chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever - 100.5; Headache; Tiredness; Other vaccine same date, vaccine date 14Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2022 16:00 (Lot number: fl8095) at the age of 5 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 14Mar2022 (Batch/Lot number: unknown) as dose number unkown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Mar2022, outcome "unknown", described as "Other vaccine same date, vaccine date 14Mar2022"; PYREXIA (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Fever - 100.5"; HEADACHE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 15Mar2022 12:00, outcome "recovering", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, fatigue.  Additional Information: Covid test post vaccination was done nasal swab and results were negative. No known allergies and other medical history reported.  No follow-up attempts are possible. No further information is expected.
I went to the pharmacy to receive the Abrysvo vaccine since I am 36 weeks pregnant.  I completed consent forms for Abrysvo and sat down to receive my vaccine.  After the pharmacist had administered the vaccine, I noticed that the box said Arexvy.  I expressed my concern to the pharmacist since the Arexvy has not been FDA approved for pregnant women.  The pharmacist replied that it was the same thing and don't worry.  I am 36 weeks pregnant and 5 days and my due date is November 1st.
PT WITH LEFT SIDE FACIAL DROOPING/NUMBNESS/PAIN ON 11/8/21
Client verbalized she experienced chest heaviness and SOB the following day after recieved the immunization. Client reported to ER as advised by nursing staff and multiple tests ran, including EKG and PE work up. CLient stated she has factor 5, so ER wanted to rule out PE and everything was normal. Client stated O2 sats normal. Client stated ER discharged with no concerns stating "it was a immune response".
I had mild pain at the injection for the first couple of days, which resolved.  On day 10 post-injection, I developed itchiness at the injection site, including a hive approximately 1 in in diameter.  The muscle are underneath the hive was swollen/hard.   After a couple of hours, the hive resolved, but the skin was reddened in the same area.  On Day 11 post injection (today), the redness/rash spread to approximately 2 inches in diameter and is a little itchy.  The muscle area under the reddened skin remained swollen/hard.  I am hoping that these symptoms will resolve.
Guillain-Barre syndrome; achy arm; tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation; This is a spontaneous report from two contactable consumers (patient's cousin and patient herself). A 68-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration in right arm on 10Feb2021 10:30 AM at a single dose for COVID-19 immunisation. Medical history included anxiety. It was reported that the patient was "physically fit. She was thin and was about 5 feet." Ongoing concomitant medications included escitalopram (reported as "generic Lexapro") for anxiety, calcium, and multivitamins. The patient previously received flu vaccine in Oct2020. She also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) via an unspecified route of administration in left arm on 20Jan2021 10:30 AM for COVID-19 immunization and felt a little soreness in arm and light headache the same day. Two nights later, her scalp felt on fire and had tingling sensation in her face for three weeks. A week after the first dose, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put her on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation and noticed some spikes in her blood pressure. Her physician told her to take another 2.5 mg amlodipine if needed. After her second dose, she went to sleep with achy arm. she woke up that night with a tingling sensation from head to toe. Her whole body was tingling. It was a weird and scary on and off sensation. She stated it had improved during the past two days. The patient confirmed that she had no heart rate problems. She actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. She mentioned her 97-year-old mother and husband both got the two doses with no complication or reactions. The patient's cousin was "pretty sure that it's Guillain-Barre." The patient stated the Guillain-Barre syndrome has not yet been confirmed. She had an appointment with a neurologist. The outcome of 'tingling sensation from head to toe/whole body was tingling/weird and scary on and off sensation' was recovering, of remaining events was unknown.
Client received Pfizer 1st dose on 1/1/21 and J&J 2nd dose on 8/18/21.
the first day was horrible, it peaked; sore arm, body aches; sweating, wrenched in sweat; low grade fever; chills, could not get warm, bone chills; headache, hit like a ton of bricks; every joint hurt; difficult to move; difficult to walk; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever) and CHILLS (chills, could not get warm, bone chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21 and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker, Kikuchi disease (Kikuchi's disorder) and Lumpectomy (breast cancer) (breast lumpectomy (microcalcification),). Concomitant products included CELECOXIB (CELEBREX) for Rheumatoid arthritis, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm). At the time of the report, FEELING ABNORMAL (the first day was horrible, it peaked), MYALGIA (sore arm, body aches), HYPERHIDROSIS (sweating, wrenched in sweat), PYREXIA (low grade fever), CHILLS (chills, could not get warm, bone chills), HEADACHE (headache, hit like a ton of bricks), ARTHRALGIA (every joint hurt), MOBILITY DECREASED (difficult to move), GAIT DISTURBANCE (difficult to walk) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Concomitant medication contains birth control estradylla (0.25mg/0.035mg) and claritin daily 10mg. No treatment medication reported.   This case was linked to MOD-2021-377785, MOD-2021-377322 (Patient Link).
Covid19 breakthrough.  1st vaccine received on 03/22/2021.  56 y/o with PMHX of Renal cell Cancer, Right Nephrectomy and Cecum mass admitted for lower abdominal abscess and cellutitis that failed outpatient therapy of antibiotics and Abscess drain placement.  Pt noted to have Right lower quadrant pain, cellulitis, purulent drainage around JP drains, and abscess.  Pt states has had low grade temps.  CXR with LUL infiltrate.  Room air sat 99%.  Pt requiring I&D, pre procedure Covid test positive.  ID states no particular covid tx at this time as pt asymptomatic.
hives developing over face/body & limbs 3 days p/vax given 4MAR93; resp distress 10MAR94; which resolved; joint/knee pain;
I just realized that my skin condition started days after receiving my 1st Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "Primary Billiary cirrhosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "I just realized that my skin condition started days after receiving my 1st Covid vaccine".  Additional information: Description of Event Outcome: I am a 75-year-old diabetic who also has Primary Billiary cirrhosis and I just realized that my skin condition started days after receiving my 1st Covid vaccine. I just received my 4th shot and my eczema condition continues on getting worse. As I researched chat rooms looking for some knowledge I found a trend of others who also suffered the same fate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Developed Shingles symptoms one week after the booster vaccine.  Shingles outbreak was to the left side of the face and eye.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 24-MAY-2013 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 1108AA, expiration date 18-MAY-2013 and route not reported). No adverse effect reported. Additional information has been requested.
YF-VAX was administered to patient using an expired diluent with no reported adverse event; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional via information (under the reference:00826342).  This case is linked to cases 2021SA356701 and 2021SA356051 (same reporter).  This case involves a 32-year-old male patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] using an expired diluent (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - US (0.5mL, lot U6428AA, expiry date: 30-Sep-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: same day)  It was reported "Operations manager is following-up, providing additional information on expired YF-VAX administered to 5 patients."  At time of reporting, the no adverse event was reported.  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 the 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.; Sender's Comments:  US-SA-2021SA354616: US-SA-2021SA354618:
Initial report received on 11 July 2008 from a health care professional. An 18-month-old male patient, who had a concurrent temperature of 99.1 degrees Fahrenheit, had received, per the reporter, on 08 July 2008 a first, intramuscular left thigh injection of TRIHIBIT, package lot number U15655C (TRIHIBIT is given as ACT-HIB and TRIPEDIA; however the specific lot numbers for these vaccines were not provided). An unspecified amount of time later, on the same day, the patient experienced a fever of 102.5 to 104.4 degrees Fahrenheit that fluctuated over the next four days. He was subsequently evaluated by his physician (date not reported) and prescribed Tylenol and Motrin for the fever. No diagnostic tests or laboratory data were performed. The recovery status of the patient was not reported. Follow up information was received on 14 August 2008 from a health care professional. The patient received an injection of ACTHIB (Z1011-2) and TRIPEDIA (U2059BB). The patient subsequently recovered from the events. No further information was reported. Follow up information was received on 15 September 2008 from a health care professional which resulted in an upgrade of the case from non-serious to serious. The recovery date was 17 July 2008. The only treatment the patient received was Tylenol. The patient's final diagnosis was drug allergy and the etiology was reported as vaccination. No further information was reported.
Swollen lymph nodes under injection arm, injection site swelling and redness, fatigue, dizziness, lightheadedness, nausea, joint pains
Patient had an anaphylactic reaction to the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE:1, Unknown manufactured), for covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Patient had an anaphylactic reaction to the second dose". Clinical course: Patient had an anaphylactic reaction to the second dose. When we try to order rituximab, an interaction appeared between an inactive ingredient in the Pfizer vaccine and rituximab. We would like some support or insight on what it can possibly be.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was seated for 10 minutes post vaccination, then suddenly turned pale and passed out. Patientas laying on floor on his stomach with seizure-like muscle contractions for a minute, then stood up abruptly. Patient was seated in chair again and reported feeling unwell, woozy and nauseous. EMS was called and evaluated patient. Patient declined further medical treatment or transport to hospital.
Patient broke out in hives the same day as vaccine given.  Triage nurse advised to give Benadryl, called patient on 10/18/2005 - doing well, hives have resolved.
Pt recvd 3 doses of Engerix-B & it was determined that pt was a non-responser; A bosster dose of Engerix-B was given 22FEB91;
no known adverse effects; received an expired dose of pneumovax; This spontaneous report was received from a physician referring to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were unknown. On 13-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot#N030849, expiration date: 09-JUN-2019) (strength, dose and anatomical location unknown) via intramuscular for prophylaxis (expired product administered). No known adverse effects were reported. No product quality complaints (PQC) were involved.
pt says her arm was very sore for a couple of days after getting the vax.  About 4th days later both shoulders became frozen and she was not able to lift either arm.  She could not lay down from the pain.  On 2/23/21 she went to her NP at clinic.  She was given a Decadron and Intradermal injections and a RX for Mobic.  This only helped temporarily.  The pain returned in both shoulders.  She got her 2nd Covid vax on 3/8/2021 in her left arm.  The pain was still present and never improved so she went back to NP on 3/26/21 and was given Ketorolac Tromethamine tablets.  After finishing the medicine the pain returns to both shoulders after a few days.  She went back again to NP on 4/16/21.  She was given Decadron celestone injection.  This helped the pain for just a few days and the pain has returned.
Five days after vaccination of MMR, DTap,and HIB child presented with Erythema Multiforme.
PATIENT PRESENTED TO PHARMACY 2/29/2020 with right  eye pain and WHAT LOOKS LIKE SHINGLES ON THE RIGHT SIDE OF HER FACE OVER HER RIGHT EYE AND INTO HER HAIR LINE OVER RIGHT EAR.  She was advised to seek medical attention.
*Arm too sore to move within a couple hours. Resolved within 72 hours. *Chills within 4-5 hours, progressing to fever exceeding 101 orally along with fatigue, headache, nausea and unspecified malaise.  Continued strongly for around 48 hours before largely resolving, although strong headache and mild fever has still not resolved as of 72 hours later.
Information has been received from a registered nurse concerning an 18 year old female with coeliac disease and an allergy to wheat, who on 31-JUL-2007 was vaccinated intramuscularly with 0.5ml first dose of GARDASIL vaccine (yeast). On 09-OCT-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 09-OCT-2007 the patient experienced nausea, abdominal pain, headache, lethargy and difficulty concentrating. The symptoms increased overnight. On 10-OCT-2007 the patient contacted the office by phone. The patient was advised to take ibuprofen (MOTRIN) as needed and to report to the emergency room if the symptoms worsened. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Patient was seen 10/16/08 for Well Teen Exam, given Gardasil and flu shot. Patient developed tremors, weaknesss, decreased sensation, hysteria on 10/25/08, went to ER had extensive lab, drug screening and CT of head - all WNL.  Followed up with PCP on 10/27/08 - inital neuro exam showed decreased sensation bilateral hands and grip strength and abnormal gait.  Patients right leg appeared weak with tremors primarily on right side.  Patient appeared to be depressed.  Patient has follow-up on 10/30/08, MRI of brain and neck pending, neuro consult also pending. 12/11/08-records received-office visit 11/8/07-requested testing for disease, vomited day before C/O breast pain left side times 2 days, C/O bumps in vaginal area times 2 weeks. Denies sexual activity. Assessment:URI. 10/16/08 C/O stuffy nose. 10/27/08C/O tremors shaking onset began Friday. DX hysteria with tremor.  Dragging right foot. 10/20/08. Improved denies shaking weakness. Does not remember events of Friday.
Chills, Fatigue, itching, hands hard to make a fist. Slight chest pressure insomnia anxiety anorexia.
Information has been received from a registered nurse via medical records concerning a 9 week old female with a history of constipation, seborrhoeic dermatitis capitis and jaundice (all reported in WAES # 0704USA05856) who on 29-MAY-2007 was vaccinated with Rotateq. Concomitant vaccinations also given on 29-MAY-2007 included PREVNAR; PEDIARIX; and Hib conj vaccine (manufacturer not reported). The infant was evaluated in the emergency room on 03-JUN-2007 for a possible bug bite on the left arm and right shoulder. Examination revealed very bad eczema, and a few maculopapules resembling an early varicella rash. The diagnosis was varicella/infection, early abscess. Treatment included amox 125/5, 1 teaspoon po bid. On 04-JUN-2007, the infant was evaluated for large furuncle on her right shoulder. Pus was extruded and sent for a culture. The infant was switched to augmentin. The infant was rechecked on 05-JUN-2007 which revealed improved abscess of the shoulder. Soaks and augmentin was continued. The abscess was resolving on 11-JUN-2007. The outcome of the eczema was not reported. Additional information is not expected.
I had the vaccine and around midnight I had fever and I thought that was normal but a week later I had a very intense headache and I still thought that was normal but I was worried because that was the time they had discontinued the Janssen vaccine. After that I had a very intense pain on my legs and some big and purple veins appeared from my knees down to my legs and some red veins on my thighs. The pain was unbearable, and I could not walk. I bought some creams and medicine but they did not help relieve the pain and I felt like my legs were burning and I decided to go to the ER. They did some vein exams and said I did not have thrombosis; they also did a blood test and a urine test and everything was normal. My legs still hurt until today and I really regret having the vaccine.
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 60-year-old male patient received BNT162b2 (BNT162B2), in Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for Covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022 at 08:00, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The patient did not have any known allergies. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date-14Jun2022, treatment end date-17Jun2022, Lot number=GA9630, indication: Treatment of COVID-19. Adverse event: Two mild side effects: 1. A weird metallic taste in my mouth - persistent thru the 4 days so far of dosing. Brushing teeth and Listerine masks the taste for a few minutes, but gradually returns. 2. Diarrhea - or loose bowel - transient, experienced about an hour or two after taking the Paxlovid 3 tabs in the morning and later in the evening. The medication seems to have been very effective. Started taking it within 24 hours of symptoms (sore throat, persistent cough, myalgia-as/arthralgias and low-grade fever) - and within 36 hours of treatment, was almost back to normal. Will complete the 5 days, which ends tomorrow night. I tested COVID antigen positive 2 days prior to symptoms - the test was done as a requirement to enter a Pharmaceutical Trade Meeting. Been in complete isolation since the positive test. Adverse events start date: 07Jun2022. Adverse events start time: 08:00 AM. if patient recovered was not recovered. if treatment ae was no. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and Covid 19 cannot be ruled out.