chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 18-FEB-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a medical center, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-MAR-2013, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
A non-serious spontaneous report of headache, chills, and stomach upset has been received from a Doctor of Pharmacy concerning a 17-year-old female subsequent to FLUMIST. Medical history included headaches. The patient was not taking any concomitant medications. On 08-Nov-2008, the patient received FLUMIST, nasal administration for flu immunization. The patient had never received FLUMIST before. On 11-Nov-2008, the patient experienced a severe headache, chills with no fever, and stomach upset. The pharmacist did not know the location or type of headache. The patient was treated with ibuprofen and calcium carbonate. After 12 hours, the patient fully recovered.
pt says that developed pain at the end of the tail bone, about 2 inches above the butt cheeks, in the middle of the night. She says it is tender to the touch and aggravated with movement. She states that she did not check for a rash but says it doesnt feel like there is one. Pharmacy told pt is unlikely to be from the flu shot but to follow up with md. Told pt to try tylenol and ice pack in the mean time.
This case was reported by a healthcare professional and described the occurrence of shoulder arthralgia in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tetanus toxoid vaccine; manufacturer unspecified; unknown; unknown given in May 2010. On an unspecified date in May 2010 the subject received 3rd dose of ENGERIX B (unknown route, left arm). In May 2010, less than one month after vaccination with ENGERIX B, the subject experienced left shoulder arthralgia. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional did not have the subject's chart at the time of reporting, so was unable to provide further information. Follow-up information was received on 02 September 2010. It was reported that the female subject was 46 years old at the time of event and that she had received a 1.0 ml dose of ENGERIX B. The event of shoulder arthralgia began on an unspecified date in May 2010 and was worse at the time of follow-up. The event was still considered to be probably related to treatment with ENGERIX B.
Patient states within hours of receiving pneumovax  in her right arm she experienced a burning sensation, extreme swelling, and severe pain. Her husband put ice on it. She followed up with her physician on 10/19/2020 and was told the person who administered the vaccine hit a vein. As of 10/27/2020, the patient was still unable to mover her arm and states she has weakness. Her husband states her elbow is getting deformed.
Patient had head and arm jerking after receiving DTaP. Symptoms lasted for 2 weeks. Parent reported at next visit on 6-5-07. Patient received shot on 4-26-07.
herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old patient (pt) of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 10-JAN-2008, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for long term prevention of shingles and zoster-related conditions.               On an unknown date, the pt was treated for herpes zoster as a result of zoster vaccine live (ZOSTAVAX) use. At the time of the report, the pt's outcome was unknown.
it has been 42 days since her first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus, Scleroderma and Autoimmune disorder.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been 42 days since her first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she is on a lot of medication. Concomitant product use was not provided.   Reporter did not allow further contact
Information has been received from a physician concerning a 13 month old female, with no pertinent medical history and no allergies, who on 09/27/2004 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy on 09/27/2004 included measles-mumps-rubella vaccine, pneumococcal conj vaccine (Prevnar) and Hib conj vaccine (Acthib).  There were no other concomitant medications.  On 11/01/2004 the patient experienced a rash with fried egg size lesions with new crops continually appearing on trunk and extremities, none on the face or diaper area.  The patient was afebrile.  The rash was treated with a topical steroid cream, which made the rash worse, and oral diphenhydramine hydrochloride.  No product quality complaint was involved.  Additional information has been requested.
There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter.
She developed a dry, itchy rash on her shins; She developed a dry, itchy rash on her shins; This is a spontaneous report from a contactable other hcp. A 77-year-old female non pregnant patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 08Feb2021 (at the age of 77-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. Medical history arthritis and hyperlipidemia from an unknown date and unknown if ongoing. The patient previously experienced known allergies: Iodine Dye. The patient's concomitant medications were not reported. The patient experienced a dry, itchy rash on her skin 4 days after the vaccination (12Feb2021). She think it was because it had been cold and dry out, but she was remarkably insistent that it was a vaccine effect. The patient received treatment for the events. The treatment medication was topical steroids. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Headache, Sweats, warm injection site, hard injection site, sore injection site, bruised injection site, eye pressure
Information has been received from a physician referring to a patient of unknown age and gender. On 11-AUG-2015 the patient was vaccinated with a dose of PEDVAXHIB injection (lot # K019701, expiration date 17-JUL-2017, dose and route were not reported) and a dose of PENTACEL (lot #, dose and route were not reported). No adverse effects reported. Additional information has been requested.
1230PM mom noticed rash devel behind ears & neck;mom called MD;pt fussy since vax;no fever;APAP given 925AM;pt having grunting sound no apparent resp distress,color pink;18MAy98 viral illness & rash;second of wheezing;T100.3;resp 48;
covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 19-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
PATIENT GOT INFLUENZA VACCINE & ABOUT 30 MINUTES LATER DEVELPED HIVES AND A RASH. WAS TAKEN TO OUR EMERGENCY ROOM, GIVEN VISTARIL IM, PUT UNDER OBSERVATION, AND SENT HOME WITH CHLOROPHERAMINE
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergy to chemicals and mercury sensitivity. On 28th February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm and discomfort. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and discomfort were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient was on no medication. The patient received SHINGRIX in Left arm. Within 24 hours, the patient noticed that her arm was feeling restricted in its normal fluid motion and in fact her muscle that received the shot was constricted and could not be moved without pain and limitation. The patient reported that, her exercise routines through her local health club were totally impacted. Even with having several manipulations (massage and physical therapy adjustments) into the 2nd month of these restrictions, and doing some exercises to help restore her normal arm motion and reduced discomfort. The patient continued to experience residual arm movement on her left side. The patient was asking further information to identify if SHINGRIX had contain mercury thimerosal and or formaldehyde.
This patient received his second Moderna vaccine at 12 days from his first dose instead of 28 days. This was due to an error in scheduling his appointment for his second dose as well as the pharmacist not verifying the timing of his previous dose.   I apologized that he had been vaccinated with his second dose early. He stated that he felt well "I'm all right" We attempted to share information about vaccine efficacy and side effects but he  interrupted us stating that "I'm all set" He had no questions for us and asked to get off the call. He presented as not concerned about side effects or efficacy and  seemed happy to be done with the 2 vaccine series.  Follow-up  offered phone contact info- he declined.  he stated he is seeing his PCP next  week.  QUESTIONS ADDRESSED IN THE DISCUSSION: none "I'm all right" "I'll continue to wear my mask"  CONTINUED COMMUNICATIONS REGARDING THE ADVERSE EVENT: Advised to seek care for any symptoms of concern.  For Primary Care and other care team members:  Per CDC no additional dose is needed in this situation.  Vaccine symptoms are not expected to be worse with early second dose  vaccination.  Efficacy data is not available for this situation but significant protection  from vaccination is expected.
localized reaction to vax; lt thigh 12 inc circumference, red & swollen, 10 x 6 1/2 core across, inderated; ATB therapy started & return to clinic next day for f/u; 11MAR93 resolving cellulitis; complete ATB course;
pt recvd vax & w/in 2 hrs exp shaking lasting 15 mins; unable to walk from shaking & t 101; seen at ofc; neuro exaam nl;
April 6: sore at injection site and left shoulder  April 7: sore at injection site and left shoulder, headache, fever, chills, muscle aches, fatigue April 8: fatigue, intense pain in left arm-  tricep/bicep/armpit area, sore in muscles & joints on left side only including left temple, jaw, arm, hip, thigh, ankle, and toe
no apetite; Joint pain; 102 fever; horrible headache; arthritis was acting up; sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020AMR004497). Concurrent medical conditions included arthritis.   On 31st December 2019, the patient received the 2nd dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, arthritis aggravated, sickness and joint pain. On 1st January 2020, the patient experienced appetite absent. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain were recovered/resolved.   The reporter considered the fever, headache, arthritis aggravated, sickness, appetite absent and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  On the day of vaccination by early evening, the patient had fever of 102 degrees Fahrenheit, had a horrible headache, and the patient's arthritis acted up. The patient stated that she had learned that joint pain was one of the side effects of Shingrix. By 9 pm, the patient was in bed sick as a dog. The next day the patient experienced the same things. Around noon the next day the patient took advil when the patient's temperature hit 101 degrees Fahrenheit. The patient had no appetite and once again nasty headache. By early evening the patient started to feel better and by the end of the day the side effects had passed. The patient stated that by all in all she was down for 1 day, not too bad.
The patient received her first dose of Moderna vaccine on 1/21/21. We received a report  stating she had not received her 2nd dose. The patient had cancelled her 28-day return. The appointment office reached out to the patient who reported that she had received her first dose of Pfizer vaccine  to moving to. She couldn't find the Pfizer vaccine and she "knew it would be fine because I work in healthcare so I lied to get the Moderna so I'd be done"
deltoid muscle has infection, have hematoma from shoulder to elbow, and is still spreading.
Pt. had sudden onset n/v and diarrhea with a fever approximately 6 hrs after receiving the vaccine.
Breakthrough case admission after two vaccines Pfizer 5/19/21 Lot# EW0186;  Pfizer 6/9/21 Lot# Ew0186
No signs or symptoms reported.; Nurse reported at temperature excursion on PEDVAX HIB that was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.   On an unknown date, the patient was vaccinated with improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot No: S036823 has been confirmed to be valid, expiration date was reported as 24-MAR-2021, but upon internal validation established as 31-MAR-2022, strength, dose, route, frequency and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range above 9°C (10.63 °C) and below 2 (0.0) °C, during a time frame of 4 hours and 20 minutes. No previous temperature excursions reported. There was no data logger. The onset date was reported as 02-MAR-2021.
TIGHTNESS OF CHESS, FEELS LIKE I AM GOING TO GET AN ASTHMA ATTACK. SOME COUGHING  DIZZINESS
Patient had a fever the afternoon of Oct 19 and was very sleepy, he seemed to be dehydrated. Once he began vomiting we took him to an urgent care that afternoon where he was treated for dehydration. Later that Friday evening he went into septic shock. Patient was at hospital where he was on dialysis once he arrived and a few days later patient developed a brain hemorrhage and received emergency brain surgery. About a week following the brain surgery the hospital sent a jet to transport patient elsewhere. He hands and feet became necrotic which led to amputations below the knee and elbow.
Information has been received from a registered nurse concerning a 19 year old female who on 4/16/97 was vaccinated SC in the right arm with a first dose varicella virus vaccine live (lot # 621073/0083E). In approximately July 2004, the patient had a negative titer of 0.31 (0.90 or greater is considered a positive titer for this lab). Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Follow up information was received from a physician who indicated that the patient was negative for immunity when titers were drawn on 7/9/04. No further information is expected.
Had initial site discomfort that resolved, then on 8/26/2008 "flared" with stronger reaction of 11 cm. erythema, mild edema, pain @ injection site Right deltoid.
Suffered a grand mal seizure, that lasted roughly 2 minutes. Quit breathing for a length of time and became incontinent.  Then I fell into a deep sleep for 10-15 minutes and was awoken by paramedics. As a result of the seizure my vision in my right eye became blurry.