chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed acute onset of widespread hyperpigmentation on dorsal aspect of bilateral forearms within an hours after vaccination.  No associated pain, edema, or discomfort.  The color change resolved gradually over the course of 3 days and has not recurred.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/ allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (Lot number, dose and route were not reported) that was stored in an unmonitored freezer and exposed to unknown temperatures for an unknown period of time. Vaccine was unsupported in the absence of temperature excursion details. No adverse symptoms reported. Approximately 15 doses of ZOSTAVAX were administered. This is one of several cases from the same reporter. Additional information has been expected.
pain at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc, Rheumatoid arthritis, Asthma and Blood pressure high. Concomitant products included LEFLUNOMIDE (ARAVA) for Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for an unknown indication.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  doctor recommended holding concomitant medication rheumatoid arthritis medication.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: TCR received on 15-Apr-2021 contains no new information.
2 hrs p/vax had swelling & redness of site; serum sickness type reaction; achiness & tiredness;
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 18-APR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Shortly after receiving zoster vaccine live (ZOSTAVAX) inoculation, pt suffered and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his 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; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered as not recovered. The causal relationship between shingles and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the event was considered as disabling.
pain in arm, fever of 102, not able to move arm; will not get up; pain in neck;
After I got the vaccine, within a day I ran a temperature a little over 100 degrees. I was fatigued and not feeling very well. I slept the next day. On the 17th of March 2021 I decided to do yard work outside. I came in after that and I sat on the couch. My heart started rattling in my chest. I have never experienced that before. I called my tele doctor and she said I need to go to ER and get seen as soon as possible. They confirmed that I did have A-FIB and my heart was beating at 140 beats per minute. I was given beta blockers but that didn't help so the doctors did a cardioversion on me twice to get my heart back on a normal rhythm. Since then I haven't had anymore events of A-FIB. I felt fatigued on and off for at least 3 months and I didn't have as much energy as I used to have. On April 7th I found out my PSA was high. It normally ran around 3, but it was at 8.3.
No other issues or concerns noted; a patient received a dose of MMRII that had expired; This spontaneous report as received from a medical assistant (also conflictingly referred to as "customer") refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), lot # S035356, expiry date 05-NOV-2021 (dose, route and anatomical location of administration were not reported) for prophylaxis (expired product administered). No other issues or concerns were noted (no adverse event).
Woke up 12/8 with severe pain in right upper arm, it got progressively worse with an hour of being awake that I was in tears. Felt like my muscle in my arm was twisting and burning and it would not stop. It?s been 3 weeks. I had Toradol injection,  dilaudid injection, morphine and Valium in the ER and still felt pain. I had 2 CT scans, MRI, ultrasound, blood work and angiogram. I cannot lay down with intensifying pain so I have sleep sitting up since 12/8. Will get a cervical epidural steroid injection in my neck on 1/4. I tried a cortisone shot in shoulder with short term minor relief and I?m taking Neurontin and Flexiril 3 times daily. Prednisone once daily, started at high dose and gradually reduced every 4 days, this helped but with medicine reduced, pain returned to severe unmanageable feeling and I?m taking Percocet as needed. MRI shows bulging disc that is compressing a nerve. All my consistent pain comes from my arm where the stuff was given. It?s been numb for almost 3 weeks as well. I do have ache in my neck at times and shoulder pain a lot, pain even radiates to my forearm at times. My upper arm is the worst however and it feels like a tight band is around my bicep.
The Patient is saying she started having jaw pain 3 days post vaccination.  She says the pain is like someone pulled her teeth out.  She is using excedrin to handle the pain. It's now 5 days post vaccination and she is still having pain.  I explained to the patient that it doesn't seem vaccine related, but that she should see a dentist to make sure.  She feels it is because nothing else in her life was different this week other than the covid vaccine.  I will check back with her later this week to see how she is and to see what her dentist said.
This case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site discoloration, fever and sickness. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the fever and sickness were recovered/resolved. The reporter considered the injection site discoloration, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm approximately 2 months ago from the date of reporting. The patient received both vaccines in the same arm and location. The patient developed a skin discoloration, the size smaller than a dime, at her injection site on her left upper arm after she received her 2nd dose of the SHINGRIX. The patient also states she developed a 102 degree F fever, was very sick but did not elaborate. The reporter did not consent to follow-up. No product quality complaint (PQC) was reported. The limited information was provided. The reporter was angry, did not want to provide further information, disconnected call prior to finishing safety report. Lab Comments: On an unknown date, body temperature was checked.
Progressively increasing heart rate overnight during sleep from 12/19-12/20 with highest heart rate measured at 156 and prolonged period of heart rate over 120 for 10+ minutes causing alert from Apple Watch.  Heart rate remained above 100 until later afternoon 12/20 and then down to 90s and 80s on 12/21.
Patient developed cellulitis surrounding injection site (erythema, warmth, and induration). Patient treated with ten day course of Clindamycin. Significant improvement within 24 hours after starting antibiotics.
Patient had syncopal episode while vaccine was being administer in sitting position.  Brief loss of consciousness.  Alert and oriented x4, vital signs taken.  BP 102/45, pulse 45.  100% oxygen saturation on room air.  No complaints of pain.
Information has been received from a physician concerning a 9 weeks old (also reported as 2-month-old) female with no drug reactions or allergies who on 31-OCT-2011 was vaccinated orally with her first dose of ROTATEQ (lot# 670535/0542AA, exp 09-MAR-2013). Concomitant therapy included PREVACID. On 02-NOV-2011 the patient experienced diarrhea. The physician saw the child on 04-NOV-2011 at this time the diarrhea had been occurring for 3 days at the rate of 5 to 6 time bowel movements per day. The child also vomited on while in the office. The physician ordered probiotics and PEDIALYTE. The patient went to visit physician to seek medical attention. The child was seen again on 22-NOV-2011 with decreased urination and decreased bowel movements. There was no fever but the child did have episode of vomiting while in the office. Abdominal and pyloric sonograms were performed and came back either negative or inconclusive. The child had recovered at the time of the report. Additional information has been requested.
Received 3rd hepatitis B on Tuesday am. States actually was more painful than 1st doses immediately after being given. By the following evening was getting very sore and red. On 08/22/02 arm and hand were swollen, painful  with numbness. Saw family physician who treated for muscle infection with Augmentin and Benadryl. Gradual improvement by 08/27/02.
This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. On 16-DEC-2014 the patient was inadvertently received/vaccinated with a dose of ZOSTAVAX ((dose, dose number, administration site and route not reported), instead of VARIVAX dose. No adverse effects were noted. The outcome of event was unknown. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Ankylosing Spondylitis" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral treatment included nirmatrelvir/ritonavir (PAXLOVID) from 04Aug2022 to 09Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and increased swelling and tenderness around injection site more than 24 hours after shot
Day of vaccination, pt was fussy, irritable and mildly agitated. The next day, he was extremely, agitated. By nighttime, he was literally bouncing and jumping. He jumped/bounced until 3AM (7/27/05). This is a child who normally lays down at 7:30PM and goes straight to sleep. He slept 3hrs and was overactive the next day as well. Follow up 8/9/05: On Jul 29, 2005 left developed a low fever (101.4) that lasted x 6 days. Aug 04,2005 was his first fever free day.
trembled like someone who had palsy and was real shaky; When she has to walk she feels weak; afraid of walking; cannot really say anything; This is a spontaneous report from a contactable consumer. A 67 year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, at the age of 68 years, on 25Mar2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EN6198) on 02Mar2021 for COVID-19 immunization and experienced seizure, feel woozy, felt even weaker, jittery feeling, shaky, doesn't feel well and It has left her with a stutter. The patient stated when she took the second shot on the 25th, she trembled like someone who had palsy and was real shaky. Sometimes at night she has to get her husband. He has to wrap her close to him to keep her from doing that and she'll calm down. When she has to walk she feels weak. She's afraid of walking because she shakes so much and then it seems to be getting better. The first shot she got herself back then with the second shot it's hanging on a little more and its a scary experience. She cannot really say anything. Her daughter has gotten her a bell and a whistle. The outcome of the events was unknown.  Information about lot/batch number was available. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 11-Jun-2021. On 04-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, an ultrasound and genetic testing were performed and resulted in normal findings.
This case was reported by a consumer (also the subject's mother) and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). A physician or other health care professional has not verified this report. Historic vaccinations included PEDIARIX (GlaxoSmithKline) for the first 3 doses of the series given on unspecified dates. When the subject was 15 months old, he was given INFANRIX (GlaxoSmithKline) as the 4th dose of the series on an unspecified date. On 6 December 2011 at 14:30 the subject received a dose of KINRIX (unknown route, left arm) as the 5th dose in the series and a 2nd dose of Varicella virus vaccine (Non-GSK) (unknown route, right arm). On 6 December 2011, during vaccination with KINRIX, same day as vaccination with Varicella virus vaccine (Non-GSK), the subject experienced injection site bleeding. He also experienced extensive swelling of vaccinated limb that started the same day. On 7 December 2011 the subject experienced upper arm red, mottled skin and arms itching. On 8 December 2011 he experienced skin hot to touch and decreased appetite. The mother reported that at the time of KINRIX injection there was bleeding at the site due to the subject's unwillingness to get the vaccine. Even before leaving the doctor's office, the bleeding stopped. When she got home, there was swelling noted at the site. In the afternoon on 7 December 2011, the mother noticed the left arm from the elbow to the shoulder was swollen and discolored in that the front of the arm from the elbow up to the shoulder was red and the back of the arm was mottled. The subject also complained of itching of the entire area from the elbow to the shoulder. She contacted her physician who recommended cool packs and to notify them if the area got larger. The mother reported that on 8 December 2011, the swelling was the same, has pink coloring, the skin was "hot to touch" and the subject had a decrease in appetite, but no limitations to his daily activities. The subject was treated with cool compress (Cool pack) which did not help but the "area did not increase". At the time of reporting the outcome of the event of injection site bleeding was resolved. The events of extensive swelling of vaccinated limb, upper arm red, mottled skin and skin hot to touch were unresolved. The outcomes of the events arms itching and decreased appetite were unspecified.
This spontaneous report as received from a healthcare student and refers to an unspecified number of patients of unknown age and gender. 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 PNEUMOVAX 23 lot # L038522, expiration date 11-AUG-2017 (dose and route of administration were not reported). There were no adverse effect reported. Administered doses of vaccines experienced the temperature excursions of 35.8 degrees Fahrenheit for 15 hours minutes on 18-MAY-2016 and 35.4 degrees Fahrenheit for 15 hours on 23-MAY-2016. Time frame: 30 hours cumulatively. There was no a data logger involved. There were previous excursions reported as 35.2 degrees Fahrenheit for 51.5 hours. Additional information has been requested.
Throat was swollen; Lymph nodes were swollen; Swelling on her neck; Lymph nodes were swollen; Swelling on her neck; This is a spontaneous report from a non-contactable consumer or other non-health care professional (parent reported for her daughter). A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 20-years), on 17May2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included menstrual cycle pills (not clarified further hence not coded in tab). On May2021, the patient experienced throat was swollen, lymph nodes were swollen; swelling on her neck. The treatment was received for the adverse event. Reporter stated, that I am trying to report an adverse reaction for my daughter and I need to ask some questions also. My daughter took the Pfizer shot and immediate symptoms did not show up but within 3 days she had to go emergency room twice and her throat was swollen, lymph nodes were swollen and they had to give her steroids shot and antibiotic another shot (treatment) to try to bring it down. So, the question I have is, the reaction would that be concerning for her second shot? Reporter stated that, I think she was 5 feet 3 or maybe 125 pounds. I believe she is 5 feet 2 or 3inches, 5 feet 2 and she was not sure. Reporter stated, for the vaccination date for first shot that I believe it was last Friday, I do not have the exact date or probably that was Thursday and her daughter was supposed to take the next one on 04Jun so back it of 3 weeks, it was I believe the 14th. I cannot believe they do not have a date on this document, the date she went to the emergency room it was on 19 and she took the shot 2 days before, so I believe 17, she was not sure of the date. Reporter stated for other medication or other medical conditions that no, I believe she was taking some menstrual cycle pills. I do not know what they are, I just know they are menstrual cycle pills, she is 20 years old. Reporter stated, for the treatment that when she went to the emergency room, she had to take steroids and an antibiotic, the doctor gave her that and Amoxycillin or whatever it is and then the steroid to help bring down the swelling on her neck and lymph node and stuff. Reporter stated about lab test that she went to the emergency room twice because we are assuming that this is the effect of the vaccine because she has never been sick before, she is not a very sick person. Other than the Covid and the strep throat and stuff like that. The patient underwent lab tests and procedures which included body height: she is 5 feet 3/i believe she is 5 feet 2 or 3inch on unspecified date she is 5 feet 3/I believe she is 5 feet 2 or 3inches, 5 feet 2 I think. The adverse events resulted in emergency room visit. The clinical outcome of the events was reported as unknown.
Headache; Itching at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness at injection site) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Tenderness at injection site). On 12-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (Tenderness at injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
15cm diameter, red, indurated, tender loacl rxn;achy & not feeling good but MD feels aches may not be attributable to vaccine;
pt complained of not feeling well, redness in the vaccinated arm visible, pt then complained of swelling of throat, swelling of face and lips evident, epi 0.3mg administered per protocol