chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she gave MENACTRA and BEXSERO in the same syringe to a patient with no reported adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 56 years old female patient and reported stated that she gave BEXSERO and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in the same syringe to a patient with no reported adverse event.   The patient's past medical history, medical treatment(s),concomitant medication,  vaccination(s) and family history were not provided.   On 06-Jul-2022, the patient received 0.5 ml 1X (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Formulation was unknown, lot U726BAB and expiry date: 22-Apr-2023) via intramuscular route in right deltoid for Immunization On an unknown date, the patient received an unknown dose of suspect BEXSERO not produced by Sanofi Pasteur (Formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 06-Jul-2022 the patient developed a non-serious event of she gave menactra and bexsero in the same syringe to a patient with no reported adverse event (multiple use of single-use product) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (unknown latency) following the administration of BEXSERO.  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.
Early a.m., pt c/o dizziness and "hot", crawling to BR; agitated disoriented, delirious, questionable rt sided lip droop. To ER - Brain and Neck CT and Brain/Neck MRI completed to r/o TIA or stroke. All negative. During a.m pt spiked temp to 38.6; and continued delirious with temp spikes;  blood cultures, lab, chest X Ray, Urine cultures drawn all negative;  During nite 09/21/2013, continued to have temps over 38 intermittently despite Tylenol 650 mg q 4 hours.  BP dec to 89/systolic;  IV fluid bolus given. Pt continued to c.o rt upper arm soreness.  Noted approx 3 inch induration around injection site rt deltoid which expanded over next 24 hours to a 4 inch x 8 in area of redness, hot to touch and extreme tenderness.   Additional CBC and Blood cultures drawn. Cultures all negative.  WBC inc to 16,000, with inc neutrophils, inc ESR and inc CRP.  IV antibiotics initiated and IV fluids.   Temp to normal on 9/22/13 and cognition back to baseline.  Discharge early evening 9/22/13 on po cefpodoxime 200 mg q 12 hours and will repeat CBC and CMP in one week.
pt recv vax 19APR95 & pt struggled during vax procedure on 20APR95 lt arm swollen-pt saw MD who stated swelling-hematoma from struggling; gave pt Augmentin & DPH; swelling improved-soreness less intense; moving arm more fully
Ten days after the booster, patient started itching.  Day 11 after vaccine, there were hives all over patient's head, neck and back that progressed to the front torso.  After around the clock diphenhydramine and a solu-medrol injection day 12, hives continued to cover body (VERY itchy).  Day 14, patient went to ER for IV dexamethasone due to hives, swelling in the hands and lump in throat.  Swelling subsided and hives continued.  Oral prednisone was started day 15 with taper.  Hives continue through today, day 21 post-vaccine, but are local and resolve within an hour before popping up elsewhere on the body.
Starting 12/05/2022, I felt like I had a large head cold, congestion, achy and feverish. I did an at home COVID-19 test on 12/06/2022 which came back positive. I called my doctor the same day to let them know I was positive and they prescribed me PAXLOVID. I started the medicine the same day and started feeling better within a few days of starting it. I stopped it as directed on 12/12/2022 and shortly afterwards I started testing negative and 12/16/2022 I remained negative.
Information has been received from the author of a literature, title as stated below. This retrospective, descriptive study was to investigate the hepatitis B virus (HBV) seroconversion rate among health sciences students. The study included pharmacy, doctor of nursing, and medical students over 18 years of age enrolled at a university between 2007 and 2011. The primary end point was HBV seroconversion rates among students at the initial reporting period. Seroconversion was defined as hepatitis B surface antibody (anti-HBs) level greater than or equal to 10 mIU/mL. Multivariate regression analysis was used to determine predictive factors of seroconversion. Of 777 records, data were available for 709 students. An 83.9% seroconversion rate was observed after a mean of 10 years between vaccine receipt and anti-HBs evaluation. Students with incomplete HBV vaccine series and longer time between initial series and evaluation were less likely to exhibit antibody response. This case refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot # and expiration date not reported) for prophylaxis. On an unknown date, after receiving a booster vaccination, the patient's anti-HBs value remained seronegative (nonresponder). The outcome of the event was unknown. The causality between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was related. This is one of two reports received from the same literature (Linked report MARRS # 1703USA005420). Additional information has been requested. Sender's Comments: US-009507513-1703USA005420.
herpes outbreak; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/Lot number was not reported), via an intramuscular route of administration in arm right on 06Mar2021 11:30 (at age of 39-year-old) as first dose, single dose for covid-19 immunization. The patient's medical history included HSV2 (herpes simplex). The patient did not have other vaccine in four weeks and not have other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient had not been tested for covid. The had no known allergies.Concomitant medications was not reported. On 09Mar2021 10:00, two days after the vaccine the patient showed symptoms listed in side effects as well as experienced herpes outbreak. The patient received treatment with anti-viral medication but event with medicine the outbreak was not clearing up. Asked if this had been reported as a side effect for people with HSV1 or HSV2. The outcome of the event was not resolved.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on the plausible temporal relation, the association between the event "Herpes Outbreak" and the suspect product of BNT162B2 cannot be completely ruled out. The patient's medical history of HSV2 (Herpes Simplex) is a confounding factor.
Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022; Patient was administered with dose after 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Patient had no acute illnesses at the time of vaccination and up to one month before and no chronic or long-standing health conditions.     On 15-Jul-2022 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022 at 9:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-May-2022 and administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event were unknown.  It was reported that the vial had not undergone any temperature excursions. It was unknown that the patient had ever diagnosed with or tested positive for COVID-19.The patient had no adverse effects from the booster dose of Moderna vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-608558 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608558:(patient M-H)
I have been disabled by your vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DISABILITY (I have been disabled by your vaccine) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISABILITY (I have been disabled by your vaccine) (seriousness criterion medically significant). At the time of the report, DISABILITY (I have been disabled by your vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's neurologist had figured out what was going on. Patient would liked you to send a form to the neurologist. Contact had previously provided AE report and follow-up questions had also been sent to his primary care physician. The reporter requested contact information for his neurologist multiple times however contact declined. Clarified that reporter was unable to guarantee follow-up and contact was frustrated by the statement.  No concomitant medication reported. No treatment medication reported.  Company Comment: This is a spontaneous case reported by a pharmacist, concerns an adult patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) event of Disability (I have been disabled by your vaccine) on an unspecified date after receiving a dose of mRNA-1273 Vaccine in the covid 19 vaccination series. It was reported that the Patient's neurologist had figured out what was going on. No information was provided about the details of disability, comorbidities, risk factors, symptoms, clinical course, labs, diagnostics, concomitant medications and treatment. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.
Information has been received from a licensed practical nurse concerning a 12 year old female who on 12-JAN-2007 was vaccinated with a first dose of Gardasil and a second dose on 12-MAR-2007. The patient's mother reported to the nurse her daughter did not get a period in January 2007 but she in February 2007 and she is not pregnant. Additional information has been requested.
Shortness of Breath, irregular heart beat, chest pain and slowing of heart beat. it's been ongoing since the vaccine it is not as bad now with rest but I still get the the irregular heart beat
w/in 1hr of vax pt became nauseated & vomited x 1;remained nauseated until 25FEB;area around inj site became swollen & reddened & painful;remains swollen to 26FEB96 had not applied cold or heat to area;pt advised to inform MD;
Headache, Myalgia, BURNING SENSTAION IN CHEST, CHILLS, FATIGUE Narrative:
VACCINE EXPIRED ON 5/12/18 AND WAS GIVEN ON 5/18/18.
Redness at injection site along with other symptoms; Severe arm pain; Soreness/ aches; Redness; Itching; Joint pain; Fever; Chills; This case was reported by a consumer and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, pain, erythema, pruritus, joint pain, fever and chills. On 28th September 2021, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, pain, erythema, pruritus, joint pain, fever and chills to be related to Shingrix.  Additional details were provided as follows:  The reporter was the patient.  The patient received the first dose of Shingrix (lot and expiry date unknown) and was experiencing sever arm pain, soreness, redness, itching and joint pain, aches, fever, and chills all weekend.  On Tuesday, 5 days after the vaccination, the patient started experiencing redness at injection site along with the other symptoms.  All the symptoms were reported by the patient to the doctor's office who administered the vaccine and doctor said that the symptoms were normal up to a week and asked to monitor and report if symptoms lasted longer than a week.  The reporter consented to follow-up.
CoVid like symptoms lasting 36 hours.  nausea, light headedness, chills, fever
Patient experienced fever, cough, shortness of breath. Dexamethasone PO was administered 12/28/21 for two doses. Dexamethasone IV was administered 1/2/22 - 1/11/22.
102.3 9:00pm 06/11/21 102.8 10:00pm 102.5 11:00 pm 2 acetaminophen at 1222am 102.2 -1:30am 101.1 1:50am 100.3 2;07am 100.0 2:33am 98.3 3:49am 98.5 6:30am 2acetaminophen 6:35am 98.6 11:38am 100.4 1:28pm 100.5 2:15pm 101.0 3:00pm 2 acetaminophen 3:05pm HR & o2 96 3:06pm 100.2 3:33pm 99.5 4:01pm 98.3 4:36pm 98.3 5:09pm HR 74 o2 97 5:11pm 98.4 7:08pm 98.0 8:53pm 98.8 9:52pm 98.9 10:53pm 98.0 11:20pm 99.1 1:33pm HR 90 o2 98 1:34am 97.9 7:20am 96.8 8:54am 97.4 10:24 am sweating  96.7 10:22pm 98.2 11:38pm HR 65 o2 98 2:07am  97.3 2:09am 96.4 11:38am  Fever  Muscle ache/pain (lower back, arm and chest)  Can barely move my arm  Throbbing Headache  Almost vomiting  Slight dizziness  Congestion Sneezing
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The information about concurrent condition, medical history and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot#, expiration date, strength, dose, frequency and route were not reported). On unknown dates, the patients felt dizziness after receiving GARDASIL 9. The outcome of dizziness was unknown. Additional information has been requested.
weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN, DOXYCYCLINE HYCLATE, ESTRADIOL, PROGESTERONE and GABAPENTIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb). On 12-Feb-2021, PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13 Jul 2021 and contains no significant information
Information has been received from a nurse midwife concerning an unspecified number of patients who were vaccinated IM with the second dose 0.5ml dose of GARDASIL (lot number and site note reported). The patients had complained that the second dose hurt a lot more than the first. As  of the report time, the outcome of the event was not reported. The patients had sought medical attention in the office. No further information is available.
Patient fainted minutes after receiving their vaccine while watching his mother receive her influenza vaccine.  Patient was allowed to remain and rest on the ground for many minutes before moving to a sitting upright position and eventually moving to a chair.  Patient vomited several minutes after sitting in the chair.  Water was provided.  After 30-45 minutes, the patient was able to walk out on their own.
Induration, swelling, redness and raised temperature at injection site (left leg) developed to 4" by 3" area less than 24 hours after injection.  No treatment administered.
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No information was received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, those patients might have been administered with RECOMBIVAX HB injection (dose, route of administration, indication,  lot # and expiry date unspecified), that were not stored properly. No concomitant medications reported. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of the several report received from the same reporter.  Additional information has been requested.
BP 140/110, HR 84, R22;erythema lt arm, aching from inj site-arm tightness in chest;itching all over, then hives;DPH & 02 per nasal
Patient arrived at Covid Clinic for first dose Pfizer vaccine on 2/17/21.  She and driver said this was her first dose of vaccine.  After Returning to clinic nirse called to report she had her first dose on 2/3/21 of Pfizer and next was supposed to be sceduled on 2/24/21.  However she received second dose at our pharmacy on 2/17/21 without our prior knowledge.
Headache; Dizziness; This is a spontaneous case from a contactable consumer or other non-health professional. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EH9899), via Intramuscular route of administration, administrated in left arm on an unspecified date (age at the time of vaccination 68-years-old), as a single dose for COVID-19 immunization. The patient medical history included I am border line diabetic, High blood pressure taken medication for that, Overweight, heart condition, and lost my sense of smell 10 years ago. The patient concomitant medications included LISINOPRIL as 10mg a day, ROSUVASTATIN as 5mg, and Vitamins. On an unspecified date, the patient experienced Headache, and Dizziness. On an unspecified date, the patient underwent lab tests and procedures which included Blood test: unknown; and Weight decreased: 60lbs, I have lost 60 pounds in the last 10 years. Patient took an Ibuprofen for the treatment of adverse events. The outcome for all the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Inadvertently administered a pediatric dose of Engerix; Inappropriate schedule of vaccine; Drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 32-year-old male patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   Previously administered products included hep b (adolescent doses of a Merck's Hep B in 1 in 2002) and hep b (adolescent doses of a Merck's Hep B in 2 in 2003).   On 21-JUL-2023, the patient received Engerix B pediatric (right deltoid). On 21-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Inadvertently administered a pediatric dose of Engerix), inappropriate age at vaccine administration (Verbatim: Inappropriate schedule of vaccine) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the accidental underdose, inappropriate age at vaccine administration and drug dose administration interval too long were unknown.   Additional Information: Receipt Date: 26-JUL-2023 The patient received 2 adolescent doses of a Merck's Hep B in 1 in 2002 and 1 in 2003 The health care professional (HCP) mentioned this would be an attempt as the patient's second dose of the series and the first dose was administered back. Expert noted that may be a potential of a third dose of Hep B for the patient. An adult patient was inadvertently administered a pediatric dose of Engerix, which led to accidental underdose and inappropriate age at vaccine administration. The administration of Engerix B 2nd dose after schedule which led to lengthening of vaccination schedule. The HCP did not consent to follow up.
Patient is 17 years and 10 months and she works at a physical therapy clinic. She answered the screening questions on the website and got the ok to get the vaccine.  Vaccine was given to the patient but the EUA for Covid-19 Moderna vaccine is for 18 years and older.  The patient did not develop any type of reaction. BUT due to the EUA we had to call the patient after she has already received the vaccine and inform her that we are not able to administer the second dose until further instruction from the AICP.