chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 0.3 mL of incorrectly diluted or undiluted Pfizer vaccine. When the nurse went to administer another 0.3 mL from the vial to the next patient, she noticed that there was insufficient volume. Only one vaccination was drawn from the affected vial, and that vaccination was given to this patient. Patient had left the facility at the time that the error was discovered, but he was contacted by telephone to be notified that he potentially received an improperly diluted or undiluted dose of Pfizer vaccine. Patient was notified that typical symptoms of immune response after being vaccinated, such as headache, fever, body aches, etc, may be exaggerated. Patient was instructed to use over-the-counter antipyretic acetaminophen according to bottle instructions, as needed for those aforementioned symptoms.
On 8/25/01, the pt received her 1st 40mcg IM dose of Engerix-B (lot ENG3203A4). The expiration date for that lot number was 4/23/01. On 9/17/01, the pt received her 2nd 40mcg IM dose of Engerix-B. On 9/26/01, she was found to be hepatitis B surface antigen positive. As of 9/26/01, the pt was feeling "fine". The pt's blood was re-tested and results are not yet available.
At 10:30 PM, chills started. Over the course of Thursday and Friday, pain of head, sinuses, lower back, and hips. Vomiting occurred. A slight fever of 99.4 present initially. Major fatigue with limited ability to get out of bed for two days.
pt recvd vax;w/in 1 hr exp back pain to head & neck,muscle spasm,arm pain,n,v & lightheadedness;no tx;better next day & events resolved by 4aug94;series has been discontinued;
Large erythematous plaque several inches below the vaccination site on the same arm which was itchy, painful. Also diffuse itching, red streaks over arm. Taking Benadryl and Zyrtec around the clock relieved symptoms partially. Upon my advice she stopped Miralax. Within a day redness and itching improved, completely resolved symptoms in 3 days.
No adverse event reported by patient.  This is a dose administration error.  The patient was given twice the 5-11 year old vaccine dose (20 ug instead of 10 ug).
Moderate to severe arm soreness; low grade fever 100.1F/ 100.8 after NSAID; chills; weakness; headache; swollen and painful lymph nodes (Axillary and Supraclavicular); swollen and painful lymph nodes (Axillary and Supraclavicular); This is a spontaneous report from a contactable other HCP (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30 as single dose (at the age of 38-years-old) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was a clinic. Medical history included metastatic breast cancer, diabetes mellitus and mild allergy to cefalexin. Concomitant medications included ibuprofen, fulvestrant, goserelin and metformin. The patient previously took cefalexin and experienced drug hypersensitivity. The patient previously took first dose of bnt162b2 (Solution, injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccine in 4 weeks. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. On 16Feb2021 at 08:00, patient experienced moderate to severe arm soreness and low grade fever 100.1f. After NSAIDS, fever was 100.8 and patient experienced chills, weakness, headache, swollen and painful lymph nodes (axillary and supraclavicular). Therapeutic measures were taken and patient was treated with ibuprofen. The outcome of the event moderate to severe arm soreness was not recovered while the outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
mom reports t103-101-rt arm swollen & reports discomfort;APAP alternated w/ Ibuprofen;
pt recv vax 23MAY95 & pt devel papular rash like mosquito bites 7JUL95 had febrile sz w/ t102.6 on 11JUN95; adm to hosp x 2 days; CXR shows pneumonia;
12/7/09 Muscle weakness all over, arm to back to groin; aching pain, night sweats, lower leg pain. Sx for 2 months.
"Flu shot given and five hours later patient became sick to her stomach and the room started spinning.  When she wakes up from sleep feeling like the room is spinning and struggles to focus on da-to-day tasks. Patient was still c/o of dizziness on 10/1/2020 when she contacted Health clinic. Health clinic sent referral for, Patient has not been to clinic as of 10/13/2020
patient had already received a dose at age 11 and again vaccinated with no adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 13 years old male patient who experienced patient had already received a dose at age 11 and again vaccinated with no adverse event while receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and influenza vaccine INACT SPLIT 3V (Fluzone High Dose) both for Immunisation.  On an unknown date at age of 11 years was administered meningococcal A-C-Y-W135 (T CONJ) vaccine at an unknown dose (lot details and expiry date: not reported) via unknown route in unknown administration site for immunisation.  On 22-Sep-2022, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at a dose of 0.5 ml once (lot U7373AA, expiry date: 06-Aug-2024) via intramuscular route in the right arm for immunisation.  On 22-Sep-2022 the patient had already received a dose at age 11 and again vaccinated with no adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   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.
occasional sinus headache; This case was reported by a consumer via interactive digital media and described the occurrence of sinus headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (had shingles in forehead) and ophthalmic herpes zoster (had shingles in eye). Previously administered products included Shingles (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sinus headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sinus headache was unknown.   It was unknown if the reporter considered the sinus headache to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR003422  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never wanted to get shingles as it was very painful.  The patient received Shingles vaccine and had side effect of occasional sinus headache.  The patient asked that how long the shots last and if it was one and need to repeat both shots ever X years. The follow up was not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR003422:Different dose
Shortness of breath, chest tightness.  No rash but "itchy all over".
Tinnitus. My ears are constantly ringing. It?s causing a little bit of headache (headache goes on and off). It started about 2-3 days agreed getting the first dose of the vaccine, and it?s been here since then until this moment.
Pt failed to convert p/4 doses of Recombivax & 2 booster doses of Engerix-B; evidently contracting Hep B following series of immun; Adm to hosp on 6DEC91 for viral hep; MD states pt positive for HBCAB (not specified IGM or IGG);
4 days p/vax pt devel inj site rxn of redness,warmth, tenderness & vesicles.
This initial spontaneous report was received on 20-NOV-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-DEC-2015, he was treated by a physician at a medical group (facility) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster and post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster infections. The male patient has been prescribed Lidocaine and acetaminophen and hydrocodone (LORTAB) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, dizziness, cognitive problems, insomnia, rashes, tingling in body, memory loss, headaches, migraines, tinnitus, sensitivity to light, gastrointestinal problems, all over itching, mental fog, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox that consisted of 30 itchy lesions on the trunk and 2 lesions on the face.
I woke around 7am I felt fine just a little tired nothing unusual today is my regular remote work day and I realized my throat was a little itchy and rough. Right before leaving for an unrelated doctors appointment I took an home test and it came back positive with in 3 mins time. I swabbed my throat first then each nostril. About 30 mins later I took another test which also came back positive.  Temp 98.6 O2 Stat 97-98  -I have a vdeo Dr appoint with Minute Clinic  within the next 24 hours-
High fever, swollen lymph nodes, nausea, dizziness, fainting, exhaustion, difficulty processing information,  lack of appetite
Mental dullness; impaired cognitive function; usually has no trouble remembering things, now has to write them down or can't recall them; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 40-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 22Jun2021 (Batch/Lot Number: Ew0196) at the age of 40 years old as dose 1, single for COVID-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient experienced mental dullness and impaired cognitive function that started 2 days after the vaccine (on 24Jun2021) and lasted for 24 hours. To the point where patient was scared to drive her car. She still feels off frankly as she is a health professional and usually has no trouble remembering things and now has to write them down or can't recall them. No hospitalization prolonged and no treatment for adverse events. Outcome of events were recovered with sequelae.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a positive temporal relationship, a possible causal relationship between events mental impairment and suspect drug BNT162B2 cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Client received a Hepatitis B vaccine on 6/6/18. Client called on 6/8/18 to report that she had dizziness and fatigue that evening following the vaccine. She has had some fatigue since then, and dizziness in the am's. No other symptoms or complaints. Has not fainted. Has not contacted or been to an MD.  Dizziness and fatigue have not interfered with her usual daily activities. Instructed patient to contact her MD or seek medical assistance if symptoms persisted or worsened, or if she was concerned.  Instructed that malaise and fatigue are side effects that are documented that can occur in less than 10% of clients who are vaccinated with Hepatitis B. She verbalized her understanding.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with LIQUID PEDVAXHIB (lot # K025002 and expiry date: 20-JUL-2017) which was exposed to temperatures outside of the recommended ranged. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
A little over a month after receiving the vaccine I developed SOB with activity resulting in me visiting my PCP. On 4/5 a chest X-ray was performed resulting in her noticing bronchial wall thickening and prescribed prednisone. An ECHO and stress test was ordered. On 5/17 a repeat chest x-ray was performed which was normal. The SOB continued for several months. I still suffer from it from time to time but it has gotten much better when I do.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, lot number and expiration date were unknown or GARDASIL 9 (dose, lot number and expiration date were unknown) (unspecified if the product was GARDASIL or GARDASIL 9). On an unknown date in September 2016, the patient experienced "syncope and hypo aesthesia". The outcome of the event was unknown. The causal relationship between the events and GARDASIL or GARDASIL 9 was unknown. Additional information has been requested.
pt had face rash , we gave him IM benadryl , he was fine, no anaphylaxis
The Menveo vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of diluent left in the box suggesting that an improper diluent might have been used to administer the vaccine, rendering the vaccine invalid. We are unsure what patient may have received the improper solution, so we notified all patient seen in August, and suggested revaccination. No adverse events were noted by the patient and she was revaccinated with a properly  mixed menveo dose and our state registry was updated to reflect the subpotent dose.
03nov89 pt vax w/ hepta B; 10Nov89 pt awoke w/ swelling + itching of eyes + face, rash on arms + back.  Seen in ER + tx w/ Benadryl w/o relief of itching.  Tx w/ Periactin + pruritus resolved.  Rash resolved but skin remained sensitive.
4-21-09 - 7:50 PM Mother called to after hours triage and report states that Mom reported 'arm swollen from shoulder to elbow, mild redness - no red streaks noted, no fever' fussy, "falling down more than normal." Office visit 4-22-09 at 1:45 PM Dr. noted, "4.50 cm area of splotchy redness and induration and some warmth on the posterior upper (R) arm. Nontender to palpation - No site of fluctuance - No pustule
No reaction on first shot. Second shot taken on April 5th, at 10:30pm, experienced chills and headache.  Next day had mild headache and little itchy bumps on arms and legs.   Very small.  Appearance happens with one to two bumps at a time for three weeks now.  Totaling about a dozen or so.  Also notice vision is not as sharp.
booster; tested positive for COVID-19 despite having had the 3rd booster shot; tested positive for COVID-19 despite having had the 3rd booster shot; This is a spontaneous report received from contactable reporters (Consumer).  A 44-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It's unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported IMMUNISATION (medically significant), outcome unknown; DRUG INEFFECTIVE (medically significant) with onset 20Dec2021, outcome unknown, COVID-19 (medically significant) with onset 20Dec2021, outcome recovering and all described as tested positive for COVID-19 despite having had the 3rd booster shot. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures sars-cov-2 test (20Dec2021) positive. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009098.
That morning after the 3rd vaccination I had terrible chills that started in the morning, the afternoon I felt sick. That night I slept till 4am. I also have aches and pains on my joints. Then we went on vacation on the cruise and I caught covid. And had upper respiratory symptoms. That's May the 21st 2022. Upper respiratory for a few weeks, asthma, tired. Doctor gave me Paxlovid for 5 days and after the 5 days I'm having terrible vertigo. I went to the emergency room and they gave me an allergy shot and valum and asthma medicine. The aches and pains are still there once in a while.
Papular rash, left groin area, about 21 papules with deep red flat areas around papules alternate burning and itching. I noticed rash on 4/6/09 - 3 days later, I noted 8 papules on left flank and 2 mid-back. No treatment - experienced pruritis and erythema at all sites and mild URT sign and symptom.
vial put in refrigerator 11/01/2021. used beyond 31 days.
receiving HPV vaccination before delivery; This literature market report has been received from authors of a published article, referring to a 26 years old female patient. The patient's medical history and concomitant medication were not provided. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date was not reported.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (vaccine exposure during pregnancy).    On an unknown date, the patient delivered an infant of unknown gender. The pregnancy outcome was live birth. The fetal outcome was unknown. The outcome of vaccine exposure during pregnancy was considered as recovered.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports regarding the same literature (linked case# 2107USA005600).; Sender's Comments:  US-009507513-2107USA005600:
immunocompromised patient received half booster dose as 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient received half booster dose as 3rd dose) outcome was unknown.            No concomitant medications were reported.  An immunocompromised patient who did not receive a third primary series dose as indicated but already received a booster half dose. Reporter enquired if an immunocompromised patient who failed to receive a third primary dose but received a booster dose still be eligible for Evusheld.   No treatment information was provided.
Immediately following receiving the vaccine, my heart rate became very elevated, my face, nose and head began burning and my hands were cold and tingling.  My blood pressure went extremely high.  I immediately felt my body reacting to the injection   My entire body did not feel right.   I was taken to the emergency room by ambulance.   Since having the vaccine I have had constant tinnitus that will not go away, a buzzing/nerve sensation through my entire body, dizziness and notice my heart rate feeling elevated.  I am on day 10 after the vaccine and still have these symptoms.