chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 13Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "known allergies: Walnuts" (unspecified if ongoing), notes: known allergies: Walnuts. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive Covid19 result". The patient underwent the following laboratory tests and procedures: Chest X-ray: Unknown Results, notes: Chest x-ray, consult with Doctor; SARS-CoV-2 test: positive, notes: Paxlovid was taken for 5 days per instructions for positive Covid-19 result; positive, notes: rebounded 2 days after the 5 day treatment. I had fever, facial discomfort, full throat, runny nose, cough, fatigue - full symptoms experienced with positive test results just days prior. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient had no other medication in 2weeks reported. Paxlovid used as treatment drug for COVID 19 started on 30May2022 and stopped on 03Jun2022. Paxlovid was taken for 5 days per instructions for positive Covid19 result. I responded well to its benefits but rebounded 2 days after the 5 day treatment. I had fever, facial discomfort, full throat, runny nose, cough, fatigue - full symptoms experienced with positive test results just days prior.
feeling tired; feel a little "whoo"; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Jan2021 08:00 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccine on the same day of COVID-19 vaccine. On 22Jan2021, after vaccination patient experienced feeling tired and feel a little whoo. The events were considered as non-serious. The outcome of the events was recovering.   information about lot/batch number has been requested.
This spontaneous report as received from a 55 year old female consumer refers to herself. The patient's medical history included gallbladder removed and she had drug reactions of broke out in hives by Penicillin. On 10-JAN-2000 and 27-MAR-2000 the patient was separately vaccinated with first and second doses of VARIVAX (Merck) (dose unknown) because she never had chickenpox so was recommended by physician. Concomitant therapies included TENORMIN, ZOLOFT, SYNTHROID and triamterene. On 07-DEC-2010, the patient had titers drawn. She went to the physician office and the viral titer results were "low .60 eia". At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Systemic symptoms 2 hours after immunization, headache, chills, fatigue, decreased appetite, nausea, low grade temperature. Arm swelling, pain, 5 hours after immunization, Today (8/30/18) arm: red, hot, swollen, painful took ibuprofen and TYLENOL, took BENADRYL. No sign of infection, but erythema, hot, tender 3-4 cm below injection site.
Started having shortness of breath on Tuesday, 9 March 2021. Continued 10 March 2021. Admitted to local hospital. Tests revealed bilateral pulmonary embolism. On Heparin drip until released 12 March 2021 on Eliquis. Difficulty breathing on Saturday, 13 March 2021. Diagnosis elevated white blood count from 9000 to 14000. Tests done. Released with antibiotics and pain meds. Nothing since then.
1st night after vaccination: chills and fever *Next day after vaccination  extreme mental fog (CONFUSION), mostly gone 1 day later. Since this symptom (confusion) was similar to the the main symptom I experienced when I had actually had COVID19 in December 2020, I assumed it to be normal. At any rate,  it had dissipated  within 2 days, so I didn't seek treatment.
Hives and itching to left bicep on Morning of 12/28,  Hives spreadin to all four extremeties by 0500 on 12/29.  Mild  Shortness of breath
pt recvd vax;20jul95 few hrs p/ vax devel chicken pox rash involving all 4 extremities & itching;26jul95 to md ofc; at that time itching resolved & rash fading;
A nurse reported that an adult female received and injection of tetanus toxoid (manufacturer unknown) many years ago and subsequently developed an injection site reaction characterized by swelling, readnessk and hardness. She recovered
Case number PHEH2015US002912, is  an initial spontaneous report from a health care professional received on 06 Feb 2015. This report refers to a 67-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1412801) at a dose of 0.5 ml intramuscularly on 23 Dec 2014. It was reported that the FLUVIRIN MDV dose administered to the patient reached temperature to 34 Fahrenheit for 15 hours. No adverse events were reported following the maladministration.
Information has been received from a registered nurse concerning a male pt who on approx 25Nov04 about four weeks ago was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approx 26Nov04 the day following vaccination the pt experienced a loss of his voice. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, loss of his voice was considered to be an other important medical event. Additional information has been requested.
Patient stated they felt hazy, and had chest pain 3/10, has asthma history. Used inhaled and after ~15 minutes patient stated he felt better and was discharged.
Post vax, the pt developed progressive ascending numbness/tingling of extremities, paralysis of left face and lower extremities. Dx with Guillain-Barre syndrome.
I woke up with a sore knee.  Knee stiffens when I sit down and elevate my legs.
Now Lymph node swelling in armpit closest to jab site; Exhaustion; nose running; Sore arm at jab site/jab soreness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: FJ1620) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "gestational diabetes pre diabetes", start date: 2004 (ongoing), notes: Under control; "Haemophilia- A" (ongoing), notes: from Birth, Under control; "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0150, 31Jul2021), administration date: 02Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (2nd Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0176, 31Aug2021), administration date: 23Apr2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 21:00, outcome "recovered" (19Nov2021), described as "Sore arm at jab site/jab soreness"; FATIGUE (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (30Nov2021), described as "Exhaustion"; RHINORRHOEA (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (21Nov2021), described as "nose running"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 10:00, outcome "recovered" (21Nov2021), described as "Now Lymph node swelling in armpit closest to jab site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, rhinorrhoea, lymphadenopathy.  Additional Information: Prior Vaccinations (within 4 weeks): None, Specific relevant tests for thromboembolic events with thrombocytopenia :None. Vaccination Facility Type was PHARMACY, Vaccine was not Administered at Facility. Route of Simvastatin: By Mouth and taken in early 2021. Event: Sore arm at jab site. Exhaustion and nose running began approximately 20 hrs later. Description of Event: Part 2 - yesterday I submitted exhaustion and jab soreness. Now Lymph node swelling in armpit closest to jab site.  Follow-up attempts are completed and no further information is expected
In short I had a repeat of Covid symptoms to include earache, headache, soar throat, chills and fever.  Also some aches.  Left arm at injection site sore.  Details:  approximately 1 am I woke up with chills, headache, earache and tiredness.    I took Tylenol and this continued waking up again a few hours later the same.   Eventually I felt very hot.   Upon waking again tired/fatigue, headache, earache.   At approximately 11:30 am I got out of bed,  shaky & very tired.   I eventually felt better, just tired.   (With exception of Arm still hurting).    Please note I had Covid in December and had similar symptoms, except these all hit me at the same time and felt much worse then when I had Covid.
p/vax pt exp night sweats, weakness in arms, pain in neck radiating through back of head. MRI rpt neg but pos for degenerative joint disease in neck
Left arm is red, swollen, tender, hot, painful to the touch. Swelling extends from deltoid down to arm into the elbow passing into the forearm. Fever of 100.1F.
Severe pain, headache, swelling, erythema.  TYLENOL used.
5 yr old well child. Vaccines given for school attendance. Reaction in arm where tetanus Dtap and IPV given in right delt. HCM erythematous area developed at injection site.
Patient received 2nd Moderna booster on 4/19/22. Patient first noticed itching, redness, swelling and warmth at vaccine site on left arm on 4/21/22. She returned to the local County Health Department at 0830 on 4/22/22 to report the event.  Patient states "that her arm looks better today than it did yesterday." Patient also states she put an ice pack on her arm yesterday. 10-15 mm redness/swelling noted to left upper arm. Warm to touch. Small bruise noted in lower area of redness. No red streaks or drainage. Patient complains of feeling nauseous. Nurse supervisor examined patient as well. Advised to apply warm compresses today and to follow up with primary care physician if symptoms change or worsen. Reported to Nurse/Supervisor on 4/22/22.
Symptoms:  low fever, back and chest pain, mild nausea - started 6/4/21 and get worse over 4 days. Urgent care seeked on 6/8/21, EKG shown normal, no treatment received. Symptoms abruptly disappeared on 6/10/21
Patient immediately went into a vasovagal reaction.  EMTs were immediately called, patient transported to Med Facility via Ambulance. Start to finish at our location was approximately 20 minutes.
Within five hours of shot developed fever (100.5) which lasted more than 24 hours, chills, headache, very bad body aches, back pain & ringing in ears. All has resolved  except headache and ringing in ears as of 04/23/2021 4 pm
COVID 19 Treatment; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 02Dec2022, stop date: 08Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Received other medication in 2 weeks. No known allergies. Received anti-viral product Paxlovid for COVID-19 on start date 10Jan2023 and treatment stop date on 15Jan2023.   The information on the batch/lot number for BNT162b2 NOS has been requested and will be submitted if and when received.
15DEC95 pt recv vax 16DEC95 began to run 100 temp devel solid wheal,approx size of silver dollar to DTP site;cried nonstop until 18DEC95;APAP given;pt did not eat-woke self from sleep,crying screaming
Diangosed angiodema/swollen lips. facial numbness, swelling at base of tongue   March 3, 2021 Dr dismissed affects of vaccine and suspected allergic reaction to medication (lisinopril}
patient is an obese male otherwise previously healthy, and received COVID vaccines on 8/10/2021 and 8/31/2021. Parents started noticing patient's worsening behavior--disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/22)--and followed up with clinic since December 2021.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Sep2021 (Lot number: FE3592) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis (ongoing); PREDNISONE taken for rheumatoid arthritis (ongoing); FOLIC ACID taken for rheumatoid arthritis (ongoing); NAPRELAN taken for rheumatoid arthritis (ongoing); REMICADE taken for rheumatoid arthritis (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot: EN6206, Expiry: Unknown, Anatomical site: Arm left), administration date: 07Mar2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: EP6955, Expiry: Unknown, Anatomical site: Arm left), administration date: 27Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", INTENTIONAL PRODUCT MISUSE (non-serious), outcome "unknown" and all described as "she asked him to just prescribe her the vaccine every 3 months"; IMMUNISATION (non-serious) with onset 07Sep2021, outcome "unknown", described as "1st dose received on 07Mar2021./2nd dose received on 27Mar2021./Booster received on 07Sep2021."; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of sinusitis. No follow-up attempts are possible. No further information is expected. Follow-up (17Dec2021): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP telephonic follow up activity which included that: Dosage Regimen, Event Onset date for Booster event. Follow-Up (28Dec2021): Follow-up attempts are completed. No further information is expected. Additional information: treatment for sinusitis: antibiotics for a sinus infection recently.
Pt has experienced worsening shortness of breath over the past 3 days and a dry cough.  Exposed to multiple family members at home with COVID.  Pt is admitted for COVID-19 pneumonia and troponin elevation.
Hepatitis; This case was reported in a literature article and described the occurrence of hepatitis in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included non-small cell lung cancer.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hepatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis was unknown.   The reporter considered the hepatitis to be related to Flu vaccine.  This case was reported in a literature article and described the occurrence of hepatitis in a patient of unspecified age and gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis.  The patient was a part of single-center retrospective analysis that was conducted for patients with advanced non-small cell lung cancer (NSCLC) who received prolonged cell death 1 (PD-1) or prolonged cell death ligand 1 (PD-L1) inhibitor monotherapy between March 2015 and December 2018 to interrogate if influenza vaccination in patients with NSCLC receiving immune checkpoint inhibitors (ICPI) therapy had an increased incidence of immune-related adverse events (irAEs) compared to non-vaccinated patients. Comparisons of adverse event incidence between flu vaccinated and control patients were tested using chi-square statistics. The patient had history of non-small cell lung carcinoma (NSCLC). No information on patient's family history was provided.   On an unspecified date, between March 2015 and December 2018, the patient received unspecified influenza vaccine (administration route and site unspecified, dosages unknown, batch number not provided). [In this study, influenza immunization records from both institutional and state-wide registries were obtained from 2014 -2019. 19 received quadrivalent influenza vaccine, 13 received trivalent influenza vaccine and 1 was undetermined]. The age at vaccination was not reported. The patient also received prolonged cell death 1 (PD-1) or prolonged cell death ligand 1 (PD-L1) inhibitor monotherapy (ICPI). [In this study, 33 were vaccinated during ICPI therapy].   On an unspecified date, an unknown period after vaccination, the patient had hepatitis. It was considered as irAE.  [In this study, 22 vaccinated patients had an irAE versus 53 patients who were not vaccinated during ICPI therapy. 8 vaccinated patients had an irAE leading to discontinuation of therapy].  Treatment was unknown.  The outcome of the event was not reported.  The authors commented and concluded "Our study suggests that irAEs are not significantly increased with vaccination for influenza during ICPI therapy. However, there is a slight trend toward increased incidence of irAE warranting ICPI discontinuation for which further investigation is needed. Limitations of this study include a small sample size and inability to grade irAE retrospectively."
I had no initial reaction to the vaccine, but about 3 AM I woke with a throbbing ache from left shoulder to fingertips with numbness in my fingers of both hands that would not go away. I took some aspirin, fearing I might be having a heart attack. I sat up for a couple of hours trying to look up my symptoms on the internet and found that quite a few others had similar reactions to their vaccines. I went back to bed the pain continued. It subsided during the day, but then the next night I woke up again about 1AM with the same throbbing pain in my left arm, although less pronounced. I still have a slight ache/weakness in my left arm similar to getting hit in the funny bone.
Primary series w/ other vaccine manufacturer  Pt reported 1-4-5 rating of intermittent pain left lateral mid chest pain that began while sitting after vaccine.  Pt states that it may be the way he slept. Vitals: 14:03 103/73, 67, 12, 97.3F, 100% -- > 14:08 105/63, 65, 12 Pt stable and released from the vaccination site.  Recommended that pt f/u w/ PCP.  Call 911 or go to ER is pain increases of pt develops SOB. Pt stable and released from the vaccination site.
Very sore, slightly swollen left arm, headache, swollen glands, sore throat, body aches, chills, maybe a fever. Seemed to develop into bronchitis like symptoms. Exposure to sick person day before -rode in car for several hours with persons who had bronchitis. So do not know if I got sick because of exposure, or my immune system was weak ....Dr. gave prescription for Zpack which was filled with Azithromycin 250 MG Tablets (6) on 7/23/2018.  Couldn't believe I was so sick so went over the weekend before I got the prescription. Living in senior living :  Wellness Center nurse came to our Apt.  to check on me. Said lungs were clear. Take Aleeve for discomfort and inflammation in swollen throat. I also took 12 Hour Mucinex DM to clear my head and stop the cough.
Initiated vaccination.  Syringe started to leak. Estimated patient recieved 0.1ml of vaccine.  Re-vaccinated with 0.4ml to complete dose.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 79 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
headache, productive cough, fever (101 F a few days ago), chills, body aches, nasal congestion, sinus congestion, sneezing. starting 11/22/21
Pt devel rash, fever; pt was dx as poss measles but rubella & measles IgM-nonreacter; IgM=0.317
After 2nd dose in the afternoon at 2:30pm pt collapse in the unit V/S was high blood sugar was high. Pt was held over at work for 16 hours. Shot was given at 6:45am. Paramedics was called. Sent to ER.
Large hives covering entire torso, shoulders, back, stomach, groin, neck, face, and smaller amount down legs.  Hives approx. size of a dime - nickel.  Extremely itchy and fast spreading.