chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am a teacher and received a flu shot and also a pneumonia shot on that day. A few hours later I developed pain in the arm where the injections took place. Both injections were place very high up on my left arm. The pain traveled all the way to to my hand and by the time I went to bed I was in severe pain and could barely move my arm. I have never been allergic to anything and have never had a reaction to a vaccine. I could not even touch the skin of that arm without being in tears. The severe pain lasted until the morning of October 22nd. It is still painful today but bearable. However, I have developed fairly large red marks on my upper arm that are very sensitive and hot to the touch. I am now taking a steroid and have been cooling the area with ice packs. I looks as if my skin in that area was burned.
migraine; This is a spontaneous report based on the information received by Pfizer from (Allergan Medical Information Request: US21-002211). A contactable consumer (patient) reported this female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ubrogepant (UBRELVY) from  13Jan2021 for headache-migraine. The patient experienced migraine on 23Jan2021 in the morning. The patient took a ubrogepant dose on 23Jan2021 and it relieved the pain. She was fine. On 25Jan2021 the patient had a severe migraine so she had to take another dose of ubrogepant. The patient stated that the migraines had been different since she received the vaccine. The patient wanted to know if there were any potential reactions between ubrogepant and BNT162B2, if it was safe to take ubrogepant in patients who have received BNT162B2, and if rebound headache was a reported side effect of ubrogepant. The outcome of migraines was not recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
On 2/3/2021 a severe burning sensation began on the right side of my right breast. I also felt a lump in the armpit. On 2/5/2021 a mammogram, ultrasound and biopsy were performed at the Clinic. I was informed on 2/8/2021 that I had two cancerous tumors. On 2/22/2021 I met with both the medical oncologist and breast surgeon. I?m now wondering if there is a false positive based upon articles I?ve read. Thus I?m reporting this to you.
Given the Janssen covid-19 Vaccine EUA at pharmacy.  Left arm swelled right away and I lost around  3 tablespoons of blood from the vaccine site.  I am concerned that the vaccine came out of the arm with the blood.  I was asked to wait 30 min before going home.  The bleeding stopped after 30 seconds.  Swelling went down over next hour.  No other side effects.  I am concerned that I may not be vaccinated if the vaccine came out of the arm with the blood.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included lymphoblastic lymphoma. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: On 11th September 2018, after vaccination with SHINGRIX, the patient went to the doctor and was diagnosed with an outbreak of shingles. The shingles experienced by the patient was located between his upper back and between both of his shoulder blades. At the time of reporting, the patient was on antiviral medication. However, the patient had not seen any improvement in his symptoms as he had been taking the medication for 2 days only, till the date of reporting. The patient enquired if he should receive the 2nd dose of the vaccine. The reporter provided him with information from the frequently asked questions (FAQ), (what was the immunity percentage after vaccination with only one dose) and referred the patient to his healthcare professional. The reporter also informed the patient that the vaccine was non-live and therefore should not cause disease. The representative provided an information from product information regarding immunosuppressant to the patient and verified that the patient was not on immunosuppressant at the time of reporting. The permission was obtained for contacting the patient's physician.
fatigued; anxiety; WBC was a little low; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on unspecified date, at single dose, for COVID-19 immunisation and palbociclib (IBRANCE), via an unspecified route of administration, from 06Jan2021 to an unspecified date, at 125 mg cyclic, for an unspecified indication (patient was on her 7 day break from 1st cycle). The patient's medical history and concomitant medications were not reported. The patient experienced fatigued on an unspecified date with outcome of unknown, anxiety on an unspecified date with outcome of unknown, white blood cell (WBC) was a little low in Jan2021 with outcome of unknown.  The patient underwent lab tests and procedures which included white blood cell count: low in Jan2021. The action taken in response to the events for palbociclib was unknown. She stated that fatigue could maybe be a result of her poor sleep due to anxiety.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Arm became red, swollen, warm to touch. Given Benadryl and Pepcid that day. Next day arm was sore up to neck but redness area was improving.  Two days later no symptoms, redness resolved, pain resolved.
pt recv vax 12NOV91 & flu like illness 23DEC cough, fever 101-102, joint pain, muscle ache, sore throat;joint & muscle pain worsened over time sx gone;finally dx w/scleroderma MAY92 (systemic sclerosis);tx meds;malignant renal HTN had CVA;Annual follow-up dated 10/4/00 states that the pt is on social security disability because of scleraderma. Has had 5 hand surgeries to improve function of contracted fingers.
I got really dizzy, almost passed out. Loss hearing for a moment and could only hear it from far away. Clammy and paleness.
Severe headache Extreme Fatigue Chills Muscle aches Sore arm, hot and raised
Patient has RSV as a kid and after it resolved she had bruise like spots on her skin and petechiae.  Patient had the same thing happen after she got her RSV vaccine.  She had bruise like spots and petechiae. Patient says both are getting better but wanted to report her symptoms. Patient has not seen a doctor yet or tried to receive treatment.
Pt. received flu shot 11/2/10. He is now experiencing (L) arm weakness not able to lift arm over his head. Also states periodic stabbing/throbbing at injection site. Getting progressively worse site was sore at time of injection then pain increased.
Child seen for routine well child check on 7/27/22. He was brought to the ED the following morning 7/28/22 after cardiac arrest.
My skin has become sensitive and itchy.   Any abrasion causes redness and low hives - even holding the steering wheel.    For the first day or two my skin felt hot -- similar to the feeling when you come out of a tanning bed.      I was worried about getting the 2nd shot, but i did it.   The skin condition continues, but it did not get worse with the 2nd shot.   I did get the flu feeling that is the normal reaction (for 1 day).    i am hoping that my skin gets back to normal soon.
This case was reported by a consumer and described the occurrence of acute hepatitis in a 43-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. There was no relevant medical history. It was reported that the subject had previously never been sick or experienced any illness. On 22 June 2010, the subject received 2nd dose of TWINRIX (unknown). There were no other vaccinations administered on this date. In July 2010, approximately 1 month after vaccination with TWINRIX, the subject began to feel tired and nauseous. The subject consulted with a healthcare professional regarding the events. He was hospitalized approximately one month after his vaccination and it was determined that he had acute hepatitis. He remained hospitalized for four nights and underwent a battery of testing and exams that were unspecified. The nausea and tiredness were improved at the time of reporting. His current condition was improved, although he was still undergoing treatment with steroids for his acute hepatitis, which was still unresolved. He must remain on steroids for a total of 12 weeks before it is determined if the hepatitis is resolved. The subject was not taking any medications prior to his diagnosis of acute hepatitis. The vaccination course with TWINRIX was discontinued.
Myalgia, Arthralgia, Fever, fatigue, neck shoulder pain Narrative:  used flexeril at home  Other Relevant History:
Nausea, vomiting and diarrhea for 6 hours.  Extreme lethargy and muscle weakness for 10 hours. Chills and body aches for 12 hours.
Low-grade fever: 100 F less than 12 hours after, broke next morning Headache: Right after vaccination, still occurring Blurry vision: 1 hour after vaccination, ended around 5-6 hours later Sore arm: Right after vaccination, still occurring Body aches: Day after vaccination, still occurring Body chills: Less than 12 hours later, still occurring Out of breath: Day after vaccination, still occurring
Lt deltoid area cellulitis; Seen 3 days p/immun; given Cephalexin; clinically resolved well;
dyschezia; This spontaneous report was received from a physician via a company representative and refers to a 2-month-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient experienced dyschezia. A physician was contacted. The patient recovered from the event on an unknown date. No further information was available. The relatedness between dyschezia and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
A legal complaint was received from an attorney alleging that a male child received series of Hib-Tite, Tripedia (Aventis), and Engerix B (GSK) vaccines as well as Tetramune vaccine from 22-Jun-1993 through 20-Oct-1994 and subsequently " suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via intramuscular injection of mercury" in the "thimerosal- containing vaccinatios." According to the legal complaint, The child "was born a pefectly normal, health boy whose APGAR scores at birth were well within the normal range." It is alleged at apprx. 18 months of age, the child " was neurologically devastaed by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved , specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanant injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments."
No specific adverse event, however second bivalent Moderna COVID-19 vaccine was erroneously administered at 62 years old (patient is not yet 65 years old and is not immunocompromised) which is outside of current authorization.
Broke out with rash and hives 1 day after shots. Lasted 1 week.
Information has been received from a registered nurse concerning a 14 year old female with no medical history and no known drug reactions/allergies reported, who on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown).  No concomitant medication were reported.  The patient left the office and at home on 03-JAN-2008 became flushed, shaky, burning ears, threw-up and was light-headed.  The patient rested, got something to drink and felt better later the same day.  The office discovered the adverse reaction when the patient called for the second vaccination.  Subsequently, on 03-JAN-2005, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a registered nurse and the mother of a 14 year old female student, with no medical history, no known drug reactions/allergies reported, and no illnesses prior to vaccination, who in the PM on 03-JAN-2008 was vaccinated intramuscularly in the right deltoid with a first 0.5 mL dose of GARDASIL (Lot # unknown). On 11-APR-2008 the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot # unknown). No concomitant medication were reported. The patient left the office and at home in the PM on 03-JAN-2008 became flushed, shaky, burning ears, nauseated, threw-up (1X) and was lightheaded. The patient rested, got something to drink and felt better later the same day. The office discovered the adverse reaction when the patient called for the second vaccination. Subsequently, on 03-JAN-2008, the patient recovered. No product quality complaint was involved. Additional information is not expected.
51-year-old female was being observed for 15 mins post 1st COVID vaccine and began to have an allergic reaction. She complained of throat tightness, was given 50 mg of diphenhydramine, vitals obtained, and patient remained stable. She continued to be observed and stated slight relief of discomfort in her throat. As she continued to be observed for about 30 minutes, she began to cough and stridor was heard by the physician assisting at the site, an epi pen was administered. Patient experienced relief within secs/immediately. She was transported to nearest ER for further evaluation and treatment.
Neuropathy.  I was diagnosed with Shingles 5.5 years ago and developed neuropathy which subsided over time. After the first dose of the Pfizer, roughly 72-96 hours, I noticed mild to moderate levels of neuropathy appear which has been ongoing.
got so bad of the pain that didn't wanted to receive the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (got so bad of the pain that didn't wanted to receive the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (got so bad of the pain that didn't wanted to receive the second dose). At the time of the report, PAIN (got so bad of the pain that didn't wanted to receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. No treatment information was provided.
This is a spontaneous report from a contactable physician and from a contactable healthcare professional (HCP) based on the information received by Pfizer from Sanofi Pasteur, Inc. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) intramuscularly on the left upper arm on 10May2016 at 16:00 at 0.5 ml single. The patient did not receive the second dose of the vaccine. The patient had none medical history. Concomitant vaccine administered on 10May2016 included the second dose of MENACTRA (Sanofi Pasteur, lot number 05187AA) intramuscularly on the right arm. The patient previously received the first dose of MENACTRA (Sanofi Pasteur, lot number 05187AA), intramuscularly on the right arm on unknown date at 1DF and no adverse event occurred. The reporting HCP confirmed that the patient did not receive any Sanofi Pasteur product while the physician reported that the patient received two doses of MENACTRA (Sanofi Pasteur). On an unspecified date in May2016, after the vaccination, the patient had an immediate reaction fever of 102 F and she was sick. The patient also experienced pallor and tonic clonic movement arms 2-3 sec time of administration on 10May2016 and 48 hours later, in May2016, she experienced the preseptal cellulitis. No specific treatment was required for the events and no emergency room or physician visit. The outcome of the events was unknown. The physician confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccine. Follow-up (31May2016): New information from a contactable healthcare professional includes: confirmation that the patient did not receive any Sanofi Pasteur product. Follow-up (16Jul2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Jul2016): New information reported from a contactable physician includes: reporter's and patient's information, details of vaccination, concomitant vaccine and past vaccine history, new events, no emergency room or physician visit or treatment required for the events. Confirmation that the patient provided to the physician information regarding the reported adverse events with the use of the vaccine.
itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the gluteus area Has not seen the doctor yet (2/26/2021)
After 6 hours, 100.8 fever, both eyes hemorrhaged, chest tightness, dry cough and weakness.
Right after received vaccines, pt stood up. Within 45 seconds, pt reported feeling funny and was swaying back and forth. Pt was directed back into the chair, where she began to get lightheaded, clammy, pale and sweating. Her head was lowered to between her legs. Cold clothes applied to her and head and neck. BP was also monitored at this time. After about 10 minutes, pt reported to feel better. Blood pressure had came up, pt returned to normal color and was more coherent and cognitive. Pt instructed to remain sitting for 10 more minutes and was then instructed she could get up and move around if she felt well enough. Pt did.
The patient received Pfizer 5/19 and Moderna 8/4. The patient did not notify correctly she received Pfizer and not Moderna on her first dose.
Tested positive to Covid  onto and a half later-on May 30, 2022. Symptoms started a couple of days before-sore throat, runny nose, cough. No fever, oxygen level great,
The patient received his first Anthrax immunization on June 11, 2007 and developed herpes zoster to chest and back areas.  Preventative medicine consulted and agrees with assessment
12 days p/vax devel enlarged nodes under chin, back lt neck jaw area; malaise, pressure in chest-no treatment resolving 27OCT94;
I had no side effects until the first day of my menstrual cycle.  I felt extreme fatigue, vomiting, and severe diarrhea for my entire cycle (5 days).  I also bled heavier than normal and had an uptick in noticeable, large blood clots.  Symptoms lessened on the 5th day and completely stopped when my cyle finished.
pneumonia symptoms; sore arm; This spontaneous report has been received from lawyer from a case in litigation for zoster vaccine live (ZOSTAVAX) (1810USA004176), concerning a currently 68-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in 2006, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumonia") (manufacturer unknown) as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). Afterwards, on unknown dates, she experienced sore arm (pain in extremity) and pneumonia symptoms (pneumonia). The outcome of of both events was unknown. The causality assessment between pain in extremity and pneumonia, and the vaccine were not provided.  Upon internal review, the event pneumonia was determined to be medically significant.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1810USA004176:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in May 2018, refer case US2018147868). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details reported as follows: The reporter was the patient's wife. The patient experienced a sore arm. This case has been linked with US2018147867 and US2018GSK150555, reported by same reporter.
pt woke up on 6NOV93 w/faces swollen, eyes swollen & white welts ringed in red, mostly on back; pt was taken to MD 6NOV93; no fever, no resp problems noted by grandma;
I started getting symptoms of a cough. Then next I still had a cough then I felt muscle aches. Then I felt fatigues with an elevated temp with a fever of 99. I took an at home COVID-19 test that was positive. I contacted my doctor and was prescribed Paxlovid.  I had a fever for 3 days and muscle aches and fatigue for 4 days. The cough and congestion is still lingering. I am still testing positive.
Numbness/shooting pain down arm 45 minutes after injection with MENACTRA and fever of 100 degrees and "thickness in throat".
I had severe shortness of breath, heart racing. Xray proved that I had a submassive pulmonary embolism.
TEMPERATURE EXCURSION ON PRODUCT; INCORRECT PRODUCT STORAGE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced temperature excursion on product. On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature excursion on product, and incorrect product storage on 24-JUN-2021. This report was non-serious. This report was associated with product quality complaint: 90000184025
Asked client if under 65 years of age-no indication that she was. Gave hi-dose Fluzone.