chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 9 year old daughter who in approximately 1998 was vaccinated with varicella virus vaccine live. On 28 JUN 2001 the patient broke out. The patient experienced 2.5 days of a 102.6 temperature and lesions in her mouth, throat and eyelids. The mother described this as a moderate case. Unspecified medical attention was sought. The mother reports that varicella ia spreading wildly through the community. It was noted that the patients brother (WAES #01071096) had a similar reaction after vaccination with varicella virus vaccine live and a subsequent exposure to chicken pox. Follow up information has been received from a physician indicating that the patient did not come to the office for evaluation. The physician reported that the vaccine was given in 1998, but not in his office.
smallpox vaccine administered 09dec03 x3 jabs to left arm, anthrax #1 administered to right arm. 10 days later awoke with skin rash over majority of body, itching, erythema, intense redness around anthrax injection site, less severe around small pox site.
Pfizer COVID 19 Vaccine: Sore arm for a day or two; sick badly for 3 weeks; sore back or shoulder and arthritis maybe".; sore back or shoulder and arthritis maybe".; sore back or shoulder and arthritis maybe".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (Dose: 02, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (Dose: 03, Lot number: unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pfizer COVID 19 Vaccine: Sore arm for a day or two"; ILLNESS (non-serious), outcome "unknown", described as "sick badly for 3 weeks"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "sore back or shoulder and arthritis maybe"."; ARTHRITIS (non-serious), outcome "unknown", described as "sore back or shoulder and arthritis maybe". ".   Additional information: He had a male patient who was also a veterinarian on the line and unable to get his age.  He did mention that he received 4 Pfizer COVID 19 vaccine shots and mentioned having sore arm for like a day or two and also the Pfizer Flu shot which afterwards he was sick badly for 3 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with itching at my left wrist (same arm where vaccine given). The itchy area became a papular rash. Several patches of papular rash measuring up to 3-4 cm then appeared over the next 24 hours in the C5 and C6 dermatomal distribution. Then the rash became more sensitive/painful, with pain and dysesthesia throughout my left arm and hand. The rash is now becoming more vesicular with spreading erythema.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 10-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
he had flu like symptoms after his 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (he had flu like symptoms after his 2nd dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he had flu like symptoms after his 2nd dose). At the time of the report, INFLUENZA LIKE ILLNESS (he had flu like symptoms after his 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received Vivance as concomitant medication.  Treatment information was not provided.   This case was linked to MOD-2022-628893 (Patient Link).
This spontaneous report was received from a physician refers to a 1-month old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 04-MAR-2019, about a month ago the patient was inadvertently administered a dose of GARDASIL 9 (lot # R017249 and expiration date 20-APR-2021 (also reported as 04-MAY-2021)) (wrong product administered) instead of RECOMBIVAX HB. The physician did not elaborate on the possible reason for the error. No adverse effects were reported. No PQC (product quality complaint) was reported.
swollen lymph node,  right lower base of the neck, anterior to the clavicle, pea to peanut-sized
Immediate bitter/metallic taste. Lasted 1 hour post vaccination.; This is a spontaneous report from a non-contactable consumer (patient).  A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 20Dec2020 09:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), ergocalciferol (VIT D). The patient previously took butorphanol tartrate (STADOL) and experienced drug allergy (known allergies). No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. The patient was not pregnant at the time of vaccination. It was reported that the patient experienced immediate bitter/metallic taste, which lasted 1 hour post vaccination. No treatment was received for the event. The outcome of the event was recovered on recovered on 20Dec2020 10:15.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was on a cruise and started feeling cold symptoms. My symptoms kept getting worse, and by 5:00PM I was afraid I was catching COVID-19. I went to the medical center, but they were closed so I took come cold tablets and vitamin C tablets and went to sleep. I then went to the medical center the next day and got tested for COVID-19 and the flu, and the COVID-19 test came back positive. I was only very sick the first day. I asked for PAXLOVID, but I was told there were too many side effects, and it wasn't recommended. Ever since I caught COVID-19 the first time, I've had a lingering cough. Nothing tastes good to me anymore, but my smell is okay.
3/4 cm reaction upper arm. Top red, hot, Dtap given 10/13/04.
Within 20 minutes of FLUZONE shot got the chills felt like fainting, throwing up and or having a bowel movement.  Called husband to come and get me.  Went home to bed...slept.  2 hours later had 101.2 degrees and by 5:30 had a 102 degrees temperature.  No other symptoms.  Next day had 100 degrees temperature by evening was 99 degrees.  Fine on Wed. 11/5/08
Positive COVID> 14 days post vaccine Narrative: Positive COVID> 14 days post vaccine
Has DVT on Eliquis. To ED and admitted with Pulmonary Embolism. Vomiting from COVID-19 infection and unable to take Eliquis for a few days. Started on Heparin drip and given Remdesivir. Also on empiric antibiotics. Initially admitted on 7/27 with DKA, but signed out AMA. Not in DKA this admission. Received third dose of Remdesivir and will be discharged home instable condition. Does not require O2. Will resume Eliquis. F/U with PCP 5-7 days.
Leg (thigh) markedly swollen, tender, limping, no redness fever to 104 (did have fever prior to admin). Tx: MOTRIN. Sx developed within 24 hrs and much improved in 72 hrs.
This spontaneous report as received from a pharmacist refers to a 80 year old male patient. On 14-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J005721, expiry date: 29-AUG-2014) (dose, location unspecified). Concomitant therapy included with COUMADIN. In October 2013 (in the past week) the patient experienced a dermatological reaction with redness and swelling and pain at injection site (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). The patient visited an unspecified physician on an unspecified date as a result of the injection site reaction. The patient was prescribed an unspecified antibiotic. At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
suspected vaccination failure; shingles; got covid; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In December 2021, more than 2 years after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine 5 years ago from the date of reporting. More than 2 years after receiving Shingles vaccine, a few days before the holidays, the patient got covid and then the shingles came out. The patient stated that, it was time to get another shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
pt recvd vax & w/in 10 mins following vax pt exp extreme pain @ inject site w/numbness & tingling radiating to fingertips & felt faint; 3 hrs later pt exp chills, pale & sl diaphoretic w/hands cold & clammy; VS stable; t99.8;
No additional AE information; LPN calling to report expired vaccine administered to patient; This spontaneous report has been received from a Licensed Practical Nurse referring a patient of an unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 04-APR-2022, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) at a dose reported as 1 milliliter (mL) once (vaccination scheme frequency, route of administration and anatomical site of application were not reported; lot number lot number T034003 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-MAR-2022) for prophylaxis (expired product administered).  No additional adverse event (AE) information was provided (no adverse event).
Initial report received on 21 July 2010 from an investigator participating in a trial. A male subject developed possible myocarditis 8 days after receiving a first dose of ACAM2000 and a first dose of concomitant vaccine Anthrax (manufacturer not reported) on 23 June 2010. Medical history and concomitant medications were not reported. On 01 July 2010 the subject had asymptomatic elevated troponin and was referred to the investigator on 06 July 2010. Seven days later, the subject was evaluated by cardiology and had a normal troponin, elevated CK-MB (5.6% ng/mL), normal EKG and was admitted to the hospital. An echo was found to be borderline abnormal, and perfusion stress test was normal. The subject was discharged on day 3 of hospitalization with no diagnosis. The subject was seen for follow-up on 19 July 2010 and prescribed colchicine. The subject has not recovered. According to the investigator, the event was possibly related to the study vaccine and concomitant vaccine. Documents held by sender: None.
Shoulder pain for 3 days post injections, on day 4/5 is now doing better.
Have COVID; Have COVID; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: Valsartan medication for high blood pressure.; "Interchange of vaccine products" (unspecified if ongoing), notes: He received a Johnson and Johnson COVID vaccine and 2 Pfizer COVID19 vaccines. Concomitant medication(s) included: VALSARTAN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Have COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (06May2022) Positive; (08May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was a 76-year-old male physician (drug safety expert) and was calling about Paxlovid medication. The patient had no underlying morbidities and was taking Valsartan medication for high blood pressure. He had Covid and was exposed 2 weeks ago and tested positive on day 5 after exposure with PCR and rapid antigen tests. On the last Friday in Apr2022, he prescribed Paxlovid for himself and he completed the course on Wednesday of last week which was 04May2022 and took the complete 5 day course as labeled. His COVID symptoms were mild and he was quarantining. He did a Rapid Antigen test 2 days (last Friday) after finishing treatment with Paxlovid (last Wednesday) and test was still positive. Yesterday, Sunday, he took another rapid antigen Covid test  and it was still positive. He received a Johnson and Johnson COVID vaccine and 2 Pfizer COVID-19 vaccines. He looked at data which stated that after 5 days, there should be a reduction in viral load. He wanted to know what duration of post treatment could he reasonably expect his system to be clear of Covid virus and was asking if Pfizer had any information on a timeframe of complete resolution of Covid infection after Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Prior to administration of Hepatitis A and HPV, Mother of pt asked if there was something for patient to eat, since she hadn't eaten that day. Pt was given a granola bar. (NKA)  Nurse administered Hepatitis A vaccine. Patient immediately felt light headed and woozy. Pt lay down on exam table with application of a cool compress on her forehead. She recovered and was administered HPV vaccine. Again felt light headed, was very pale, had clammy skin and fluttering eyelids. She was examined by Dr.  who reassured Mom and pt.  After 15 minutes patient was able to walk (with  a steady gait) out of the office with her mother. Mom later reported that patient complained of a burning sensation in her arm and chest. She developed a headache and then spasms in her back. All signs and symptoms have resolved with the exception of pain at the  HPV injection site.
Shingles; shingles, including any and all of its sequelae; This spontaneous report was received from a lawyer and a 63 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 14-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On 09-APR-2017, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of shingles, including any and all of its sequelae was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles, including any and all of its sequelae to be disabling.
Treatment of COVID-19; Treatment of COVID-19; Dose 2 and Dose 4: Pfizer/Dose 3: Moderna/Dose 1: Jannssen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH97206) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Oct2021 as dose 2, single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 3 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "unknown", described as "Dose 2 and Dose 4: Pfizer/Dose 3: Moderna/Dose 1: Jannssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.
Golf ball size area of redness and swelling at the injection site with itching at the site only (localized)
patient admitted to hospital with diagnosis of Covid-19 on 2/11/22.  Initially states she tested positive for Covid 19 approximately 3 weeks ago.  Since that time she became more weak and short of breath. O2 sats in ED on room air was 79%.  States decreased appetite due to food tasting bad, maisea, fever, chills and temp 100.7.   Note patient would be potentially immunocompromised due to mantle cell lymphoma- on Imbruvica.
Vaccinations administered on 04/23/18 at 6 month well baby visit. Patient seen again on 06/27 for 9 month well baby visit; concerns of bump on forehead- Child had fallen off couch- No LOC reported- All findings were routine. Patient seen on 07/18 for Hospital Follow up after being admitted from 07/07-07/13 with acute transverse myelitis.
Frequent urination in early evening, fever of over 101, uncontrollable shaking and chills, chattering teeth, extreme pressure in head, (fear of stroke), muscle pain, joint pain, red, swollen injection area, severe headache, pulse of over 140 continuous for two hours. Extreme fatigue for two days and joint and muscle pain. Fever subsided by afternoon the following day. This is day three and I still am not "normal"
Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 13:15 (Lot number: ER8727) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN; VITAMIN D 2000. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 27Feb2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". Additional information: The lymph node adverse event was new, After my 2nd dose & 3rd dose I had chills, and fatigue that lasted less then 24 hours.  Follow-up attempts are completed. No further information is expected.
patient filled out vaccine form for covid shot after having an appointment for covid shot, and listed patient age as 16 years old.  pt DOB is  invalid age was caught after patient received vaccination when paperwork was being submitted to insurance and would not allow team to complete insurance processing due to patient age being too young. team called patient's parents and patient's father said he is aware that his son will be 16 years old in 2 weeks, and implied that he did not care if his son was not yet 16.
?After 1 dose of SHINGRIX in 3 days pt experienced rapid heartbeat, bronchitis, excess mucus, extreme fatigue, extreme trouble breathing, blood work issues. MD was most concerned about HR and bloodwork. Pt felt like she could have died.  Had to be put on a nebulizer as a result.
PT REPORTS TROUBLE BREATHING, CHEST TIGHTNES, FLUID IN THE LUNGS
4/19/04 15:00 Pneumovax administered to pt left deltoid. No swelling or erythema at injection site. Pt vomited in PM 4/20 c/o pain at left shoulder, worse with movement. Pain 8/10. Temperature 39 degrees C. Both shoulder x-ray. No significant findings, ortho consult suggested Toradol and PT. 4/21/04 Decreased pain in shoulder (4/10). Pt discharged with Motrin after 2 and gel pack for left shoulder.