chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kidney stone, last time he had one was in Jul or Aug2021; Hives/raised bumps on his arms and front chest; being itches/itching shortly after each dose; These bumps are turning into hard skin cells; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on Jun2021 (around noon to 1300) at age of 65 years old as single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient got the Pfizer shot twice, first shot was in mid Jun and the second shot was around Sep2021. He ended up with some type of hives or raised bumps on his arms and front chest after both doses. These bumps were turning into hard skin cells, didn't know how to explain them. He went to the dermatologist and they took biopsies of the ones on his arms. He did not know if it was covid vaccine related but both times it happened within a couple of days of getting the shots. It first started as being itches/itching shortly after each dose and now his skin cells were all hardening up on his arm. He went to urgent care to ask for something to stop the itches and he was given a prescription for Triamcinolone Cream. He stopped at a dermatologist and they were dumbfounded as to what it was and were concerned about the lumps. He asked if there was any connection with the bumps and the covid shot and dermatologist stated she had not seen that before. However, he talked to the pharmacist when he went to pick up the ointment and they told him that they had heard of this happening. He was now on a tapered dose of prednisone and he will try different ointments, he thought one was called clobetasol. He just took his last prednisone. He was left handed. He may have gone to ER after the first dose since he was opening up his bill and it said he was in the ER in June. Confirmed he was not admitted. He only went to ER for kidney stone or something else and he was not having a kidney stone in June. Events resulted in visit to Physician Office: dermatologist and urgent care. The patient had kidney stone, last time he had one was in Jul or Aug2021. When asked did he have to worry about these hard skin lesions, the patient stated he was probably not using the correct term by calling them lesions but his skin was scaly and hard and growing up and down his arm and were now up to his shoulder. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have been diagnosed with serve migraine headaches now.  So are worst then others.  I stay in contact with my doctor.  I get a shot each month for the headaches.  The headaches make my neck and shoulder hurts.  These symptoms have been going on since the first shot and has gotten worst since the second shot.
Information has been received from a registered nurse concerning a female who on 16-FEB-2007 was vaccinated with her first dose of Gardasil (lot# 654702-0011U). Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). Subsequently the patient experienced depigmentation at the right deltoid injection site. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Rash to head and neck 2 hours after vaccines which lasted about an hour, then went away.  Father of baby said 2 small red dots appeared again same night then went away quickly.
felt funny and clarifies it was a sensation in his body that something was going on.; His left hand was tingly for a day and a half; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.), PARAESTHESIA (His left hand was tingly for a day and a half), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.), PARAESTHESIA (His left hand was tingly for a day and a half), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 24-Jan-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.) and FATIGUE (Fatigue) outcome was unknown and PARAESTHESIA (His left hand was tingly for a day and a half) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator
Headache,dizziness, sob, chest pain, nausea, vomiting, fever, muscle and joint pain.
This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included hip replacement (right hip). On 27th March 2019, the patient received SHINGRIX (intramuscular). On 28th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved. It was unknown if the reporter considered the pain in hip to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The pharmacy did not provide lot number. The patient experienced right hip pain, 24 hours after receiving SHINGRIX in left arm. The reporter did not consent to follow-up.
Patient complains of swelling at site of injection. stomach cramping and headache. Swelling at site of injection approximately the size of a nickel.
Patient recieved vaccine without any issues on 4/16/21. Patient walked to waiting area with pharmacist, was not having any issues or concerns, and was observed for several minutes by the RPH. Approximately 5 minutes after receiving the COVID-19 shot, the patient passed out, fell out of his chair, and hit his head. The patient immediately regained concousness and sat back in his chair. The RPH immediately had a pharmacy associate call 911 and observed the patient. Patient stated he felt a liquid tingle go down his arm from where he received his vaccine then passed out. Patient stated he had a headache and appeared clammy. RPH provided an instant ice pack and observed patient until EMS arrived. EMS provided care to patient and determined he did not need to go to the hospital. Patient was advised to go to hospital if he becomes nauseus. Patient claimed he was okay and just has a headache. Patient's mother took him home.
Nauseous; vomiting; fever of 101; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscularly administered in Arm Left on 19Apr2021 at 10:30 (Batch/Lot number was not reported) at the age of 32 years old as single dose for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination was methadone. The patient previously received the first dose of bnt162b2 intramuscularly on 29Mar2021 at 10:45 at the age of 32 years old in arm left for covid-19 immunisation and about 36 hours after the first dose the patient got extremely nauseous, diarrhea so bad she thought she was going to pass out. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Other. In Apr2021, about 36 hours after the second dose the patient got extremely nauseous. Second time was more vomiting and a fever of 101- this still happened 36 hours after injection (Apr2021). Treatment was not received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling, redness, itchiness, and heat with slight tenderness 3+ Inches surrounding the injection site that appeared 8 days post injection.  Slight reactions reported to v safe following the vaccine had gone away entirely. Doctor described the response as an immune response. Symptoms have not subsided since they began.
PATIENT IS 16 YEARS OLD, AND THE VACCINE IS NOT APPROVED FOR THE AGE
Arm is reddened and bruised with a "lump" no other s/s.
Idiopathic vasovagal reaction, lasted about 30 seconds. emergency response activated. Evaluated by EMS after and released with mother.
Chronic pain; lot of health issues; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect.   A contactable female patient with (unspecified age and unit) reported that she received first dose of  bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 22Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient just read from the fact sheet not to take pain medicines. On an unspecified date, the patient experienced a lot of health issues and chronic pain. Patient had taken tylenol and motrin for pain relievers 2 nights ago as treatment. She was asking if there was any timeframe where she can take the pain reliever safely. Cold transfer to  due to longer wait time (19 calls ahead). The outcome of the events lot of health issues and chronic pain was unknown.  Follow-up attempts are completed. No further information is expected.
red; swollen hard; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching). At the time of the report, ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
On 12/10/01, the pt developed a fever with max of 102F on 12/10, 12/11, 12/12/ and 12/13/01. She had a rash consistent with varicella on my exam on 12/12/01. The rash resolved by 12/14/01. No crusting.
Patient received her Moderna third dose; Arrhythmia; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 001B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received her Moderna third dose). In July 2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations). On 10-Jul-2021, EXTRA DOSE ADMINISTERED (Patient received her Moderna third dose) had resolved. At the time of the report, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (Heart palpitations) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. It is stated that patient experienced heart palpitations and arrhythmias a few weeks after her third vaccination.  It is stated that patient was lied and told the pharmacy that it was her first dose when she went for her third dose.  Company comment: This case concerns a  65-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred within a month after she received an Extra Dose (third dose) of mRNA-1273 (Moderna Covid-19 vaccine) under a pretense of first dose at the pharmacy. The rechallenge was not applicable as event occurred after the third dose. However, the extra dose administered remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: updated reporter details, updated patient demographics, added dose details.; Sender's Comments: This case concerns a  65-year-old, female patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred within a month after she received an Extra Dose (third dose) of mRNA-1273 (Moderna Covid-19 vaccine) under a pretense of first dose at the pharmacy. The rechallenge was not applicable as event occurred after the third dose. However, the extra dose administered remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
local redness, swelling; area warm to touch; redness from site of inject down to elbow-inner aspect of arm; advised cold compress to area & analgesic;
Information has been received from a licensed practical nurse concerning a female employee who in April 2003 was vaccinated with a first dose of varicella virus vaccine live (lot #643536/0801M). On 12-May-2003 the patient was vaccinated with a second dose of varicella virus vaccine live. On 03-Dec-2003 a titer was drawn and revealed that the client had failed to seroconvert. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. The nurse also reported another female employee who had a similar experience after therapy with varicella virus vaccine live (WAES #0312USA02283). Additional information has been requested.
Vaccines were given on 5/14/18 and mom called on 5/16 to state that pt's right leg is red, hardish, tender and has a bit of swelling. Informed mom a side effect to DTaP after 3 or 4 doses is swelling to arm or leg for 1-7 days. Mom denied pt being fussy or having fever. Informed mom to give it one more day, if symptoms get worse for her to bring in pt. Gave mom home care instructions of Ibuprofen or Acetaminophen for tenderness, and cool pack for leg. Advised mom of risk for infections so to monitor site and if worse to bring her in for evaluation. Mom verbalized understanding. Attempted several days in last weeks to f/u on pt, no answer, and unable to leave vm. On 6/4/18 Mom returned call and stated pt is doing better. Mom stated rash/swelling lasted about 5 days then it bruised for 2 more days. Mom stated she used ibuprofen and ice pack on leg.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M010480, expiration date 01-MAR-2018 and lot # M009766, expiration date 23-FEB-2018, (dose and route of administration were not reported) reconstituted with doses of properly stored sterile diluent (MERCK) (dose, lot number and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 6-14 degrees Fahrenheit for 9 hours and 15 minutes. Data logger was involved in recording of the temperature excursions. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1707USA005091.
2 weeks after receiving shingles vaccine, patient broke out in red rash on chest that progressively became worse (large, red, raised areas all across chest. The dermatologists determined patient had had an allergic reaction to shingles vaccine based on presentation and prescribed patient a prednisone. Patient still using prednisone taper started taper on 6/28/16.
09/03/21  The patient presents with SOB xPTA. Pt who is fully vaccinated is believed to have COVID-19 is experiencing SOB. Pt has a hx of a paralyzed right diaphragm and is on a nasal canula. Pt is currently feeling better after receiving a breathing treatment and denies V/N/D.  The onset was just prior to arrival.  The course/duration of symptoms is constant.  Degree at onset moderate.  Degree at present mild.  The Exacerbating factors is none.  The Relieving factors is beta-agonist.  Risk factors consist of Paralyzed right diaphragm.  Prior episodes: none.  Therapy today: oxygen.  Associated symptoms: denies chest pain, denies fever, denies chills, denies cough, denies nausea, denies vomiting, denies abdominal pain, denies back pain, denies weight gain and denies hemoptysis.
7/22 at 2 am, pt started c/o L breast tenderness.  That afternoon developed fever and was seen at urgent care and tested negative for covid.  Breast examined and was told to go immediately to ER.  At ER, was dx'ed with breast abscess with cellulitis and transferred via ambulance for admission and surgery, started on IV Clindamycin.  Surgery done on 7/24, drained 50 cc of pus.  Afebrile since surgery.  Dc'ed home on PO Clindamycin x 8 days. Pt denies any trauma to chest or skin lesions prior to infection.
The morning after, all my joints flared and tendons.  It hasn't stopped.  I waited 3 weeks and did 1 round of steroids (given by my pcp locally.  That briefly subsided and then I had seen my Rheumatologist because i still wasn't getting better and still had tendonitis on both achilles, post tibial, and SI joint inflammation with rt side sciatica.  All of which were under control prior to the vaccine.    He switched me to cosentyx and i had to do another round of steriods for the tendonitis and SI inflammation.    As of today 7/29/21, my Si inflammation is doing better, but my achilles and post tib tendonitis still has not resolved.
Information has been received from a licensed practical nurse concerning a 7 y/o white male with minimal reactive airway disease who on 30Sep1996 was vaccinated IM in the left thigh with a dose of varicella virus vaccine live. There was no listed illness at the time of vaccination. The reporter indicated that on 24Apr2003 the pt broke out with chickenpox. It was noted that the pt had greater than 50 lesions. Unspecified medical attention was sought. Follow up information has been received from the licensed practical nurse which indicated that on 25Apr2003 the pt came to the dr's office with a rash which started "yesterday". A physician diagnosed the rash as "probable varicella." The reporter also noted that there was no note in the chart that stated which route of administration was used. It was indicated that the patient recovered. There were no diagnostic tests or laboratory results. There were no adverse events following prior vaccination. No further information is expected. The reporter also noted that she has been seeing many cases of chickenpox in children who where previously vaccinated with a dose of varicella virus vaccine live.
Pt vaccinated with Engerix-B developed all over erythema like a sunburn, severe itching over arms chest legs, diffuse maculopapular rash, raised red & itchy rash.
lt deltoid, red, tender, swollen, fever of 100, rash 9.3cm; pt evaluated examined, DPH, Amoxicillin x 5 days & ice & APAP;
Fever 102 degrees, Headache, Weakness, Swelling and Hives/Welts from Shoulder under arm and on top to elbow, Painful, Basic Metabolic Panel (8), CBC w/differential, CBC w/differential w platelet, Urinalysis w/culture reflex.
She indicates it's been 11 years since she had a tetanus shot so she received Adacel today. The pt is a 39 year old woman here or discussion of a possible allergic reaction to her tetanus shot. She saw another doctor as a new pt on the 11th and received Adacel in the left deltoid. The following day she felt febrile and diffusely achy and then earlier today awoke with the addition of some swelling under her arm. She has never had a reaction like this before. Symptoms are not progressive at this time and involve no respiratory distress or throat congestion. Examination of her left deltoid region reveals no significant erythema. No palpable nodularity, although she is tender to palpation. Mild left axillary fullness as well as left epitrochlear fullness and discomfort with palpation. There is no streaking or cutaneous change noted. Adverse event following single dose Adacel vaccine on 4/11/06. She is currently stable and will improve with time. I did give her a sample of Clarinex 5mg one po daily for the next five days to see of that would help any of her symptoms improve. I review the Adacel package insert with her which did indicate 6 1/2% incident of lymph node selling, 9% incidence of sore and swollen joints and 21.9% incident of body ache or muscle weakness. Her reaction is consistent with these. I am not sure she should never receive another tetanus booster, but I would recommend pre-medicating with Benadryl and consideration should be given to premedicating with low-dose steroid.
w/in 2 hrs p/vax pt became very listless fever began about 8PM (low grade); 11PM fever was 105; cont throughout noc; emesis; had convuls;
Sudden swelling and itching at injection site (previously resolved), mouth bumps and itching, lip swelling and itching, hives on face
pt lied and said he was coming in for moderna dose #1. after checking databse, we noticed pt had already recieved prior moderna vaccines. pt was fine after today's vaccine and simply lied to us.
Patient is here with left upper abdominal pain and left chest pain that started last night.  Patient had his second MODERNA vaccine on May 20, 7 days ago, has not felt well since then.  Initially had muscle aches back pain fever or chills.  Reportedly stayed in the hot tub too long and he may have gotten dehydrated.  Patient had onset of left upper abdominal pain and left-sided chest pain last night.  He took some over-the-counter medications without any relief.  He has had a history of some stomach problems and IBS in the past but they usually resolve on their own.