chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immed p/vax lt arm @ inj site became angry red-pink penny sized blister-appearing spot in center;hand knot noted size of marble entire area around inj site edematous & warm;(approx tennis-ball size are);ice to site;
soreness  at injection site, muscle aches throughout my body, particularly upper back between shoulder blades.
stoke, weakness/numbness rightside of body,   3 stents placed  in carotid artery
Information has been received from an office receptionist concerning a female cousin with a history of cold sores who on an unspecified dates was vaccinated with the first and second dose of GARDASIL. After each doses the patient experienced cold sores that were larger and clustered, more intense outbreaks than ever before. At the time of the reporting the outcome of the patient was unknown. Additional information is not expected.
Racing heart; Chillswent back and forth all day; brain fog; stayed all day in bed; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease. Concomitant products included FLUOXETINE and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ILLNESS (sick). On 12-Apr-2021, the patient experienced PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed). At the time of the report, ILLNESS (sick), PALPITATIONS (Racing heart), CHILLS (Chillswent back and forth all day), FEELING ABNORMAL (brain fog) and DISCOMFORT (stayed all day in bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   AB negative blood type. No treatment drugs were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was not applicable.   This case was linked to MOD-2021-081268 (E2B Linked Report).; Sender's Comments:  MOD-2021-081268:First dose case
Left upper arm red and angry at injection site. Assessed by physician Dx: with cellulitis. Treated with Bactrim
Mild (4/10) nose bleed 5/14, within the bounds of being relatively normal. Severe/Worse (6/10) nose bleed 5/15, low viscosity/high flow rate. Blood flowed into the throat before out the nose; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the left arm on 13May2021 at 19:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included sport induced asthma, (3/10) no inhaler prescribed and allergy to erythromycin since an unspecified date. The patient's concomitant medications were not reported. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. The patient also received previously the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the left arm on 22Apr2021 at 19:45 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14May2021 at 19:00, the patient experienced mild (4/10) (unit unspecified) nose bleed 5/14, within the bounds of being relatively normal and severe/worse (6/10) nose bleed 5/15, low viscosity/high flow rate. Blood flowed into the throat before out the nose. Both times nose bleed lasted under 2- 3min. The patient was advised via phone call from nurse and physician. Therapeutic measures were taken as a result of adverse event which included treatment with unspecified medications. The clinical outcome of the event mild (4/10) nose bleed 5/14, within the bounds of being relatively normal and severe/worse (6/10) nose bleed 5/15, low viscosity/high flow rate. Blood flowed into the throat before out the nose was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 3 vaccines MOderna 3/2/21 lot# 010A21A;  Moderna 3/30/21 lot# 018B21A;  Moderna 11/23/21 Lot# 058H21A
Positive test; Positive test; This is a literature report.  A 68-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), as dose 1, single (Lot number: Unknown), as dose 2, single (Lot number: Unknown), as dose 3 (booster), single (Lot number: Unknown) and as dose 4 (booster), single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive test. Additional Information: The author stated this patient received 4 doses of Comirnaty; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of COVID-19 and Drug ineffective.,Linked Report(s) : US-PFIZER INC-202200740728 Same article, other patient;US-PFIZER INC-202200832854 Same article, other patient;
While laying down I began to feel faint, an increase in pain in my headache. I got up and sat on the floor with my head between my legs. Broke out in a cold sweat. Started to loose consciousness. Arms (middle-upper) to my hands began to tingle and went numb. I lost muscle control in both of my hands and my fingers were very stiff, I could not move them. My feet and lower legs were also tingly. I felt nauseous and in need of the toilet. I was able to crawl to the bathroom at which point I had diarrhea. I regained feeling and motor control of my hands shortly after but continued to experience extreme light headed ness for the next hour.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 05-DEC-2014, the patient was vaccinated with GARDASIL, Lot # K008335, expiry 23-JUN-2016, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
COMPLAINED OF SEVERE HEADACHE AND GENERALIZED WEAKNESS, WITH RECURRING "HEADACHES DAILY AT NOON".
FLUVIRIN was in box labeled PPD therefore. 1cc was given ID in pt left arm. Dime sized slightly reddened area noted at injection site.
pt recv vax & exp inj site rxn consisting of redness & swelling extending down arm to elbow regions w/in 24hr of vax;pt has an allergy to PCN;rxn described as upper arm 2/3 red, warm, indurated;
This spontaneous report as received from a nurse via field representative refers to an approximately 66 year old male patient. No information about medical history, concurrent conditions was reported. On 20-NOV-2009 the patient was vaccinated with ZOSTAVAX (lot#, dose, frequency, route, indication not reported). No concomitant medications were reported. On 14-NOV-2014, he came into the doctors office with shingles on his right shoulder. The patient did not have any burning or pain, but the physician thought it was shingles. He also did not have any other symptoms. The patient sought medical attention (went to doctor). There was no product quality complaint. The event was treated with SAMVIR. No intervention was done to the event. The outcome of the event is unknown. Causality of the event was not specified. Additional information has been requested.
Lymphoedema; Swollen lymph nodes; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LYMPHOEDEMA (Lymphoedema) and LYMPHADENOPATHY (Swollen lymph nodes) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Blood pressure high, Heart disorder, Overweight, Osteoporosis and Arthritis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). In February 2021, the patient experienced LYMPHOEDEMA (Lymphoedema). At the time of the report, LYMPHOEDEMA (Lymphoedema) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No information regarding corrective treatment was reported by the patient. Caller wanted to report this for her mother, and wanted to know if the lymphoedema will persist, if she is going to be able to walk again, or if this will pass.   This case was linked to MOD-2021-034007 (E2B Linked Report).; Sender's Comments:  MOD-2021-034007:First dose
Lip tingling, swelling and itching which last approximately 2 days. Treated with 25mg once a day for 2  days. Is now resolved.
Aphthous ulcer in throat, currently being treated with Prednisolone solution gargle, still not healed after 6 days of treatment.
High core body temperatures (extreme sweating) while at the same time having very cold feet, very sharp pain in the palms of both hands, sharp pains in wrists and right arm also inside left knee, hand soreness, and head ache in the am after waking. fatique.
Patient was fully vaccinated as of April 2021 and resulted in testing positive for COVID on 8/14/2021 and has been admitted to the hospital
Fully vaccinated.  Covid symptoms started 5/6/2021 (cough, chills, muscle aches, fever), tested positive for Covid 19 on 5/7/2021
Patient received bivalent booster 2 days previously.  Patient noticed large, red, circular rash about 2.5-3 inches in diameter on upper arm the next day.
This spontaneous report as received from a nurse refers to a 6 months 14 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Two weeks after receiving the vaccine, I experienced abdominal cramping that I would compare to being in labor. It was violent. Severe, unpredictable diarrhea. I didn?t associate it with the shot so I proceeded assuming I had eaten something bad etc. A few weeks later I ended up in urgent care and all tests were perfect. The doctor suggested I had an autoimmune response to the vaccine. My PCP concurred and tried me on a dose of prednisone and I had some relief until the prednisone ran out. Ultimately the cramps and diarrhea continued until I had to take short term disability from my job to get it under control. The ultimate diagnosis is that I now have microscopic colitis, which has a known trigger of medications.
This spontaneous report was received from a registered nurse refers to a 8 week old patient of unknown gender. On 08-NOV-2013, the patient was vaccinated with a 0.5 ml pediatric dose of VAQTA in error instead of HepB vaccine (manufacturer unknown). No adverse effect reported, no product confusion, no PQC discovered, just medication error. Additional information is not expected.
This case was reported by a physician and described the occurrence of elevated gamma glutamyl transferase in a 44-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included Aspirin. On 12 December 2008 the subject received 1st dose of TWINRIX (unknown). On 21 January 2009, 40 days after vaccination with TWINRIX, the subject experienced elevated gamma glutamyl transferase (120). A repeat test was done on 12 February 2009 and gamma glutamyl transferase was found to be elevated to 268. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. It was not known if the event was related to vaccination with TWINRIX. It was noted that the subject was vaccinated with monovalent hepatitis B vaccine, which by lot number appeared to be ENGERIX B, on 12 February 2009. The increased GGT was from a blood draw prior to administration with hepatitis B vaccine.
More pain than usual at inject site. Persistent pain 3.5 mts later. Site looks ok. No abnormality palpable.
This spontaneous report was received from a pharmacist refers to a 15 year old female patient. The patient's concurrent condition, concomitant medication and medical history were unknown. On an unknown date in November 2017, 15-SEP-2018 and 29-OCT-2018, the patient was vaccinated with GARDASIL 9 injection, an received 3 doses via intramuscular route (strength, lot # and expiry date unspecified) for prophylaxis. No adverse effects were reported.
On 8/6/02, the pt was febrile with tactile temperature which responded to Tylenol, but he was showing normal activity the morning of 8/7/02. Mother took him to the pediatrician who examined the child and did not find any focus of infection. He was afebrile at the time. He was given normal DTAP and IPV vaccine at that time. When the pt returned home, he became febrile again. The mom gave him Tylenol and gave him a cool bath. After removing from the bath, she noticed some abnormal behavior. The pt began seizing, approx. 5 hours from time of vaccine. The mom called 911 and EMS took the child to the hospital where the pt continued to have generalized, tonic-clonic seizures refractory to Dilantin, phenobarbital and valium; he was then pharmacologically paralyzed with vecuronium and intubated to stop his status epilepticus. His seizure episode lasted approx. 18-20 minutes total. On exam in ER: Vital signs: BP-90/50, his pulse was in the 180's, his temperature was 37.6C. His perfusion was moderate. He had some decreased perfusion in the extremities and empirically, had some rigors associated with increased temperatures. He had been given some Tylenol. His pupils were 1:2mm and reactive. He had some conjunctivitis. He had an ET tube in place. He had no evidence of abrasions on his skin. On his chest and lung exam, he had coarse breath sounds and decreased breath sounds on the right side throughout. His left breath sounds were coarse. His abdominal exam was soft and non-tender and non-distended with no organomegaly. His extremities were normal. His hospital course was unremarkable. He improved in all aspects, received Dilantin, which was changed to Tegretol, which caused a rash and was discontinued. He also received Ceftriaxone and acyclovir until he ruled out for meningitis. His entirely negative work-up left us to consider the possibility of vaccine reaction, or at least a vaccine-related fever that led to an atypical complicated febrile seizure. As it occurred within hours of his 4th DTAP dose, we thought that it was a
Patient is an 84yo female with extensive PMH as listed above who presented to the ED due to AMS with question of stroke v. Seizure activity. Patient was intubated on arrival for airway protection. Patient has no new stroke findings on CTH. Still question of seizure activity with unknown etiology. Neurology consult in ED suggested correlation with stroke HX. Question of infectious process as well with acute hypoxic respiratory failure after just having COVID v. Cardiogenic shock form CHF (congestive heart failure) with recently found severe reduced EF of 26%, PH, severe MR. Patient's declining status could be multifactorial.
Patient was vaccinated with her second Moderna covid19 vaccine on 5/21/21. She had no prior history of infections or hospitalizations and is a controlled type 1 diabetic since her 30's.  She was admitted to the hospital after being evaluated in the  emergency room on 7/27/2021 with her husband due to complaints of fevers and temps of 101-105 since  7/25/2021.   She started having chills, abdominal pain, decreased appetite, dysuria, nausea, vomiting, and confusion and memory issues and has been taking ibuprofen and Tylenol without relief.  She saw her PCP and her urine was positive for a UTI and she was started on Cipro however her medications were sent to the wrong pharmacy and she was not able to pick these up and due to continued worsening symptoms she came into the ER for evaluation.  Patient reported she has always considered herself healthy  and her hemoglobin A1c has been around 7 for quite some time.  She reported lately over the last 2 months  since her covid 19 vaccines she has been having recurrent sinus infections and is also been having a problem with her Dexcom  implant sensor suffering infections and rashes due to it.  In the ER she was febrile with a temperature of 102.3 heart rate of 106 leukocytosis with lactic acidosis, hyponatremia and acute kidney injury as well as a urinalysis positive for UTI.  Chest x-ray showed moderate nonspecific patchy linear density in the left lung base she was noted to be confused blood and urine cultures were obtained she was given sepsis fluids Tylenol and ceftriaxone 1 g and subsequently admitted to the hospitalist service for severe sepsis, urinary tract infection, acute metabolic encephalopathy, hyponatremia, L sided pneumonia and acute kidney injury.  She was continued on IV fluids as well as ceftriaxone pending cultures.  Patient's blood blood cultures were positive for E. coli.  Patient's urine culture ended up growing a mixed flora and UTI was ruled out. The source for the e coli bacteremia was unclear but her hospital course was complicated by severe, protracted diarrhea, abdominal pain, poor appetite and nausea/vomiting.  stool cx was negative and c diff PCR x 2 was negative.     The cause for the patient's diarrhea was unclear and a colitis was suggested.  Surgical consult was obtained and the surgical team followed her throughout her hospital course.  They did not feel that the gallbladder was causing acute pathology or issues given her negative exam and normal liver function test. CT chest revealed b/l axillary adenopathy of unclear cause. She was discharged home on 7/31/21 after her fever, appetite and diarrhea improved to complete her antibiotic course. She was still having temperatures of 99.9 on discharge and some diarrhea. her white blood cell count was 11.8 with no neutrophilia. She has never had covid 19 infection. Her spouse needed to take a leave from work after discharge to help her while she recovered at home.
I developed a viral infection in my right eye. My doctor suspects it is the herpes simplex 1 virus. I developed symptoms on Saturday that I thought were consistent with something being stuck in my eye or having a scratch on the surface of my eye. I saw my doctor on Monday and he confirmed that I had a viral eye infection. He believes HSV 1 is the most likely cause. I have never had another symptomatic infection from that virus (no cold sores or other eye infections). I started taking oral valtrex and prescription eye gel drops. I am still taking the medication and will consult with my doctor once I?ve completed the current course of pills.
Patient fainted after receiving the vaccination. She started to lean forward in her seat. I caught her before she fell. She recovered in under 20 seconds. The mother refused further medical attention but agreed to be monitored for 20 minutes after. The patient drank some water and felt better afterward. After the observation period no further issues or adverse event was noted and the patient decided to go home.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 33-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Spontaneous abortion) on Nov-2017 and Pregnancy on Jul-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 27-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pregnancy test: positive (Positive) positive pregnancy test. On 16-Mar-2021, Ultrasound scan: normal (normal) Normal.         Concomitant drug include Vitamin B-13 1 Daily via Oral route used for indication Pregnancy  from FEB 2021.  No treatment information was provided.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in  response to the event was not applicable.
Vasovagal response immediately after administration 1:05pm.  Patient stated she could not hear and was seeing black spots within 1 minute of administration.  Patient became very pale. Paramedics were called and arrived at 1:18pm and assessed patient as having vasovagal response. Patient fully recovered at 1:45pm.
100.3 fever. Aches and pains like the flu. Severe headache, Chills at night. Nausea. Can't sleep. maybe Insomnia, Dry mouth.
ITCHING; BURNING; RASH; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was 165 kilograms, and height was not reported. The patient's concurrent conditions included hypertension, thyroid, remission from multiple myeloma, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 25-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced burning. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching, and burning. This report was non-serious.