chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a legal firm regarding a case in litigation concerning a 27 year old black male with folliculitis keloidalis, acne and dermatitis papillaris capillitii who on 1/2/91 was vaccinated with measles virus vaccine live. Concomitant therapy included measles-rubella vaccine (duration, dose and indication not reported), yellow fever virus vaccine live, influenza virus vaccine, BCG vaccine, MGc vaccine, poliovirus vaccine, adenovirus vaccine, PLG vaccines I, II and III, typhoid vaccine, diphtheria toxoid/tetanus toxoid. It is alleged that subsequently, the pt experienced abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis. The pt's abnormal hair growth on his face (thinning and excessive), acne, blindness, blurred vision, bone fractures, Cushing's Syndrome, easy bruising of the skin, folliculitis, infections, mild weakness in the arms and legs, mood swings, moon face, osteoporosis, slow healing of cuts and wounds, skin atrophy, stunted growth, weight gain and dissecting folliculitis persisted. Upon internal medical review, the pt's alleged blindness was considered an "Other Important Medical Event". Additional information has been requested.
started experiencing chills; vomiting; headache; swelling at the left arm (the place where the vaccine was injected); This spontaneous case was reported by a physician and describes the occurrence of CHILLS (started experiencing chills), VOMITING (vomiting), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at the left arm (the place where the vaccine was injected)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (started experiencing chills), VOMITING (vomiting), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at the left arm (the place where the vaccine was injected)). At the time of the report, CHILLS (started experiencing chills), VOMITING (vomiting), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at the left arm (the place where the vaccine was injected)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 weeks old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and then they noticed that on the chart it says that the product has expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine, Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) (PCV) and Hepatitis B vaccine (Hepatitis B vaccine) all for Immunisation.  On 15-May-2023, the patient received a 0.5ml dose (dose 1) suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of lot UJ668AAA and expiry: 13-May-2023 via intramuscular route in the right thigh for immunization.  On 15-May-2023, the patient developed a non-serious event product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event product was administered to a patient and then they noticed that on the chart it says that the product has expired with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a registered nurse concerning a 2 year  old male, with an allergy to peanuts, egg and wheat, who on 06/28/1999 was vaccinated with first dose of varicella vaccine SC in the right thigh. There was no other illnesses at the time of vaccination. His mother reported that in December 2000, he broke out in a "full-case of chicken pox." Subsequently, the child recovered in December 2000. Additional info is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (barely sore arm) and FATIGUE (little tiredness/barely tired). At the time of the report, PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) outcome was unknown. No concomitant medication was reported by the reporter. The reporter informed that patient was over 70 years and not immunocompromised. Patient was scheduled for surgery. Patient talked with surgeon and doctor, and they told him to get the shot. No treatment medication was reported by the reporter. This case was linked to MOD-2022-527272 (Patient Link). Reporter did not allow further contact.
Devel varicella 13 days following administration of Varivax; course complicated by pneumonia;
My face (cheeks) went numb.   My tongue and throat started to tingle, like I was having an allergic reaction.  I had taken a Claritin for allergies before I received the injection.  The numbness started approximately 30 minutes after receiving the injection.  It last until I took additional allergy medicine three hours after the injection.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 CKD STAGE 3B (GFR 30-44) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 UNSPECIFIED ANXIETY DISORDER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/15/2022 CHF EXACERBATION, UNSPECIFIED
pt recvd vax 20OCT93 & pt hospitalized 18NOV93; dx HIB meningitis & sepsis; treated w/Rocephin; discharged; hearing test has been scheduled @ time of this report;
Pt. came to the clinic stating she was "just not feeling well" on 10/5/2021.  After further questions, she had a cough for about 5 days. Pt. is on supplemental oxygen for her COPD.  Her 02 sats were at 89 which were not unusual for pt. Provider seen pt. and he ordered a Covid-19 test. Test came back positive. Pt. was sent home with family member and given instructions to take pt. to ER if she shows any signs of having a hard time breathing. Family took pt. to the hospital on 10/9 or 10/10. She passed away on 10/12/21
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 30-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
After vaccinating at 2:00 mom breast fed infant. After breast feeding an area of erythema the size of a quarter on right LT and a mild rash to upper chest under chin area noted. He breast fed with no difficulty breathing or distress noted. Mom reports he has been teething and felt the rash was related to this and moister under chin and chest area. Adviced to follow up with medical provider if symptoms become worse. Did a follow up call and mom reports the erythema on leg and rash went away that same day and infant doing well.
She was given 4 shots, 2 in each leg.  Whatever she received in her left thigh (probably DTaP) caused it to swell, become red, inflamed, and extremely tender.  Swelling went down after the first day.  She favored that leg for about a week, and it was red and inflamed for 10 days.
RECEIVED LESS THAN 0.5ML OF VACCINE AS A BOOSTER DOSE (0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 76 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series was 2) to right arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (both events dose number in series was 2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of vaccine as a booster dose (0.3 ml) and off label use was not reported. This report was non-serious.  This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211210058, 20211210160, 20211210588, 20211210112, 20211210610, 20211210733, 20211209679, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210019, 20211210197, 20211210385, 20211210408, 20211210409, 20211210549, 20211210585, 20211210590, 20211210662, 20211210670, 20211210824, 20211212082 and 20211212088.
Pt had syncope event aprrox 8 minutes after receiving vaccine. Paramedics called and cleared (pt) by paramedics. Pt fell and hit back of head on floor. Pt breathing OK and no other signs of discomfort on initial analysis (after fainting).
Having severe running nose; Sniffling; Sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer.). The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "Having severe running nose"; RHINORRHOEA (non-serious), outcome "unknown", described as "Sniffling"; SNEEZING (non-serious), outcome "unknown", described as "Sneezing".  Additional information: Reason for no lot number: of COVID Vaccine: Complainant hung up abruptly/transfer incomplete. Reporter queried stating this sinus related stuff or severe reaction. Limited information was available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 days after the injection, I developed a red, itchy streak down my arm and hives on my opposite hand.
Patient came in with a rash that was approximately 3"x3". Patient stated that the rash was itchy. Pharmacist on duty informed patient to take liquid Benadryl and call MD regardless if it improved or not.
The patient was doing well during his observation time and when his time was up and he was being released he started sweating profusely, complained of loss of vision, ringing in ears and was cold to the touch. EMS was called and arrived about 10 minutes later. Patient did not lose consciousness and was communicating well the entire time. BP was normal, BG was normal and when EMS transported the patient his left side of face began to droop. EMS left the facility with the patient at 2:12pm and the patients emergency contact was notified.
Approximately 20 hours following the injection I was suffering from extreme fatigue and fever.  Slept for twenty hours straight and then felt okay.   Almost five years ago I was diagnosed with spinal stenosis and have been pain free during that period, almost five years.  Following the second Moderna injection I experienced severe pain in my left hip and X-Ray showed acute right-sided low back pain due to spinal stenosis.  It's interested that the flair up and pain was dormant until the second dose of vaccine was administered.  I assume the vaccine triggered the flair up but it did occur quickly after the second injection.
patient vaccinated with J&J covid vaccine in january.  on 1/16 admitted to the hospital for breakthrough vaccination covid infection.  pt was hypoxic and covid PCR was positive on 1/16
Two days after I recieved the vaccine I  overslept and I didn't wake up until after 9 AM and I usually have to be up by 8. I woke up and thought I would feel better by an hour. I was lethargic. I slept all day that first day. 2nd day I was lethargic but was able to get up and move around, then all of a sudden I was very tired again. There were times I did fall asleep without realizing. Late Wednesday 03/17/2021 I felt out of breath and by Thursday 03/18/2021 I started having heart palpitations and out of breath. Late Thursday and into Friday I felt fatigued but it was decreasing. By Monday 03/22/2021 I felt better, but I didn't feel like myself again until mid week of following week. I did use guidance on CDC website which was helpful because I determined how sick I was and if I needed to seek help.
Extreme fatigue the day after the vaccine, sore around lymph nodes (hips and armpits)
red spots that appeared on her face after receiving the vaccine.; red spots that appeared on her face after receiving the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious), SKIN REACTION (non-serious), outcome "recovered" (2021) and all described as "red spots that appeared on her face after receiving the vaccine.".  Additional information: The patient developed red spots on her face within 5 minutes of getting the shot.  HCP stated that the patient was at her vaccination site to receive a booster dose of the Pfizer Covid-19 vaccine. The patient wants the booster shot but the pharmacist was looking for information on if this was an allergic reaction before administering the booster. The reporter confirmed that they did not give the other shot, the booster. The patient said she developed red spots on her face within 5 minutes of getting the shot. It was explained that they did not give the previous shots for the patient, so she had no information regarding those shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hospitalized 7/20/22-7/24/22. Abdominal pain, blood in stool, weakness, decreased appetite, GI bleed with colitis,
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Small fibre neuropathy" (unspecified if ongoing); "Known allergies:Cat scan dye" (unspecified if ongoing). The patient had received other medications in in 2 weeks. Concomitant medication(s) included: LYRICA, start date: 24Dec2020; KLONOPIN, start date: 03Feb2010; PEPCID [FAMOTIDINE], start date: 06Jan2021; ZOLOFT, start date: 03Dec2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti-viral medication Paxlovid from 30Sep2022 to 05Oct2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. started Oral Typhoid pills on 3/18/08 and took a pill on 3/20, 3/22, 3/24. Pt did experience Nausea and Diarrhea shortly after taking the first dose. Pt came to office today for Twinrix #3 accelerated and stated that she is exhausted and still having diarrhea daily. Instructed pt to go to her primary doctor.
Swollen arm , Hot to touch, red bumps & Itchy. 8 days after injection.   13 days after shot slightly swollen, still hot to touch and red.  Looked it up found ( Covid Arm) on internet, called doctor but they did not know what to do. have been taking Benedryl
A couple of weeks after receiving my second Moderna COVID vaccine shot, my back pain became unbearable.  I scheduled a checkup with my primary doctor.  To begin the process of determining the cause, Dr. scheduled bassline lab work.  The results determined I had Diabetes.  Further testing suggested Type 2 Diabetes.  In trying to develop an effective treatment plan, my blood sugar numbers remained out of control along with terrible headaches and fatigue.  In October, 2022, I had my first appointment with an endocrinologist, Dr. His lab work determined that it had turned into Type 1 Diabetes. I have endured 135 lab tests, multiple medication adjustments, and now chronic illness that has no possibility of going away.  I will soon be put on an insulin pump.
On 3/16/96, the pt received one dose of varicella virus vaccine live and on 4/5/99, the pt developed a full blown varicella like rash with crusting and lesions over his entire body.
Woke up with extreme vertigo. Definitely major balance issue. Still feeling dizzy and out of sorts.
not hearing very well; Shaking; Chills; Pain; I am not already feeling very well, I feel dizzy.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown, single for covid-19 immunization. Medical history included being diabetic, asthma, high blood pressure and arthritis. Concomitant medication included insulin for diabetes. The patient stated, "I am sorry but I am being kind of brushing because I am not hearing very well". The patient was not feeling really well. She was shaking pretty bad; the patient took the injection yesterday. She took something for the pain and it went away. This morning when she got up, everything shake, she was already not feeling very well, she feel dizzy. The patient wanted to know what she can and cannot take. She took her insulin yesterday and took her medicines in the morning and now, she was not feeling well like she said feeling shaky, dizzy. The patient stated that it does not say there is the side effects that you feel shaky, chills, and pain and headache. The patient has not had the headache. The patient got the pain the first day and now she was shaking pretty hard. The outcome of the event pain was recovered on an unspecified date while the other events was unknown.  Information about Lot/Batch number is requested.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Medium, Additional Details: patient states she is having pain on left side of face and ear. She has rush on face and arm is swore. Pt also states they had fever blisters but have since resolved however she still has fever.
Moderna COVID-19 Vaccine EUA  Patient incorrectly indicated age on authorization form - indicated birthdate in 2002 and age not under 18.  Shot given.  Patient with no known adverse effects at this time.