chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse who reported that improperly stored doses of VARIVAX lot #M047662, expiration date 02-DEC-2018; lot #M048200, expiration date 07-DEC-2018; lot #N012618, expiration date 21-APR-2019; lot #N008826, expiration date 12-SEP-2018; and lot #N001527, expiration date 13-JAN-2019 (dosages and routes of administration not provided), and PROQUAD lot #N008826, expiration date 12-SEP-2018; lot #N002917, expiration date 24-JUL-2018; lot #M035145, expiration date 30-JAN-2018; and lot #M048201, expiration date 05-JUN-2016 (reported as 05-JUN-2018) (dosages and routes of administration not provided) were administered on multiple unspecified dates to multiple unspecified patients (ages and genders unknown). The vaccines were reconstituted with properly stored sterile diluent (MSD) (lot number and expiration date unknown). The nurse was unable to specify which lot numbers were administered, so all improperly stored lot numbers were provided. No adverse effects were reported. Temperature: 15°F to 46°F (16°F) Time frame: 2 hours Previous temperature excursion: No Data logger involved: Yes. No additional information provided. Lot number N008826 is not a valid lot number for VARIVAX. Lot number N001527 has been verified to be a valid lot number for VARIVAX. Lot number N008826 has been verified to be a valid lot number for PROQUAD. Additional information has been requested.
I was diagnosed Perineal Abscess August 1, 2022.  In October I had a MRI I was diagnosed Complex Anal Fistula.  I was supposed to have surgery and I did not end up having it.  I had a Sigmoidoscopy in January 2023.  She referred me to Dr.  She is Hospital.  On the February I had a drain placed in the fistulas.  I had that in for 5 days then came out.  I still have the ceton.  I went a week about and had a pelvic MRI.  They showed a new abscess in the fistula at that point.  I will have a office visit with Dr. this afternoon.  I will have another exam under anesthesia.  The doctors are baffled due to the fact all this has to do with someone with Crohns and I do not have Crohns.  This is a chronic illness I have developed.
2 days p/MMR vax pt devel severe h/a; LP-meningitis; cult neg;
No additional AE.; VARIVAX was administered after expiration; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 16-MAR-2023, the patient was vaccinated with a dose of expired varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter subcutaneous injection, 0.5 milliliter, lot #U008180, expiration date: 12-MAR-2023, administered for prophylaxis(route of administration was  not provided) (expired product administered). This dose did not experience any temperature excursion. No additional adverse event.
mom called stated child has small reddened area on lt leg r/t shots;mom called 3 days later pt states PMD said it was 12 cm x 5cm;
Day following the vaccination I had fatigue, muscle and joint aches and swollen lymph nodes. By the second day (today) the rest of the symptoms went away but still have very swollen lymph nodes.
pt recvd vax; 48 hrs later,devel severe edema accompanied by redness; had a similar rxn p/ 2nd inject; rxns abated a/ was seen by hlthcare prov;
Rash all over body occurring several hours after receiving vaccine;  had received Td previously with no adverse reactions.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unspecified date in 2016, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's vaccine inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of the events was considered not recovered. Causality assessment was related.
Patient present for 2nd dose of infant bivalent moderna. The wrong vial was used and patient recived  a lower dose of vaccine then what was recommended. Patient received 10mcg of bivalent moderna instead of 25mcg dose
The patient experienced extreme redness and heat that started in the face, moved to her ears, down her neck, to her chest and then to her arms and hands. The patient took one Benadryl while the hives were starting down her neck. The patient took a second capsule while the hives were starting down her arms. Within 1 1/2 hours later the redness and heat started to subside.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single, as dose 2, single and as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jun2022, 7 days 8 hrs after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 26Jun2022 to 30Jun2022. Clinical course: Other medication in 2 weeks included nasal spray for allergy in Jun2022. The case was reported as non-serious.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained about muscle soreness and weakness on his left side. Said that he was unable to get out of bed due to the symptoms for about 6 days.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On 06-AUG-2014, the patient received vaccination with ZOSTAVAX (lot # L035506, expiry date: 16-DEC-2016) via subcutaneous route and received it again on 29-MAR-2016 (extra dose administered). No adverse effect was reported. Additional information has been requested.
Gave the patient .5mL which was written in the bag instead if the .25mL that was stated in  the CDC website.
On Wed May 31st woke up with stomach ache and severe nausea. Small pea sized bump at injection site and it was tender. Thursday June 1, most of nausea had resolved but bump at injection site was now marble sized and went from tender to painful.  By Saturday June 3rd it had increased in size to a golf ball and was extremely painful to touch and arm movement was restricted due to pain. Today is Sunday June 4th and it has increased in size to about a small tennis ball. It is still very painful.
Skin around injection site got very red and eventually began to dry out and get rough and the slough off. Still has discoloration at the injection site, it is whiter than the rest of her skin.
pt recvd vax; 15aug95 devel gen rash; devel few on 15aug95 & more on the 16aug95;
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (dose, route and lot # not reported) post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Large nodule at injection site (L arm), lymphadenopathy L cervical region, paresthesias to fingers R hand.
Shortly after receiving vaccination patient's wife began honking her car horn.  This nurse went to vehicle, patient was clammy, cool to touch, diaphoretic.  He was not verbal and had vomit coming out of his mouth.  EMS contacted.  Vital signs were within normal limits.  EMS cleared patient.  Wife attributes reaction to severe anxiety related to anything medical.
On 07-15-21 we had a nurse vaccinating for Pfizer at one table and a nurse vaccinating for Janssen at another table. Each table keeps their vaccines in color coordinated boxes that is assigned for each vaccine being administered. At approximately 12:20PM the nurse who was vaccinating Janssen closed her pink box labeled J&J and stepped away 6 feet from her table to speak to the service representative that was checking in our patients. Unbeknownst to us, the nurse vaccinating Pfizer walked to the other table and grabbed vaccines from the pink box labeled J&J and took them back to her station and put them into her clear box. There were a total of 2 vaccines taken from the Janssen box. At approximately 12:45PM the nurse vaccinating Janssen returned to her table and noticed that two vaccines were missing from her box. The other nurse then proceed to give her one back. The nurse vaccinating Janssen immediately brought the syringes to a supervisor for disposal. Based on the timeline we have compiled a list of patients that were vaccinated by the nurse who took the Janssen vaccines. Patient was to receive her first dose of Pfizer but now based on the above instance we are unsure if she was given Janssen. Administration was informed of the instance and one of our MDs has called and notified the patient.
4FEB97 temp 104.8, sz-unresponsive-ER;5FEB97 temp, irritable, shaking, sz, rash;6FEB97 saw neurologist who dx febrile sz secondary to vax;
no adverse effect; The patient received dose of PNEUMOVAX 23 that had been improperly stored; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 21-AUG-2019 the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # S004547, expiration date 12-AUG-2020 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 47F degrees Fahrenheit for 1 hour, as recorded by a data logger. There was no previous temperature excursion.  No adverse effects reported.
Patient called stating Wednesday night a few hours after she received the vaccine that she was having muscle pain all over and feeling dizzy and losing balance. She called the pharmacist Thursday morning who advised she go to the Emergency Room
Abdominal pain, SOB, cough, melena, nausea and vomiting.
Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves male patient (age not reported) who was vaccinated with a dose of vaccine INFLUENZA VACCINE (lot number, Exp. Date, dose, route, site and date of administration not reported) which was packaged too warm and then too cold after they were sent by the medical center staff to other affiliate clinics. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a health professional concerning a 14 month old female who on 10-SEP-2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 0276?). There was no concomitant medication. On 09-NOV-2004 the patient experienced about 4 lesions. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved.  Additional information is not expected.
Red itchy sore blotch on upper left arm (although not exactly at vaccination site); Red itchy sore blotch on upper left arm (although not exactly at vaccination site); Red itchy sore blotch on upper left arm (although not exactly at vaccination site); This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:45 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included venlafaxine, glucosamine and multivitamin taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: EL8982), via an unspecified route of administration, administered in Right arm on 01Feb2021 11:45 AM for COVID-19 immunization. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient did not know about known allergies. Facility where COVID-19 vaccine was administered at Doctor office/urgent care. On 23Feb2021 22:00, patient experienced red itchy sore blotch on upper left arm (although not exactly at vaccination site). There was no treatment for the events. The clinical outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Dose administered to adult patient from pediatric vial instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine).    This case contains information for the 11th patient out of 26 patients as described by the reporter.  No concomitant medication information was reported.   The reporter stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster doses. The reporter was not aware of any adverse events after the vaccines were administered.  Treatment information was not provided.
Erythema annulare centrifugum; Vaccination Site Erythema; Vaccination Site Pruritus; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA ANNULARE (Erythema annulare centrifugum), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE PRURITUS (Vaccination Site Pruritus) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA ANNULARE (Erythema annulare centrifugum), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE PRURITUS (Vaccination Site Pruritus). At the time of the report, ERYTHEMA ANNULARE (Erythema annulare centrifugum), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE PRURITUS (Vaccination Site Pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Additional information On 11-Jan-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a certified medical assistant refers to the patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On an unspecified date, ROTATEQ (lot # L013204, expiration date 28-JAN-2017) was improperly stored to 32.7 degrees Fahrenheit for 90 minutes. Then on unspecified dates since 04-JAN-2016, unspecified patients received the improperly stored doses of ROTATEQ by oral route (dose was unspecified). No adverse effects had been reported. It was unknown if the patients sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports from the same source. Additional information has been requested.
Patient with history of mental disability brought to the ED by caregivers at her group home for complaints of facial swelling, redness and shaking that started the day of vaccination.  The time these symptoms started was not specified in the medical record.  Temperature was 101.4F, HR was 107.  Patient was admitted for possible sepsis vs. allergic reaction and was discharged the next day after symptoms improved and it was determined this was likely a reaction to the COVID vaccine.
Angioimmunoblastic T Cell Lymphoma - unkown cause, hypercalcemia related to lymphoma.  We are not sure if the vaccine contributed or caused the lymphoma but would like it reported. He died May 2022 from the lymphoma. His health declined after receiving the vaccine.
Nausea, vomiting, diarrhea,  body aches. Lasted 2 days.
Substantial pain in R shoulder, which started with vaccination along with clicking noises and, on exertion scraping sensation in joint. On June 17 received Prednisone orally for 5 days.  This provided substantial relief.  Saw an orthopedist on June 24. Some bone on bone contact in the shoulder,  but prior to the vaccination there was no pain or motion limitation in the joint.  For my age, I'm very physically active with weight lifting (for over 60 years) and rock climbing.  Following vaccination, I was very limited in what I could do. I appear to be slowly healing, but will not get the second injection.  The disruption to my life from the first shot was too great.
Unbearable pain after the flu shot on the same day. Had to take 5 ADVIL at a time. Have trouble to sleep at night due to the pain. Difficult to do computer work and carry stuff/limited motion range. Shoulder is still painful and stiff. Saw 3 doctors, taking pain medications and doing physical therapy now pain is not getting better severely disrupts my way of life.
It had a little itchy area at the injection site; the next day it was reddened but not really itchy and it stayed a few days and then left. I did go to the Dr and he looked at it. He thought it was from the shot and in the muscle. He did give me a prescription - Cephalexin to take.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1080 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Evening of 5DEC91 stiffened up, cry nothing mom never heard a/high pitched; eyes half open w/blank stare x 30 sec-1min; then quiet soft cry; 17DEC91 same episodes x 2 between 10-12 MN did not appear to hear or see parents during episode;
Vax given @ hlth dept am 26Feb91-ER visit that noc /w 105 T.No seizure activity-admitted to Hosp & found otitis med /w treatment given-sinus infection also.
Severe abdominal pain, rectal clotting and bleeding. Bad headaches, slight numbness in extreme ties.
Patient started with swollen injection site 2 and 1/4 inch in diameter. Hurt to touch and hot to touch. Headache, bodyache, severe fatigue, and nausea. On April 13th blood pressure started to rise and was 160/106. Patient decided to go to the  Emergency Department and was seen by Dr. She was prescribed ibuprofen, Zofran, acetaminophen. Dr concluded that all symptoms were from the Janssen vaccine.
Large red lump approximately one inch in diameter that is hard to the touch, causes pain and discomfort to baby. Area appears bruised and feels like a contusion.