chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received her booster dose (dose#3) on Thursday 12/2/21 around 4pm with no issues. Starting the following morning (Friday 12/3/21) she noticed her arm feeling more sore. By Friday evening, her arm was starting to swell and feel not. It has continued and into today (Saturday 12/4/21). Pt reported this to pharmacy at 6pm 12/4/21 and describes a swollen and sore area that is about 3"x3" on her deltoid. Says it is tender and feels hot to the touch. She does not have itching or swelling in any other areas. Recommended that she take some tylenol/ibuprofen and ice the area, and to follow up with a doctor tomorrow if it does not start to improve or if it worsens.
stage one kidney cancer; had aspiration pneumonia; she went in the hospital for throwing up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (Pfizer covid vaccine first dose: 28Feb2021, Lot: EN6203, Expiration: unknown, NDC: unknown), administration date: 28Feb2021, when the patient was 59-year-old, for COVID-19 immunization; bnt162b2 (Pfizer covid vaccine second dose: 21Mar2021, Lot: EN6208, Expiration: possibly Jun 2021, NDC: unknown), administration date: 21Mar2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: PNEUMONIA ASPIRATION (hospitalization, medically significant) with onset 01Feb2023, outcome "unknown", described as "had aspiration pneumonia"; VOMITING (hospitalization) with onset 01Feb2023, outcome "unknown", described as "she went in the hospital for throwing up"; RENAL CANCER STAGE I (hospitalization, medically significant) with onset 01Feb2023, outcome "unknown", described as "stage one kidney cancer". The patient was hospitalized for renal cancer stage i, pneumonia aspiration, vomiting (start date: 2023). The event "stage one kidney cancer" required physician office visit. It was reported that the patient had kidney cancer, removed 10% of her left kidney. She went in the hospital for throwing up and had aspiration pneumonia and they found a spot on her kidney. She went to a urologist and urologist told her she needed an MRI. Spot was more than 4cm and it needed to come out and was found to be stage one kidney cancer. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging (2023): Spot was more than 4cm, notes: it needed to come out and was found to be stage one kidney cancer. Therapeutic measures were taken as a result of renal cancer stage i, pneumonia aspiration, vomiting.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306764 Same patient, same product, different event, different dose;
Pt said felt lightheaded, severe weakness joint, muscle and pain. Had headache. Felt chills, but did not take temperature.
This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 50-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix with an associated reaction of therapy non-responder (completed 3 dose series as dose 3 in May 2nd 2020, dose 2 in Nov 27 2019 and dose 1 in Oct 30 2019, for tolerance refer case US2022000443). Concomitant products included HEPATITIS A VACCINE, HEPATITIS B VACCINE (TWINRIX). On 22nd December 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years. To the same patient, nurse administered Twinrix 2nd time 12 days apart between Dose 1 and Dose 2, which led to shortening of vaccination schedule. The reporter consented to follow up.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-APR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 2556, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient was seen in ER 05/23/18 and reported weakness, shortness of breath, and headache. Office Visit on 05/25/2018: Patient was seen in the ER on Wednesday for weakness, syncope and 2 episodes of collapse reported prior to arrival. She believes this is from her PREVNAR vaccine that was received during her diabetic appointment on Monday.
This is an observational study case, initially received on 19-Oct-2018, concerning a 23-year-old, pregnant female, subject of body mass index: 50.1, weight: 285 pounds and height: 63 inches, enrolled in a prospective observational safety study. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject's obstetrical history included one previous pregnancy, with preterm live birth and no birth defects were reported. The subject's last menstrual period date was 04-Jan-2018. The subject's historical conditions included vaginitis (from 01-Mar-2018 to 05-Mar-2018), Candidiasis, gonorrhoea and vulvovaginitis (unspecified date in Mar-2018). The subject's historical drug included METROGEL for vaginitis, DIFLUCAN for candidiasis, Azithromycin for vulvovaginitis and Ceftriaxone sodium for gonorrhoea. The subject's current condition included sickle cell trait (from 22-Feb-2018), nausea (from 22-Feb-2018), pre-eclampsia (from 15-Mar-2018) and cholelithiasis (from 02-Sep-2018). The subject's concomitant medications included Prenatal vitamins for pregnancy and DICLEGIS for nausea. The subject didn't use tobacco, alcohol or illicit drugs during pregnancy. On 22-Feb-2018, the subject underwent prenatal fibrosis mutation analysis test, spinal muscular atrophy screen test and 24 hour urine test; no major congenital malformation noted. On the same day, Hgb (haemoglobin) electrophoresis test performed showed sickle cell trait, which was considered as major structural or chromosomal congenital malformation. On 01-Mar-2018, the subject underwent prenatal test (ultrasound) which showed no major congenital malformation noted. On 09-May-2018, the prenatal advanced trisomy test, ultrasound test and MSAFP (maternal serum alpha-fetoprotein)/ serum markers performed showed no major congenital malformation noted. The prenatal ultrasound tests were repeated on 14-May-2018, 06-Jun-2018, 05-Sep-2018, 19-Sep-2018, the subject underwent prenatal ultrasound tests and no major congenital malformation noted. On 11-Oct-2018, the pregnant subject (38 week and 5 days of gestation period) was administered Flu vaccine cell subunit QIV NVD (batch number: 252664, dose, route of administration, anatomical location and expiry date: not reported). On an unspecified date in 2018, the subject had dysmature placenta. 39 week and one day of gestation period the subject gave live birth to a female baby (singleton) with body weight: 2863 grams, head circumference: 33.7 cm and length: 48.9 cm through Caesarean section. The APGAR (appearance, pulse, grimace, activity, and respiration) score at one minute was 8, at five minutes 9 and no data at 10 minutes. The outcome of the event was not reported. The subject's estimated date of delivery was reported as 21-Oct-2018.
fever/back of his head & low grade fever of 100F; development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head; got his  3rd/booster dose; got his  3rd/booster dose; low energy; flu-like symptoms; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 02Sep2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation. Historical vaccine included bnt162b2 (COMIRNATY) as dose 2 for covid-19 immunisation .The patient experienced got his 3rd/booster dose (off label use) (extra dose administered) on 02Sep2021, fever/back of his head & low grade fever of 100f on 16Sep2021 , low energy, flu-like symptoms in Sep2021, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head on 16Sep2021. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on 16Sep2021. 2448-hour post-vaccination- development of fever, low energy, and almost flu-like symptoms. Lasted 2-3 days then went away. >Approximately 2 weeks after (Starting 16Sep) up until today- development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head & low-grade fever of 100F. In line with this, caller would like to know if there were any reports similar to his experience specifically on the painful lymph nodes and its development 2 weeks after vaccination. The outcome of the events fever/back of his head & low-grade fever of 100F, development of lymph nodes on his left side, same side where he got the vaccine- characterized to be very painful like someone punched him on the back of his head was not recovered. The outcome of the event low energy, flu-like symptoms, was recovered in Sep2021.  The lot number for BNT162B2 was not provided and will be request during follow-up.
First symptoms was my left arm where flu shot was given, began to be very sore days later. Continued throughout the whole arm and my hand, wrist and fingers. Then my neck started to be stiff and sore. Then my right arm was stiff and sore. This eventually grew to my legs, knees, and angles.  Primary Doctor gave me physical and suggested I see a Rheumatologist. In January after this Dr. took extensive blood work. It was determined I had Auto Immune Disease which will eventually become Rheumatoid Arthritis. Was healthy before October 9th, 2008.  Ankles and left hand still swollen and knee joints are painful.  4/6/09 Received Rheum medical records of 12/17/08-3/29/2009. FINAL DX: undifferentiated connective tissue disease, likely seronegative inflammatory polyarthritis, fibromyalgia syndrome Records reveal patient experienced neck, leg & arm pain since 11/2008.  Neuro consult done 12/17/08 dx w/C5-6 DDD.  Referred to PT & MRI.  Referred to Rheum for fibromyalgia 12/08 & tx w/meds.  Rheum 2nd opinion 1/22/09 for polyarthritis unimproved w/meds revealed active synovitis.  Tx w/steroids & recommended plaquenil although pt declined.    6/9/09 Medical records recieved DOS 12/21/07 to 2/26/09. FINAL DIAGNOSIS: Inflammatory polyarthritis. Post vaccination patient presented with left arm and shoulder pain, neck pain. Hand, thumb, wrist pain, weakness. Knee pain. Sent for rheumatology consult.
balding; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 19:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 27Mar2021 at 15:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient had medical history that was unspecified and has known allergies. The patient received other medications within 2 weeks of vaccination that were unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination the patient had been tested for COVID-19. The patient had undergone COVID-19 test on 08Mar2021, and was tested negative. On 17Mar2021, may be 2 weeks after the first COVID-19 vaccine, the patient noticed when combing her hair, that she started to see a comb full of hair instead of few strands, and hair in the top was gone as patient was balding. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event balding was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Received vaccines on 10/6/22 at approx 10:20 am at office. That night at approx 1:00am was noted to have generalized tonic clonic seizure lasting 1 minute. No prior hx of seizures. Per mother, EMS called and pt evaluated at hospital, where per mother's report, the patient was febrile (no documentation of fever available to me). Subsequently returned to baseline neurologic status and discharged. Presented to urgent care on evening of 10/7/22 for follow up, which is where I was the examining physician. Physical exam normal. VAERS report submitted by me, unknown whether also submitted by hospital.
Information has been received from a physician concerning a 7 year old patient who in 2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). In 2007, the patient developed chickenpox with lesions all over the body 6 weeks after the second dose. Unspecified medical attention was sought. No lab diagnostic studies were performed. On approximately 24-AUG-2007 the patient recovered. There was no product quality complaint. Additional information has been requested.
TIREDNESS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included leg pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included meloxicam for leg pain. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness. This report was non-serious.
A medical assistant states that an improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant Human albumin (rHA(PROQUAD) (strength, route, dose, frequency, and anatomical location were unknown) with lot # S031702 and expiration date for prophylaxis.         The administered dose of vaccine experienced the temperature excursion of 32.7 °F degrees Fahrenheit for 4 hours. There was a digital data logger invloved, but there was no previous temperature excursion. No additional adverse effects reported.
Case number PHEH2014US002265 is an initial spontaneous report received from a pharmacist on 29 Jan 2014: This report refers to a male patient of unknown age. He was vaccinated with FLUVIRIN (batch number: 1309301 and expiry date: Apr 2014) intramuscularly at a dose of 0.5 ml on 19 Jan 2014. Pharmacist reported that FLUVIRIN was stored improperly. Opened and unopened multi dose vials of FLUVIRIN had reached 20 degree Fahrenheit for 12 to 18 hours. Pharmacist did not know if the vaccine had frozen during the excursion. No adverse event was reported following this administration error.
Pt felt sick & slept very soundly 12JUN90-evening p/receiving immun; there was no fever & felt fine the next day, on 18JUN felt a bug like bite @ inject site; Area became red, swollen & warm 3" in diameter lasting 10 minutes;
Pt 2 days later with redness swelling of (R) thigh, knee. On 24 hours later crawling, then by aft walking. Then mom noted redness, swelling brought in no T, no V no whz.
One week after receiving vaccine, patient began having "IBS" like symptoms with alternating constipation and diarrhea that has not resolved.  Patient has also had abnormal periods.  Her period ended 5 days before the vaccine and then returned 1 week after the vaccine. since receiving the vaccine she has had spotting for several days between periods.
On the 7th day of nausea, vomiting, diarrhea, headache, sore throat
After receiving the HPV vaccine, the patient experienced brief period of dizziness and was told to lie down on the exam room table. Patient had a brief episode of unconsciousness but remained on the table as her mother was standing by her. Vitals were done and blood sugar was taken. After 2-3 minutes the patient sat up and new set of vitals and blood sugar were done. Patient became fully alert and oriented. Vital signs stable. She states she had not eaten anything for breakfast this morning. After a few more minutes, patient states she felt much better. Her mother was in the room with her. Explained to patient's mother that dizziness can sometimes happen after administration of Gardasil vaccine and to contact her if anything changes. Patient's mother agreed, they decided to go home afterwards.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitants was provided.
swelling of left leg specifically left calf noted by family shortly after vaccine was administered (Dad states next day and mom states about a week later).  Seen in office for problem 2/17/23 and in ER 2/18/23
has an auto-immune disease, involving her thyroid; This is a spontaneous report from a Pfizer sponsored program support via a contactable pharmacist. A 18-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 18-year-old) as 1 ST DOSE, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced that she has an auto-immune disease, involving her thyroid. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Autoimmune Thyroid Disorder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient called and reported symptoms following morning that started during the night - vomiting, HR = 130, weakness, temp greater than 100. Pt. was advised to go to the ER.
Information has been received from a female nurse of unknown age via a company representative referring to herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had redness and a rash near the injection site. The outcome of the events was unknown.The causality between the event and PNEUMOVAX 23)was not reported.
I felt degraded right arm fine motor movement from Sunday till this morning. I am almost normal now but this was odd that i felt lack of sensation in arm (right where as shot was given in left) - as i work in technology i felt that i was not able to type properly, my brain was telling to type correctly but fingers were not. Very strange feeling for a day.
Pt was having a syncope episode about 5 minutes after the vaccination. Mother states that he hates needles.
mom in clinic 2MAR93 for 2nd shots; states p/1st shot pt ran temp >102 & leg was swollen w/lump in it; pt taken to MD; MD felt pt should recvd Dt from now on & ok to give HIB;
p/vax pt exp varicella like rash w/less than 5 lesions noted;the reporting MD did not consider pt rxn r/t vax;
After about 2 and a half hours, right side neck lymph node swelled up -also pain & tingling in right arm-both lasted 2 days. I got the shot on my right side. Also got a headache & fever the first night,
Arm swelled (welts), burning, hot to touch, ache under arm, redness & swelling traveled up & down arm. Emergency room visit, received cefuroxime Axetil.
p/vax pt devel breakthrough chickenpox;it was noted that pt md was notified of varicella rash via phone call;rash was verified by MD:
3 months after my 2nd vaccine I started getting headaches. They were just in the front and temples at 1st but soon became ALL over my head, including the back where your head hits the pillow. They got more and more intense. They got even worse after my booster shot, serious every day non-stop pain. I went to every type of doctor to determine the cause: ENT, Allergist, Cardiologist, Dentist, Oral Surgeon, PCP, Orthopedist, Neurologist. I had blood work for everything, also a head Cat scan, neck and brain MRI?s and nothing was found. I was given migraine injections which did nothing for the pain, I was taken off some medications which, again, did nothing for the pain even after being off them 60 days and longer. Finally, I was given Botox injections all over my head and neck which almost completely removed the headaches for 30 days, but I still had pain in the back of the head where your head hits the pillow. I?ve NEVER had headaches like this before. No one could can them.
Subsequent to receiving vax, pt experienced crying, irritability and loss of appetite from evening of vax which lasted three days. Pt seen in ER on 01/25/2001 for persistent screaming and loss of appetite. Seen in office 01/26/2001 for irritability.