chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-JUL-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), at a healthcare facility/office (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-SEP-2016, the patient was treated at the healthcare facility/office (by an unspecified healthcare professional), for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 01-JUN-2017, the patient sought subsequent treatment at a medical center/hospital, for a continued and worsening vesicular outbreak, which were diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving 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 reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Additional information has been requested.
Pt becomes dizzy with tightness in chest. Flushes and sweating intermittently. Sxs occurred 1 hour after shot. Pt did this after Hep B2 but did not report to vaccinator.
extreme hives all over the body (head to toe) - still having hives to-date Treatment: zyrtec, famotidine, singular, docepin, hydroxyzine, lexapro
pt recv vax 23FEB96 & on 24FEB97 pt devel chickenpox;9 other pt were reported as well (WAES 97030174, 97031076-97030178, & 97030180-97030184);
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent to patients inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of shingles was not recovered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
This spontaneous report as received from a 69 years old female patient via laboratories regarding herself. The patient's medical history included rectal hemorrhage. Current condition included sulfa drugs hypersensitivity, multiple sclerosis and osteoporosis. On an unknown date in October 2012, the patient vaccinated with a dose of zoster vaccine live(manufacturer unknown)(reported as ZOSTER IMMUNOGLOBULIN)(lot number, expiry date and dose were not reported) intramuscularly. Other suspect therapies included GELNIQUE(strength : 10%) gel (1 sachet, every day) topically from 18-OCT-2012 for spasm bladder and zoledronic acid (dose and frequency not reported) intravenously from an unknown date, for osteoporosis. No concomitant medications were reported. On 21-OCT-2012, the patient experienced burning while urination, feeling weak, stomach hurting and bloating, urine more yellow, blood in stool and stomach hurting and bloating. The event feeling weak and not confirmed by the patient physician. No treatment was provided. The outcome of burning while urination, urine more yellow and stomach hurting and bloating was reported as not recovered. The outcome of feeling weak and blood in stool was reported as recovering. The patient indicated that feeling weak was possibly caused by her multiple sclerosis. On 21-OCT-2012, GELNIQUE was discontinued and on an unknown date in October 2012, zoledronic acid was discontinued for an unknown reason. Additional information has been requested.
CONSTANT LOW DEEP COUGH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included it was unknown if patient had drug abuse or illicit drug use or consume alcohol or smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced constant low deep cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of constant low deep cough was not reported. This report was non-serious.
Fever 101 - 102 within 24 hours of vaccine administration. No other sxs initially, then fussy and not same activity level for next 2 days.
Caller states he had all of the side effects and was in bed for a couple of days and took him out of commission; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (19Oct2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of unspecified age and gender received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, at dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he had all of the side effects and was in bed for a couple of days and took him out of commission from an unspecified date. He asked if this happened fairly easily. The outcome of the events was unknown at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Slight dizziness; pale skin improved within approximately 5 mins. Adverse event occurred shortly after vaccination.
6 minutes after administration patient displayed symptoms of labored breathing, pale skin pallor, and was no longer verbally responding. Patient was slumping in their seat and eyes were not focused. One dose of auto-injector epi-pen was administered 1-2 minutes after symptoms presented. 1-2 minutes after epinephrine administration patient's mental status was back to normal. Monitored patient until paramedics arrived. Patient was allowed to go home following paramedics' assessment.
Pt had onset of fever/chills/aches for 48 hours after vaccination. Fever/chills resolved but aches are still persistent 3 weeks later. Pt had visit with Dr and decided to report persistent aches.
Dizzyness Flushed face and neck Swollen tongue Minor facial swelling around eyes Epi Pen and 50mg of Benedryl, bp remained normal, patient remained fully conscious. 911 called and transport to Emergency Dept
1/17/13 3 days nasal congestion; fever 99.9; restlessness; vomited due to congestion; decreased urination; hard to nurse; very fussy, calmed by car ride. 1/17/13 tried albuterol, antipyretic, benzocaine in hear to provide comfort and promote rehydration. 1/18/13 fever gone, wet diapers normalized, still very fussy, falling asleep, legs "would start moving and 'rubbing together' and pt. would wake up". 1/18/13 visit - cries when put down, resume normal nursing, hip abduction 80 degrees (<90 degrees), neuro - arched back when ear examined otherwise no neurologic abnormalities, PE essentially normal, gained 0.1 lb., advised ER parents declined, after nap less fussy. 1/28/13 no further contact since 1/18, visit for cough (irritability improved 2 days after 1/18), wheezed - prescribed albuterol, all prior sx had resolved before this new illness.
5/18/99 pt returned for eval of cont lt arm & s/p lyme vax;pt cont to c/o lt arm pain;
First vaccine dose administered on 4/20/21. Patient was admitted on 4/29/21 with shortness of breath and pleuritic chest pain. CT scan revealed pulmonary embolism and doppler showed vascular access (Hero graft) thrombosis. Patient was treated with heparin and warfarin, and was discharged on 5/5/2021 after being converted to apixaban.  Patient missed scheduled dialysis treatment (no call/no show) on 5/8/21 and 5/11/21. Subsequent welfare check found the patient expired at home.
28APR96 approx 3PM devel a fever 105 ax, stomachache;2MAY96 fever 102;MD reports it was viral;
Patient received both doses / have shingles/Suspected vaccination failure; Patient did have shingles; Patient is a 45 year old female and received Shingrix; The patient actively had shingles and HCP prescribe Shingrix to 45 year old patient; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the vaccination failure, inappropriate age at vaccine administration and off label use were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st 2 doses. The health care professional reported that Patient was a 45 year old at the time of reporting and patient received both doses of shingrix from a different HCP, administration time was unknown of the 2 doses or when the last one was given which led to inappropriate age at vaccine administration. The HCP wanted to give the patient an additional dose even though she had already received both because she actively had shingles, which led to off label use (off label use in unapproved age group and indication) .  The patient did have shingles, health care professional forgot to put it in the description. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown. The reporter did not consent to follow up.
Information has been received for varicella virus vaccine live. This was originally reported by a consumer concerning an approximately 6 month old male baby who in March 2002, was vaccinated with a dose of varicella virus vaccine live. In September 2002, the patient experienced grand mal convulsion. The outcome was unknown. Upon internal review, this event was considered to be an other important medical event (OMIC). Additional information has been requested.
Please has complained of very sore localized pain to the injection site that is still persistent after 5 weeks.
Patient in observation area after covid 19 vaccination. Patient stated she became dizzy, tried to put head between her legs. RN observer walked over to assess patient and saw that patient had approximately 10 seconds of unresponsiveness. EMS activated. Vitals signs taken BP 98/55, 99%, HR 50. 10 minutes later BP was 120/71, 100%, HR 55. Patient condition improved and patient was alert and oriented x3 in no acute distress, ambulating on transfer. Patient transferred via ems to hospital.
Vaccine manufacture date was 9/2023 but expired 01/31/23, administered 02/03/2023
At my routine doctors visit, my EKG came back abnormal -- Dr. Said it showed inflammation of the Atria.  It has always been normal in previous years.
Tested positive for Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: Positive.     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.   Concomitants include High blood pressure medicine, Medicine for high cholesterol, Diabetes medication and Heart medicine.  No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received, No new information
four day after 1st dose of Moderna Covid-19 vaccine EUA developed a red, very itchy rash on back of neck. Rash has spread into scalp and top of shoulder area with secondary splotches on hip, abdomen & inner area of left arm.
Several hours after receiving flu shot in left arm developed pain entire left arm, shoulder and neck with swelling left arm. Stated she had fever at home. Presented to Employee Health Clinic 24 hours after receiving the shot in our office. Left arm swollen and continued to c/o pain left arm and shoulder and neck. Employee sent to Occ Health Clinic for further evaluation. Told she had adverse reaction to flu shot.
About 1 minute after administering Hepatitis A, HPV9, and MCV4 vaccine to patient he became unconscious. As his father and I lowered his body down onto exam table patient's body became stiff and limbs started contracting. Patients body then begin to uncontrollably jerk. I turned patient onto his side and had patient's father stand behind him to help hold him while I paged 911 code over phone system. Jerking lasted about 45 seconds then patient was conscious, alert, and oriented x4 again. Observed patient in clinic room for 20 minutes after incident occurred and then left clinic with father. Referred to PCP for a follow-up visit. Reported incident to County Director in person.
Felt like a mild flu - overall body aches, headache, burning eyes - symptoms appeared approximately 7 hours after receiving vaccines; about 20 hours after injection, a mild fever of 99 degrees, and it only lasted about 10 hours; about 36 hours after injection, symptoms subsided to mild aches and burning eyes, but accompanied by a brief period of nausea.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-JUL-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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. Additional information has been requested.
About an hour after vaccination onset itching on face/head progressing to body wide within 1-2 hours. Took BENADRYL 25mg by mouth about three hours after onset. Some improvement, took x 3 days, 1x/day for resolution. No rash, no hives.
I21.4 ACUTE NON ST ELEVATION MI 5/27/2021 ATRIAL FIBRILLATION, UNSPECIFIED
12/31 exposed to a person that later tested positive for COVID. 12/3 developed symptoms of sore throat. 12/4 PCR tested and positive results. 12/3 developed body aches and congestion. 12/5 and on have continued to have congestion and sore throat of varying degrees
caught a cold; cough type symptoms; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that: a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, received "first dose and then caught a cold and cough type symptoms on an unknown date and now her HCP has prescribed to her a steroid Prednisone to assist". Therapeutic measures were taken as a result of caught a cold cough type symptom. Outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Some discomfort in the arm at injection site; * days later arm itchy,red and swollen; arm got red; arm slightly swollen; achy; headachy; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE DISCOMFORT (Some discomfort in the arm at injection site), VACCINATION SITE PRURITUS (* days later arm itchy,red and swollen), VACCINATION SITE ERYTHEMA (arm got red), VACCINATION SITE SWELLING (arm slightly swollen) and VACCINATION SITE PAIN (achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no adverse event reported). Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE and OMEPRAZOLE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (achy) and HEADACHE (headachy). On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (* days later arm itchy,red and swollen), VACCINATION SITE ERYTHEMA (arm got red) and VACCINATION SITE SWELLING (arm slightly swollen). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (Some discomfort in the arm at injection site). On 24-Jan-2021, VACCINATION SITE PRURITUS (* days later arm itchy,red and swollen) and VACCINATION SITE ERYTHEMA (arm got red) outcome was unknown, VACCINATION SITE SWELLING (arm slightly swollen) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (Some discomfort in the arm at injection site), VACCINATION SITE PAIN (achy) and HEADACHE (headachy) 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.   No concomitant information provided. No treatment information provided.
Information has been received from a physician concerning a 14 year old female who on 21-JAN-1997 was vaccinated SC with a first dose of Varivax (lot# 617907/1076D). On 10-JUL-2006 the patient developed chickenpox. Subsequently the patient recovered. Additional information is not expected.
Information has been received from a registered pharmacist concerning a 69 year old female patient with allergy to aspirin who on 15-FEB-2011 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot # and expire date not reported), subcutaneously in the right upper arm. Registered pharmacist stated that on 16-FEB-2011, the patient experienced redness, soreness and warmth at the injection site of the right upper arm. The patient called the physician's office and was advised to use BENADRYL, TYLENOL, and ice compresses. The patient called the pharmacist on 18-FEB-2011 to report that the area of the reaction "looked like a big bruise" and measured "about 4 inches by 7 inches". The patient also mentioned to the pharmacist that the patient experienced the area of reaction "looked like a big bruise". The patient also mentioned to the pharmacist that "her ear was infected" and she was self-treating with unspecified ear drops. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a registered pharmacist (R. Ph) concerning a patient with no known allergies, birth defects and medical conditions (also reported as aspirin allergy) with no illness at the time of vaccination who on 15-FEB-2011 at 12:15 pm, was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number and dose not reported). On 16-FEB-2011, "day after vaccination", the patient reported red and sore hot spot. Also it was noticed that it became worse after couple days and subsided after 1-1 1/2 week. The patient did not seek medical attention. At the time of the report, the patient recovered. No further information is available.
Client reported feeling anxious and warm.  Respirations even and unlabored. Skin pink, warm and dry.  1611 Blood pressure 148/96  pulse 56.  Patient reported a history of  panic attacks and that this was a mild attack.  1630  144/78 pulse 80 Client calm.  Reports no history of allergic reactions to vaccines, medications or foods.   1635 patient calm, released.  Informed to Go to ER if any further problems and to report this to V-safe.
Started complaining that back hurt; to the point that had to take bra off. On 11/8 went to ER and after testing diagnosed with muscle pain; prescribed pain medicine but never took it. 18 days later collapsed in bedroom and paralyzed waist down. Went to ER and later admitted to the hospital. The MRI identified a spinal sepsis, they scraped off T4->T9; admitted for surgery. 6 days later transferred to another facility. Stayed there from November 24 thru January 10. Today still in physical therapy, using wheelchair and relearning how to walk.
Next am left upper arm sore and I would wake when on left side. Also thighs and all leg joints extremely sore
w/in 30 mins of vax pt returned to office w/body rash (trunk area), facial swelling around eyes & forehead, Epi & Susphrine administered & DPH po rx'd; sx resolved w/in 1 1/2 hrs; referred to allergist; dx anaphylactoid react;