chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty sleeping the night of vaccination (restless sleeping); restless sleeping; painful arm; In the morning woke up with really bad headache; Brain is very foggy/fuzzy.; entire body was sore; This is a spontaneous report from a contactable consumer reported for herself. A 24-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247), via an unspecified route in the left arm on 11Feb2021 at 12:45 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Patient did not have allergies to medications, food, or other products. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 3247) via an unspecified route in the left arm on 20Jan2021 at 14:00 (age at vaccination: 24-year-old), as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 11Feb2021 at 23:00, patient experienced difficulty sleeping the night of vaccination (restless sleeping) and painful arm. In the morning, woke up with really bad headache on right side of temple and entire body was sore besides the arm in which vaccination took place. Brain is very foggy/fuzzy. Patient did not receive any treatment for the events. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt returned to the office on 2/8/02 to have a TB test read. Mother asked about left deltoid which was swollen, red and hot to touch.
Site: Pain at Injection Site-Mild, Additional Details: Patient states that wrist is uncomfortable. States that injection itself was not the issue that he sat down and a few minutes after injection after he started to move his arm it began to feel uncomfortable.
10minutes post vaccine administration, patient complained of itchiness at right deltoid and itchiness to her left hand. Medical provider was called for evaluation, Order given by medical provider to administer  Benadryl 25 mg PO.  Patient evaluated for 30 additional minutes. At the completion of the observation time, patient denied symptoms, patient ambulated out of observation area and instructed to follow up with PCP. Patient verbalized understanding.
pt recv vax 25MAY95 & 30JUN97 pt devel pimples on back, feet, testicles;pt presented to MD office on 1JUL97;
Red circle rash around or just below injection site - 3" in diameter. Slightly itchy. Treatment with hydrocortisone cream, not effective. The rash area is warm to the touch and has a darker red rim around the area.
Swelling - localized to injection site - 10x13cm area of erythema on left upper extremity - treated with oral steroids.
no adverse effect reported; A HCP called to report that a improperly stored dose of VARIVAX 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 concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (manufacturer unknown).  On 11-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/once, lot #W003820, expiration date: 02-FEB-2024 (strength, and route of administration were not provided) administered for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in 6 degrees Fahrenheit (F) up to 14 F for 14 hours 10 minutes, and in 14 F up to 46 F (16.7F) for 5 hours 40 minutes (product storage error). There was no previous temperature excursion. No adverse effects reported.   This is one of two cases received from the same reporter; Sender's Comments:  US-009507513-2208USA006387:
Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe chills fever nausea  weakness and tiredness. Was unable to perform daily to asks the whole next day.
Patient felt lightheaded immediately after receiving vaccine. With 3-4 minute, she lost consciousness. She was laid on floor and breathing was monitored. After approximately 1 minute, she regained consciousness. She was able to answer questions such as her name and where she was. EMS was called and they checked vitals and monitored. She refused additional treatment and transport to hospital.
CHEST PAIN; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-APR-2021, the subject experienced chest pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and chest pain. This report was non-serious.
Two days following vaccination patient experienced chills, cold sweat & fatigue.  Reports have a "fever".  Dizziness, congestion, diarrhea, runny nose, cough, SOB and headache.  Symptoms lasted 5 days and patient reports "feeling much better" on 1/24/08.
Body aches, fatigue 24hrs later Injection site soreness, redness, swelling, with a knot under skin
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning an adult female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2011, the patient inadvertently received expired FLUMIST. The product expired on 20-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
My left testicle began to have random shooting pains that were slightly uncomfortable and after a few weeks of that pain progressively getting much worse and the shooting pains happening more frequently one night my entire scrotum (including my right testicle) began to hurt so bad and for such long periods I went to the emergency room. I had an ultrasound done as well as tests for STDs and STIs and had no structural damage in my testicles nor any sexually transmitted problems. It has gotten somewhat better but there is still some general discomfort in my scrotum. While it was at its worse my scrotum was somewhat swollen (which it still is slightly), very red, and looked as if there were numerous blood clots on the surface of my scrotum.
Patient was given a Pfizer Bivalent Booster on 9/15/2022. The information was presented to staff on 9/27/22. The patient mother was called on 9/27/22.   Patient mother made aware child received incorrect Bivalent Pfizer vaccine. Patient mother verbalized understanding.  Patient mother denied that the patient was currently having any distress.  Patient mother denied having to take child to Emergency Room or Primary Care provider.  The patient mother was informed that according to committee there is no need to administer an additional Covid Pfizer booster. Patient mother verbalized understanding. Patient mother encourage to reach out to primary care physician regarding medical needs. I reviewed side effects and serve allergic reactions with parent.  Encouraged parent to seek emergency services for severe allergic reactions by calling 911 or going to the nearest hospital. Patient mother verbalized understanding.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 26-NOV-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
After 4 month vaccines had a gasping episodes resulting in ER visit today, only DTAP given and later in day had another gasping episode.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that he received a dose of SHINGRIX vaccine 2 months before the time of reporting. The patient had pain in the left arm (injected arm) that lasted a month. The patient stated that it was not a big deal but was surprised that it lasted that long. The patient did mention it to his doctor. The patient had given permission to contact the physician. This case has been linked with case US2018152725, reported by the same reporter.
An event of vaccination exposure during pregnancy occurred in a 33-year-old female.  The report was received from a medical assistant.  The client, who was 4-months pregnant at the time of vaccination, did not indicate she was pregnant.  The patient received a one-time dose of FLUMIST on 13-Dec-2007.  On 13-Dec-2007 the reporter indicated FLUMIST was administered to a woman who was four months pregnant at the time.  The patient did not make known her pregnancy prior to the vaccine administration and no adverse events were reported.  Follow up obtained on 09-Jan-08 confirmed no adverse events were reported.  Outcome: no adverse events.  Further dosing with FLUMIST is not indicated.  Causality assessment is not applicable for this vaccine exposure during pregnancy.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. On 01-May-2008 the patient delivered via C-section a healthy male infant that weighed 6.10 ounces. Follow-up informatoin on 06-Oct-2008 includes the mothers pregnancy history and the outcome of this pregnancy.
Rec'd vaccine on 1/9/21. On 1/11/21 she developed swelling to both hands to the point it caused pain.
Patient was given wrong formulation of Pfizer. Instead of 12+ formulation, patient was given pediatric formulation.
Extreme vertigo; Dizziness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness). At the time of the report, PAIN IN EXTREMITY (Sore arm), VERTIGO (Extreme vertigo) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Platelet count at MD's office was 7000 on 7/27. Admitted to hospital. IVIG given, 5 gram dose. Small petechia lesions spread all over body. 9/22/06 Received medical records from hospital which reveal patient was admitted on 7/29/06 with small erythematous petechia like rash on face for 2 days which began under the eyelids then progressed over the entire body & inside the throat.  No ill family members. Dx: panthrombocytopenia, most likely idiopathic thrombocytopanic purpura.  Received IVIG.  Patient only seen in heme/onc clinic for labs, no consult available./ss
Four dime size hives on right side of face; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Four dime size hives on right side of face) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (Four dime size hives on right side of face). On 17-Apr-2021, URTICARIA (Four dime size hives on right side of face) had resolved. Not Provided      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.
Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fatigue, 5-6 days, brain fog, 6-7 days, joint aches,6-7 days, dizziness and loss of balance, still have but not as severe , full body thrush, day 2-5.  Extreme soreness at injection for 4-5 days
A small cluster of round rashes the size of a quarter at the site of injection.  She compained of itchiness and pain that come and go. The symptoms has not been resolved ever since.  Advise patient to see her primary doctor.
Deep-vein thrombosis of L lower extremity, leading to multiple pulmonary thromboemboli with near complete occlusion of L pulmonary artery. Dilated, tortuous deep veins of both lower extremities. Hypertensive atherosclerotic cardiovascular disease. Preliminary Autopsy Report: Cause of death: Pulmonary Thromboembolism due to DVT. Manner: Natural. Autopsy performed 10 Apr 03. Reports will be faxed.  News article, dated 7 Apr 03, asserts "Three days ago, patient had complained of cramps behind his knee. Like most of us journalists "embedded" in the military, he had endured days and nights of working, eating, and sleeping in our vehicles as convoys snaked their way around. He consulted military doctors and described his symptoms over the phone to overseas physicians. They suspected DVT, or deep veinous thrombosis, and advised him to seek proper medical attention. He ignored their advice, swallowed some aspirins, and kept on working."
Presented to ED with complaint of facial swelling and pain onset today. Endorses difficulty swallowing. Patient notes that she got the Moderna COVID-19 vaccination yesterday. Patient admitted. Patient was monitored in the ICU she was empirically treated with antibiotic therapy for pharyngitis but was not felt to be bacterial this was discontinued.  She maintained her airway without any increase in secretions or stridor.  She was transferred to the floor and has done well on systemic steroids and scheduled Pepcid as needed Benadryl.  Patient has some mild generalized edema but overall seems improved no urticaria.  Airway is stable with no stridor and no dysphagia.  Patient did have polycythemia on admission however this improved with IV fluids likely due to IV but would recommend outpatient follow-up and repeat CBC in 2 weeks VD.
Pt received first and second dose of varicella virus vaccine live. Subsequently, ELISA testing within 60 days post vax revealed negative seroconversion following second dose of the vaccine. Four other pts were reported with similar episode following vaccination with varicella virus vaccine live.
Headache / Jaw pain / tingling of mouth and tongue then chin, face, neck and arms / nausea
A few minutes after vaccines were given while waiting in exam rm, pt was sitting on exam table mom went onto to other exam room where sister is being seen-nursing staff heard a loud noise and saw pt slumped on the floor in the hallway. Looked pale, was stable after a few minutes able to drink water. Child doesn't recall what happened. Remembered getting the shot but doesn't remember going out of the room. She said she "felt sick after shots".
I had sore arm at injection site for a couple of days. Then, 2 weeks later, a rash began to emerge and is now to the point that I am concerned because it is getting worse each day (3 days now). Arm is painful and burning. The center of the now growing rash is white and about 3/4 inch diameter while the red rash is now 3.5 inches in diameter. No rash at time or immediately after shot. I have history of reactions to insect bits but not to vaccinations. Further this started out of the blue 2 days ago - fully 2 weeks after the fact. I have not contacted a doctor and hope it begins to subside by tomorrow.
On Monday afternoon I experienced low grade 99.5 and body aches. School nurse performed a Rapid Covid Test and results were negative. The next day I experienced fever 100.5, body aches, joint pain, chills, and cough so I went and had a rapid covid and flu test performed and both were negative. Family doctor suggested the two day covid test and the results were negative on Friday. If I don't have covid then are they side affects from vaccine.
This case was reported by a physician and described the occurrence of rectal bleeding in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX and Hep B. Previous and/or concurrent vaccination included PNEUMO vaccines (non-gsk) ;non-GSK manufacturer given on 13 April 2009. There were no concurrent medications. The subject was reported to have no relevant medical history and was reported to be a healthy infant. The subject had rectal bleeding with the first dose of ROTARIX. (Please see A0781881A). On 13 April 2009 the subject received the 2nd dose of ROTARIX (oral). On 13 April 2009, the subject also received the 2nd dose of PEDIARIX (unknown) and the 2nd dose of Hep B (unknown) and experienced accidental overdose. On an unspecified date in April 2009, one week after vaccination with ROTARIX, the subject experienced one episode of rectal bleeding which resolved. This case was assessed as medically serious by GSK. The physician considered the rectal bleeding was probably related to vaccination with ROTARIX.
Pneumonia - Admitted to hospital 2/21/05 with hypoxemia and LLL pneumonia. Tx with tequin, rocephin, azithromycin, augmentin. Discharged 2/23/05. Influenza A & B - symptoms started > 5 days prior to hospitalization, so no antiviral rx. started. Discharge summary states hypokalemia dehydration. msv
Received influenza vaccine at medical clinic where she is employed. Later reported administration was much more painful than usual. She also reported vaccine was administered higher on arm than usual. She expected pain to decrease after a couple of days, but pain has continued until present, nearly a month after administration.  She has not been seen by a provider so outcome is not yet known.  Symptoms are also being reported to  human resources department as possible workplace injury.
Fever of 103.8F, shortness of breadth, chest pain, joint pain from jaw to toes including every joint in the body in between jaw and toes, body aches, nausea, vomiting, loss of appetite, weakness, and dizziness.
approx 4hr post vax dental appt became feverish, hot p/vax;pt dizzy, chills, h/a, hoarse;
Rash below 2nd Shingrix vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 3rd March 2021, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: Age at vaccination not applicable. The age group was not reported but it was selected as adult as per the vaccine indication. On the day before reporting date, the patient experienced rash post 2nd dose of shingrix.
Sore arm right away after the shot.  Chills started approx. 24hrs later, fever of 102 degrees F
At time of shot, at time of needle placement she had a tingle, surge from site to elbow, next morning-arm very painful, could not move arm, no strength in arm, no redness or swelling, now still has limited movement in arm, can not raise above her shoulder to level to shoulder.  She also received a flu  hd shot that same day in the same arm.
Patient had his shots that afternoon, slept for a little while, then woke up crying changed his diaper and was holding him and he went very white, limp, and unresponsive. We took him to the ER on the way was trying to get him to move and wake up, appeared to not be breathing, was very pale in color. Once in the ER started to move one arm a little still very pale. Was tranferred to another hospital by ambulance and had a series of tests done and stayed for two days. Was put on an apnea monitor and sent home.
I had sore throat, sinus congestion, moderate cough and fever of 102.3. I completed a home COVID-19 test on June 13  and it was positive. I then took a COVID-19 PCR on June 16 and it was also positive. My doctor prescribed Paxlovid. I only took 2 to 3 days because could not tolerate the metallic taste. My symptoms. All of my symptoms subsided within 6 to 7 days.  I made a complete recovery.
Patient was given the Quadracel  in the right deltoid on 5/22/19. Mother reported baseball size area of redness, swelling to area of right deltoid on 5/23/19. Mom also said it was painful and warm to touch. She also noticed a red rash on abdomen and right forearm that had mostly resolved on 5/24/19. Treatment included cool compresses and Benadryl.  Mother was advised to notify clinic if no improvement or worsening of symptoms.
Vomiting, diarrhea, weakness, started vomiting around 9:00 PM 6/17/08 and vomited til after 5:00 AM. Went to ER then back home at 8:00 AM. Appt with doctor 6/16/08.
On July 3rd I began to feel fatigued and a bit of a cough with a runny nose. My symptoms stayed about the same. I tested positive for COVID-19 from a home test on July 3rd. The doctor prescribed PAXLOVID and I took the 5 day course. I began to start feel better on day 6. As of today I am much better but still fatigued.