chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 10 weeks old patient of unknown gender. On 18-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Grandmother reports patient began having trouble breathing, eyes rolled back, foamed at the mouth, and her lips turned blue. Symptoms occurred at about 4:00PM on 1/9/03, while patient was riding in the car. Patient was seen in the emergency room and admitted to the hospital for further evaluation. No fever, NML. Exam in ED except for rhinorrhea.
#2 MMR given - outdated vaccine used. Expir. date 5/17/14. Mother informed of options for titer or serology in 4 wks or another dose of MMR and states she will think about it and let me know. Mother was informed on 9-3-14 and states child seems fine.
Pt had whole body rash with the vaccine. No angioedema or airway involvement but will not be getting dose #2.
Case number PHEH2014US025034, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 68-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Pediatrics East has 3 different COVID vaccines (6months-5years NO dilution required; 5-11 years DILUTION required;  12+yeas NO dilution) RN pulled out 5-11 year old vaccine to thaw for the advised time of 15 minutes. Second RN pulled up advised dose of 0.2mL and administered dose, patient stayed in treatment room for 15 minutes for observation before checking out. Later on it was noticed that the vial was not diluted with the required 1.3mL before administering dose. Both RNs immediately reported this to practice manager and Doctor.
This spontaneous report as received from a nurse practitioner via company representative refers to a 15 year old female patient. "Within the last few weeks", in approximately 2013 the patient was vaccinated with GARDASIL (lot # not reported), accompanied with PNEUMOVAX23 (lot # not reported) and Dtap vaccines (unspecified manufacturer) simultaneously. The patient experienced syncope and within minutes fell and bumped her chin, which required stitches. This was completed in the office. The outcome was unknown. Additional information has been requested.
Toe went numb on right foot and next morning had a lot of swelling and cert painful under the foot. Whole top of foot and toe was really swollen and a lot bigger than the other couldnt walk or put pressure on my foot. Have been home unable to work since december 30th
Patient felt lightheaded and felt like her teeth were numb which is common with patients migraines. Patient had migraine before vaccination and took an over the counter migraine medication before receiving the vaccination.  Nurse checked patients vitals 132/88, HR 79, O2 99% on room air. At 5:04 patient started to feel nausea and her legs felt cold. Nurse offered for patient to go to ER at that time and patient wasn't interested. At 5:07pm hand and arms felt cold and she felt a little shaky. Nurse called rapid response in hospital around 5:10pm, at 5:14pm patient was going to ER.
2:00 AM awoke with joint pain. Took 2 Advil and went back to bed.  This medication aleviated the pains.  Slight chills during the day (put on extra sweater), fatigue all day, napped off and on all day.  Symptoms gone by next morning.
Patient was given COVID19 (Pfizer-BioNTech) dose #1 on 1/22/2021 and COVID19 (Pfizer-BioNTech) dose #2 on 2/4/2021, 13 days after first dose. On 2/5/21, patient denies any side effects from vaccine
Eyes bloodshot within 1 hour after vaccinatio, loose stools, headache, temp 98, green drainage from both eyes
Mild chicken pox rash with 2-3mm pink papules and tiny 1-2mm pustules and vesicles on an erythematous based scattered on her cheeks, posterior neck, post-auricular area, upper back and very few on anterior chest wall.  Low grade temperature elevation (100).
noticed achiness to arm where vaccine was received; taking Ibuprofen 3 times a day with some relief
Upper arm severely swollen, hard, red and itchy for 36 hours.  Gave Benadryl and Tylenol.
pt recvd vax 1130AM 26FEB96; 145PM screaming & diff to console;no fever;
Seen in ER. Child was found limp and vomiting 1 1/2 hr after dinner. Remained limp in ER for 4hrs in ER but alert at time of discharge. Referred to Neurology per dr.
Vaccine administered 11/3/06. 11/8/06 atient developed a bronchopneumonia syndrome, treated from ED with 5 days of Azithromycin. On 11/17/06 I admited him to hospital with a TIA causing left hemiparesis and speach deficit. He cleared neurologically but still feels terribly weak. -- Maybe unrelated, but I thought I'd report.  MR from PCP received.  HPI: Four days S/P flu vax. patient developed symtoms of bronchitis vs. pneumonia and was treated in the ER with Zithromax.  He was seen on day 10 s/p vax still c/o weakness, fever, and unintentional weight loss. Assessment:  Viral URI. On 11/17/2006 (2 weeks s/p flu vax.) he awoke from a nap with left sided hemiparesis, facial ptosis, and slight expressive aphasia. He was admitted to the hospital with a DX: Resolving CVA/TIA. Impression: resolving CVA/TIA probably in the left midbrain area. F/U visit on 11/21/2006  for c/o weakness, severe fatigue, and 10 lb. weight loss since getting flu shot. Assessment: Fatigue with terrible loss of appetite, ? pallor, ? due to flu vax. pneumonia recovery, TIA recovery, ?? another process in the brain/brainstem. TIA, Bronchitis acute. MR received from hospital.  No new COSTARTs.  No discharge summary sent with records. No d/c summary available.
On Monday Jan. 10th, 2022 at 10:00 AM, we discovered that we had added wrong amount of diluent.  0.13 ml was added instead of 1.3 mls.  The dose was given to pt. at 2:40 pm on Friday Jan. 7, 2022.
Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient most likely "passed out." Reported temporary vision loss. Vitals checked by nurse. Pulse was in 40s. Minute clinic provider also filled out non-patient safety report.
soreness @ site immed; soreness cont as of April now c/o generalized lymphadenopathy; 10AUG94 No addtl info recvd;
Vaccination on March 15, 2021.  Onset of severe vertigo one day following the vaccination, leading to a fall.  Several other less severe vertigo attacks.  Decreased balance persisting one month after vaccination
exp large localized rxn on 10/2/99;noticed on medial aspect upper rt extremity from deltoid area down to antecubital area;no c/o pain or discomfort;has gotten much better/improved since Saturday per pt;
Area of induration 12 cm x 15 cm developed on upper left arm well below injection site, no itching, but tender. Worst day after injection, improving by 2nd day.
Recieved vaccine that expired on 4-17-2022, from Moderna internal communications:  "Analysis of the vials associated with your storage excursion is complete. The vaccine administered on April 19, 20, 21, 2022 from lot number 016J21-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
pulse rate high; throat and tongue swelling; throat and tongue swelling; decreased lung function; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat and tongue swelling), SWOLLEN TONGUE (throat and tongue swelling), PULMONARY FUNCTION TEST DECREASED (decreased lung function), DYSPNOEA (shortness of breath) and HEART RATE INCREASED (pulse rate high) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOCILIZUMAB (ACTEMRA), PANTOPRAZOLE, METHOTREXATE and PREDNISONE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PHARYNGEAL SWELLING (throat and tongue swelling) and SWOLLEN TONGUE (throat and tongue swelling). In April 2021, the patient experienced PULMONARY FUNCTION TEST DECREASED (decreased lung function) and DYSPNOEA (shortness of breath). On 05-May-2021, the patient experienced HEART RATE INCREASED (pulse rate high). On 14-Apr-2021, PHARYNGEAL SWELLING (throat and tongue swelling) and SWOLLEN TONGUE (throat and tongue swelling) had resolved. At the time of the report, PULMONARY FUNCTION TEST DECREASED (decreased lung function) outcome was unknown and DYSPNOEA (shortness of breath) and HEART RATE INCREASED (pulse rate high) had not resolved.            No treatment medication was reported.    Reporter did not allow further contact
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: Patient got her vaccine and was fine but she started turning pale while she was in the the waiting area. I offered her some water to keep her hydrated and tried taking her bllod pressure but she fainted before I could get that. I laid her down on the floor, elevated her feet while my technician called 911. she Regained consciousness before paramedics arrived. They took her blood pressure and everying was withing range. she opted out of going to the hospital and was fine before she left.
AUTOIMMUNE RESPONSE; IMMUNE RESPONSE DAMAGED THE VALVES OF VEINS AND REFLUXING BLOOD; VEIN INFLAMMATION AROUND BOTH WRISTS/HANDS, EYES AND CHEEKS; VEIN INFLAMMATION ON BOTH ANKLES AND FEET; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, one month after vaccination the patient experienced vein inflammation on both ankles. Next day on 22-APR-2021, the patient experienced vein inflammation around both feet, and wrists/hands. The patient was unable to put on socks and was using compression socks for the first time in his life. He stated that the vaccine works well but it generates an autoimmune response (immune response damaged the valves of his veins). On 26-APR-2021, the patient experienced vein inflammation around both eyes and cheeks, autoimmune response and immune response damaged the valves of veins and refluxing blood. The patient also saw a cardiologist who did, Electrocardiogram (EKG), Venous CT (computerized tomogram) scan with contrast but they did not show any cause and did a test possible venogram which showed that the valves in the veins were damaged and refluxing blood and the patient stated that this all occurred overnight, and the physicians could not put a cause to why this occurred. The patient underwent ultrasound of legs with result of no clots but showed varicose veins overnight. The patient referred to an immunologist in June who stated that it was a possible autoimmune response from the Covid-19 vaccine. The immunologist also stated that the proteins work well but he may have residual spike proteins in the blood causing an autoimmune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein inflammation on both ankles and feet, autoimmune response, vein inflammation around both wrists/hands, eyes and cheeks, and immune response damaged the valves of veins and refluxing blood. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817503-COVID-19 VACCINE AD26.COV2.S-autoimmune response. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Patient claims extreme pain and swelling of the hand and forearm area to the point where he had to seek medical treatment at a short wait clinic. Injection site was not involved according to patient. Was given prednisone for inflammation. Pt. recovered without further treatment.
Severe body aches on one side of body, strong chest pain, swelling of lymph nodes - especially under arm pit. Localized to injection site. Aches began to subside 12 hours after onset. Swelling of lymph nodes resolved in ~5 days. Cheat pain remaining after 7 days.
Unaware that changed the dosing schedule for 6m-4yr. Originally was going by the schedule of 3-8 weeks after 1 dose, with spacing of 4-8 weeks after the second dose as well. Gave 3 covid injection of bivalent too early. Pt was due for third vaccination at least 2 months after dose two. Gave vaccination a month early by mistake.
This case was reported by a nurse via call center representative and described the occurrence of diastolic blood pressure increased in a elderly female patient who received Shingrix for prophylaxis. Concomitant products included Norvasc and hydrochlorothiazide. On 19th June 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, 5 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the patient experienced diastolic blood pressure increased and blood pressure systolic increased. The patient was treated with Cozaar. On an unknown date, the outcome of the diastolic blood pressure increased was not reported and the outcome of the tiredness was recovering/resolving and the outcome of the blood pressure systolic increased was unknown. It was unknown if the reporter considered the diastolic blood pressure increased, tiredness and blood pressure systolic increased to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left deltoid. The health care professional stated that she experienced extreme tiredness. Less than a month after receiving Shingrix, the patient was experiencing very high blood pressure specially diastolic ranging 100 to 111 mm Hg. The health care professional noticed increase in blood pressure when she went to her podiatrist for work on her foot 5 to 6 weeks ago. Upon escalation, the health care professional also stated that her systolic blood pressure was up to 158 mm Hg about 7 weeks ago from the date of reporting and was 100 mm Hg one day before the date of reporting. The health care professional stated that she went to her attending back in May and blood pressure was normal. The health care professional went back to her attending and was put on Cozaar and started taking Cozaar in morning on the day of reporting.
Sore arm. Aches all over my body all last night. Took an Aleve for the sore body aches.
Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received three doses of PENTACEL; lot number C3338AA received on 11 January 2010, lot number C3404AA received on 09 March 2010 and lot number C3494AA received on 11 May 2010; and one dose of TRIPEDIA; lot number U3497BA received on 15 November 2011 (routes and sites of administration not reported). The subject developed a cough on 05 July 2012, approximately seven months after the last dose of pertussis vaccine. On 07 July 2012, the subject developed cold-like symptoms and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
No ADR, timing ERROR 2nd dose given 44 days after 1st  Narrative: No ADR, timing ERROR, 2nd dose given 44 days after 1st
1115-FLUZONE given; 1130 child developed hives and fussiness;1140-epinephrine given, MD notified; 1152-prednisolone 10 mg given, continued twice daily for 3days.
Pediatric dose given and should have been adult, nurse called helpdesk and patient to receive full adult dose ASAP and get 3rd dose on schedule.
Suddenly appearing eight days after initial injection, I developed a large (2x3) ovoid itchy red welt-like spot at injection site.
Starting the week after the second dose persistent migraine headaches that are not relieved with over the counter pain medications. Experiences headache every day. Nothing helps to relieve the headaches.
Vial was never put it in the refrigerator; No Adverse event; Vaccine administered to the patient after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator), EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date) and NO ADVERSE EVENT (No Adverse event) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 062E21A, 011M20A and 013L20A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient had not received any other vaccine within 1 month prior to administration of Moderna COVID-19 vaccine. The patient had not experienced any similar event in the past.  It was unknown whether the patient was ever tested positive or diagnosed with COVID-19 or not.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator), EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date).    No concomitant medications were reported. It was reported that the vial was never put in the refrigerator.  The vial did not undergone any temperature excursions. Adverse event did not caused patient to seek medical care. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-615657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615657:Same Reporter (Patient -)
RASH WITH SOME SWELLING AROUND INJECTION SITE WHICH MIGRATED DOWN THE LEFT ARM.  TREATED WITH COLD COMPRESS, RECOMMENDED A DOSE OF BENADRYL. NO DIFFICULTY BREATHING OR SIGNIFICANT PAIN REPORTED.
Got shot about 08:20, noted right eye tearing at bedtime that night. The next morning the right eye was hurting and tearing and left side of mouth drooping, saliva discharge, headache. Being treated with steroids for Bell's Palsy.
Information has been received from a 58 year old female consumer with no known drug allergies and a history of genital herpes who in February 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) "for the prevention of shingles".  The patient called to report her positive experience with ZOSTAVAX (Merck).  The patient reported, prior to receiving ZOSTAVAX (Merck), she was diagnosed with genital herpes and would experience weekly outbreaks.  Subsequently, immediately after receiving ZOSTAVAX (Merck), she noticed that she no longer had the genital herpes outbreaks.  The Patient sought medical attention.  She was seen by the physician.  There were no laboratory studies performed.  At the time of report, the patient's status was unknown.  Additional information has been requested.
pt fainted approx 2 minutes after vaccination while sitting in waiting area.  911 was called. Pt was placed supine and was unconscious for approx 60 seconds with involuntary movements  of arms and upper body consistent to passing out (not seizure like in intensity).  confused, clamy/nauseas  upon awakening, remained supine for 2-3 minutes. upon sitting up pt became dizzy and laid down again.  paramedics arrived began assessment.  BP, EKG, BG all normal. pt reports not having eaten today, also reports congenital heart defect that was corrected surgically while an infant.  Mother arrived and decision was made in conjunction with paramedics to take pt to hospital for further eval based on his symptoms of lightheadedness/nausea continuing.