chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer BioNTech COVID-19 Vaccine EUA Patient experienced a seizure 9 hours after receiving his first dose of COVID-19 Pfizer vaccine. Patient has a history of seizures but has been well controlled with levetiracetam and has been seizure free for several years.  Patient's wife called the pharmacy to report the event 6 hours later, and the pharmacist recommended the patient to follow up with primary care physician as soon as possible. Patient  was evaluated by his physician and had dosage of levetiracetam increased. Patient was referred for further testing.
p/vax pt devel a sterile abscess at inj site. no further info.
This case was reported by other health professional via call center representative and described the occurrence of adverse reaction in a patient who received DTPa (DTaP) vaccine. Co-suspect products included Hepatitis A vaccine and Polio (oral or inactivated unknown) (Polio vaccine). On an unknown date, the patient received DTaP vaccine, Hepatitis A vaccine and Polio vaccine, On an unknown date, an unknown time after receiving DTaP vaccine, Hepatitis A vaccine and Polio vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to DTaP vaccine, Hepatitis A vaccine and Polio vaccine. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by a medical assistant. The age at vaccination was reported. The patient experienced unknown reaction after receiving Dtap, polio, and hepatitis A vaccine in 2009. All vaccines were from unknown manufacturer. No patient information or vaccine information was available.
On 10/23/21 patient presented to ER. Patient is an 80-year-old male presents emergency department for further evaluation treatment of increasing shortness of breath.  Patient was diagnosed with COVID-19 8 days prior on 10/15/21.  Patient states that over the last 4-5 days he has noticed increasing shortness of breath as well as increasing cough.  Patient denies any headache, vision changes, fever, chills, sore throat, difficulty swallowing, chest pain, heart palpitations, nausea vomiting diarrhea, abdominal pain, constipation, difficulty urinating, painful urination, increased urinary frequency, blood in his urine, patient denies any new numbness or tingling in his extremities.  Patient denies any new edema in his extremities.  Patient denies any recent travel.  Patient states that when he tested positive for the virus he did not have any symptoms.  Patient is completely fully vaccinated with Moderna back in Feburary-March.  Patient has a significant medical history of hypertension.  Hyperlipidemia.  Obesity.  Abdominal aortic aneurysm.   ED course-single-view portable chest x-ray shows bilateral infiltrates.  CMP significant for chloride elevated 109. Anion gap decreased 9.5.  BUN creatinine ratio elevated 21. Albumin decreased 3.2.  Total bilirubin elevated 1.8.  Glucose elevated 209. Troponin within normal limits.  BNP within normal limits.  CBC significant for white blood cells elevated at 14.16.  Absolute neutrophils elevated 11.8. During admission he received oxygen, remdesivir, dexamethasone, ceftriaxone and doxycycline. CT negative for pulmonary embolism. Hospital course was prolonged due to type of the disease but overall progressed and improved. He has finished 5 days course of remdesivir.  He is still on a Decadron for total 10 days duration. On the day of discharge he is feeling very comfortable at rest.  On 2 L nasal cannula On exertion he does require 7 L but does not show any signs of any distress. He is feeling functional and will be able to manage at home Exam on the day of discharge Skin turgor good Lungs no rales rhonchi crepitation Heart regular rhythm Extremity no edema.   Due to slightly increase hypercoagulability risk:  COVID, he is given Lovenox for next 10 days at home as his activity will increase He is instructed to come to emergency for any acute sudden major changes. Discharged on 10/29/21
Firstly, I had a very bad reaction to the booster that began the evening of the shot. Fatigue, headache, nausea, fever, body aches and cough. I was ill for approximately 3 days total. On the 6 th day following the injection I  had very bad ringing in my ears that has not gone away. I have this ringing in my ears constantly. I have tried over the counter pain relievers, over the counter allergy medication but nothing seems to be working. No sleep and having difficulty concentrating as well as sometimes feeling vertigo and loss of balance.
pt admitted to hospital in sickle cell crisis after a fall at home; confused; febrile, hypoxic; positive for COVID; increasing O2 requirements (15L NRB); pRBCs given;  hx of HTN,COPD, sickle cell; condition worsened and pt experienced cardiac arrest and expired in the hospital
I experienced bleeding in my legs that continued to worsen, until I began bleeding from my mouth, and urinated blood 4 days from the onset of symptoms. When I sought care the blood work showed that I had a low platelet count. I was given an infusion of platelets which did not up my count, I was given steroids, and an autoimmune globulin infusion. I was diagnosed with ITP also known as Idiopathic thrombocytopenic purpura, and the doctor said they found no reason that explained the cause of my illness. I am still undergoing treatment and observation, and I am under a conditional release from the hospital.
pt had difficulty swallowing and tightness in throat. no difficulty breathing. gave pt 1 tablet of 25mg benadryl and pt felt better and left store.
Patient became pale & fell to floor at check out counter of MD's office. No loss of consciousness. Approx 3-5 minutes after receiving vaccines.
Information has been received from a registered nurse concerning a 15 month old female with no known allergies or medical history who on 07-MAY-2007 was inadvertently vaccinated with a dose of Zostavax (lot# 656608/0032U) instead of a dose of MMRV. Concomitant vaccination on the same day included a dose of DTaP (unspecified) (+) tetanus toxoid, a dose of Vaqta (inactive) (manufacturer unknown), a dose of PedvaxHIB, and a dose of Prevnar. The reporter stated that this was not a product confusion, it was an office staff error. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. Additional information was received. The patient is a female weighing 35 pounds 1 oz and height of ?? inches tall at the time of the report. The patient had a recent episode of otitis media and "had just finished unspecified antibiotic therapy a few days prior to vaccination. On 07-May-2007 the patient was vaccinated intramuscularly in the right thigh with a dose of OMPC, MSD, a dose of PEDIARIX, lot # AC14B040AA and a dose of PREVNAR, lot # D08684B and intramusculary in the left thigh with a dose of hepatitis A vaccine inactivated (lot # 65433B/0604F). The patient experience no adverse event. No further information is available.
Pt. presented to clinic to catch up on immunizations, had not received a 4 yr old well child with vaccinations.  Pt. should have received Tdap and IPV separate.  We did not have IPV single dose and DTaP/IPV (Kinrix) was administered.  Pt. tolerated well with no reactions noted.
3rd dose August 9th 2023; 2nd dose in their facility on June 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old male patient who received HBV (Engerix B) (batch number D23D3, expiry date 15-MAR-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 09-AUG-2023, the patient received the 3rd dose of Engerix B. In JUN-2023, the patient received the 2nd dose of Engerix B. In JUN-2023, not applicable after receiving Engerix B, an unknown time after receiving Engerix B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose in their facility on June 2023). On 09-AUG-2023, the patient experienced drug dose administration interval too short (Verbatim: 3rd dose August 9th 2023). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 09-AUG-2023 The reporter reported on reporting day that patient was administered Engerix B. The reporter reported that first dose was administered in unknown facility and the second dose in their facility. The reporter asked question that should the 3rd dose be repeated. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccinations schedule. The patient received 3rd dose of Engerix-B vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
After vaccines, immediately seemed less interest in her feedings, seemed less happy, less laughing and squealing for a few weeks.
Symptom start date (6/09) Symptom start time (9:30PM): Chills, headache/migraine, body aches, loose stools (6/10)
Patient received vaccine 5 min prior, then left lightheaded, nausea, put head down, sat back up got worse then felt jittery and heart beating faster. Patient assisted to stretcher, cool cloth applied and vitals taken. Patient reassured and education given about vaccine and side effects.
got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) outcome was unknown.            No concomitant medication information was provided. It was reported that patient received 2nd booster in Jan. Patient got covid-19 infection in July and received antibody treatment.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine (reported as second booster dose). The patient received unspecified antibody treatment. Exact date of vaccinations, onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine (reported as second booster dose). The patient received unspecified antibody treatment. Exact date of vaccinations, onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 1) [gender, race, and ethnicity unknown] received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
LEFT HAND SORE; LEFT CHEST MUSCLE SORE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 62 year old Asian (Not hispanic or latino) male. The patient's height, and weight were not reported. The patient had no history of covid-19 on test.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 09-APR-2021, the patient experienced headache (right side of head, sometimes in left side) but no fever. Six weeks later, his antibody test was performed. On 05-MAY-2021, no antibody (coded as: suspected immunological vaccine failure) found in the test. On 06-MAY-2021, he had left chest muscle sore. He also developed left hand sore. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and left chest muscle sore, had not recovered from suspected immunological vaccine failure, and the outcome of left hand sore was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000178890. The suspected product quality complaint has been confirmed to be void: No based on the PQC evaluation/investigation performed. This case, is linked to 20210516564 (same reporter).; Sender's Comments: V0: 20210516323- Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine 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
The patient is a 85 year old female with PMH as below. She has been tired and sleepy for the last several days. Her facility sent her to the ED. In the ED, her Hg was 10.3. She had a CTA Chest done which showed no PE but it did show a right base infiltrate. Her SPO2 was 90% on room air and improved to 99% on 2L. LE U/S showed no DVT. D-dimer was elevated.
4 hour episode of racing heart the day of the injection.  Soreness of heart and muscles in the area of the heart.  Heart/muscle  pains continue to this day.
expired Menveo given on 11/7/22. Vaccine expired 10/31/22.
After receiving my third dose, I had a significant amount of pain and soreness. I am still feeling this pain every morning as I wake up. I did receive my flu vaccine several weeks after receiving my third dose. On 10/21, I went to an orthopedist to make sure I didn't tear anything. He didn't see any rips, tears, arthritis or bursitis. I was given a 12 day dose pack of prednisone. It starts with a high dosage which really helped until I finished the pack. After returning from a trip, where I use a backpack, I noticed the pain came back. I was given another round of prednisone, by my PCP, 15mg and I am currently down to 10 mg of prednisone in the morning. I have trouble getting up because of the pain, but it usually subsides after I take the prednisone. I have an appointment to see a rheumatologist on 12/15/2021.
PT IS UNABLE TO LIFT ARM, FEELS NUMB, PAINFUL, UNABLE TO MOVE, STARTED ON 10/23/17 AND NOTIFIED US ON 10/25/17.
This spontaneous report as received from a healthcare worker refers to a male patient of unknown age. Pertinent medical history was unknown. On 31-MAY-2013 the patient was vaccinated with initial dose of VAQTA (intramuscular dose, anatomical location and lot number was unknown) and the reporting physician was intended to administer the second dose of VAQTA on 16-FEB-2015, which was greater than 18 months after the initial dose (inappropriate schedule of drug administration). Concomitant medications were unspecified by reporter. The reporter also reported that she intended to use two pediatric 0.5 ml doses to equal one adult 1.0 ml dose. The patient was in the office on unspecified date but the healthcare worker did not administer any doses to the patient. No adverse effect reported. The outcome of the event was unknown. No additional information reported. Additional information has been requested.
Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HBV (Engerix B) (batch number P4DJ5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 10th January 2023, an unknown time after receiving Engerix B and unknown after starting Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The registered nurse asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Engerix B that had expired on 15th December 2022, which led to expired vaccine used.
Body aches; Joint pain; Chills; Dizzy; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications and other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 01:00, the patient experienced body aches, joint pain, chills, dizzy and heart palpitations. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 27Oct2020 and tested negative. Therapeutic measures were taken as a result of the events and included treatment with 2 gelcaps of acetaminophen 500 mg, every 6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events general body pain, joint pain, chills, dizzy and palpitations was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
her arm was sore; her elbow was in a lot of pain; This is a spontaneous report from a contactable other healthcare professional.  A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported), via unspecified route of administration on an unspecified date at the single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported), via unspecified route of administration on an unspecified date at the single dose for COVID-19 immunization. On an unspecified date the patient experienced her arm was sore, her elbow was in a lot of pain. It was reported that patient receiving her second COVID 19 vaccine, she stated she a slight reaction her arm was sore, then she woke up the next morning her elbow was in a lot of pain, no additional information noted. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
2/7 - broke out in hives/rash all over entire body and tongue swelled 2/8 - swelling under chin
Started to notice an area on my left side clavicle/base neck that felt like a marble that moved when touched on Sun.1/17,stayed the same until I woke up on Tue 1/19 (6:00am)with swelling of that area and there was a very thin red line approx. 4 inches long over the area of swelling. During the day the red line faded until it was gone around 3:00pm. Still some swelling, not as bad as when I woke up.
Rashes and hives began on the eleventh day following my Moderna booster. This is the third moderna shot I had received. Hives are all over - face, scalp, arms, groin, chest and arms. It is itchy. The hives are long and thin, like slashes. So far I've had hives for 7 days and steroids for a total of 6 days.
Drowsiness; Fever; Restless sleep; Body aches; Chills; Nausea; He felt generally unwell; Woke up with a little headache; This is a spontaneous report from a contactable consumer . A 23-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation the patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on an unspecified date (at age of 23-years-old) as single dose for COVID-19 immunisation. It was reported that patient received the second dose of Pfizer COVID-19 vaccine around 10:30. No effects until about 19:30 when some drowsiness began. Around 21:00 fever started. During the night, he experienced restless sleep (including fever dreams, body aches, and chills) and a little nausea. In the morning the fever was gone but he felt generally unwell. That slowly got better throughout the day. On the second morning, he woke up with a little headache and feels pretty normal now (the afternoon of that day). Event took place after use of product. The Outcome of the all the events was Unknown.   No follow-up attempts are needed. No further information is expected.