chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and sex. No pertinent medical history, drug reactions or allergies were reported. On 25-FEB-2014, the patient received a dose of PROQUAD (lot #, expiration date, dose, frequency, route of administration were not reported) injection and a dose of VARIVAX (Merck) (lot #, expiration date, dose, frequency, route of administration were not reported) injection. No adverse symptoms were reported. No concomitant medications were reported. It was not reported if patient was given any treatment. It was not reported if any lab diagnostic studies were performed. Additional information has been requested.
Patient reports that he had no abnormal symptoms until 2 weeks after vaccine, when he had some swelling and pain at vaccine site suddenly appear. He used a warm compress on the site, and the swelling went away. He states that his shoulder does not hurt, nor does his arm upon movement. The pain only occurs when touching the site of injection. It has gotten better a month later, but there is still some tenderness upon touching, other than that no pain upon movement or on any other area of the arm.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 10-OCT-2016, the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II (lot # K015375, expiration date: 18-SEP-2016, dose and route of administration were not provided). The patient has not reported and adverse experience. Additional information has been requested.
04/15/2022  A few days after my vaccine I began to itch at the bottom base of my skull, and moved up towards the sides of my ears in my hairline. I also now have a bit of a rash on the left and right sides of my forehead. It started to go down my back towards the lower spine, and on the left side of my body as well. I also had some visual rash forming on my chest as well that was itching very badly as well. I was given a prescription for a cream and then when seeing a dermatologist I was given a liquid prescription, clobetasol scalp solution, to help with itching and rash formation in my hairline. It has been helping to soothe the itching. The patch on my chest has cleared up, my side and back are still itching. I have seen general improvement on my symptoms.
sick after a few hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick after a few hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse, a physician and a certified medical; assistant concerning a 15 year old female who in July 2007, was vaccinated intramuscularly with a first dose, of GARDASIL vaccine (yeast) (lot # not reported). On 10-JUL-2008 the patient received meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) first; then she received a second dose of GARDASIL vaccine (yeast) 0.5mL intramuscularly (lot # 659964/1978U), and lastly she received varicella virus vaccine live (VARIVAX) (MSD). The patient fainted after the injections. The patient was talking when she passed out, fell and hit her chin on the side of the exam table. She required 8 stitches that were completed in the physician's office. The patient returned to the office in about 1-2 hours and the physician stated "she was fine and smiling". The registered nurse considered stitches in chin to be an other important medial event but the physician and the medical assistant did not consider it to be an other important medical event. No additional information was available. Additional information has been requested.
pt recvd vax & 10-12 hrs later had brief episode of SOB, itching @ inj site 12FEB96; pt was not given 4th dose of vax by clinic;
itchy red rash on left arm injection site this started 7 (2/24/2021) days after getting injection and is still present at the time of this reporting.
This spontaneous case, initially received on 14-Oct-2016, was reported by a health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 14-OCT-2016. Dose regimen: 0.5 single dose, Route of administration: Intramuscular. Batch number: 10949221A (expiry date: 05-Jun-2016). No additional suspect drugs. Adverse event description: On 14-Oct-2016, gave expired dose to employee, no reaction noted (outcome: not reported, special circumstances: expired drug administered without adverse event). Reporter's comment: The reporter classified the event as a medication error and considered it non-serious.
terrible headache; Temperature of 104 degrees, the next day temperature is 103 degrees; she had a temperature of 104 degrees with chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees), CHILLS (she had a temperature of 104 degrees with chills) and HEADACHE (terrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees) and CHILLS (she had a temperature of 104 degrees with chills). On 07-Feb-2021, the patient experienced HEADACHE (terrible headache). At the time of the report, PYREXIA (Temperature of 104 degrees, the next day temperature is 103 degrees), CHILLS (she had a temperature of 104 degrees with chills) and HEADACHE (terrible headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 104 degrees (High) 104 degrees. On 07-Feb-2021, Body temperature: 103 degrees (High) 103 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The significant follow up received in which outcome of the event was updated(Unknown to Recovered).Added lab data from initial source document.
Pt present to Rx and asked me to look at injection site - oval inflamed area with red border about 1 1/2 - 2" in diameter - center was not as red. Instructed pt to see md after reviewing, side effects with her.
Pt received KINRIX LA IM & VARIVAX LA SUB Q.  Top of arm swollen & red.  Advise mom to use warm & cold compresses; and give child TYLENOL or MOTRIN.
Dizziness, room spinning. Unsteady gait, bumping into walls. Still ongoing, no treatment prescribed yet, waiting for my doctor to call me back. I just am reporting this. I reported to Novartis Vaccines, Vaers, and left message for clinic. Waiting for calls from everyone.
Patient called and is complaining of nausea and vomiting. Patient does not report any other changes in lifestyle or food consumption in the last few days.
Approximately 4 hours after receiving vaccine, patient experienced profound weakness, felt hot, severe nausea, and pallor. This lasted approx 1.5 hours.
he received the first  dose of vaccine and fell to the floor almost immediately, paramedics responded, BP was low but no other issues, he was released without further medical attention
Information has been received from a 23 year old female patient with allergic reaction to an unknown antibiotic (hives, rash) and asthma who on 15-MAY-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included ORTHO TRI-CYCLEN, prednisone, FLOVENT, SEREVENT, and albuterol. On 15-JUN-2007 the patient began to feel very sweaty, experienced dizziness and convulsions and lost consciousness. She was taken to a hospital and treated by the emergency department. She was not admitted as an inpatient. On 22-JUN-2007 she again became very dizzy, experienced convulsions, her hands and arms were tingling, her arms felt numb, and again she lost consciousness. She was taken to the hospital again and was treated by the emergency department. She was not admitted as an in-patient. On 30-JUN-2007 same thing occurred. She felt a "weird rush to her head," felt tingling and dizzy, and again lost consciousness. She went to a hospital again and treated by the emergency department. Again, she was not admitted as an in-patient. She reported that the only diagnoses made were "inappropriate sinus tachycardia and syncope". Since these three trips to the hospital, she had episodes of her hands beginning to tingle, "rushes to her head," and dizziness. She did not lose consciousness again. She still has dizziness all the time. It was reported the following tests were done: magnetic resonance imaging (MRI), electroencephalography (EEG), electrocardiogram (EKG), sonogram and heart monitor diagnostic tests were done but the results not available. At the time of this report the patient was recovering. Upon internal review, convulsion was determined to be an other important medical event. Additional information has been requested.
He started not feeling too well; coughing like slimy kind of cough; Like congestion; he started to have some chills; Pain in arm; He got sick so bad; I think last year respiratory infection like his chest; He was hot;  he had about 100.4; Diarrhea; He got sick so bad; I think last year respiratory infection like his chest; head seems to be very stuff; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient took the first shot on 20Jan2021. The first day he felt okay he didn't feel like they gave him the shot as it went well. Then he has some arm pain (pain in arm) at night on 20Jan2021 about strictly went away. He took it on 20Jan2021 about 12'oclock in the afternoon. On Friday on 22Jan2021 and Saturday he started not feeling too well. He started coughing like slimy kind of cough on 22Jan2021. He was like congestion and then he started to have some chills and stuff like that on 22Jan2021. So that was almost three weeks ago. Like Saturday so this past Saturday was two weeks so today it was Tuesday so almost two and half weeks he hasn't gone out of the house. It was unknow if he was fine before he went took the shot. He got sick so bad 3 or 4 days later and he hasn't really feel well since then. Like before he took the shot but then also don't know if he has something different. He didn't go to get tested for Covid. He hasn't lost taste or smell. He seems like continuing he has like last year this time when we were in different part. He seems like he had last year respiratory infection like his chest but then he got better. He is easy to get all sick. He had fever he had like every time his temperature was always but he had about 100.4 in Jan2021. One at night he got chills and he was hot. He two Tylenol, he took lot of Tylenol in last two weeks. He felt like after he took the Tylenol he felt like it would take his temperature he took Tylenol right away and the fever went down. He hasn't had any fever it is been like 97 for 4-5 days. He has he feels like he had congestion but unknow if he picked up for cold or congestion just and right now try to see if he takes the shot tomorrow and he had just weird diarrhea. He still have his nose and his head seems to be very stuff. The wife did not know if he got sick from the shot or not. The outcome was unknown.
Fever 102.3, aches, headache, chills. Improved with tylenol.
Information has been received from a nurse concerning a patient (age and gender not reported) who on 11-DEC-2007 was vaccinated (route and site not reported) inadvertently with a dose of Gardasil (lot# not reported) instead of Pneumovax 23.  The incident was due to human error and there was no product confusion.  The patient did not experience any known symptoms.  Additional information has been requested.
Mild pain and injection site; Fatigue; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain and Shingrix with an associated reaction of fatigue (1st dose received within past 3 year, refer case US2020AMR189287).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and fatigue. The patient was treated with naproxen. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and fatigue were unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix within the past 3 years. Post vaccination the patient experienced mild pain at injection site and fatigue which required naproxen. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189287:same patient, 1st dose
Coughing up phlegm; constantly trying to clear throat; congested nose; difficulty breathing; Neck is a little swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen). At the time of the report, PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen) outcome was unknown.        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.   No treatment information was provided by the reporter.
pt devel a red, swollen area 5x5 cm & two small vesicles @ the inject site; also had fever, chills & a swollen lymph node; devel under the arm; @ the time of this report pt is improving;
The immunization sight was itching and warm. Thick red circle around the area Red and yellow blotches. Starting to swell and getting larger.
Information has been received from a registered nurse concerning a male child who was vaccinated PO with a first 2 ml dose ROTATEQ vaccine live (human-bovine) after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
The patient became flushed in the face and light headed immediately after receiving the vaccine.  She was given an ice pack to apply to her head.  15L O2 via non rebreather was applied for 5 minutes.  She began to feel much better.  The oxygen was removed.  She was given water.  She was monitored for an additional 30 minutes.  She was discharged home ambulatory.  No complications.
expired ACT-HIB was inadvertently given to a child with no reported adverse event; Initial information received on 13-Jul-2022 regarding an unsolicited valid non-serious case from a healthcare professional.  This case involves a 1-year-old male patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently given to a child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 13-Jul-2022, the patient received 0.5ml total dose of suspect HIB (PRP/T) VACCINE strength: standard (lot: UJ525AAB; Expiration Date: 11-Jul-2022), Drug Treatment Duration: not applicable, via intramuscular route in the right thigh for Immunization and on the same day expired HIB (PRP/T) VACCINE was inadvertently given to a child with no reported adverse event (expired product administered).  It was reported, the caller is wanting to know what to do.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Approx 10 minutes after meningococcal vaccine given, pt was waiting in line to check out, leaning against wall and suddenly fell to floor hitting chin on the counter top, pt unconscious for about 1 minutes; pt alert and oriented upon nurse arrival. Vital signs WNL. Rescue squad arrived and transported to hospital.
nurse administered Typhim to a 1 year old patient, no AE.; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 year old male patient who was vaccinated by nurse with 0.5 ml dose of vaccine typhoid vi polysaccharide vaccine [typhim vi] (lot number R1B73 and expiration date 20-Mar-2021) via intramuscular route in the left thigh On 06-Dec-2019.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (mmr vaccin).  It was an actual medication error case due to product administered to patient of inappropriate age.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme tiredness, sleepiness, some chills and a little achy.  All symptoms recovering after several hours of sleep.
Moderna arm--delayed allergic reaction in the injection site.  I also have two scars from smallpox vaccine at childhood nearby. The while area is swollen and itch.
Cellulitis.  Treating with Keflex.  Fever, abdominal pain, nausea/vomiting.
This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 21-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # N002204 with expiration date on 19-JAN-2019 (dose and route of administration were not reported). There was no adverse effect reported. The administered dose of the vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 2 hours and a previous excursion of 6 to 14 degrees Fahrenheit for 7 hours and 36 minutes. Data logger was involved in recording of the temperature excursions. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010464.
Started my period the day after getting the first dose, about 2-3 weeks earlier than it should've been
death; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 25-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient died due to a domino effect started by taking the flu shot. It was unknown if the reporter consented to follow up.; Reported Cause(s) of Death: Unknown cause of death
SOB, hard to breath, throat closing, tingling and itching in mouth and on lips.   Two days later ER visit with pneumonia.
ON 2/20, PT BEGAN HAVING ITCHY ARM AT INJECTION SITE AND A HEADACHE