chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a normal, healthy 13 month old femalem pt with no immunosuppression or known recent exposure to varicella who on approximately 25-APR-2000 was vaccinated with a dose of varicella virus vaccine live. On 15-MAY-2000, the pt experienced acute ataxia, presenting with an inability to sit or stand. The physician indicated that when the pt's parents try to place the pt in a standing position shefalls to the right. The pt began to walk approximately 1 month prior to onset. the pt did not develop a rash or any other symptoms. It was noted that the pt had experienced a "febrile illness" approximately three and a half weeks prior to onset of the exact date of vaccination, therefore he was not able to confirm if the febrile illness occurred pre- or post-vaccination. Within one day of onset, the pt had a CT scan of the head, lumbar puncture, and a "number of other laboratory tests including blood chemistry" which were all normal. The reporting physician was uncertain if the acute ataxia was related to therapy with varicella virus vaccine live. The physician was interested in submitting a sample of CSF for PCR analysis. Follow-up information from a physician indicated that the pt was "not well at all, as it now seems she has Leigh's disease (subacute necrotizing encephalomyelopathy), (though this has not yet been confirmed) and is deteriorating rapidly." The pt had been hospitalized, but on 24-MAY-2000 she was discharged because there was nothing more they could do for her. In addition to ataxia, the pt also experienced cranial nerve involvement, dysphonia, dystonia of her hands and abnormal eye movements consisting mainly of opening her eyes very wide and keeping them that way for a period of time. At the time of the report, CSF PCR results were pending. Follow-up information reported that the PCR results from a University on the CSP specimen were negative for UTV. Additionally, it was noted that there has not been any significant change in the pt's condition- she continues to do poorly and the pt's physician believes that her prognosis is not good. Upon internal reveiw, acute ataxia was determined to be an Other Medical Event (OMIC).
Patient developed symptoms of hard breathing and redness around lip area and tongue swelling and difficulty speaking. We called 911 immediatly and they came and assisted patient and took her to ER. She refused to get an Epipen since while we are monitoring her at the pharmacy she said not to give her Epipen since she is allergic to Epipen. Her symptoms started  improving before she went to the hospital and they still took her to make sure she gets fully assessed.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender with no medical history and drug reactions or allergies reported. On unspecified dates, the patients were vaccinated with VARIVAX (dose, lot number, expiration date and route of administration not reported). No concomitant medications were reported. The reporter stated that patients experienced local reactions further described as injection site reactions a couple of days after the administration of VARIVAX. The physician did not recall specific patients or specific patients' details. The outcome of injection site reaction was unknown. The relatedness between injection site reaction and VARIVAX was not reported. Additional information has been requested.
a staph infection; her eye was red, watery, puffy/The puffiness under her eye is hard; her eye was red, watery, puffy/The puffiness under her eye is hard; her eye was red, watery, puffy/The puffiness under her eye is hard; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 6-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 25Apr2021, as 2nd dose, single for Covid-19 immunisation. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date, as 1st dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. On Wednesday, 28Apr2021, her eye was red, watery, puffy and felt like she had or was getting a staph infection. The puffiness under her eye was hard. Patient was a female, age not sure but think mid 50's. The outcome of the events was unknown.   Information on batch/lot number was requested.
10 days post vax pt was diagnosed with otitis media with heat rash on face and temperature of 101 and stuffy nose. Pt treated with Amoxicillin. Spots noted, hard to touch, red in color, no oozing or scabbing.
6/29/19 Woke up at 11 PM perspiring profusely,  low grade temperature 100 degrees,  very weak, painful muscle aches all over body including fingers and toes, had difficulty walking,  in general he felt very ill as if he had flu symptoms. Lasted 48 to 72 hours. Took tylenol for pains. Still feels mild symptoms are persisting. Did not go to doctors because he was told these symptoms are common after the second Shringrix shot.
SECOND INJECTION OF GARDASIL- FATIGUE, POLYDIPSIA, COLD EXTREMITIES, CHEST DISCOMFORT, TINNITUS, HEADACHES, MUSCLE PAIN AND WEAKNESS, SEVERE ABDOMINAL PAIN, BLOATING, SLEEP TROUBLE, IMPAIRED CONCENTRATION, CHILLS, HAIR FALLING OUT IN CLUMPS.  THIRD INJECTION- SAME SYMPTOMS AS ABOVE WITH INCREASE IN INTENSITY AND DISCOMFORT.
Pt recvd 1 dose of Engerix-B approx 2 wks ago; 3 hrs p/dose had dizziness, severe h/a, nausea, vomiting & swollen, local rxn;
feeling tired, nausea, slight fever (around 99), fatigue, diarrheal
Client received vaccine at 1pm on the 8th, after 30 minutes her left arm started to tingle, spread to hand and later evening had painful frozen shoulder. She took tylenol for discomfort. On the 9th/10th had fatigue. On the 12th at 7pm experienced deep ache and pain between right knee and thigh with tingling in her calf, and tingling in right ear to jawline, chin, and bottom lip. On the 13th pain moved to right hip and groin, went to ER. Did Ultrasound to rule out DVT. BP was elevated 168/92, typically low. Woke on 14th feeling shakey, sweating, deep abdominal burping. All of these things happen when she eats gluten, but has not had any gluten. Additional information for Item 18: She continued to have sore joints, elevated heart rate, nausea, diarrhea, extreme thirst, no appetite, extreme fatigue. On the 15th still elevated heart rate, burping, drowsy, decreased appetite, headache, tight neck and frozen shoulder. On the 16th she said she slept well, no headache, but continues to have tingling in her left arm, right leg, and jawline. Symptoms are a little better but still having fatigue and elevated heart rate. Client stated multiple times that all of these things happen when she has any gluten in her diet. She cooks all of her own food and has not had any contamination with gluten. Client has not been "diagnosed" with celiac disease, but knows she has it.
My arm was still sore the next day from the shot. Over the next few weeks it continued to be sore in the muscle/ upper area. I really don't run to the doctor over every ache and pain, after all I'm 71-72 and it's to be expected.  My wife also received the shot at the same time I did. I had a pre-op appointmenet with my doctor in April so I mentioned it to him that my arm was still sore after approx. two months after I got the flu shot. He ordered an xray and mri. Based on the results he referred my to the Institue. They recommended physicla therapy which I'm doing.  My arm still hurts  y arm still hurst rer rm still hurstti  r
Serious derm reaction to both shingrix and moderna vaccine; Raised red rash on arms and chest; Raised red rash on arms and chest; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included mrna 1273 vaccine (Moderna (Mrna Ribonucleic Acid Vaccine)) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received Shingrix and Moderna (Mrna Ribonucleic Acid Vaccine) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction (serious criteria other: Serious as per reporter), red rash (serious criteria other: serious as per reporter) and raised rash (serious criteria other: serious as per reporter). On an unknown date, the outcome of the skin reaction, red rash and raised rash were unknown.   It was unknown if the reporter considered the skin reaction, red rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had a serious derm reaction to both shingrix and moderna vaccine. The reporter asked if there were any common properties. The patient experienced raised red rash on arms and chest. No other information was available regarding the timeline of the patient receiving both vaccines or duration of symptoms. The reporter did not consent to follow-up.
not much energy; kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (not much energy) and FATIGUE (kind of tired) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 ASTHENIA (not much energy) and FATIGUE (kind of tired). At the time of the report, ASTHENIA (not much energy) and FATIGUE (kind of tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: second dose information received
Initial report was retrieved on 30 October 2014 during a routine media monitoring by a company representative. A female patient (date of birth not reported) had received on an unspecified date in November 2013 a INFLUENZA VACCINE (manufacturer, lot number, route and site of administration not reported) and four days later on an unspecified date in 2013, experienced Acute Disseminated Encephalomyelitis. According to the mother of the patient, she took her daughter for her routine flu shot and four day later fell ill. The daughter is bedridden and can no longer walk. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Immediately after the vaccines, the child looked pale and blood like foam came in the mouth. The child pooped too. The doctor came & stated after checking his mouth that he is normal and it is due to immunization.
Pt received vaccination/dosage under the approved age.  No adverse  symptoms reported by mother/physician.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age.  The patient's medical history, concurrent conditions and/or concomitant medications were not provided. On an unknown date the unspecified patients were vaccinated with VARIVAX lot # L034369, expiration date 08-SEP-2017 for prophylaxis. The healthcare worker reported that unspecified patients were administered improperly stored VARIVAX  on 07-DEC-2016 and 29-DEC-2016.  The doses of the vaccine were exposed to a temperature of 12 degree Fahrenheit for 45 hours.  There were no prior temperature excursions.  Data logger was not involved. No adverse effects were reported. No further information was provided. Additional information has been requested.
Patient noted erythema, warmth, swelling, and itching approximately 48hrs after injection.
Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Weakness, malaise, sleepiness, no myalgia. Arm is slightly sore.   C/O headache high temp. Pt started had chill x last night pt believes poss shot reaction. No sign local reaction. Pt had Anthrax shot. Systemic reaction to Anthrax. No URI.
Pfizer vaccine was prepared by provider incorrectly. 1.8ml saline drawn up in syringe, then in same syringe 0.3ml undiluted Pfizer covid vaccine drawn up, 2.1ml injected into patients deltoid
Pt recvd a series of 3 Engerix-B 5JAN90 & 7FEB90 & 30JUL90 subsequently tested for Hep B antibodies & found not to have converted;
This spontaneous report as received from a consumer refers to her son, a 16 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with dose 1 GARDASIL on 24-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The consumer reported that on 29-JUL-2012 her son said he "wasn't feeling well". On 30-JUL-2012 he developed a fever of 103 degrees F. The patient called physician for medical attention. TYLENOL and ADVIL were given for treatment. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Pt recvd vax & devel fever; parents noticed dec movement of lt lower extremity, in absence of pain; pt's weakness cont to progress over period of 1 month; pt avoided weight bearing on lt leg; deep tendon reflexes were present x/lt knee jerk
11/12/21 at around 11:00 am I started to have issues with dizziness  and tachycardia. It progressed to having to hold on to desk while standing. I went to urgent care.  They felt it was a reaction to the immunizations and thought it would last about 48 hours.  Other symptoms experienced was Swollen lymph node under left arm that was injected.  Ineremintent fever that reached 102.8 and started around 5am on 11/12/21.  H/A, fatigue, and Chills.
Rash, blotchy on face, torso, like hives no SOB no wheezing.
I developed cellulitis in my arm. I went to the doctor and they prescribed antibiotics and steroids. The following weekend I went to my primary doctor and the symptoms had subsided.
Redness around the injection site, area about 4"x8". Started to develop the day after vaccination, patient circled the area, it spread about another inch the next day, but has since shrinked.
Muscle aches; fever; chills; bones hurting; pressure on head; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection (at the age of 31-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. It was unknown if the patient had any known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Jan2021, the patient experienced muscle aches, fever, chills, bones hurting and pressure on head. It was unknown if treatment was provided for the events muscle aches, fever, chills, bones hurting and pressure on head. The outcome of the events muscle aches, fever, chills, bones hurting and pressure on head was recovered in Jan2021. Since the vaccination, it was unknown if the patient had been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient (a retired physician) of unspecified age and race received PREVNAR 13 at single dose via an unspecified route for immunization on unknown date. Medical history and concomitant medication were not reported. On unknown date the patient experienced fever, very red and swollen upper arm and swollen lymph nodes. The outcome of the events was unknown.
I received shot 1 of the Pfizer-BioNTech mRNA vaccine on 2/17/2021.  IMMEDIATELY afterward, I had a headache and dizziness and brain fog (including trouble forming sentances and forgetting words).  These symptoms have persisted every day since the vaccine.  These symptoms have diminished slooooooowly over the past 14 days but are still present today.
Moderna 2/12/21, 3/12/21, 1/7/22. Positive on 1/25/23
a couple of days later "hot"; red on the arm she got the shot; 10 days after she got a reaction on the arm she got the shot:sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (a couple of days later "hot"), VACCINATION SITE ERYTHEMA (red on the arm she got the shot) and VACCINATION SITE PAIN (10 days after she got a reaction on the arm she got the shot:sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she got a reaction 'red and sore' 10 days after getting the shot and a couple of days later, she reported it being 'hot'.  Patient was also treated with an unspecified antihistamine.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
Body aches; Fever; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration as a single dose in right arm on 05Feb2021 at 17:00 for an COVID-19 immunisation. The patient medical history was not reported. The patient had no known allergies. 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 received concomitant medication (names not specified). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient experienced fever, nausea, chills and body aches. The patient did not receive any treatment for adverse events. The outcome of events was not recovered.
pt recv vax & became pregnant (LMP 30DEC95);estimated date of delivery 15OCT96;ultrasound performed @ gestational wk 17 revealed a lack of fetal heart beat;D&C was performed shortly thereafter;
Adverse event I am actually reporting is a diagnosis of breast cancer found in the left breast. Diagnosis date of 12/16/2021. Completed both COVID vaccines and boosters.
Patient walked out the vaccination room for about a minute or so after 1st dose of Pfizer then suddenly blacked out, fell chin down to floor, got a cut on the chin and bleeding; patient sit up after the fall,  was responsive, pain level 3-4 due to the cut on the chin, chilling and shaking. Paramedic arrived  after 5 minutes and transferred patient to hospital
MOC reported w/in 40min of vax pt devel a sl rash;4hr later devel gen urticaria & swollen ears;tx w/DPH & recovered;
ACHINESS FOR A WEEK ON AND OFF; TIREDNESS FOR A WEEK ON AND OFF; This spontaneous report received from a consumer concerned an 84 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achiness for a week on and off. On 11-MAR-2021, the subject experienced tiredness for a week on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness for a week on and off, and tiredness for a week on and off on 18-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210403886.
Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with no pertinent medical history and no history of drug reactions or allergies who on 03-APR-2008 was vaccinated with the first dose of GARDASIL (lot#: 659964/1978U) 0.5 ml IV, and on 05-JUN-2008 was vaccinated with the second dose of GARDASIL (lot#:658556/1060U). Concomitant therapy included BENADRYL and ADVIL. After vaccination on 05-JUN-2008, the patient mentioned that she may be pregnant. On 05-JUN-2008, a urine pregnancy test confirmed the patient was pregnant. The patient's last menstrual period was 20-APR-2008, the estimated delivery date is 25-JAN-2009. The patient sought medical attention with a physician office visit. Follow up information received on 28-MAY-2009 from a registered nurse stated that the coach with seasonal allergies and a history of pyelonephritis and one previous pregnancy that resulted in spontaneous abortion on 05-JUN-2008 at 11:15 a.m. received the second dose of GARDASIL intramuscularly into the left deltoid. Concomitant therapy included BENARYL, vitamins unspecified, and MACROBID given for history of pyelonephritis. The patient was prescribed ADVIL for pain. The patient had a ultrasound on 25-JUN-2008 which confirmed the EDC on 02-FEB-2009 and a MSAFP on 21-AUG-2008, which was normal. On 04-SEP-2008 the patient developed pyelonephritis. Her outcome was not reported. On 06-FEB-2009 the patient gave birth to a normal female at 40 4/7 weeks from LMP, who weighted 7 lbs; her apgar score was 8/9. It was reported that there were no complications, during pregnancy and labor/delivery. There were no congenital anomalies. No further information is available.