, suspected clinical vaccination failure). On OCT-2021, in between the time, the patient was tested and the time he tested positive for covid, he did undergo some blood work for which the results were not reported. The patient contracted covid-19 greater than 28 days post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000196859.; Sender's Comments: V0 20211018511-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Very sore arm; Very tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 27Jan2021 at 08:00 (at the age of 47-years-old) as a single dose for covid-19 immunisation. The patient had no allergies to medications, food, or other products and other medical history was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received allergy medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, at 17:00 pm the patient had very sore arm and very, very tired. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Jan2021.
Patient states felt itchiness at vaccine administered site after vaccination. by 2 hours later had right face large red raised rash over entire cheek, red raised rash on entire back and neck area, red itch blotches over front rib cage, both feet and ankles swelled, red raised rash on inner aspect right foot.
Information has been received from a 64 year old female patient with no pertinent medical history who on 27-SEP-2010 was vaccinated with the first dose of RECOMBIVAX HB (unspecified manufacturer). There was no concomitant medication. On 01-OCT-2010 the patient experienced diarrhea, loss of appetite and dizziness. It had not had lab diagnose study performed. The patient stated that the symptoms have not abated as of the time of the call. The patient was unable to identify the manufacturer of the Hepatitis B vaccine, the dose or route of administration. The patient stated that she was not able to take any medications, that any medications ever administered have made her ill in one way or another. The patient was not willing to get into the specifics of these other medication reactions. No further information is available.
The second Moderna intramuscular injection  felt different from the first injection.  This one hurt when injected.  About 3:15p.m. that same day, I noticed the arm started hurting.  It later became very painful and I had lost strength in the arm and I could not lift my arm.  This was alarming to me and I thought there may have been nerve damage.  The fatigue, fever and headache came the next day and the arm was painful and unusable.  At 2:30pm  on Saturday, Feb. 27th, I took 3 Aleve to relieve the pain in my arm.  I had hoped to not take anything after getting the vaccine, but I could not stand the pain any longer.  I researched online and read about SIRVA.  I thought that was  responsible for the pain.  The Aleve helped.  By Sunday, Feb. 28, 2021, the pain had abated and I could use my arm.  My fever, fatigue and headache had gone too.  My intention in submitting this is to request that more explicit reactions be listed so that someone like me, living alone, would know that this is a possible reaction and to let it run its course.  This caused me undue stress, on top of feeling lousy and being in a great deal of pain, not the mention my fear of never being able to use that arm again.  That may sound like an overreaction, but until you have had a  limb rendered useless, no matter how hard you try to move it, it is frightening.  I would appreciate any feedback on my experience and I would like to know if others have experieinced this too.  Thank you.
chills, body aches, skin hurt, nausea, lack of appetite and diarrhea (along with sore arm)
Facial weakness and slow pressive decrease in expression followed by inability to swallow.  She felt tired and has difficulty raising her arms, along with difficulty with upper reflexes.  11/30/2009 MR and DC summary for 10/13-10/19/2009. Patient with c/o's weakness bilateral upper and lower extremities, facial weakness, dysarthria, numbness in fingertips and toes. Neuro exam noted absent ankle reflexes bilaterally, IR guided LP. Tx: IV IGG, Dc Dx GBS
This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of VAQTA, injection (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old patient who was vaccinated with a dose of DAPTACEL expiry date: 08-Oct-2018 (lot number not reported via intramuscular route in unknown administration site) on 19-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to expired vaccine used. It was reported that a 15-month old received a dose of DAPTACEL on 19Oc2018 that expired on 10/8/2018. It was reported that the patient had no adverse event developed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
anxiety; is making her eat a lot more; leg-cramps; itching on her heals; stomach cramps; excessive sweating; diarrhea; nosebleed; headache; very tired; couldn't even walk because she felt like her skin was about to break; water retention; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DIARRHOEA (diarrhea), FATIGUE (very tired), PRURITUS (itching on her heals) and ABDOMINAL PAIN UPPER (stomach cramps) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm got swollen). On 18-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (very tired), MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) and FLUID RETENTION (water retention). On 19-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed). On 21-Apr-2021, the patient experienced PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps), PAIN IN EXTREMITY (leg-cramps) and HYPERHIDROSIS (excessive sweating). On 22-Apr-2021, the patient experienced ANXIETY (anxiety) and INCREASED APPETITE (is making her eat a lot more). On 18-Apr-2021, HEADACHE (headache) and MOBILITY DECREASED (couldn't even walk because she felt like her skin was about to break) had resolved. On 19-Apr-2021, DIARRHOEA (diarrhea) and EPISTAXIS (nosebleed) had resolved. On 21-Apr-2021, PRURITUS (itching on her heals), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN IN EXTREMITY (leg-cramps) outcome was unknown, HYPERHIDROSIS (excessive sweating) had resolved. At the time of the report, FATIGUE (very tired), ANXIETY (anxiety), FLUID RETENTION (water retention), PERIPHERAL SWELLING (arm got swollen) and INCREASED APPETITE (is making her eat a lot more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient complain that her arm started to feel hot, swollen, and red about 6 hours after vaccination.  After two days, the swelling  has gotten worse and she went to her doctor who diagnose her with cellulitis and prescribe her cephalexin.  As of today(2 days) after the vaccination, her arm is still swollen.
This spontaneous report as received from a physician refers to a multiple unspecified patients of unknown age and gender. No concurrent conditions, allergy/drug reactions, medical history and concomitant medications were reported. On an unknown date, multiple unspecified patients were vaccinated with either ROTATEQ lot#M004542 with expiry date:08-OCT-2017, lot#L039141 with expiry date: 16-AUG-2017 or GARDASIL 9 lot#M007764 with expiry date:30-JAN-2018 (dosing details were not reported) that was improperly stored. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Patient states left feeling okay, but about 1-2 days later they noticed they had a rash that appeared adjacent to the vaccination site. It became very painful, red, and rash filled. Patient stated a level of pain they had to take one of their pain medications and they cannot lift up there arm for simple task like put on deodorant, which really concerned the patient. They have had no other treatment or anything on that arm by the site.
Fatigue; Headache; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 15:30, the patient experienced fatigue, headache and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache and soreness at injection site was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
RAPID / ERRATIC HEARTBEAT, LIGHT HEADED,  CHEST DISCOMFORT LASTING ABOUT 4 HOURS 3/23 PRIMARY CARE PROVIDER APPT 4/8 RAPID / ERRATIC HEARTBEAT, LIGHT HEADED,  CHEST DISCOMFORT LASTING ABOUT 1 HOUR 4/22 CARDIOLOGIST APPT 4/23
Temporal artery was protruding from sudden, painful, tension headache-leading to emergency room visit, >3" diameter enlarged gland in armpit, muscle/joint pain,  fatigue  (ongoing)
I had severe inflammation, joint pain and swelling in my hands and fingers. I suffer from RA and Crohn's and haven't had a flare-up in years, but had one of the worst flare-ups of my life after receiving my second dose. I had distorted vision and went to the eye doctor for a full vision exam; they noticed swelling on the optic nerve and prescribed me eye drops to help reduce the irritation. My doctor prescribed me Prednisone to help reduce the inflammation and joint pain. I was taking the steroid medication for at least 6 months and had to wean myself off the medication without suffering from any pain from not taking it. I still have some inflammation, but not as bad as it was when my reaction began.
Fever, body aches, headache, temperature. Symptoms mostly resolved by the next day, 10/17/21.
Pt t102.4, vomiting 2 days p/2nd shot; pt had to go in hosp started having sz, blind cannot roll over, stand up, crawl, hold anything in hands, poor head control; pt almost brain dead, fed w/feeding tube; continuous crying; high-pitched cry
One day post vax, the pt complained of a fever. Denies any other signs or symptoms of infection or disease. Pt offered an appointment to see practitioner but he declined. Advised rest, fluids, and analgesics.
Pt recv vax on 11/12/98; on same day pt exp headache, fever (100.2F), nausea x 5 day; tx=Midrin
Red, swollen below site sore left arm. Pt. advised to go to urgent care.
Information has been received from a medical assistant concerning a 4 year old male with rhinitis and increased immunoglobulin E (IgE) levels at the time of vaccination with a history of immunology problems and fever with unspecified vaccinations who on 10/18/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). The medical assistant believed that the vaccination was given in the left leg but was unsure of what route and exact location. On 10/18/06, 12 hours after the vaccination, the pt developed left leg pain and fever. After 24 hours, the pain increased and the pt refused to walk. After 48 hours the pt became very febrile (exact temp was unk) and developed tachycardia. The pt was hospitalized for several days and treated with unspecified IV antibiotics. The medical assistant considered left leg pain, tachycardia and fever to be other important medical events (OMIC). The office reported that the vaccination was from a multi dose vial and reported that they would like a lot check. The office gave 4 dosed from the exact vial and no other reactions reported. The physician was concerned because they have other vials and do not feel comfortable giving those doses to children in their pediatric pulmonary office.