chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022; No Adverse event; Received expired  2nd dose after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022) 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 EXPIRED PRODUCT ADMINISTERED (Received expired  2nd dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day and was administered on 01-Aug-2022).    No concomitant product use was provided.  The patient received 2nd dose (6-11 year) beyond 30 days in the refrigerator.  The vial was initially stored in the refrigerator either on 30-Jun-2022 or 01-Jul-2022 not sure which day.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case is created for pediatric patient 1   This case was linked to US-MODERNATX, INC.-MOD-2022-636327, US-MODERNATX, INC.-MOD-2022-636330 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-636327:Paediatric patient -2 US-MODERNATX, INC.-MOD-2022-636330:Paediatric patient -3
Cellulitis redness/warmth/swelling at site of injection of MENACTRA and flu and Tdap vaccines, treated with KEFLEX.
Patient contacts Employee Health Department on 10/17/18 to report that she has been having numbness and tingling in her feet since about 10/09/18. States 'something is different with me since I had my flu shot'. The numbness and tingling started intermittently, but is constant to her knees as of 10/17/18. She reports has difficulty walking a straight line. She has had a heart valve replacement and notices 'more thump that is louder than usual' also. She states that her mother was diagnosed with Guillain-Barre at the age of 84 years of age and recovery did not go well.  She has an appointment with her PCP, on the afternoon of 10/17/18. She states she will keep Employee Health office informed of her status. Reports on 10/22/18 that she will be having a spinal tap this week and that her PCP has started her on gabapentin. On 11/05/18, patient calls Employee Health to say that "I've been told that I have Guillain-Barre. I am just exhausted". Also reports that has no ability to fight infection and is waiting for her PCP to tell if she needs to take time off of work. She is also to double the dose of her gabapentin as tolerated for the constant pain her legs. She is having giving way of one ankle at times, but then it does not bother at all the next time she walks. She will be having a nerve conduction study later this week to see how extensive condition is. I explained that I would be entering what she has shared with me into the VAERS system.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red). At the time of the report, vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported.
Information has been received on 5/23/01 from an RN concerning a pt between the age of 15 and 18 months of age who about 3 weeks ago, on approx. 5/1/01, was vaccinated with 1 dose of MMRII (lot 637431/0026L) and in the early part of 5/01 received 1 dose of varicella virus vaccine live (lot 636368/1341K). Seven to eighteen days later, the pt reported to the ER with a low-grade fever (previously reported as high fever). It was also reported that 4 other children, vaccinated from the same lot of MMRII, and developed similar symptoms (WAES01072621). It was reported that all of the children are "doing fine now" and were recovered. The records of testing prior to release of this lot (637431/0026L) have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Nausea, fever, malaise, dizziness Patient went to hospital and was admitted, Still at Hospital 4 days later.
Patient presented to the ED and was subsequently hospitalized for appendicitis within 6 weeks of receiving COVID vaccination.
Had seizure on midnight 8-18-07.  Seen at hospital - Dse discharge orders attached.  On meds three different kinds.  Can not tolerate any of the meds issued so far for seizures.  Has not had any futher seizures.  Mother states in car gurgling so mother looked bac at child and noticed something wrong then stopped the car and childs was staring up at one side and could not get him to focus.  Temperature unknown as did not have a way to check. 2/5/08-records received for DOS 8/19-8/20/07-DC DX: Seizure. Admitted for having 2 seizures. Urine drug screen positive for only Valium that he received from EMS. Per 60 day follow up: I called the patients mother and talked to her. She states doctors were surprised child had not had seizures earlier in his life. He has a spot on his brain from having a lack of oxygen at birth. They are keeping him on seizure medication. Have tried 3 different kinds. The one he is on now works well. It is ZONEGRAN or a generic of it. He takes 3 capsules a day. Mother states since his first seizure lasted 1-1/2 hours, the doctors do not want him to have any more. He is scheduled for another MRI the 2nd week of Feb. He is being followed by a Physical terapist, Occupational therapist and a speech therapist. It does not sound like the doctors feel it is vaccine related. Child is doing as well as can be expected.
18 days post administration of ZOSTAVAX, patient developed lesions similar to chicken pox all over her body. Initially, temp of 101.6 was recorded (rectal) but no fever in subsequent days. She was admitted to the infirmary under contact isolation, treated with calamine lotion and acyclovir 800mg 5x daily x7 days. Scabbed over and cleared in about 8-10 days.
Rash-comes and goes, red blotches, located in places in contact with clothing, itchy Treatment-Claritin once a day
Less than 1 minute after receiving vaccines, RECOMBIVAX HB, MMR and GARDASIL 9, pt fainted. Cardiac - Vasovagal.
develop a pretty significant rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (develop a pretty significant rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (develop a pretty significant rash). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) for Generalized rash, at an unspecified dose and frequency. At the time of the report, RASH (develop a pretty significant rash) 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 takes several medications for several conditions (24 medications, PA offered to fax it; no new medications, all prior to the rash except the COVID-19 vaccine). It was a generalized rash, not only on the injection site. Treatment activities for event was done with Medrol Pak.
No adverse effects; Not administered a full dose of a vial of pedvaxhib; This spontaneous report was received from a pharmacist regarding a 8 week old premature male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 25-FEB-2020, the patient was not administered a full dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (incorrect dose administered)(strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. The pharmacist described that unspecified brand of needle was not fully secured to an unspecified brand of syringe. It was reported that most of the vaccine went into the bed sheet as the plunger was pushed. The nurse did not report to the pharmacist that the patient suffered any additional adverse effects (no adverse effects).
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent unspecified season.  The patient's past medical history included low blood pressure. Concurrent medical conditions included tetanus. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. When the patient received Influenza vaccine, she always experienced flu. As a result she no longer received the Influenza vaccine. This case has been considered as a suspected vaccination failure case since the confirmation of lab test and the time to event onset for influenza was unknown at the time of reporting. This case has been linked with case US2017GSK146824 (same patient).
This spontaneous report was received from a physician, via a company representative, referring to six male patients of unknown age. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients died. It was unknown if an autopsy was performed. The causality assessment was not provided. ; Sender's Comments:  US-009507513-1905USA004181: US-009507513-1905USA004180: US-009507513-1905USA004179: US-009507513-1904USA013391: US-009507513-1905USA004182: US-009507513-1905USA004177:
Erythema, urticaria, swelling around injection site began next day after getting vaccine.
I threw up all night; Headache; Sore arm; Chills; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL9266; Expiration date: 31May2021), for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "not recovered", described as "I threw up all night"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea". Therapeutic measures were taken as a result of vomiting, headache, pain in extremity, chills, nausea.  Additional information: He had his second shot of Pfizer on the 9th very next day, he had really sore arm, chills and then on this last Saturday he couldn't go to work as he threw up all night. Since that point of time, he had headache and nothing takes that, he had nothing but the headaches and nothing take this headache and nausea away. He had got chills and headache and he had never got headache before; he could not take this headache. The patient stated the very next day from the shot, he had soreness in his arm, which he didn't in the first time. He started getting chills, whole day almost 24 hours. Then everything was fine and then actually Friday night, he started getting nauseated, he threw up all night. The patient took only self-treatment and took Ibuprofen or Tylenol or Advil something to make it better, but nothing took it away. Just the recommended dose 2 pills may be every 6 hours something like that.  No follow-up attempts are possible. No further information is expected.
A spontaneous report was received on 10-APR-2014 from a registered nurse concerning a male patient (age unknown). The patient received the GARDASIL vaccine serious intramuscularly on the following dates: first dose on 08-OCT-2013, second dose on 13-FEB-2014 and the third dose on 09-APR-2014. No adverse effect reported. Additional information has been requested.
This non-serious initial spontaneous case, was received from other non-health professional on 21-Sep-2017, concerning a 28-year-old adult female patient. The patient's historical vaccine included unspecified flu shot (influenza vaccine) 3 times (on unspecified date). The patient had no medical history. The patient's concomitant medications included unspecified vitamins for an unknown indication. On 20-Sep-2017, at 09:29 hrs, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: expiry date: not reported). On the same day, after 5 minutes of vaccination, the patient started to feel numbness in fingers, hand, wrist and elbow. She felt a heaviness, weakness in arm and could not use both arms for driving car wheel and felt like her arm did not function. It was reported that, flu shot was more painful and patient had not experienced injection site swelling and redness. The patient did not receive any treatment for the events. It was started that, the patient got the events in the right arm. It was reported that, by the third day of vaccination the patient had no feeling of numbness. However, from then, the patient experienced small episode of localized, transient numbness, that also subsided 2 weeks post-vaccination. The patient recovered from the event numbness of upper extremities 2-weeks post vaccination. The reporter assessed the report as non-serious. Significant case correction received on 13-Oct-2017 Coding for the event feels like her arm is not functioning was changed to muscle weakness upper limb. Acute numbness in her wrists and elbows that started 5 minutes after receiving the vaccine/after 5 minutes, patient started feel numbness in fingers, then hand and wrists, up to the elbow was changed to numbness of upper extremities. Amended narrative accordingly. Follow-up report received on 26-Oct-2017: Route of administration, anatomical location was added. It was reported that, third day after vaccination the patient had no feeling of numbness. However, from then, small episode of localized, transient numbness was experienced, that also subsided 2 weeks post-vaccination.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. This report is on a 30 year old white male who died on 5/31/02. He developed a rare bile duct (liver) cancer following anthrax vaccination. An April 2003 medical article by four military doctors showed a positive correlation between anthrax vaccine and malignant neoplasm of the gall bladder and bile duct. Specifically, there was an adjusted incidence of 2.92 more likely to have this condition post vaccination than pre-vaccination. According to his wife, the military never submitted a report on his illness or death.
Tinnitus slowly got worse over the first few days. By night four, it caused severe insomnia. Other side effects include: sore arm at injection site; sore neck opposite side of injection site; diarrhea (day 3); fatigue.
This case involves a 1 years old male patient who experienced when nurse gave injection it dripped down the patient's leg with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and while treated with PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination. On 15-Dec-2021, the patient started taking PREVNAR (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) Unknown dosage unknown intramuscular (with an unknown batch number) for Prophylactic vaccination. On 15-Dec-2021, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot UJ570AAA via intramuscular route in left leg for  Prophylactic vaccination. On 15-Dec-2021, the patient developed a non-serious event, "when nurse gave injection it dripped down the patient's leg with no reported adverse event" (incorrect dose administered) (same day latency).It was reported, " when nurse gave injection it dripped down the patient's leg. She asks for appropriate follow-up. She is not sure which vaccine, Prevnar or Pentacel, was the one that dripped" Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) was not applicable. It was not reported if the patient received a corrective treatment for the event (when nurse gave injection it dripped down the patient's leg with no reported adverse event). At time of reporting, the outcome was Unknown for the event when nurse gave injection it dripped down the patient's leg with no reported 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 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.
pt recv vax 6JUL98 the noc of 6JUL98 lt arm was very sore;by Tuesday evening/noc lt arm edematous to below elbow & twice it's usual size;MD notified by parents who told them to go to urgent care;dx cellulitis;10JUL98 arm red & swollen;
Per patient, since the day patient received the flu vaccine in his left arm, he has been experiencing pain. (it has been about 3 weeks since the time of the vaccination). He stated he has pain when lifting his arm as well. He has not visited MD for his symptoms yet.
6 inch area of swelling, redness, warm to touch beginning on day 2 and persisting through day 5.  No beneficial response to topical steroids, oral antihistamines.
10 min after receiving ZOSTAVAX the pt said his throat felt sore and swollen. Didn't want epipen yet. Called 911, EMS came. Pt said throat was getting worse but no prob breathing. Just difficulty swallowing. Kept saying throat was getting worse so gave epipen about 40 min after shot and went with EMS. Came back after ER and said was better.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 3:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 3:36 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 62.49.  Concomitant medication of the patient was not reported.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature of 32 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 09-Feb-2021 and beyond use date for the vials was reported as 10-Mar-2021. The vaccines moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to 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. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).