chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced no symptoms; an improperly stored dose of ROTATEQ was administered to a patient on 12/3/2019.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 03-DEC-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R016790, expiration date 20-APR-2020; dosage detail and strength were not reported) orally for prophylaxis.  Administered doses of vaccine experienced temperature excursion of 53 degrees Fahrenheit (F) for 1 hour. There was no previous temperature excursion. Digital data logger was involved. The patient experienced no symptoms.
Confirmed Pfizer vaccine with parent prior to administration without confirming the previous administered dose.  Noticed after administration when completing COVID vaccine cards that patient's received Moderna as first dose, not Pfizer.  Patient was well when departing the office.  Family/provider aware of error.
8/1/03 mother noticed a pimple like raised red spot on right leg. On 8/4/03 there were 3 distinct and raised areas. No fever or other signs/symptoms.
Myalgia, Arthralgia, sweats; arm soreness at injection site  Narrative: Myalgia, arm soreness, sweats; resolved 24 hrs from onset
Adverse event: flushing in the face and lower back spasm. Outcome: paramedic evaluated patient's blood pressure, eyes, lungs, orientation and more for a period of 20 minutes. Symptoms subsided before patient left pharmacy.
Heart palpitations, began about 1:15AM, on Tuesday 9-23-14 through about 7:50AM.
swollen lymph nodes along the collar bone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female of unspecified age received bnt162b2 (reported as COVID-19 vaccine), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received vaccine Friday (unspecified date) and had developed swollen lymph nodes along the collar bone on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
sustained scarring; painful rash outbreak across her back and was diagnosed with shingles / continues to have rash outbreaks; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 18-MAY-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a painful rash outbreak across her back and was diagnosed with shingles. The pt sustained scarring and continued to have rash outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events of herpes zoster and scar to be related to zoster vaccine live (ZOSTAVAX) (reported as injuries caused by zoster vaccine live (ZOSTAVAX)).  The events of herpes zoster and scar were considered to be disabling.
Information has been received from a medical assistant concerning a 17 year old female with no known drug allergies and who had childhood asthma, and positive family history of hypertension, stoke and cardiac disorder, who on 05-AUG-2008 was vaccinated with the first and only dose of GARDASIL vaccine (yeast), 0.5 ml. There was no concomitant medication. The medical assistant reported that on 05-AUG-2008, shortly after received GARDASIL vaccine (yeast), the patient experienced for 20 minutes racing heartbeat and chest pain. The medical assistant reporter that prior the vaccination, the patient had occasional chest pain for the six past months. On unspecified date an "EKG" was performed (results not provided). The patient saw the physician. At the time of the report the patient had not recovered. Additional information has been requested.
Redness, warmth and swelling developed 36 hours post vaccine with the left arm measuring 4 cm larger than the right. Probable cellulitis.
Mother suffering from sarciodosis, however was improiving until she recieved the Johnson and Johnson vaccination.  She became very weak, very hard to breath .  She was admitted to the Hospital and stayed for about two weeks. Since released from the hospital she never got her strength back and lost more weight. My mother passed away 5/28/2021.
Patient had injection site redness. It happened right away after giving the ZOSTAVAX. She stayed for 15 min after. It did not spread or cause any itching or discomfort to the patient. No treatment was necessary.
This is a spontaneous report from a noncontactable other healthcare professional. A 50-year-old (non-pregnant) female patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 50, via an unspecified route of administration, on an unknown date in 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. On an unknown date in 2021, patient experienced fever. The clinical outcome of the event fever: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Patient reports having severe arthritis. Specifically reports pain and stiffness in the hands and knees. Patient reports that the pain and stiffness is worse in the morning, but decreases with activity.
Nauseous; Stomach upset; Vomiting; Diarrhea; Chills; An allergic reaction to the Covid-19 vaccine; Had sore arm; was very cold; generally didn't feel well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had an allergic reaction to the Covid-19 vaccine. After the injection, injection was still fine but after the injection later in day, the patient had a sore arm  on 05Jan2021 and next morning on 06Jan2021 felt kind of nauseous, her stomach was upset, then started vomiting then had diarrhea at the same time and then started getting chills. She was very cold, chills were come in waves, it were come and go she had to get in bed and cover up with blanket to keep warm and she just generally didn't feel well. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient likely caught COVID after vaccine; Patient likely caught COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient likely caught COVID after vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Admission Date: 3/12/2023 Discharge Date: 03/23/2023   PRESENTING PROBLEM: Lethargy and Weakness   HOSPITAL COURSE: Patient is an 85-year-old female who was admitted on 03/12/2023 for acute weakness, lethargy, confusion for few days prior.  Patient was found to be COVID-19 positive and had a UA consistent with urinary tract infection.  Patient's diuretics were held and she was rehydrated, started on Rocephin from 3/12-3/15 though urine culture showed mixed flora consistent with contamination.  Believe metabolic encephalopathy secondary to COVID-19.  Patient improved 48 hours later.  PT/OT worked with the patient and recommending subacute rehab for deconditioning.  Placement was found patient has been medically stable.  Only changes to chronic disease management is Lasix reduced from 40 mg to 20 mg and subtherapeutic INR levels pharmacy recommended increasing warfarin dosing on Monday Wednesdays and Fridays from 0.5 mg to 1 mg.
Rash started on 7/23/11 - on the back, gradually spread to all over the body. Palms & soles spared. Hx MMR, Varicella administered on 7/14/11. No other symptoms. Rash appeared erythematous morbilliform, papular about 2-3 mm to 7-8 mm in size. Child well appearing.
Sudden chills.  Cold as I've ever been.  Could not move until I could get over shock of cold.  Headache, dizziness, disoriented.  Next day, fatigued,  Used car and ran into wall of garage.  Not alert.  Overall feeling bad.
patient recieved varicella on 5/28/08 called the office the next day re; pain,swelling and redness at injection site. pt was seen on 5/30/2008 by N.P and diagnosed with localized reaction to varicella. area noted by practitioner to be erythamatus with small knot about quarter size in middle. advised cool compresses to site and benedryl 25mg q6hrs
arm feels sore and heavy; arm feels sore and heavy; This is a spontaneous report from a contactable nurse (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that arm felt sore and heavy on an unspecified date after vaccination. The outcome was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
2/15/2022 11:29 AM by RISK,RDE. A 27 year old female that presents today for initial visit to get established . Today she complains of having chest pain that feels it is inside and more towards the back of the upper chest x 2 - 3 months. This gets exacerbated with deep breathing. She believes this first started after she got her first pfizer covid vaccine on 11/12/2021. She felt a pain in her L hand right away for a few seconds when she was getting the vaccine in the L arm. She remained sore at the injection site. After 3 weeks from the vaccine she started to feel intermittent L sided chest pain, L upper arm pain and L hand pain that comes on independent of each other. Laying on either side and deep breathing  triggers the pain.  No associated shortness of breath no cough no wheezing. No fever no chills. No N/V/D, no abdominal pain.
"I thought the nurse put a wad of cotton under my bandaid until I looked at my site and realized I had a 4 cm hematoma.  Hematoma lasted from 10/8/13 until 10/19/13.  My arm is still sore but I didn't have any other symtpoms or difficutly using my arm. I don't bruise easily."
Patient received a booster dose only 2 months after completely their primary series instead of 5 months.
This spontaneous report was received from a physician referring to a 28 year old female patient with an allergy to aspirin. The patient's medical history included urticaria. Concomitant therapies included unspecified birth control pills. On an unknown date, the patient was vaccinated with VARIVAX for prevention of chicken pox (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, 20 min after vaccination the patient developed hives on both arms. The patient self-medicated with BENADRYL and the hives resolved within 24 hours. The patient was seen at the physician's office 10 days after receiving the vaccine and presented with induration and erythema at the injection site. The physician did not specify if treatment was provided. No studies or laboratory tests were performed to the patient. The outcome of induration and erythema at the injection site was reported as not recovered. Causality assessment was not provided.
Body rash all over, 3 area's look like ring worms, swollen area; fever 101.6 also cold, flu like sx went to MD for cold sx;
Prolonged pain, swelling in muscle where   injection given (7 days) affecting  ability to move arm without pain
3 days p/vax devel several red, raised spots on both forearms near elbows;s/in 8hr those spots became larger-hive like several hr later devel full body rash;taken to ER;
Both doses of Pfizer COVID vaccine. On IUD no periods prior after vax, period back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication was not reported. The patient previously took dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced both doses of pfizer covid vaccine. on IUD (Intrauterine device) no periods prior after vax, period back on an unspecified date (Patient on IUD - not normal to have any menstrual bleeding) (Event took place after use of product). Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
RIGHT RING FINGER SWOLLEN; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced right ring finger swollen. Treatment medications included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right ring finger swollen. This report was non-serious.
Patient reported that she had experienced fever, headache, joint pain, pain and redness and injection site along with feeling "foggy" shortly after receiving the first Moderna vaccine dose.  These symptoms lasted for 5 days.
Information has been received from a registered nurse concerning a 74 year old male patient with hypothyroidism and asthma, a history of deep vein thrombosis and no drug reactions/allergies, who on 30-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (Lot number 664669/0152Z). Concomitant therapy included levothyroxine, MOTRIN, SPIRIVA and COUMADIN. The nurse reported that on 25-FEB-2011 the patient broke out in shingles in the right side of the face and in the right eye. Acyclovir was given as a treatment for the experience. On 06-APR-2011 the patient recovered from shingles. The patient sought unspecified medical attention. Additional information has been requested.
Ran a fever for 18 hours. It was 103 degrees for the first 12 hours, then dropped to 101. Had body aches including an ear and head ache. My blood pressure went up to 159/60. I was very tired and thirsty all day.
ADACEL was given to a 6 year old patient, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a six-year-old male patient who was vaccinated with a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6321AA and expiry date: 07-Jun-2021) via an unknown route in the left vastus lateralis for prophylactic vaccination on 08-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of this report, No symptoms reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Pt recvd vax 23JUL92 & later that day exp dizziness & arm soreness which persisted for 3 wks; pt later recovered; No further details were provided;
2:20 pm, Co dizziness and diaphoresis. Immediately evaluated by onsite EMS and NP 2:22pm - VS 120/75; P 70; Sats 99  on RA Provided cool water and a breakfast/cereal bar.  Patient stated symptoms had passed. 2:35 pm- BP 125/78/p 73 - Sats 99%n RA
Severe swelling from shoulder to forearm. Red color flesh shoulder to elbow. Inability to raise arm for 5 days. Extreme pain/tenderness, chills, dizziness, extreme fear by me and my loved ones. I have been previously hospitalized with pneumonia. I have been advised that due to this event my vaccine is less efficacious.
Patient started with a headache, sore left arm, some nausea, low grade fever of 99.5 Friday evening. Patient is still having these issue when he came at this time. Site don't feel hot or warm to the touch. No change in color or site in his arm. we let him know to use cool packs on his arm for pain and Tylenol also for pain.
07/26/2010 MILD. Other.  A rash all over occurred 1 hr after getting the vaccines.
Within 12 mins of receiving the first vaccine I started to swell in the right cheek and right eye and my blood pressure was elevated.  They did monitor me at the vaccine site and gave me Benadryl and monitored me.   Within in an hour my lower jaw started to swell and itch.  I was taken to the Hospital, they decided to give me an IV of Benadryl, and steroid.  They decided to discharge me when my blood pressure went down.  I few days after I started to develop cold sores around my mouth and in my nasal cavity.  The doctor decided to prescribe me medicine that treats shingles. I continued to feel tired and not myself.
redness & swelling @ inj site lt deltoid induration, redness, swelling in lt forearm;6-8 inches 15hr p/vax;tx w/med;
pt recv vax 1997 & inadvertently was vaccinated w/2nd dose of pneumococcal vax in JAN98;JAN97 pt exp high fever, acute pain, n/v;pt has been in & out of hosp;also noted that events all cycle;
Redness at injection site, first noticed on 01/16 over a week after vaccine was received. Over the course of 01/16, the red patch grew from being a little larger than a quarter to being the size of my fist. The skin is not bumpy and the texture is not changed but it is red and warm. I have not noticed any other symptoms so far.
No additional adverse effects reported; administered intramuscularly instead of subcutaneously; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.   On 13-AUG-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA, lot # S021622, expiration date 09-JAN-2021 (dose, strength and anatomical location were not reported) intramuscularly instead of subcutaneously, for prophylaxis. No additional adverse effects were reported.
On 11/3/11...lethargic and sore.  On 11/4/11, still lethargic and general malaise with the beginning of a terrible headache and nausea which became vomiting around 5 PM.