chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced generalized compulsive seizures; This spontaneous report has been received from a vaccine/patient coordinator on behalf of a physician, regarding a 4 months-old (by the time of the event) female patient. The patient's pertinent medical history included ventricular septal defect as current condition, her previous drugs reactions or allergies and concomitant medications were not reported.  On 13-APR-2022, the patient was vaccinated with the second series of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (lot number 1742434, which was determined to be a valid lot number, expiration date: 16-MAR-2023), and with diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) intramuscular (lot number U7125AA, which was determined to be a valid lot number, expiration date: 15-JUL-2024) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) both administered intramuscularly (lot number EX1979, expiration date: 31-DEC-2023) . All suspect vaccines were administered as routine vaccination (doses and anatomical locations were not reported).  On 21-APR-2022, the patient experienced generalized compulsive seizures that lasted for 45 seconds (generalised tonic-clonic seizure). The patient was taken to the emergency room and was under observation for several hours; treatment (unspecified) was given for the  event.. She had a head ultrasound and labs done; the results were normal. The outcome of the event was reported as recovered.  The causal relationship between generalised tonic-clonic seizure and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) and pneumococcal vaccine CONJ 13V (CRM197) (PREVENAR 13) was not reported.  Upon internal review, the event generalised tonic-clonic seizure was determined to be medically significant.
Low-grade Fever, chills, nausea, dizziness x 24 hours
pt recv vax; T 105 per mom;motrin given;f/u on 19jul95 no problems;
Asymptomatic COVID-19 infection; Asymptomatic COVID-19 infection; dose 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left, administration date 27Oct2021 15:30 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single, via an unspecified route of administration, administered in arm left, administration date 13Apr2021 16:00 (Lot number: EW0161) at the age of 47 years as dose 2, single and via an unspecified route of administration, administered in arm left, administration date 23Mar2021 16:30 (Lot number: EN6207) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not pregnant at the time of vaccination. The patient has no history of COVID-19 infection and has no known allergies. There were no concomitant medications. The patient received no other vaccines within 4 weeks.  The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021 15:30, outcome "unknown", described as "dose 3"; VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Asymptomatic COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (26Dec2021) positive; (PCR) (22Dec2021) negative. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Information has been received from a physician concerning a 12-month-old female patient who on 16-JAN-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (655380/1326F) (rHA). On 26-JAN-2008 the patient came back to the office with a nickel sized lump where the shot was given. It was reported that the onset of symptoms was on 25-Jan-2008. The outcome was not reported. No product quality complaint was involved. The physician also reported that the patient's twin developed an adverse event following vaccine administration (WAES# 0801USA05879). Additional information has been requested.
After that I was brand new, cured. Moderna vaccine was a resolution tom my illness; Moderna vaccine attacked my body; I was like Covid-19, really sick; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sickness (Patient was really sick.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick) had resolved.            Concomitant information was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Bruising at the site (L arm) redness down and warm to the touch about 4 inches around injection site.
went from normal to paralyzed/being paralyzed; Guillain Barre syndrome; Incredible pain; learning to walk again; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced paralysis (Verbatim: went from normal to paralyzed/being paralyzed) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant), pain (Verbatim: Incredible pain) and walking difficulty (Verbatim: learning to walk again). The outcome of the paralysis and walking difficulty were resolving and the outcome of the guillain barre syndrome and pain were not reported.   It was unknown if the reporter considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine.     It was unknown if the company considered the paralysis, guillain barre syndrome, pain and walking difficulty to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case  was received from the patient via interactive digital media. The patient reported that shingles vaccine greatly increases the risk of developing Guillain Barre Syndrome and you did not want any of that, so look it up.  The patient stated that he/she was learning to walk again after being paralyzed for 5 months and possibly kill you. The patient stated that he/she went from normal to paralyzed and in incredible pain plus on the ventilator.  The patient stated that, 9 months later he/she was learning to walk again.  The patient stated that he/she had rather had shingles again any day over this. The follow-up could not be possible as no contact details were available.
Flushing, headache, nausea, diarrhea, muscle and joint pain, on/off chestpain/discomfort, discomfort/pain in lungs, sleep difficulty, chills/shivering, brain fog
Urticaria, hives left neck, right side of face, bilateral lower legs topical anti-itch applied in occupational health. Advise f/u with PCP.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Within normal limits.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  It was reported that, the vial did not undergo any temperature excursions.  Date the vial was initially stored in the refrigerator: 19-Nov-2021   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up was received: Patient's demographics were updated.
3 x 3 cm area of redness at vaccination site  15 minutes after vaccine (L arm). 15 mg ATARAX given.
Pt. complained of throat tightness at 10 AM. Injection was given at 8:45 AM. BP - 109/70 - 10:10 AM - 10:15 AM - EPI pen given, 10:16 AM - BP- 116/66, P - 71 10:20 AM - BENADRYL, IM in R leg, 10:30 AM - BP - 116/66, P- 67 10:40 AM - BP - 103/66, P - 69 10:55 AM . Discharged by MD.
on 10/2/21 at 553pm I gave the patient her 1st dose of pfizer vaccine and told her she would have to wait for 15 minutes after the shot was given  along with the other 2 family members getting the 1st dose of the pfizer vaccine. At 630 pm her son who was the language interpreter said that she was not feeling well after getting the shot now and was complaining of trouble swallowing and  breathing problems. I had her sit down in the vaccination booth and called 911 and described to the 911 assistant what the patient was complaining about and that i was going to give her an epipen injection because based on the symptom complaints i thought she was having an analphylatic reaction. I was concerned that her larynx was swelling and that was why she was having trouble swallowing . I explained to her that i would have to give her an epipen shot in her right upper thigh because i and the 911 assistant felt that she was having and analphylatic reaction to the vaccine and that she would have to be admitted to the hospital for further observation. she refused the epipen shot and going to the hospital. The paramedics then came and checked her blood pressure/heart rate/heart rhythm and oxygen and told her that based on their checking her vitals that everything appeared normal. One of the paramadics had her and her sign on his computer labtop a form refusing to be taken to the hospital. At 650pm the paramedics left and i contined to stay with her and her son. At 655pm she said she was okey and and left the pharmacy with her son. i feel that  based on what the paramedics said that she had and anxiety attack and not an allergic reaction to the pfizer vaccine
Redness, swelling, and itching of upper arm injection site. Diagnoses with cellulitis on 10/16/2016.
rash on both sides of her body.; swollen lymph node under right arm; swollen lymph under left arm; This is a spontaneous report from a contactable consumer (patient). Via medical information team. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 19Feb2021 (at the age of 79 years old) as dose 2, single for covid-19 immunisation. Medical history included osteopenia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of admimistration on 20Jan2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced rash on both sides of her body, swollen lymph node under right arm and swollen lymph under left arm. Patient stated that she has received both of the pfizer covid 19 vaccine. She stated that it has been two weeks since her second dose. She reported swollen lymph nodes under both arms and a rash on both sides of her body. She wanted to verify that these are reported side effects because they have lasted so long. Itch rash on both sides of body was reported as worsened. Patient stated she has had two doses of the Pfizer vaccine, stated she was 2 weeks past the second dose, was having side effects, wanted to know if it was possible to have them this far out still. Stated she has swollen lymph nodes under her arms and a rash on both sides of her body that is driving her crazy. The outcome of the events rash on both sides of her body and swollen lymph under left arm was not recovered. The event outcome swollen lymph node under right arm was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Since being vaccinated, I have had extreme trouble breathing.  I get short of breath quickly doing  mundane activities.  It is getting progressively worse and I am scheduling an appointment to see my doctor.  I had an episode last night where I could not stop coughing and took almost an hour to catch my breath so I could speak.
This spontaneous report was received from a pharmacist and refers to a 69 years old, female patient. No information was provided regarding the patient's historical conditions, or concomitant medications. The patient was allergic to aspirin, penicillin, codeine, sulfa and iodinated contrast agents. The patient received PREVNAR 13 on 01-OCT-2016. On 04-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (indication as reported as following up after receiving PREVNAR 13), intramuscularly, in the left arm, Lot # R006465, expiration date of 24-OCT-2019 (dose was not reported) and also was vaccinated with influenza virus vaccine live (unspecified), intramuscularly, in the right arm (dose, indication, lot number and expiration date were not reported). On an unspecified date in October 2018, the patient started experienced in her left arm a red, raised rash of 3 inches away from the injection site covering the elbow and bicep. On 05-OCT-2018, the patient used BENADRYL cream and stayed at home. On 07-OCT-2018, the patient went to the pharmacy and her arm looked normal and no rash remained. It was unknown if laboratory diagnostic studies were carried out. The outcome for the events of rash erythematous and rash popular was reported as recovered on an unspecified date in October 2018. The causality between the therapy with PNEUMOVAX 23 and influenza virus vaccine live (unspecified) and the events were not reported.
Highest  fever of 107 but hovers around 103 with Tylenol.  Pain in joints from head to toes. Swollen armpit,like a golf ball and it is very painful. Vomiting and hard to keep anything in including .Tylenol and pain killer oxy 10 mg. I'm really dizzy but my fever has moved back down to 103 , these symptoms are still about 38 hours after the 2nd vaccine.
30+ pounds of edema, bilat pleural effusions, HTN requiring treatment, thoracentesis.  Saw ID/pulm/neph. 8/15/08-records received-11/29/07-after 6th dose of anthrax vaccine on 11/3/07 developed moderate arm soreness and headache. Sore thighs, nausea, fatigue, malaise, and generalized weakness over following week. Flu-like symptoms. Two weeks later developed swelling of feet, shortness of breath and neck pain. Possible serum sickness. Impression includes hypertension probably secondary to serum sickness. On 1/17/08-positive for , weight change, night sweats, fevers, hematuria, irregular periods, ringing in ears, heat and cold intolerance, difficulty walking, back pain, change in hair, dizziness, depression, decreased memory.
"Janssen COVID-19 Vaccine EUA" This writer was having a session with a client and her mother at the playground on 4/8/2021 and writer felt weak towards the end of session. Per mother's report, writer's eyes rolled back into her head and writer was about to fall backwards off the picnic table, but the mother caught writer. This writer was unconscious and then came back alert, but could not see for two minutes. This writer experieced severe abdominal pain and needed to use the restroom right after and had a bowel movement. dehydration (J & J vaccine night before at7pm) headache, difficulty breathing and blurred vision and a fever of 99.4 the next day. This writer was taken to immediate care and an EKG and Urine test was done. This writer was diagnosed with Syncopal Episode and dehydration.
Pain every where, from shoulders, arms, legs down to my feet; the pain in my knee kept me from bending it; Pain every where, from shoulders, arms, legs down to my feet; severe pain in all my muscles; severe joint pain; arm was extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was extremely sore), PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), MYALGIA (severe pain in all my muscles), ARTHRALGIA (severe joint pain) and ARTHRALGIA (the pain in my knee kept me from bending it) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was extremely sore), MYALGIA (severe pain in all my muscles) and ARTHRALGIA (severe joint pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), ARTHRALGIA (the pain in my knee kept me from bending it) and ARTHRALGIA (Pain every where, from shoulders, arms, legs down to my feet). At the time of the report, PAIN IN EXTREMITY (arm was extremely sore), PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), MYALGIA (severe pain in all my muscles), ARTHRALGIA (severe joint pain), ARTHRALGIA (the pain in my knee kept me from bending it) and ARTHRALGIA (Pain every where, from shoulders, arms, legs down to my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-115057 (Patient Link).
Aching all over, sore throat, head congestion, chills. No body temperature taken - called M.D. who called in Rx for AUGMENTIN. Sx started 11/6/15 evening time and today feeling better but still congested - took CLARITIN this A.M.
Presented to ER for sudden weakness, mental status changes which improved over 1-2 days.
Patient observed at 10:49 sliding down in his observation chair. On assessment pt had a syncopal episode. Assisted to wheel chair and taken to private observation area with supplies to lay on cot. Full set of vitals obtained as follows: O2 sat 98% RA, HR 59, RR 15, BP 100/85. Pt stated he was dizzy and hot. Fanned pt, further observed, vitals taken at 10:59 as follows: O2 sat 99% RA, HR 62, RR 14, BP 118/75. Assisted pt to drink water, stated no PMH, no current medications, and stated he was nervous. Vitals taken at 11:09 as follows: O2 sat 99%, HR 65, RR 12, BP 122/76. Pt stated he was feeling better. Assisted pt to sit up and took a full set of vitals as follows: O2 sat 99% RA, HR 80, RR 15, BP 115/60. Vitals....
Information has been received from certified medical assistant and patient's mother concerning her currently 17 year old daughter with no known pertinent medical history, no known drug reactions/allergies and no concurrent conditions who in November 2007, was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported). There were other vaccines given concomitantly. The consumer reported that on an unspecified date, rather than night or within the next few nights of receiving the vaccine, her daughter had a seizure during sleep. The consumer's daughter was taken to the emergency room and was given IV's. The consumer reported that her daughter was seen by a neurologist who diagnosed right frontal lobe seizure. Since the patient had only one seizure, no treatment was needed. On an unspecified date, the patient was fully recovered and would not be receiving any more GARDASIL vaccinations. Upon internal review, right frontal lobe seizure was determined to be an other important medical event. This is one of several reports received from the same source. No further information is available.
Slight numbness on the left side of my face. It feels like a congested sinus. I received the H1N1 vaccine at about 5:30 pm 11/12/09. Symptoms appeared about 2 hours later and still persists 11/13/09.
Sweating purple pigment; purplish tinge to her hands; Purple pigment under nails; Body Aches; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NAIL DISCOLOURATION (Purple pigment under nails), SWEAT DISCOLOURATION (Sweating purple pigment), INFLUENZA LIKE ILLNESS (Flu-like symptoms), SKIN DISCOLOURATION (purplish tinge to her hands) and MYALGIA (Body Aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 032B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MYALGIA (Body Aches). On 18-May-2021, the patient experienced NAIL DISCOLOURATION (Purple pigment under nails) and SKIN DISCOLOURATION (purplish tinge to her hands). On 19-May-2021, the patient experienced SWEAT DISCOLOURATION (Sweating purple pigment). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and MYALGIA (Body Aches) had resolved. At the time of the report, NAIL DISCOLOURATION (Purple pigment under nails) had not resolved and SWEAT DISCOLOURATION (Sweating purple pigment) and SKIN DISCOLOURATION (purplish tinge to her hands) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: AFTER 4 TO 5 MINUTES SKIN COLOR CHANGED-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium