chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MEDICATION CAME OUT OF BASE OF NEEDLE; INAPPROPRIATE ADMINISTRATION; MEDICATION RAN DOWN THE PATIENT'S ARM; SYRINGE SYSTEM USED FOR VACCINE ADMINISTRATION WAS DEFECTIVE; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609, G200714 and expiry: 09-JUN-2021) 0.5 ml, administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced medication came out of base of needle. On 23-MAR-2021, the subject experienced inappropriate administration. On 23-MAR-2021, the subject experienced medication ran down the subject's arm. On 23-MAR-2021, the subject experienced syringe system used for vaccine administration was defective. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from medication came out of base of needle, and the outcome of inappropriate administration, medication ran down the patient's arm and syringe system used for vaccine administration was defective was not reported. This report was non-serious.
Patient is experiencing pain in her left shoulder and has been since receiving her flu shot six weeks ago. She has seen her doctor and received an ultrasound, however the pain has not resolved.
Patient developed fever of 101 degrees.  We had to take her to the doctor 5 times over the course of April 2015 - June 8, 2015.  Visit 1 she developed an ear infection and fever, visit 2 was pink eye and fever, visit 3 was a virus and fever, vist 4 was a virus, rash, and fever, doctor's visit 5 was another ear infection and fever.
Nausea; High fever 101; Mussel aches; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200], as first dose via an unspecified route of administration, in left arm on 14Mar2021 at 01:00 AM (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient's medical history included diabetic, ulcerative colitis and non alcoholic steatohepatitis (NASH) also the patient was allergic to Morifine. The patient was diagnosed with COVID-19 prior to vaccination. The patient received prescribed medicines (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021, the patient experienced high fever 101, muscle aches (reported as mussel aches) and nausea. The patient did not receive any treatment for the reported events. The clinical outcome of the events high fever 101, muscle aches and nausea were resolved with sequelae. No follow-up attempts are needed. No further information is expected.
A little more than 5 hours after vaccination, patient experienced symptomatic hypoglycemia with a Blood Sugar reading of 48 after eating 1/2 candy bar and drinking gatorade.  She took a nap (knowing that what she had just consumed would increase her blood sugar) and woke up feeling better.  She ate dinner, and her blood sugar afterwards was elevated at 397.  She noted that this drop in blood sugar following the vaccine happened with the first dose as well, though she never reported it (symptomatic hypoglycemia with a blood sugar reading of 46).
Booster shot of Moderna COVID-19 vaccine caused some fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's other relevant history was not reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Daily Dose: CF, Solution for injection in prefilled pen. On an unknown date, the patient experienced FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue). At the time of the report, FATIGUE (Booster shot of Moderna COVID-19 vaccine caused some fatigue) outcome was unknown.            Concomitant Drugs were not reported.  The patient had received booster dose of COVID-19 vaccine manufactured by Moderna and experienced some fatigue.  The reporter's causality for the event Booster shot of Moderna COVID-19 vaccine caused some fatigue with HUMIRA(Adalimumab) drug was no reasonable possibility.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This case was reported by a nurse and described the occurrence of pain in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. The subject had received an unspecified number of immunizations of influenza virus vaccine (manufacturer unknown) in previous years with no adverse events following receipt of the immunization. On 05 January 2006 the subject received a dose of Fluarix in the right arm (lot AFLUA154AA). Approximately 12 hours later, on 05 January 2006, the subject experienced pain in the arm and the neck. The subject was seen at a physician's office. At the time of initial reporting, the event was ongoing. The nurse considered the event to probably be related to vaccination with Fluarix.
Have swelling of Lymph Nodes; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunisation. The patient's medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, losartan, and amlodipine for hypertension. The patient experienced swelling of lymph nodes on 15Jan2021. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
Developed pain in left shoulder/upper arm, rashes, and myalgias following injection of the vaccine in the left deltoid. This was the first time she received this shot. Methylprednisolone 125 mg once, prednisone 60x3, 50x3, 40x3, 30x3, 20x3, 10x3 mg every day.
She developed nausea, vomiting that has persisted from 2/11/21 (first visit to see me) until today 3/4/2021 (second visit)
Patient developed Bells Palsy (R) side about 21 day after the vaccination with HPV.
Multiple seizures, shaking, nausea, stiffness, black outs, dizziness, lethargic.
Information has been received from a physician concerning a 76 year old male who on 09-MAR-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#656608/0032U).  Subsequently the patient developed paresthesias.  Unspecified medical attention was sought.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested.
Patient here with parent. patient's parent provides consent for patient to receive COVID vaccine today.  Pt given Pfizer vaccine ped dose 0.2 ml/10mcg , Left deltoid, in error, pt should have rec'd Pfizer 0.3ml/30 mcg instead based on his age of 12 yrs. health officer notified and she  recommended that pt be offered full dose of vaccine in 3 wks with  parent's consent. If parent declines additional dose pt should have adequate immune response. Attempted to reach parent x 2, left VM w/ PHN cell phone w/ call back to discuss options.
malaise/non-specific onset w/in 24hr of vax;resolved w/in a week;
The spontaneous report has been received from a nurse practitioner concerning a female patient of 60 years. The patient's medical history, concurrent diseases and concomitant medications were not provided. The patient received FLUMIST quadrivalent (intranasal) on 12-Oct-2014. The patient was administered FLUMIST quadrivalent on 12-Oct-2014 and had the flu on 13-Jan-2015. The outcome of the event of patient administered FLUMIST quadrivalent on 12Oct14 and has the flu on Jan13 was unknown. The reporter assessed the event patient administered FLUMIST quadrivalent on 12Oct14 and has the flu on Jan13 to be non serious.
Shortly after receiving the shot I could feel the vaccine moving from my left arm toward my back and up the left side of my neck. My left jaw began to have a stinging feeling and I experienced pain. The next day my left jaw remained a tolerable pain, and late that evening I felt a pain behind my left ear. Currently, the pain comes and goes and my health insurance company recommended I go to an urgent care facility.
Information has been received from a registered nurse concerning a 10 year old white male who on 24 Nov 1999 was vaccinated subcutaneously with 0.5 ml first dose of Varivax (lot # 631168/0710J). On 13 Apr 2006 the patient developed a varicella rash on his back, buttocks and legs with a total of less than 50 lesions. He also had a fever. Unspecified medical attention was sought. Subsequently, it was reported that the patient recovered. No product quality complaint was involved. Follow up information indicated that on 13 Apr 2006, the patient presented with a rash on the back of both legs and buttocks. Less than 50 lesions were present. The outcome was recovered. Additional follow up information indicated that the reporter was not successful in finding any new information. Additional information is not expected.
This spontaneous report as received from a consumer refers to a 61 year old female patient with high blood pressure, atrial fibrillation, erythromycin allergy and rocephin allergy, reporting on herself. The patient's medical history included Myocardial Infarction. On 04-SEP-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route and lot number were not reported) for prevention of shingles. Concomitant therapies included Nexium, losartan potassium (manufacturer unknown), warfarin sodium (manufacturer unknown), atenolol (manufacturer unknown), ramipril (unspecified) and Tranxene. On 11-SEP-2013, the patient experienced headaches and had a rash-like redness at the injection site where she received ZOSTAVAX. The patient also experienced gum and mouth pain. The patient did not seek medical attention. The outcome of headaches, rash-like redness at the injection site, and gum and mouth pain, was not reported. The relationship between the ZOSTAVAX and the events was not reported. Additional information is not expected.
chronic kidney disease; the vial from the first dose was improperly stored; the vial from the first dose was improperly stored; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6199), via an unspecified route of administration on 12Mar2021 (at the age of 66years) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient wanted to know, what percentage does the Pfizer COVID vaccine first shot cover and how accurate it is. On 12Mar2021, the patient got his first Pfizer COVID vaccine. He was going through kidney and liver testing right now. He was diagnosed with chronic kidney disease 17Mar2021. He was in the process of getting his liver examined. He was wondering what percentage of protection he got from the first shot. On 03Apr2021, he was informed by his vaccination site that he needed to receive another dose because the vial from the first dose was improperly stored. He was told that he would have to take it over again. It was not a manufacturer error it was the pharmacy error. The pharmacy didn't refrigerate the vaccine properly. He got his second "first" shot on 06Apr2021. The vaccine that day had lot number EN6202. Then he was scheduled to get another shot. He is scheduled for his second (third) dose 27Apr2021. On 27Apr2021, he will be getting his 3rd shot (as reported). He stated has no idea what that first shot did to him or it had any effect good or bad. The outcome of events was unknown.
02/20/2021 woke up around 12:00AM with a severe headache, body aches, and chills. Took 1-2 Aleve and that seemed to relieve it and I was able to get back to sleep. Woke up the next morning still feeling fatigued and chills. Slept the majority of the day, with symptoms improving by evening time, and slept that night as well. 02/21/2021 I woke up feeling pretty much back to normal. 03/11/2021 I was working at my job as a receptionist. I answered the phone and it seemed as if I was hearing multiple voices and had a very difficult time hearing what the client was needing. I was using my left ear and would describe it as a tinny sound in my left ear. 03/15/2021 notified PCP that I had been experiencing tinny sound in left ear. I also let him know that I had an MRI with in the last 2 years, as I frequently get heartbeat sounds in left ear. MRI in 2019 was normal. PCP messaged and scheduled me that I had an appt the following day. 03/16/2021 Saw Dr. referred me to an ENT the following day. 03/16/2021 saw ENT and was scheduled for an MRI on 04/03/2021. PCP prescribed course of prednisone titrating off towards the end. MRI results were normal. Had audiology test 04/2022 with no lose in hearing.
Patient called pharmacy complaining of adverse effect from vaccine given the previous day SHINGRIX patient having whole body weakness and felt sleepy the whole day. Instructed patient to seek medical treatment right away. She said she will.
red inflammed, about 4 to 5 inches diameter. pt states hot to the touch and itchy. was painful first 2 days post-injection, now not painful just itch
brown and red discharge; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04May2021(at the age of 32-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient previously took first dose of Covid-19 Vaccine(Covid-19 vaccine-Manufacturer Unknown: Lot number-unknown) as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 21:00 the patient experienced brown and red discharge. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event brown and red discharge was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 6 minutes post vaccine, while in the observation area, patient had a vasovagal episode. He fell to the ground from the observation chair and immediately came to. Patient has small abrasion under right eye, some right shoulder pain. Prior to vaccination, patient disclosed fear of needles. Patient arrived around 2:30p initially, vaccinator prepared him to be vaccinated laying down on cot. Patient was nervous and decided to reschedule. Patient returned at 4pm and decided to receive vaccine. Patient did not want to be vaccinated laying down.   Patient refused EMS and refused to be evaluated by physician in Emergency Department and stated he would follow up with his physician.  Patient observed for extended period and released.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 15-JAN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # and expiry date not provided) dose 1 for vaccination. On 02-DEC-2013, the patient was vaccinated with the second dose of PNEUMOVAX23. No adverse event reported. Additional information is expected.
Absence of period; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Absence of period) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced AMENORRHOEA (Absence of period). At the time of the report, AMENORRHOEA (Absence of period) had not resolved.            Concomitant medications were not reported. Reportedly, the patient was not pregnant as she took a pregnancy test. Treatment details were not reported.   This case was linked to MOD-2021-062142 (Patient Link).
Patient received rotavirus vaccine at 6 months of age when child did not qualify for the vaccine. Child had never received a dose of rotavirus and was too old to receive it for the first time. Rotavirus should only be given to child before 15 weeks old. No symptoms or sign.
Client inadvertantly given 0.2mL of undiluted formulation of Pediatric Pfizer, resulting in higher than recommended dose being administered. Client had no adverse reaction for 30 minutes after vaccination while being observed by clinical staff. Doctor on call notified immediately, who recommended we tell parents and discuss increased risk of adverse reaction or side effects. Parent verbalized understanding and had no further questions or concerns.
Patient experienced an increase in blood pressure and dizziness that was not resolved as of 09/14/2020. Patient and wife contacted his physician who told them to contact the pharmacy.
Day 1 headache, fatigue  Day 2 fatigue, pain at injection site Day 7 bruise at injection site Day 8 swelling redness itching heat at injection site and itching/rash on front of the neck
it was rpt from territory representative concerning pt who was vax & subsequently devel diarrhea & vomiting;
29OCT began exp high fever, sweat, T103, feel dizzy, lightheaded, h/a, twinges in stomach, no appetite;
I work up with a sore throat on 06/26/2022 and did a home test and was COVID positive.
This spontaneous prospective pregnancy report as received from a 21 year old female consumer refers to herself. The patient had no pertinent medical history or drug reactions/allergies. On 10-JUN-2011 the patient was vaccinated with the first dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. On 02-SEP-2011 the patient was vaccinated with the second dose of GARDASIL (Lot# unspecified) dose, frequency, route and location unspecified. No concomitant medication was reported. The patient performed a "home pregnancy test" at an unspecified date after the second vaccination which showed that she was pregnant. LMP (Last Menstrual Period) was 31-JUL-2011 (estimated date) and EDD (estimated due date) was 06-MAY-2012 (estimated date). Trimester(s) of exposure were the first. No adverse effects were reported. No treatment was given for the event. The patient did not seek medical attention. Follow up information was received from a nurse. She indicated that per the patient's medical record, a history note taken on 17-JUN-2012 indicated that the patient had 3 prior pregnancies: in 2007, November 2010 and in December 2011. She reported that in December 2011, the patient experienced a 16 week spontaneous abortion. And the patient delivered a healthy baby at 39 weeks with no pregnancy complications on 18-FEB-2013 (which has been captured in MARRS 1403USA003044). Additional information has been requested.
SWOLLEN SUPRACLAVICULAR LYMPH NODE ON THE LEFT SIDE NECK AND MUSCULAR PAIN IN LEGS TWO IBUPROFEN EVERY NIGHT AT BED TIME FOR 5 NIGHTS.  TODAY IS DAY 29 -  LYMPH NODE IS STILL SWOLLEN BUT SIGNIFICANTLY SMALLER IN SIZE
Pain in LA after immunization. Diagnosed with rupture of supracromial bursa by orthopedist.
red bumps on face, fever 102 @ noc vomited; fever 103; diarrhea;
Day after shot upper back of arm red and raised with swelling, hot and itchy. Called pharmacy 2 days after shot. Came in 3 days after. More swelling and past elbow. Saw MD. Not skin infection.
Fever, headache, muscle ache, fatigue, arm soreness. Began about 12 hrs after vaccination and continued just over 24 hrs
pruritus, erythema and swelling of the deltoid at location of the Pneumovax shot.
This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored PNEUMOVAX23 injection (lot number L014876, expiry date 13-JAN-2017, strength, dose, frequency and route were not reported) (incorrect product storage). No adverse effect was reported. Product quality complaint was not involved. No further information was available. Additional information has been requested.
Initially for the first 3 days my arm hurt and was unable to do simple tasks.   Developed a delayed reaction to the vaccine 12 days after receiving  it.  Developed a rash that is approxiamently 3.5 inches wide by  5 inches in length.  It is dark in color and raised as well as itchy.  I am also experiencing tingling in my tongue and lips as well as feeling that my tongue is slightly swollen as well as my throat.   The rash is warm to the touch and slightly sensitive to touch as well, and is  giving off heat.  It has gotten slightly larger in the past 2 days.  I DO NOT have a fever. Monday evening started taking Allegra.  It helps to keep the reaction I am having in my mouth and the itchiness for about 12 hours
This spontaneous report was received from a female consumer of unknown age and refers to herself. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patient received two of the three necessary "shots"(doses) of GARDASIL (exact dose, route, anatomical location, lot# and expiry date unknown) for prophylaxis. Approximately on 23-MAY-2017, reported as "two weeks ago", she was due to receive the third shot (dose) of GARDASIL (exact dose, route, anatomical location, lot# and expiry date unknown) (inappropriate schedule of drug administration), however the hospital was now out of the vaccine (product availability issue). This report was just a precaution, if she does not receive the final dose. There was no Product Quality Complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Documented that 0.2 mg were administered and should have been 0.3 ml administered.