chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 45-year-old nurse practitioner (also a patient). No pertinent medical history reported. Drug allergies include Sulpha and latex allergy. The nurse reported that on an unknown date in 1970 (reported as early 70's) she was vaccinated with MMR II human serum albumin (HSA), subcutaneous (dose not reported). The nurse stated that she had titres drawn in 2002 (exact date not reported) and tested negative for mumps. On an unknown date in 2002 the nurse reported that she was given a booster dose of MMR II subcutaneous. On an unknown date in 2011 she again had titres drawn and again tested negative. There was no significant disability or incapacity. There was no hospitalization required. The event was not life-threatening. No PQC involved. The outcome of the events was unknown. The causality of the event was unspecified. The case has been linked with the cases (same reporter link) # 1406USA012141 and 1406USA012138. Additional information has been requested.
Injection site inflammed, red, warm and painful.  Size: 70mm x 50mm.  Delayed reaction, patient only noticed on the morning of report.  Hydrocortisone cream applied to area.
I have begun to have night terrors.  Starting 2 days after my second dose.  These are not your average bad dreams where one wakes up with an elevated heart rate, this is far worse.  I have on atleast 3 occasions now had it so bad the I am literally stuck in dreams and wake up screaming terrified.  The first event was so bad I almost went put a window before I was fully awake.
Pt that states she received a flu vaccine from our clinic at the school in October. 2-3 days later, it was worse; very painful, difficult to use. States that it is hard to get left arm into sleeve, or to reach/grab for a file, shut off alarm clock. The pain stops her dead in her tracks. Saw PCP in January who advised her to call us.
Patient couldn't receive the 2nd dose; Exposed to COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient couldn't receive the 2nd dose) and EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021. Concurrent medical conditions included Hypertension ("Patient is under high blood pressure medication").    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient couldn't receive the 2nd dose). In February 2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19). On 03-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient couldn't receive the 2nd dose) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that the patient could not get the scheduled 2nd dose of vaccine on 02-Feb-2021 as she was exposed to COVID-19 and later the vaccination center personnel declined to vaccinate as the recommended time period was passed.    Concomitant medications included High blood pressure medications. Treatment information was unknown.
8/16/04- received anthrax #1, typhoid, meningococcal- no problems 8/26- primary SPV- left upper arm- mild local rxn 9/2/04- anthrax #2 9/3/04- noticed 1-2 "bumps" underarm- left 9/4/04- increase in number of lesions left underarm- also similar lesions on right underarm and upper right inner thigh- mild pruritus- "pain from itchiness"- no f/c, malaise, or other sx/sx of infection 9/5/04- similar lesions now found on upper left inner thigh- worsening pruritus 9/7/04- seen by CM
No adverse event.  MODERNA vaccine given to 16yo female, vaccine not approved for this age group
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Two weeks of daily migraines preceded, onset (Oct 19th) of progressive weakness starting in lower extremities. Systemic tingling sensation. Next day had altered taste and unilateral tongue numbness. Weakness continued to progress affecting upper extremities and core with fatigue, heat intolerance and pain in lower extremities. Eventually there was loss of continence as well. Patient was diagnosed with Guillain Barre, was hospitalized and treated with plasmapheresis and IVIG. A second hospitalization was required when symptoms recurred after three weeks of inpatient therapy. Another inpatient therapy stay was required after the second hospitalization to recover ability to use arms, legs, hands, regain control of toileting, relearn to walk and recover from the floor. Patient is still recovering.
Information has been received from a 31 year old female for VARIVAX (Merck), a Pregnancy Registry product, with no drug reaction/allergies and no pertinent medical history, who on 05-NOV-2010 was vaccinated with a first dose of VARIVAX (Merck) (lot # 666850/0714Z). There was no concomitant medication. On 21-NOV-2010 the patient discovered she was pregnant and no adverse effect reported. Annual physical tests were performed. The patient did not seek medical attention. The patient's date of last menstrual period was in the beginning of October 2010. The estimated delivery date would be 09-JUL-2011. Follow up information has been received from a healthcare worker concerning the patient above who delivered her baby in their office. It was reported the patient's LMP (last menstrual period) was 10-OCT-2010, EDD (estimated date of delivery) 19-JUL-2011. The patient delivered a healthy baby girl via C-section (reason unknown) on 28-JUN-2011 at 37 weeks gestation. The neonate had no congenital anomalies. It was reported that the baby weighted 5 lbs, 6 oz, length 19". There were no reported delivery complications. It was unknown if a prenatal varicella titer was done on the patient. Upon internal review, C-section was determined to be an other important medical event. No further information is available.
10 days post vaccine, suffered severe painful lesions, skin tingling, deep stabbing pain, along dermatone from left medial thigh to left lower back(paraspinous), deep painful neuropathy. On March 5, patient went to center for primary care on for help. Was diagnosed with "shingles" and given Rx of Valcyclovir for antiviral and gabapentin for nerve pain.
Initial unsolicited case received from a consumer (the patient's parent) on 18 November 2014. A 8-year-old male patient, with a reported medical history of facial and body tics, had received an intramuscular dose of FLUZONE, (batch number UI189AB) in the left deltoid on 15 November 2014. The patient had no identified illness at the time of vaccination. On 17 November 2014, i.e. 2 days post vaccination, the patient developed facial tics; he was "shaking his head yes and no (not in relation to a conversation) and opening his mouth for no reason". The parent reported that the tics were more exacerbated and very obvious since vaccination. The patient had facial and body tics in the past: parent reported that before vaccination, "they were very mild". At the time of the report, patient was not recovered. Documents held by sender: none.
after1st dose broke out in hives all over the trunk of her body and down both forearms; Elevated blood sugars(340), then extreme low blood sugar (58)-Exactly 38 Hours; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient (not pregnant) received the first does of BNT162B2 via an unspecified route of administration on the right arm on 19Mar2021 at 08:15 AM (Batch/lot number :EN6199) at the age of 16-year-old as single dose for COVID-19 immunization. Medical history included type 1 diabetes. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication included insulin. On 19Mar2021 at 20:15, 12 hours after the shot, the patient elevated blood sugars(340), then extreme low blood sugar (58). On 20Mar2021 at 22:15, exactly 38 hours after 1st dose, broke out in hives all over the trunk of her body and down both forearms. A dose of antihistamine was given and within 1 hour her hives had disappeared with no other symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. Antihistamine  was taken as treatment for events. The outcome of hives was recovered on 20Mar2021 at 23:15. The outcome of blood sugar level fluctuation was unknown.  No follow-up attempts are needed. No further information is expected.
12/04/2001 5:30 AM woke up with sore neck, puffy eyes; fatigue, achy, nausea, sore throat and later that day complained of chills. Took two Tylenol at 6 AM, noon and 5 PM on 12/04/2001. 12/05/2001 Still with nasal complaints, no sneezing, but neck still sore. Continued 2 Tylenol every 4 hours. Did not call PCP but did see chiropractor for sore neck with relief by Friday 12/07/2001 symptoms were gone.
Reports that 1 day after receiving his booster he started to experience dry throat and nose, and cough. He states he "had to use Vix on his mouth and nose to sleep".  Denies SOB. States on the 12/26/21 he was hospitalized and his WBC's were up to 24.8 and his blood sugar was off and was diagnosed with sepsis.  He states he had CT scans and xrays and was put on antibiotics.  He states his WBC on 12-15-21 was 8.11 and today was 16.5
The experiment of Menomune done last wk of March or the first wk of April 1969.  Follow-up: I'm still alive, and ready to put justice where it should be. This experiment on the 1969 basic training recruits, was done outside. They lined up approximately 100 - plus. Recruits every fifth (5) recruit got a shot in the arm with a air inoculation gun. Two vaccines were given at that time. They didn't tell no one what was going on at that time. I have documentation. That one of the vaccines was or could be Menomune. The other I don't know what is was. Like I said they didn't advise what was going on. I know that a civilian gave the shots. I spent 3 wks in hospital hooked up to a IV and a shot in the butt every hour. Call me and I'll tell you the rest of story. I received you letter that you sent to me. I've worked on this research almost three years. If it wasn't for my medical records not being. I've wouldn't done this research from the start. It's taken all over, till recently I didn't know that two vaccines were being tested till a lady that told me from the FDA. That made me realize about the person either in from of me or right behind me. It was the cut mark left by the inoculation gun. He must of had moved his arm, and left a upside down V in his arm. I've learned that the vaccine menomune was one, the other is still a mystery. What information I've given you people is all I known, I'm lucky to still be here. Being on IV for three weeks and a shot in the butt every hour is something I don't want to do again. The FDA and are the two parties responsible for the experiment. Basic training recruits being used as a Guinea Pigs, you need to ask some people at FDA, you might find out what you and I need to know. I haven't seen anything that states this experiment was secret. I still want to study report that Dr. talks about in his notes, let me know what your results are? P.S. When we lined up for the shot, they didn't tell no one nothings, and haven't told anything yet. Almost 40 years, lets put his behind us. And tell me what I want to know! The shot was given the last week of March or the first week of April 1969. It was a beautiful spring day.
my ears started ringing; some amount of loss due to the ringing i wasn't able to hear high frequency at low volumes; I called in sick; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: En6200), via an unspecified route of administration in left arm on 17Feb2021 12:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The vaccine facility type was a school or student health clinic. Medical history included heart attack in Oct2020. The patient had no known allergies. The patient did not have covid prior vaccination and was not covid tested post vaccination. The patient did not have other vaccine in four weeks. Concomitant medications included atorvastatin; clopidogrel and metoprolol. It was reported that on 18Feb2021 (the day after the patient got the covid shot) at approximately 17:00 his ears started ringing, he called in sick and got a doctor's appointment asap. The patient said that there was no blockage or infection, so he got a referral to an audiologist to get hearing test. The test only revealed some amount of loss due to the ringing he wasn't able to hear high frequency at low volumes. The patient was concerned about getting second shot. Not sure what to do. The events resulted in doctor or other healthcare professional office/clinic visit and was considered disability or permanent damage. There was no treatment for the events. The outcome of the events was not recovered.
triggered lyme disease; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; she experienced one year ago such as her  teeth hurt, developed a diminished sense of smell and taste and dry cough.; This is a spontaneous report from a contactable consumer or other non hcp.    A 72-year-old female patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 19May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, states he had the first shot and second one due this week however he had some family guests.  Caller added that his wife received first dose of pfizer covid vaccine 19May2021 and the shot triggered Lyme disease. She believes she had covid one year ago however it was never confirmed via testing. States her shot also triggered the same 'covid ' she experienced one year ago such as her teeth hurt, developed a diminished sense of smell and taste and dry cough. It took 2 weeks for her sense of smell and taste to come back after the covid vaccine shot. Also her teeth hurt a few days after the first shot for 2 days then it resolved. The outcome of the events lyme disease was unknown and tooth ache, cough, ansomia, aguesia was recovered.  Information about the Lot/batch number has been requested.
PT NOTIFIED PHARMACY OF REDNESS/SWELLING/WARM TO TOUCH 10 DAYS POST IMMUNIZATION
Information has been received from a registered nurse concerning a 20 year old male patient who on 24-NOV-2010 was vaccinated with his first dose of GARDASIL (Lot # 666163/0664Z, expire date 18-SEP-2012), 0.5 ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified). Two days later, on 26-NOV-2010 the patient developed hives and itching on his stomach, arms and legs. The patient was treated with BENADRYL and hives resolved within two days (on 28-NOV-2010). On the same date (on 28-NOV-2010) the patient recovered from itching. The patient did not seek medical attention. Additional information has been requested.
Patient: 12 year old male presented to clinic to receive his 2nd dose of vaccine on the scheduled 21st day from his 1st dose. EHR 'flagged' patient as "too early" and LPN staff, LPN requested advisement from this nurse.  Upon review,  EHR reflected documentation by Mr., LPN on 12/2/2021 that the patient was given MODERNA BOOSTER dose vaccine on 12/2/21. Patient's parents verified that patient DID schedule & receive Pfizer for first dose at this location on 12/2/21. Patient was subsequently given the Pfizer 2nd dose of 0.3 ml as it was the 21st day since his 1st dose.
*Note I do not know if this was related to vaccine or if son had another illness.  VSAFE encouraged me to report  on 3/4 ~6pm  complained of mouth pain (unknown etiology) , had shakes,  eye pain and developed >103 fever later that evening (~10pm).   Rapid test Covid - neg.  Next morning (3/5)  mentioned "could feel his heart beat"   (3/5) went to pediatrician - strep test and Rapid PCR Flu/COVID - negative. Was told could return to school if fever resolved.  Fever stayed ~102 for 24 hrs (although resolved with 6 hr dosing of motrin and then would return).  Headache and tired and intermittent oral pain  on 3/5-3/6.  Temp elevated but not fever on 3/6.   Seemed normal on 3/7 although tired rest of week.  3/11-3/12 hoarse no other symptoms
the patient was administered an improperly stored dose of VARIVAX on 1/31/2020; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 31-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route was not reported; lot # S024362, expiration date: 06-AUG-2021) for prophylaxis (was identified on 03-FEB-2020). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were unknown by the reporter). The vaccine underwent temperature excursion of 8.1 degrees Fahrenheit (F) for 42 minutes. There was no previous temperature excursion. The digital data logger was involved in recording excursion details.
R cerebellar stroke/left subclavian aneurysm , specifically an acute infarct in the superior medial aspect of the right cerebellum extending to the superior right aspect of the cerebellar vermis in the distribution of the right superior cerebellar artery.  I had a life-threatening stroke at 6 AM on 16 July 2021, resulting in a trip to the local emergency room and 4 days' hospitalization.
Second dose of vaccine to be administered past day 36; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose of vaccine to be administered past day 36) outcome was unknown.        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 concomitant medication included.  No treatment medication included.  No side effects reported by the patient after the first dose.
Had episode on 2/24/21  of altered mental state, was w husband and he noted this.Said bizarre things.  Has no memory of this, lapsed recall for about 8 minutes. Has never had a similar episode. No hx of psychosis, bipolar or major mental illness of any kind, When returned to alert/aware  mental state, was terrified and crying. No stressors, says has stable life, no violence or threats. Seen in ER 2/24/21, but no brain imaging or EEG.  Clarifies that dizziness and HA went on for several days, beginning same day 2/19 after got 2nd dose Covid vaccine, but the confusion/altered mental state was only for about 8 minutes. on 2/24. Still dizzy/HA/fatigue and some SOB as of 3/2/21.  No fall or head trauma.
No additional AE information. No other AEs.; Patient was administered a VARlVAX post expiry; This spontaneous report was received from a physician (discrepancy: also reported with qualification of "other" on the source document) and refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 13-JAN-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) lot # S000132, expiration date 02-JAN-2021, dose of 0.5 ml (formulation, strength, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events were reported. Outcome was unknown.
Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on her upper thighs and upper arms/continued to have rash since its first appearance even until today) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.