chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a multiple unspecified patients of unknown gender and age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (strength, dose, frequency, route of administration were not provided), lots # M037014 with expiration date of 22-NOV-2017 and M038864 with expiration date of 12-DEC-2017 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.8 degrees Fahrenheit) for 60 minutes. Lot # M037014 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (32.5 degrees Fahrenheit) for 5 hours, 50 minutes; 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.2 degrees Fahrenheit) for 3 hours, 30 minutes and total time in the range 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours, 10 minutes. Lot # M038864 experienced previous temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit (40.6 degrees Fahrenheit) for 3 hours,10 minutes. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1706USA009296: US-009507513-1707USA000708.
Acutely confusional, disorientated, H/A, vomiting. Pt went into stupor-needed to be restrained.
ROTATEQ "given more than 10 weeks later" from initial dose; This spontaneous report was received from a nurse prescriber via company representative and refers to an infant patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported). On an unknown date (reported as "more than 10 weeks later from initial dose"), the patient received second dose of with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). Both vaccines were administered for prophylaxis.
A mole appeared in my lower left abdomen. The mole has a shiny silver spots. This mole has never been there
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:27 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.13.  No concomitant medications were reported.  Batch number 035C21A administered on 27-Oct-2021 had  temperature 29 at 09:00 AM and 32 at 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and on 05-Oct-2021 and beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov2021. Product moved to clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Fever, lethargy, possible seizure. Also found to have ear infection, and viral infection.  Treated with one dose of ceftriaxone (I believe) and Augmentin.
beyond 36 days from receiving first dose; contracted COVID-19/diagnosed with COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (contracted COVID-19/diagnosed with COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond 36 days from receiving first dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LOVASTATIN, PROPRANOLOL and MONOCLONAL ANTIBODIES for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (contracted COVID-19/diagnosed with COVID-19). On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond 36 days from receiving first dose). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond 36 days from receiving first dose) had resolved. At the time of the report, COVID-19 (contracted COVID-19/diagnosed with COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: Positive.     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.   No treatment information was provided.
Child became cranky on 7/23.  Noted to have fever of 100.5 (ax)on 7/23 at 7 PM.  Mother administered Motrin po.  Soon after, child was noted to have seizure activity consisting of full body jerking and vocalization.  Seizure lasted approx. 4 min.  Fever and fussiness continued for 2 days with highest noted temp of 101.  Sibling who received vaccine same day also developed fever on 7/25 and had seizure activity.
High fever, hysterical laughing, nonsense speech, rash on legs especially right thigh has a bright red rash area about two inches in diameter
Patient claimed that the Bell's palsy on the right side of his face appeared on the morning for 1/13/14 when he woke up. He assumed that it was from the flu vaccine that he got from the pharmacy. He reported it to us on 1/17/14.
She had acute onset of dizziness vertiginous type, very significant difficulty even walk 3 days after her vaccine.  Similar to symptoms of labyrinthitis. No stroke like symptoms weakness, but was very very dizzy went to the emergency room. She had a CAT scan and blood work that was normal.  She had no upper respiratory symptoms prior within several weeks so that timeframe and no high fevers chills or sweats or any significant side effects from the vaccine.   She is now feeling fine today and had been offered and took meclizine.
Got injection on Feb. 16 , on the following Tues. noticed soreness at the injection site and the site was hot.  This continued   with occasional light itching  and the redness continued to expand to encompass the top of my arm from the shoulder to the elbow.  On March 6th I broke out in small bumps like mini blisters and the itching intensified.  The redness is fading but the injection site is still red and hot to the touch.
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 30-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Was diagnosed with with herpes, but that was not the right diagnosis.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES VIRUS INFECTION (non-serious), outcome "unknown", described as "Was diagnosed with with herpes, but that was not the right diagnosis.". The event "was diagnosed with with herpes, but that was not the right diagnosis." required emergency room visit.  Additional information: on 12Dec2022, she had the Prevnar 20 vaccine. she has had trouble with other vaccines. So far she has been to the Emergency room three times. She was diagnosed with with herpes, but that was not the right diagnosis.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, the pt had erythema in mid right deltoid extending to just below the elbow. Sight fluctuance mid lesion. No fever.
After my 4th dose of my Covid 19 vaccination which was Pfizer vaccination I developed a chronic cough, experienced fever and a sever case of sinus drainage. I visited the Urgent Care and was examined and diagnosed with Covid 19. I was then advised to follow up with my Primary Care physician 21 days later. I was prescribed Albuterol and Flovent.
Developed headache, dizziness, nausea, face tingling, sore throat/tight throat. No shortness of breath, no rashes. All vital signs normal. Symptoms improved while being monitored in clinic, although still felt a bit nauseous at the time of discharge. Patient did not want to present for further medical care.
3 x 4 cm area of erythema, slight warmth. No swelling or edema at site of DTAP; pt treated with ice and rest.
Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was  administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation.  She was taken to Regional per EMT's.
After administration of vaccine, we were notified by local Authority that the vaccine had experienced a temperature monitoring event outside of our facility.  Patient was notified of CDC guidelines that recommend revaccination.  Patient came in 10/13/2022 for revaccination.
pt recv vax 24FEB94 & later devel a fever of 106 & had swelling of lt leg;fever devel noc of vax as well as swelling & lasted 2 days;mom called ER-child not seen;
Headache, Myalgia, NauseaVomiting, Angina, hot flashes Narrative: Patient received J&J vaccine x 1 on 03/22/21. Reported symptoms  beginning that same afternoon, which included injection site pain, headaches, and  nausea. Patient also reported "teeth pain, hot flashes, leg pain, chest pain, pins and needles in hands/feet, left upper body pain." As of date of report ( 04/15/2021), patient reports had not yet fully recovered. Reported took Tylenol for symptoms.  Report notes patient has had a previous reaction to another vaccine, however no  information is provided in regard to what vaccine, when, where, etc.
No additional AE reported; Nurse reported that PROQUAD was inadvertently administered to the following patient after its labeled expiry date.  The involved PROQUAD had a labeled expiry of 3/19/2023 and was administered on 4/28/2023.; This spontaneous report was received from a nurse and referred to a 4-year-old male patient. The patient's medical history, concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 28-APR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #U029321, expiration date: 19-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). The vaccine had not undergone any temperature excursions. The reporter was unable to provide the lot number and expiry date for the sterile diluent; however, she stated it was not expired. No additional adverse event was reported (no adverse event).  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2305USA000867: US-009507513-2305USA000923:
Lightheaded. Did not have anything to eat all day. Felt better after eating banana. BP 140/63, HR 99 at 14:25. BP 129/60, HR 92 at 14:40 upon discharge.
Petechiae noted around eyes, hairline, forehead, ears. One line of petechiae noted on (R) shoulder. Developed petechiae 2 hours after vaccines.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016247853) on 18-May-2016. This case was linked to 2016SA098084 (same reporter, same event). This case involves an 18-year-old male patient who was vaccinated with a dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route and site of administration: not reported) on 25-Apr-2016. Patient's medical history and concomitant medication was not reported. On an unspecified date, following the vaccination, patient had blisters. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
On the afternoon of 04/10/2023 the clinic MA unknowingly administered an expired of Hib vaccine. HIB vaccine lot number was UJ667ABA with and expiration date of 04/07/2023. The manufacturer is Sanofi Pasteur. The vaccine was to be taken off the shelf by 04/07/2023. The patient?s guardian was contacted and another appointment for re-administration was scheduled. Procedures have been put in place in order to avoid further incidents. A two-point check will be conducted prior to administration. MA will check the expiration date from the vial and compare it to the box. MA will also make a note in our Pharmacy book were vaccine lot numbers and expiration dates are kept. Moving forward a list of upcoming vaccine expiration dates will be printed weekly in order to quickly remove them from the inventory, therefore adding another safety net to the process at hand. We updated our policy for administration and documentation of vaccines. Team members now must print a copy of report for vaccines needed, compare to what we have on stock; highlight which vaccines need to be administered and finally pull them from our fridge. After pulling the vaccine MA needs to do two-step check comparing vial and the box to make sure there are no discrepancies
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 2:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:48 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.56 for dose administered on 03-Mar-2021 and 77.63 for dose administered on 31-Mar-2021. No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 to 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a  temperature monitor at every hour.  No treatment medications were reported.
Information has been received from a physician concerning an unspecified number of female patients who were administered vaccinations with GARDASIL (Lot# not reported) in the buttocks. The patients outcomes are unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified ages, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch numbers and expiry were not reported) dose, start therapy dates were not reported, 1 total, administered for prophylactic vaccination. The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, patients experienced suspected covid-19 infection, and suspected clinical vaccination failure, and were hospitalized (dates unspecified). The reporter stated that, "hospital has no beds open because his doctor came out and told him the hospital is full of Covid patients who were fully vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000216499. This case, from the same reporter is linked to 20220213367.; Sender's Comments: V0: 20220217362-covid-19 vaccine ad26.cov2.s- suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20220217362-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. 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).
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and influenza-like symptoms. On an unknown date, the outcome of the pain, headache and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: GlaxoSmithKline representative called to report two adverse events on SHINGRIX. The pharmacist told GlaxoSmithKline representative that he had two patients with severe flu like reactions after having the first dose of SHINGRIX. The patient stayed in bed for 2 to 3 days, missed 3 days of work and would not be receiving the second dose of SHINGRIX. The symptoms were pain, headache, general flu like symptoms. One case happened during the summer and the other one two months before the date of reporting. It was unknown which of the two reports happened during the summer or two months before the date of reporting. There were no additional addresses listed for initial reporter. The reporter did not have a phone number for pharmacist. This case has been linked with the case US2018203979, reported by same reporter.
This spontaneous report as received from a nurse regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On multiple unspecified dates the patients were vaccinated with improperly stored M-M-R II (dose, frequency, route and lot number were not reported) for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. No data logger was involved. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.